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Wang, Aobo, and David C. Wheeler. "Catchment Area Analysis Using Bayesian Regression Modeling." Cancer Informatics 14s2 (January 2015): CIN.S17297. http://dx.doi.org/10.4137/cin.s17297.
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A catchment area (CA) is the geographic area and population from which a cancer center draws patients. Defining a CA allows a cancer center to describe its primary patient population and assess how well it meets the needs of cancer patients within the CA. A CA definition is required for cancer centers applying for National Cancer Institute (NCI)-designated cancer center status. In this research, we constructed both diagnosis and diagnosis/treatment CAs for the Massey Cancer Center (MCC) at Virginia Commonwealth University. We constructed diagnosis CAs for all cancers based on Virginia state cancer registry data and Bayesian hierarchical logistic regression models. We constructed a diagnosis/treatment CA using billing data from MCC and a Bayesian hierarchical Poisson regression model. To define CAs, we used exceedance probabilities for county random effects to assess unusual spatial clustering of patients diagnosed or treated at MCC after adjusting for important demographic covariates. We used the MCC CAs to compare patient characteristics inside and outside the CAs. Among cancer patients living within the MCC CA, patients diagnosed at MCC were more likely to be minority, female, uninsured, or on Medicaid.
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Loughran, Thomas P., Wendy Cohn, Gloribel Bonilla, and Roger T. Anderson. "Cancer Prevention from the Viewpoint of UVA Comprehensive Cancer Center." Cancer Prevention Research 15, no. 11 (2022): 715–20. http://dx.doi.org/10.1158/1940-6207.capr-22-0365.
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Abstract Prevention is a cornerstone of the guiding mission of the University of Virginia Comprehensive Cancer Center, which is “to reduce the burden of cancer for the patients of today, through skilled, integrated, and compassionate care and to eliminate the threat of cancer for the patients of tomorrow, through research and education in an environment that promotes diversity, equity, and inclusion.” We find it useful to conceptualize different opportunities for cancer prevention using NCI's Health Behaviors Research Branch's multilevel translational framework. The latter considers three intersecting continuums: cancer control—from prevention through survivorship; translation—from basic sciences to dissemination and implementation; and level of influence or impact—from genetics to policy. An advantage of this heuristic is that “prevention” is inherently defined as an inter-programmatic concept cutting across basic, clinical, and population science research rather than solely as a programmatic domain of Population Sciences. Through the UVA community outreach and engagement, we apply this multilevel framework to mitigate the social determinants of cancer risk and outcomes that drive cancer inequities in our catchment area. Below, we provide examples of our prevention research and translation along the model continuums and focus on equity.
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Arays, Ruta, Zeeshan Ahmad, Lorinda Howard, et al. "Review of Palliative 223Ra in Metastatic Castration-Resistant Prostate Cancer: Experience at West Virginia University Cancer Center." Journal of Nuclear Medicine Technology 49, no. 1 (2020): 70–74. http://dx.doi.org/10.2967/jnmt.120.254474.
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Alder, Laura, Harry Douglas Bear, and Mary Helen Hackney. "Racial disparities in utilization of gene expression testing in breast cancer patients at an academic medical center." Journal of Clinical Oncology 37, no. 27_suppl (2019): 142. http://dx.doi.org/10.1200/jco.2019.37.27_suppl.142.
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142 Background: Gene expression profiling of breast cancers, such as the OncotypeDx (ODX) test, PAM 50 and Mammaprint, can define the risk of distant recurrence and assist with decisions about adjuvant chemotherapy. A recent study of all breast cancer patients in Virginia found that only 11.7 % of Caucasian Americans (CA) and 5.1% of African Americans (AA) received genomic testing. Methods: We utilized the Virginia Commonwealth University Health System (VCUHS) Tumor Registry and billing data from 2010-2017 to identify all patients that met the following criteria per NCCN guidelines for genomic testing: early stage (stage I or II) breast cancer, estrogen and/or progesterone receptor positive and lymph node-negative breast cancer. We also obtained records from Genomic Health on ODX testing ordered through VCU Health. Additionally, ODX utilization was stratified by race. We then performed Chi Square analysis. Results: 1080 patients were eligible per NCCN Guidelines. Of these, 248 were eliminated due to having only radiation performed at VCU. 39 were eliminated because initial treatments were at outside hospitals. Of the remaining 793, 536 were CA, 232 AA, 9 Asian and 16 other. Among the patients for whom a genomic test was appropriate, the proportion who actually had such a test performed were: 83.4% for CA, 71.98% for AA, 55.56% for Asians, 81.25 % for Others and 79.7% overall. There was a significant difference between utilization in CAs and AAs (p < 0.001). Conclusions: Breast cancer patients at VCU Health are far more likely to receive gene expression profiling overall compared to the Commonwealth of VA as a whole. This may reflect more equitable and guideline-compliant care in an academic/safety net health system.
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Cobb, Dustin, Jacopo de Rossi, Lixia Liu, Erin An, and Daniel Lee. "127 CAR T cells targeting the integrin alpha v beta 3 exhibit robust anti-tumor responses against diffuse intrinsic pontine glioma and glioblastoma." Journal for ImmunoTherapy of Cancer 9, Suppl 2 (2021): A136. http://dx.doi.org/10.1136/jitc-2021-sitc2021.127.
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BackgroundDiffuse intrinsic pontine glioma (DIPG) and glioblastoma (GBM) are two highly aggressive and mostly incurable gliomas with little therapeutic advancements made in the past several decades. Despite immense initial success of chimeric antigen receptor (CAR) T cells for the treatment of leukemia and lymphoma, significant headway into the application of CAR T cells against solid tumors, including gliomas, is still forthcoming. The integrin complex alpha v beta 3 (avb3) is present on multiple and diverse solid tumor types and tumor vasculature with limited expression throughout most normal tissues, qualifying it as an appealing target for CAR T cell-mediated immunotherapy.MethodsPatient-derived diffuse intrinsic pontine glioma (DIPG) cells and glioblastoma (GBM) cell lines were evaluated by flow cytometry for surface expression of avb3. Second-generation CAR T cells expressing an anti-avb3 scFv were generated by retroviral transduction containing either a CD28 or 4-1BB co-stimulatory domain and CD3zeta. CAR T cells were evaluated by flow cytometry for CAR expression, memory phenotype distribution, and inhibitory receptor profile. DIPG and GBM cell lines were orthotopically implanted into NSG mice via stereotactic injection and monitored with bioluminescent imaging to evaluate avb3 CAR T cell-mediated anti-tumor responses.ResultsWe found that patient-derived DIPG cells and GBM cell lines express high levels of surface avb3 by flow cytometry, while avb3 is minimally expressed on normal tissues by RNA sequencing and protein microarray. Second-generation CAR T cells expressing an anti-avb3 single-chain variable fragment (scFv) were designed and generated by retroviral transduction containing either a CD28 or 4-1BB co-stimulatory domain and CD3zeta. avb3 CAR T cells demonstrated efficient, antigen-specific tumor cell killing in both cytotoxicity assays and in in vivo models of orthotopically and stereotactically implanted DIPG and GBM tumors into relevant locations in the brain of NSG mice. Tumor responses were rapid and robust with systemic CAR T cell proliferation and long-lived persistence associated with long-term survival.ConclusionsThese results highlight the potential of avb3 CAR T cells for immunotherapeutic treatment of deadly brain tumors with reduced risk of on-target, off-tumor mediated toxicity due to the restricted nature of avb3 expression in normal tissues.AcknowledgementsWe would like to acknowledge the following core facilities at the University of Virginia: The Research Histology Core, the Biorepository and Tissue Research Facility, and the Molecular Imaging Core which are supported by the University of Virginia School of Medicine and through the University of Virginia Cancer Center National Cancer Institute P30 Center Grant. We would also like to acknowledge the University of Virginia Center for Comparative Medicine for providing animal care and services.
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Khimani, Farhad, Brendan F. Curley, and Mohammed Almubarak. "Survey Of Patients Referred To a University Cancer Center For Benign Hematology: Quality Measures and Patient Understanding." Blood 122, no. 21 (2013): 2952. http://dx.doi.org/10.1182/blood.v122.21.2952.2952.
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Abstract Background Traditionally, benign blood disorders are being evaluated and managed by hematologists who are also trained in oncology. Many of these physicians have their clinics located in Cancer Centers. Based on our clinical observations, the term “Cancer Center” is misleading to many benign hematology patients and it may affect their perception of their disease and/or reason for referral. There are currently no studies investigating patient understanding of benign hematology, the impact of a referral to a cancer center on a patients' well being or their understanding of a referral- therefore we designed this survey to explore those issues. Methods At West Virginia University/Mary Babb Randolph Cancer Center we drafted a survey. This IRB approved, anonymous and voluntary survey included twenty-eight questions that abstracted patient data that included: age, gender, race, level of education, understanding of reason for referral, knowledge of basic training aspects of hematologists, and multiple questions on stress and the impact of emotional well-being of a referral to the cancer center. Multiple-choice questions were drafted with 4-6 answer choices with no option for unknown. Surveys were collected from exclusively new patient benign hematology visits from May 2013-July 2013. Patients were surveyed at outpatient appointments after a verbal consent was obtained prior to their first contact with a hematologist. Results A total of 55 patients consented and received the questionnaire. Of the 55 questionnaires, 4 were incomplete and thus were excluded. 41.2% (21) responders were males, 58.8% (30) were females, 76.4% (39) were >40 yrs, 98% (50) were Caucasian, and 56.8% (29) had at least some college education or above. 60.7% (31) of patients surveyed stated that they were surprised when they found that their appointment was at the Cancer Center and 39.2% (20) stated that they received no explanation as to why they were referred to the cancer center prior to the visit. 70.5% (36) of patients did not know what benign hematology was and only 54.9% (28) patients knew that cancer doctors are also frequently trained to see benign hematology patients. 49% (25) of patients stated that their primary care physician's office did not explain that their referral to the cancer center was for a benign hematologic problem. 45% (23) and 41.1% (21) of patients expressed an increase in their anxiety and stress levels, respectively, when they found out their referral was to a Cancer Center. 27.4% (14) of patients said they were afraid they might have cancer during the process of referral and 37.3% (19) actually thought that the reason for their referral to the Cancer Center was an evaluation for cancer. Only 11.7% (6) patients expressed that they would prefer to be referred at a benign hematology clinic that is not located in a Cancer Center. Conclusion Referral to Cancer Center for benign hematologic diseases appears to increase stress and anxiety of patients and patients may perceive that they are referred for evaluation of a cancer diagnosis. Careful explanation by the entire team including referring physicians, hematologists, and office staff as to the reason for evaluation of a benign hematologic disorder may decrease stress and increase understanding of this subset of patients. Disclosures: No relevant conflicts of interest to declare.
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Wiseman, Kara P., Lindsay Hauser, Connie Clark, et al. "An Evaluation of the Process and Quality Improvement Measures of the University of Virginia Cancer Center Tobacco Treatment Program." International Journal of Environmental Research and Public Health 17, no. 13 (2020): 4707. http://dx.doi.org/10.3390/ijerph17134707.
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Tobacco use after a cancer diagnosis can increase risk of disease recurrence, increase the likelihood of a second primary cancer, and negatively impact treatment efficacy. The implementation of system-wide comprehensive tobacco cessation in the oncology setting has historically been low, with over half of cancer clinicians reporting that they do not treat or provide a referral to cessation resources. This quality improvement study evaluated the procedures for assessing and documenting tobacco use among cancer survivors and referring current smokers to cessation resources at the University of Virginia Cancer Center. Process mapping revealed 20 gaps across two major domains: electronic health record (EHR), and personnel barriers. The top identified priority was inconsistent documentation of tobacco use status as it impacted several downstream gaps. Eleven of the 20 gaps were deemed a high priority, and all were addressed during the implementation of the resulting Tobacco Treatment Program. Prioritized gaps were addressed using a combination of provider training, modifications to clinical workflow, and EHR modifications. Since implementation of solutions, the number of unique survivors receiving cessation treatment has increased from 284 survivors receiving cessation support during Year 1 of the initiative to 487 in Year 3. The resulting Tobacco Treatment Program provides a systematic, personalized, and sustainable comprehensive cessation program that optimizes the multifaceted workflow of the Cancer Center and has the potential to reduce tobacco use in a population most in need of cessation support.
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Tossas, Katherine Y., Bianca D. Owens, Savannah Reitzel, et al. "The Chickahominy T.R.U.T.H. (Trust, Research, Understand, Teach, and Heal) Project—A Tribal Community–Academic Partnership for Understanding the Impact of Structural Factors on Perceived Cancer Risk in Rural Virginia." International Journal of Environmental Research and Public Health 21, no. 3 (2024): 262. http://dx.doi.org/10.3390/ijerph21030262.
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In 2022, the Virginia Chickahominy Indian Tribe partnered with Virginia Commonwealth University Massey Comprehensive Cancer Center to investigate concerns about a potential cancer cluster near a local landfill. While investigating cancer clusters is complex due to long latency and multifactorial causes, the community’s concerns about structural factors driving cancer risk warrant exploration. Thus, the Chickahominy T.R.U.T.H. (Trust, Research, Understand, Teach, and Heal) Project was created as a community–academic partnership to (1) identify structural factors and barriers associated with perceived cancer risk and care; (2) assess cancer knowledge, care access gaps, and perceived risks, including testing private and community water sources; (3) develop and deploy culturally tailored cancer education and resource navigation, including groundwater safety education, policies, and remediation. We will conduct 150 in-person interviews and water tests among residents within a four-mile radius of the landfill, and deploy 1000 structured questionnaires among Charles City County residents. In this paper, we provide an overview of the ongoing project design, development, and progress in support of the project’s objectives. This collaborative investigation aims to address cancer health disparities, enhance research and health policy advocacy, and honor the sacred knowledge of an underserved community, laying the groundwork for a long-term partnership to guide future research questions.
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Yu, Stephen Lee, Seth Holler, Sijin Wen, Xiaofei Wang, and Thomas F. Hogan. "Lutetium-177–PSMA-617 experience in Appalachian patients with advanced prostate cancer at West Virginia University Health Science Center." Journal of Clinical Oncology 42, no. 16_suppl (2024): e17045-e17045. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.e17045.
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e17045 Background: Lutetium Lu-177 vipivotide tetraxetan (Lu-177) allowed for improved biochemical and radiographic response rate with relatively low toxicity for metastatic castration-resistant prostate cancer (PC) after multiple lines of therapy. In the 2021 VISION study (DOI: 10.1056/NEJMoa2107322), Lu-177 was reported to have a median overall survival (OS) of 15.3 months in patients (pts) with advanced prostate cancer (PC). We reviewed the result with Lu-177 for the treatment of advanced PC at a rural tertiary academic center at West Virginia University Health Science Center (WVU-HSC). Methods: All PC pts receiving one or more doses of Lu-177 at WVU-HSC were retrospectively reviewed. Pts were followed until death or the last clinic visit. All pts were established patients at WVU-HSC for management of the advanced PC between July 2022 and February 2024. Data was tabulated with descriptive statistics and median survival was calculated from Kaplan-Meier method. Results: Over an eighteen months period 34 pts received 126 doses of Lu-177. 26 pts were referred from outside the WVU-HSC specifically for Lu-177. Demographics from data collection showed predominantly Caucasian pts (91% Caucasian). The time from the initial PC diagnosis to the first dose of Lu-177 was a median of 67 months (range: 10 months-367 months). The median age at the first dose of Lu-177 was 65 years (range: 45-80). 18 patients (53%) remain alive as of Feb 2024. 14 pts (41%) completed 6 cycles of Lu-177 and 11 pts (32%) remain alive. The Kaplan-Meier median OS for these 34 pts starting from the first cycle of Lu-177 was 10 months. Conclusions: A 2022 estimated cost for Lu-177 was $42,500 per dose (excludes administration) so “payors” may have been charged more than $5,000,000 for the Lu-177 for these patients. Lu-177 may be of more benefit earlier in the PC disease spectrum, or perhaps pre-treatment PSMA imaging can better target patients who will benefit from Lu-177. Our observed median OS of 10 months did not match the 15.3 reported in the VISION study (DOI: 10.1056/NEJMoa2107322). Further data evaluation and collection are warranted from different communities to investigate the differences observed in the survival data reported in the literature and observed in the clinic setting. [Table: see text]
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Ali, Shamsher, Mark W. Knestrick, Lori Aciavatti, Sijin Wen, and Nilay Arvind Shah. "A survey on social media use and expectations in cancer patients." Journal of Clinical Oncology 35, no. 15_suppl (2017): e18183-e18183. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e18183.
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e18183 Background: Social media encompasses a wide variety of web based and mobile technologies. It has become increasingly popular, allowing for rapid communication and dissemination of information. Many believe that social media can be used as a platform for patient education and knowledge sharing. This survey intended to assess patient use of social media and patient expectations for its role at our cancer center. Methods: The study took place at West Virginia University (WVU) Hospital/Mary Babb Randolph Cancer Center, a tertiary care center. This IRB-approved, anonymous, and voluntary survey included twenty-five questions that abstracted patient data which included: age, gender, cancer type, level of education, internet use, information sources for given cancer, use of social media, and the use of WVU cancer website and social media. The survey was distributed by nursing staff to patients who were at least 18 years of age Results: 370 surveys were collected in total. 87.6 % of patients reported using social media, with Facebook as the most commonly used platform at 85.6 %. 70% reported to view or update social media sites daily. All patients reported at least monthly internet use with 61.1 % of patients reported using the internet daily. 32.7% of patients interact with WVU Cancer Centeron social media daily. When asked how patients search for background information or reviews about their provider, 57.8% of patients reported they used our institution’s website. 55.7% of patients believe it would beneficial to contact their cancer provider through social media. Only 22% of patients reported they use social media for medical information. Conclusions: With the increasing use of social media for medical information over the past several years, it is crucial for academic centers and providers to keep up with the growing demand to provide accurate and practical information for patients. Our data suggests our patient population would like to see an increased use of social media from the cancer center and its providers. The information can be used to update our cancer website and social media sites to provide patient-centered cancer information in hopes that patients will have one reliable source for all of their disease related questions and concerns.
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Noorbakhsh, Seth, Zachary A. Koenig, Noah Hewitt, et al. "Atypical Hyperplasia Found Incidentally during Routine Breast Reduction Mammoplasty: Incidence and Management." Plastic and Reconstructive Surgery - Global Open 10, no. 2 (2022): e4141. http://dx.doi.org/10.1097/gox.0000000000004141.
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Background: Atypical ductal hyperplasia (ADH) and atypical lobular hyperplasia (ALH) of the breast are premalignant lesions. Although the literature on ADH and ALH as a whole is well-developed, research on ADH and ALH incidentally discovered during breast reduction is less robust. Methods: In this study, 355 patients undergoing bilateral reduction mammoplasty at West Virginia University were retrospectively reviewed. A variety of demographic and clinicopathologic variables were collected for each patient, and the incidence of atypical hyperplasia was calculated. Four patients (1.13%) were found to have atypical hyperplasia, three ALH, and one ADH, which is within the range reported in the literature. For patients incidentally found to have atypical hyperplasia, an in-depth analysis of postoperative management was performed. Results: Of the four patients with atypical hyperplasia, three were referred to a cancer center, and one patient followed only with plastic surgery. The three patients who were referred to a cancer center saw a breast surgeon, whereas the patient followed only by plastic surgery did not. None of the four patients received anti-estrogen therapy, but each patient who followed with a cancer center was offered treatment and declined. Conclusions: As a relatively uncommon finding with complex management guidelines, atypical hyperplasia discovered on breast reduction should be referred to a cancer center for long-term follow-up and management when possible. Further research is needed to assess if the management of atypical hyperplasia discovered incidentally after routine reduction should mimic treatment of atypical hyperplasia found after biopsy for suspicion of malignancy.
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Curley, Brendan F., Farhad Khimani, and Alvin Howard Moss. "Physician orders for scope of treatment (POST) forms in metastatic cancer patients: A 3-year single-university–institution retrospective review." Journal of Clinical Oncology 31, no. 31_suppl (2013): 133. http://dx.doi.org/10.1200/jco.2013.31.31_suppl.133.
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133 Background: Physician orders for dcope of treatment (POST) forms are standardized forms for patient preferences for end-of-life care. These forms contain orders by a physician who has identified a patient who is seriously ill with life-limiting progressive, advanced illness. Utilization of the POST form in advanced and metastatic cancer patients has not yet been evaluated. Methods: At West Virginia University/Mary Babb Randolph Cancer Center, we performed an IRB approved retrospective chart review of all patients who died of metastatic or advanced malignancies from 2010-2012. Statistical analysis was performed with SPSS Version 20. Results: 139 patients were identified who were diagnosed with metastatic cancer and treated at West Virginia University who died from 2010-2012. Of those 139 patients, 26 (18.7%) completed POST forms. 51 (36.7%) patients received systemic oncologic treatment in their last thirty days of life. In the last ninety days of life, patients averaged 16.2 days hospitalized. 123 (88.4%) patients had at least one hospital stay in their last three months of life, with 82 (58.7%) having two or more stays. 65 (46.8%) patients had a hospital readmission within thirty days. 39 (28.1%) patients had an ICU stay with an average duration of 2.6 days. Almost half of all patients reviewed (67, 48.2%) died in the hospital. Patients averaged 2.9 CT scans and 5.2 X-rays over the last ninety days of their life. 116 (83.5%) patients had an end-of-life discussion, with an average time from discussion to date of death of 24.5 days. Only 60 (43.2%) were identified as having a palliative care consult completed. Conclusions: The American Society of Clinical Oncology (ASCO) recommends implementation of Palliative Care at the time of diagnosis of advanced cancer. POST forms appear to have a positive impact on end-of-life care in this population of advanced cancer patients. Increasing their implementation in metastatic oncology patients will likely improve end-of-life care. [Table: see text]
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Bell, Ronny A., Tomi Akinyemiju, and Stephanie B. Wheeler. "Abstract C112: Understanding and addressing cancer disparities among American Indians in North Carolina: The Southeastern cancer health equity partnership." Cancer Epidemiology, Biomarkers & Prevention 32, no. 1_Supplement (2023): C112. http://dx.doi.org/10.1158/1538-7755.disp22-c112.
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Abstract North Carolina (NC) is home to the largest American Indian population in the Eastern United States (approximately 300,000 residents, about 2.8% of the total NC population), represented by eight state and federally recognized tribes (Eastern Band of Cherokee Indians, Sappony, Occaneechi Band of Saponi Nation, Meherrin, Haliwa Saponi, Coharie, Lumbee, Waccamaw Siouan) and four urban Indian organizations (Metrolina Native American Association, Guilford Native American Association, Triangle Native American Society, Cumberland County Association for Indian People). This population experiences significant health disparities largely related to adverse social determinants of health and limited access to health care. With regards to cancer, disparities exist for incidence and mortality for certain cancer, although there are limited data available with regards to cancer screening stage at diagnosis, treatment and survivorship. Furthermore, evidence suggests that racial misclassification contributes to a significant underestimation of the true cancer incidence and mortality in this population. To address the cancer care needs of NC American Indians, a unique collaboration was established in 2021 among the leadership of the Community Outreach and Engagement programs at the three NCI-designated Comprehensive Cancer Centers in North Carolina (Duke Cancer Institute, University of North Carolina Lineberger Cancer Center, Wake Forest Baptist Comprehensive Cancer Center). The collaboration, entitled, The Southeastern American Indian Cancer Health Equity Partnership (SAICEP), has as its mission to "understand and address the cancer-related health needs of American Indian communities in our catchment areas and beyond." SAICEP includes: (1) a quarterly speakers' series, featuring nationally recognized experts in the area of American Indian cancer research and care; (2) educational outreach and engagement activities at tribal and state cultural events; and, (3) cutting-edge culturally respectful research to understand and address cancer disparities at the tribal and state level. Partnerships have been established with tribal leaders across the state as well as researchers at the University of North Carolina at Pembroke in the traditional homeland of the Lumbee tribe (the largest tribe in the state). Future endeavors will include partnerships with tribes in other states in our catchment areas (Virginia, South Carolina). Citation Format: Ronny A. Bell, Tomi Akinyemiju, Stephanie B. Wheeler. Understanding and addressing cancer disparities among American Indians in North Carolina: The Southeastern cancer health equity partnership [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr C112.
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Curley, Brendan F., Quoc Van Truong, Anjaly Belur Curley, Mark Culp, Yanqing Hu, and Mohammed Almubarak. "Patient understanding and impression of hematology/oncology fellows." Journal of Clinical Oncology 30, no. 34_suppl (2012): 9. http://dx.doi.org/10.1200/jco.2012.30.34_suppl.9.
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9 Background: Hematologists/oncologists spend years training in a fellowship program. At academic centers, patients receiving treatment are often seen by fellows. It has not been established what patients understand about fellowship training, therefore our purpose was to explore their understanding and if they are content with fellows taking part in their care. Methods: At West Virginia University/Mary Babb Randolph Cancer Center we drafted a survey. This anonymous and voluntary survey abstracted patient data that included: age, sex, race, level of education, type of cancer diagnosis, amount of time being treated for cancer, experience being cared for by fellows and basic knowledge of a hematology/oncology fellowship. Multiple-choice questions were drafted with 4 to 6 answer choices with no option for unknown. Surveys were collected over a three-week period from July 3, 2012 through July 24, 2012. Patients were surveyed at outpatient appointments, infusion center visits, and laboratory draws. Results: 226 surveys were collected. Statistical analysis was performed and a binomial regression was fit to the data. There is evidence that higher levels of education are more likely to give correct answers (p value 0.035). Patients who stated they had not seen a fellow or were unsure they had seen a fellow were more likely to select incorrect answers (p value 0.001). There is no statistical significance differentiating between cancer types in likelihood of getting answers correct (Table). 1.77% of those surveyed felt they completely understand the role of a fellow in their care, while 84.51% desired further information about fellows. Only 2.21% disliked having a fellow involved in their care. Conclusions: Patients at academic centers being seen by hematology/oncology fellows appear to have a lack of knowledge of a fellow’s role and background but have a desire to be educated. Educational initiatives can be introduced to teaching institutions to help patients better understand the role of a fellow. [Table: see text]
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De Magalhaes Filho, C. Daniel, Chung-Wein Lee, Nikolai Suslov, Jerry Fong, and Miguel Garcia-Guzman. "622 PD-L1 is a potential predictive biomarker for response to RM-1929 treatment in recurrent head and neck squamous cell carcinoma patients." Journal for ImmunoTherapy of Cancer 8, Suppl 3 (2020): A658. http://dx.doi.org/10.1136/jitc-2020-sitc2020.0622.
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BackgroundRM-1929 is an antibody-dye conjugate comprised of cetuximab covalently linked to the photoactivable dye, IRDye® 700DX (IR700). After systemic infusion of RM-1929, illumination of the tumor with 690 nm non-thermal red light activates the drug and results in targeted and rapid tumor necrosis. Previous preclinical data have shown that RM-1929 treatment triggers immunogenic cell death and activates the innate and adaptive immune response. A retrospective analysis of PD-L1 expression from the phase I/IIa clinical trial in patients with recurrent head and neck squamous cell carcinoma (rHNSCC) (NCT02422979) was conducted. The analysis explored correlations of PD-L1 expression, including combined proportion score (CPS) and tumor proportion score (TPS), with clinical outcomes such as response rate and overall survival.MethodsPD-L1 expression prior to RM-1929 treatment was assessed by immunohistochemistry in 18 out of 30 patients enrolled in Part II of the trial, based on sample availability. PD-L1 expression was evaluated using TPS and CPS. Responders were defined as patients that achieved complete response or partial response, and non-responders had either stable disease or progressive disease. Overall survival (OS) was analyzed using the Kaplan-Meier method.ResultsResponders (n=10) had a TPS of 4.3±2.4 (mean±SEM), which was substantially lower than in non-responders (n=8) with a TPS of 39.4±11.8. Similarly, CPS was lower in responders (8.6±3.6) compared to non-responders (50.0±13.5). The best target response rate for all patients included in this analysis was 56%. Patients with CPS=40 had a response rate of 76.9% (n=13) compared to 0% in patients with CPS>40 (n=5). This suggests that a CPS cut-off of =40 led to enrichment of the best target response rate. The median OS of patients with CPS=40 (13.0±0.8 months) was also higher than in patients with CPS>40 (3.1±0.8 months) and in all patients (12.0±2.9 months).ConclusionsThese results suggest that rHNSCC patients with lower PD-L1 expression levels may be more responsive to RM-1929 treatment and CPS/TPS could potentially be predictive biomarkers in identifying patients with a higher probability of benefiting from this treatment. Given the limited number of patients in this analysis, additional clinical trials will be needed to validate PD-L1 expression as an effective predictive biomarker for RM-1929 treatment.AcknowledgementsThe authors would like to thank all patients and their families for their participation in this trial. The authors would also like to thank the following investigators for the contribution of samples included in this trial analysis: Dr. David Cognetti (Thomas Jefferson University Hospital), Dr. Ann M Gillenwater (University of Texas MD Anderson Cancer Center), Dr. Mary Jo Fidler (Rush University Medical Center), Dr. Samith T. Kochuparambil (Virginia Piper Cancer Institute ), Dr. John Campana (University of Colorado Head and Neck Specialists), and Dr. Nilesh R. Vasan (University of Oklahoma Health Sciences Center).Trial RegistrationNCT02422979Ethics ApprovalThe trial was approved by the following Instution Ethics Boards and IRB# as listed: UCSF Institutional Review Board (#17-21904), Thomas Jefferson University, IRB (#16C.328), University of Oklahoma Health Sciences Center Institutional Review Board (#5723), University of Texas MD Anderson Cancer Center - Institutional Review Board (#IRB 2 IRB00002203), Quorum Review IRB (#30458/1), Rush University Medical Center Institutional Review Board (#15030601-IRB01), and Catholic Health Initiatives Institute for Research and Innovation (CIRI) Institutional Review Board (CHIRB) (# IRB00009715).ConsentN/A
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Bower, Kathryn, Sijin Wen, Aaron Cumpston, and Nilay Arvind Shah. "Survival outcomes in patients with good risk acute myeloid leukemia: A single-center retrospective review." Journal of Clinical Oncology 37, no. 15_suppl (2019): e18519-e18519. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e18519.
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e18519 Background: Cytogenetics and gene mutations play a significant role in determining necessity of allogeneic transplant in patients with AML. Core binding cytogenetic factors (CBF) such as t(8;21), inv 16, and t(16;16) as well as molecular mutations in nucleophosmin-1 (NPM1) and bi-allelic CCAAT/enhancer binding protein alpha (CEBPA) mutations in cytogenetically normal patients have conferred improved relapse-free survival (RFS) and overall survival (OS) rates. We report outcomes of these “good-risk” patients in an Appalachian population, to evaluate differences from previous reports. Methods: A total of 79 patients with AML diagnosed between July 2007 and July 2017 at West Virginia University (WVU) who qualified for good-risk disease per ELN 2017 criteria were retrospectively analyzed for RFS and OS. Eighteen of these patients were excluded from our final analysis: 10 for primary refractory disease and 8 for proceeding to transplant in first remission. Results: A total of 61 patients were included in our analysis, with a median age of 56 (range 11-81), 32 females, and 29 males. Good-risk features included 29 patients with NPM1, no patients with CEBPA, 19 with inv 16, 9 with t(8;21), and 1 with t(16;16). All patients received cytarabine and an anthracycline induction chemotherapy, and a median of 4 cycles (range 1 -4) of high-dose cytarabine consolidation chemotherapy. The RFS and OS at 4 years was 36% and 50%, respectively. There were no occurrences of treatment-related mortality among the patients. Among the 22 patients relapsing, 12 (55%) were able to achieve a second remission and received allogeneic transplant. Conclusions: Our outcomes appear somewhat lower than previous reports, but continuing to highlight the ability to achieve long-term remissions in this subset of patients, without the need for allogeneic transplant. Continued efforts should focus on improving outcomes in these patients, to further prevent relapses.
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Boyd, David, and Chuck Harrell. "Abstract P1-13-04: Potentiating Alpelisib in PI3K Pathway Overactive Triple Negative Breast Cancers." Cancer Research 83, no. 5_Supplement (2023): P1–13–04—P1–13–04. http://dx.doi.org/10.1158/1538-7445.sabcs22-p1-13-04.
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Abstract Potentiating Alpelisib in PI3K Pathway Overactive Triple Negative Breast Cancers David C. Boyd1,2, Amy L. Olex3, Tess Leftwich1, Nicole Hairr1, Alex K. Duong1, Narmeen S. Rashid1,3, Mohammad A Alzubi1,2, Holly Byers1, Aaron D. Valentine1, Julia E. Altman1, Emily Zboril1, Jacqueline M. Grible1, Madelyn Esquivel1, Scott A. Turner1, Andrea Ferreira-Gonzalez1, Mikhail G. Dozmorov5, J. Chuck Harrell1,2,6 1Department of Pathology, Virginia Commonwealth University; 2Integrative Life Sciences Program, VCU; 3Wright Center for Clinical and Translational Research, VCU; 4Department of Biology, University of Richmond; 5Department of Biostatistics, VCU; 6Massey Cancer Center, VCU. There is an urgent need for new therapeutic options for basal-like Triple Negative Breast Cancers (TNBC). To mirror the NCI-ComboMATCH study, and identify new synergistic drug combinations, we analyzed a set of 20 breast cancer patient-derived xenografts and 14 cell lines to identify targetable targets in each model. The Oncomine Comprehensive Assay v3 was performed to assess 161 genes for hotspot mutations, focal copy number variants, amplification/deletions, and RNA-fusion genes. Next, each PDX and their isogenic drug-resistant sublines were analyzed with bulk RNA-sequencing (217 samples) and cell single-cell RNA-sequencing (~100,000 cells). Of all NCI-MATCH defined targetable mutations, 37% of the models contained pathogenic PIK3CA amplifications or mutations. PIK3CA is one of the most common oncogenic aberrations identified in patients and the PI3K pathway is overactive in the majority of TNBCs, therefore we sought to target it across all models and identify the most efficacious synergistic drug partner. Short-term cultures of each PDX model were screened with a library of &gt;1,000 FDA-approved/experimental drugs to identify compounds that were cytotoxic. Synergistic drug screens were then performed with each drug in combination with the PI3K inhibitor byl-719 (alpelisib) a current standard-of-care drug used for PI3K mutant ER+ disease. Synergism was identified using coefficient of drug interaction (CDI) calculations and 10 drugs were identified as synergistic across several models. Using several criteria, including clinical status and pathway analysis, 3 drugs were selected for CompuSyn-based synergism testing and each was confirmed to be synergistic in vitro. Testing with in vivo models of each drug combination has thus far confirmed that each is synergistic per CDI metrics. Those combinations are currently being tested for efficacy in the metastatic setting with a set of basal-like PDXs. Citation Format: David Boyd, Chuck Harrell. Potentiating Alpelisib in PI3K Pathway Overactive Triple Negative Breast Cancers [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-13-04.
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Shaw, Andrew Cota, Hanna Kelly Sanoff, and Mark E. Smolkin. "Effect on patient care of repeat pathologic review for breast cancer." Journal of Clinical Oncology 31, no. 15_suppl (2013): 6599. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.6599.
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6599 Background: Many cancer centers routinely re-review outside pathologic specimens. We hypothesized re-review rarely changes patient treatment plans. Methods: Of 1495 patients seen at the University of Virginia with a diagnosis of breast cancer from 2006-2011, the 276 cases with both internal and outside pathology reports comprised the study cohort. Interobserver agreement (kappa coefficient, K) between internal and outside diagnoses were calculated for histopathology, lymph node, margin, ER/PR, and HER2 status. We then evaluated if the change would result in a change in therapy or surveillance per the National Comprehensive Cancer Network (NCCN) guidelines. The effect of region and teaching affiliation of outside institutions was explored. Results: For the 276 cases with re-reviewed pathology at UVA there was absolute agreement for ER/PR and surgical margins, and excellent agreement for lymph node, K= 0.93, and histopathology, K=0.93. Agreement was good for HER2, K=0.83. 3 cases were changed from HER2 positive to negative (2) or intermediate (1). Of 9 changes in histopathology, 2 had a major upgrade: 1 ADH to DCIS; 1 DCIS to carcinoma. 3 had a major downgrade: 2 from DCIS to ADH; 1 from carcinoma to DCIS. 2 cases changed from ALH to LCIS. Lymph node status was changed from positive to negative in one out of 31 reviewed cases. Treatment plan would have changed for all 13, 4.7% of all patients. Changes were made almost exclusively (11/13) if referred from a hospital with no or minor teaching affiliation, including all major histopathology changes and changes in lymph node and HER2 status. Conclusions: Interobserver agreement for breast pathology between pathologists at an NCI designated cancer center and outside institutions was good. However, 4.7% of women had discordant results that would lead to a change in their care. Changes were most common for noninvasive carcinoma and benign atypia. In order to best utilize resources, referral centers may want to consider limiting re-review to the pathology from centers with high risk for discordance.
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Farrell, N. J., C. J. Bradley, and L. M. Schickle. "Breast cancer diagnosis and treatment in a safety net setting: Differences between insured and uninsured patients." Journal of Clinical Oncology 25, no. 18_suppl (2007): 6566. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.6566.
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6566 Background: Despite the safety net system and many other means of providing free or low cost care to women with breast cancer, disparities in health outcomes between uninsured and insured women with breast cancer exist. In this study, we evaluate the role of health insurance on breast cancer treatments at a large safety net hospital system. Methods: From the patient population at the Massey Cancer Center at Virginia Commonwealth University Health Care System (a large regional safety net provider), we selected women ages 21 to 64 diagnosed with breast cancer between January 1999 and March 2006 (n=1,381). We used billing records to identify health insurance status of these patients. First, we compared the stage of disease and tumor size at diagnosis for women with and without insurance. Next, we compared the number of days between diagnosis and surgery and the number of days between surgery and chemotherapy initiation. Finally, we estimated the number of days it took these groups of women to complete a common adjuvant chemotherapy regimen of doxorubicin plus cyclophosphamide (AC) or doxorubicin plus cyclophosphamide followed by paclitaxel (ACT). Results: Our analysis shows that women without insurance were more likely to have more advanced cancers and correspondingly larger tumors. Uninsured women experienced considerable delays from the date of diagnosis to surgery and from surgery to chemotherapy initiation compared with insured women (21.5 and 22 days longer, respectively). Uninsured women also took significantly longer to complete adjuvant chemotherapy regimens relative to insured women (4 and 26 days for AC and ACT, respectively). Conclusions: To understand the disparities that exist in breast cancer outcomes among women with and without health insurance, we must understand the different experiences these groups of women have with treatment. In this study, uninsured women had more advanced cancers, and experienced considerable delays receiving and completing treatment relative to insured women. Our study demonstrates the value of health insurance in the timely provision of health care even in a safety net setting where care is guaranteed. No significant financial relationships to disclose.
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Moss, A. H., J. R. Lunney, S. Culp, et al. "Prognostic significance of the “surprise” question in cancer patients." Journal of Clinical Oncology 27, no. 15_suppl (2009): 9588. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.9588.
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9588 Background: In patients with advanced cancer, failure to accurately estimate and communicate prognoses can lead to overly aggressive care at the end of life with less attention to important palliative care issues such as pain and symptom management and patients’ values and goals for care. The “surprise” question—would I be surprised if this patient died in the next year?—has been recognized as an innovation to improve end-of-life care in the primary care population by identifying patients with a poor prognosis who are appropriate for palliative care. It has not been previously tested in cancer patients. The purposes of this study were to determine the feasibility and outcomes of the use of the “surprise” question in a cancer center population. Methods: Between July and November 2007, oncologists prospectively classified consecutive breast, lung, and colon cancer patients being seen at the Mary Babb Randolph Cancer Center of West Virginia University into “Yes” and “No” groups based on the surprise question. Patients were followed and their status at the end of one year-alive or dead-was determined along with patient demographics, type of cancer, and stage at presentation. A multivariate Cox proportional hazards regression analysis was used to identify variables associated with patient death. Results: Oncologists classified 826 of 853 prospective patients (97%), with 131 (16%) classified into the “No” group and 695 (84%) into the “Yes” group. At the end of the year, 71 patients had died; 41% of the “No” patients compared to 3% of the “Yes” patients (P <.001). The surprise question ‘No‘ response was more predictive of patient death than stage of cancer, cancer type, or age (hazard ratio 7.53, P value <.001). The “Yes” patients lived longer than the “No” patients (359.8±32.8 days versus 270±131.5 days, P <.001). The sensitivity of the surprise question “No” response was 75% and the specificity was 90%. Conclusions: We conclude that the surprise question is a simple, feasible, and effective tool to identify cancer patients with the worst prognoses who should receive the highest priority for palliative care interventions, particularly advance care planning. No significant financial relationships to disclose.
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Coleman, DeJuana, Martha Thomas, Tri Minh Le, Paul Raymond Kunk, and Matthew Reilley. "Germline screening rates and patterns for patients with pancreatic cancer at an academic medical center." Journal of Clinical Oncology 40, no. 16_suppl (2022): 10590. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.10590.
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10590 Background: Current National Comprehensive Cancer Network guidelines recommend germline genetic testing for all pancreatic cancer patients irrespective of family history. Germline testing provides insight on inherited pathogenic variants that may influence care. Approximately 10% of pancreatic adenocarcinoma (PDAC) patients have pathogenic mutations which may have treatment implications and warrant the introduction of targeted therapy approaches. Patients with germline BRCA1/2 or PALB2 mutations have increased sensitivity to platinum chemotherapy and PARP-inhibitor therapies. Germline testing results may have important implications for patients’ family members for earlier targeted screening. A better understanding of the current state of testing is needed to develop systems to improve screening rates. We conducted a retrospective review of clinical practice patterns at an academic cancer center to assess the current uptake. Methods: Patients with pancreatic adenocarcinoma seen at the University of Virginia Health System within the 2021 calendar year were identified. Retrospective review of genetic counseling referral and germline genomic screening for individual patients was performed. Results: 210 patients with pancreatic adenocarcinoma were identified. 39 (19%) PDAC patients had a referral to genetic counseling placed in the electronic medical record and 44 (21%) completed germline screening. Of the patients referred to genetics, 17/39 patients (44%) met with a genetic counselor which led to germline screening, 3/39 (8%) patients were referred and saw genetics after receiving germline testing results. Among patients who completed germline screening, 27/44 (61%) had testing initially ordered by their oncologist with referral to genetic counseling based on testing results 3/27 (11%). Conclusions: Despite guideline recommendations, germline testing rates are low among this PDAC population. Genetic counselors are essential members of a multidisciplinary team and guide patient discussions and decision making with regards to germline testing. Typical practice has involved referral to meet with a genetics counselor prior to testing; however many patients elect not to schedule a visit and consequently do not obtain germline screening. Barriers may include costs associated with genetic counseling/testing, time constraints, and patient understanding of the relevance of testing for their cancer care. We observed that offering germline testing to PDAC patients with referral to genetic counseling based on results and patient preference is a viable practice pattern. Upfront clinician driven germline testing may offer an opportunity to improve access to germline screening. Prospective clinical trials are needed to increase rates of germline testing and genetic counseling for PDAC patients.
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Venkata, Prabhakar Pitta, Arhan D. Rao, Santosh Timilsina, et al. "Abstract P3-07-19: Anti-depressant Amitriptyline Augments the Efficacy of Tamoxifen in ER positive breast cancer." Cancer Research 83, no. 5_Supplement (2023): P3–07–19—P3–07–19. http://dx.doi.org/10.1158/1538-7445.sabcs22-p3-07-19.
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Abstract Anti-depressant Amitriptyline Augments the Efficacy of Tamoxifen in ER positive breast cancer Pitta Venkata Prabhakar1, Arhan D Rao1, Timilsina Santosh1, Deepika Singh1, Ratna Vadlamudi1,2, Virginia Kaklamani3, Manjeet Rao1,2. 1Greehey Children’s Cancer Research Institute, University of Texas Health San Antonio, San Antonio, TX, USA. 2Mays Cancer Center, University of Texas Health San Antonio, San Antonio, TX, USA. 3Department of Medicine, UT Health, San Antonio, USA. Background: Breast cancer (BC) is the most common cancer in women and the leading cause of cancer-related deaths in women worldwide, with 1 out of 8 women being diagnosed with invasive breast cancer during their lifetime. The majority of breast cancer patients (80%) are diagnosed with Estrogen Receptor positive (ER+) breast cancer. The most commonly used treatment option for ER+ Breast cancer is endocrine therapy, such as Tamoxifen(TAM). Although survival of breast cancer patients has dramatically improved with the use of endocrine therapy, acquired resistance and debilitating side effects of treatment became major concerns. Therefore, safer treatment options that effectively suppress cancer progression, reduce treatment associated side effects, and improve efficacy of standard of care therapies are much needed. Repurposing of clinically approved or investigational drugs has become promising alternative approach for treating cancer. Therefore, we tested the repurposing potential of anti-depressant Amitriptyline for the treatment of ER+ breast cancer. Methods: The anti-cancer effect of Amitriptyline was determined in vitro using short and long-term viability, migration, and apoptosis assays. To substantiate the in vitro data, the effect of Amitriptyline on tumor growth was assessed using orthotopic xenograft model. RNA-seq analysis was performed in Vehicle and Amitriptyline treated breast cancer cells to understand the mechanism of action. Finally, to test whether amitriptyline can sensitize ER+ breast cancer cells to endocrine therapy, we performed cell viability assays after treatment with Amitriptyline and Tamoxifen. Results: Amitriptyline treatment resulted in significant reduction of short term and long term viability, as well as, migration of ER+ BC cells. Furthermore, Amitriptyline treatment significantly increased apoptosis in BC cells. Our RNA-seq analysis revealed that Amitriptyline treatment inhibited important genes involved in cancer growth and survival including E2F signaling, G2/M pathway, and DNA repair pathways. Confirming our in vitro findings, Amitriptyline treatment blocked the growth of ER+ BC growth in pre-clinical orthotopic xenograft model of breast cancer. Importantly, Amitriptyline treatment sensitized ER+ BC to TAM, showing highly synergistic effects. Amitriptyline treatment significantly improved the effects of TAM on cell viability, survival, migration, and apoptosis. Furthermore, Amitriptyline augmented the efficacy of Tamoxifen in TAM resistant BC cells. Conclusion: Our study establishes potential of Amitriptyline as a repurposable drug as safe and robust treatment option for ER+ patients, either as a monotherapy or in combination. We are poised to begin a clinical trial and test the therapeutic efficacy of Amitriptyline for treating breast cancer patients. Citation Format: Prabhakar Pitta Venkata, Arhan D. Rao, Santosh Timilsina, Deepika Singh, Ratna K. Vadlamudi, Virginia Kaklamani, Manjeet K. Rao. Anti-depressant Amitriptyline Augments the Efficacy of Tamoxifen in ER positive breast cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-07-19.
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Hasan, Faten, Erin Kennedy, Kristin Guertin, et al. "Diet Quality and Inflammatory Index Score Among Women's Cancer Survivors." Current Developments in Nutrition 5, Supplement_2 (2021): 976. http://dx.doi.org/10.1093/cdn/nzab051_020.
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Abstract Objectives In 2018, women's cancers accounted for 38.6% of new cases and 26.9% of cancer deaths in females worldwide. The risk of recurrence is partially attributed to lifestyle factors linked to inflammation, including diet quality. Adherence to U.S Department of Agriculture Dietary Guidelines, measured with the Healthy Eating Index (HEI-2015), and consuming an anti-inflammatory diet, measured with the Energy-adjusted Dietary Inflammatory Index (E-DII), are found to improve quality of life and reduce recurrence risk. The purpose of this study was to investigate HEI-2015 and E-DII scores in women's cancer survivors. Methods Survivors of women's cancers (N = 52, 65 ± 12 yrs) were recruited to complete a demographic questionnaire and three 24-hour dietary recalls using the Nutrient Data System for Research (NDSR). HEI-2015 and E-DII scores were calculated from average intakes. Linear regression analysis was used to examine the association between demographic factors (age, BMI, education, rurality, income, financial security, years since active treatment, and weight goals) and HEI-2015 and E-DII scores. Pearson Correlation was used to examine correlation between the two. Results On average, HEI-2015 score was 55 ± 13.5 (29.7–84.6), lower than the national average, and E-DII score was -1.14 ± 2.24 (−5.66–3.22). 54% of women had anti- inflammatory (&lt;−1), 17% had pro-inflammatory (&gt;1), and 29% women had relatively neutral (−1 to 1) diets. Women with a graduate degree (P = 0.03) and who completed treatment more than 4 years prior (P = 0.01) had higher HEI-2015 scores. There were no associations between SES and E-DII scores. Most notably, higher diet quality was associated with more anti-inflammatory diets (r = −0.67, P &lt; 0.001). Conclusions While diet quality of women cancer survivors is comparatively low, the association with its inflammatory potential is a promising avenue for preventing recurrence. Higher E-DII scores are correlated with increased inflammatory markers, cardiovascular disease and metabolic syndrome risk, greater risk ratio and 75% increased mortality for several cancers. Guidelines for reducing inflammation will allow Registered Dietitians to provide specific, evidence-based oncology nutrition services, such as education, counseling, and medical nutrition therapy (MNT). Funding Sources This was funded by the University of Virginia Cancer Center.
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Ali, Soham, Kathryn Fortune, Jack Masur, et al. "Effect of dipeptidyl protease 4 (DPP4) inhibitors on progression-free survival in patients with metastatic renal cell carcinoma: A single-center retrospective analysis." Journal of Clinical Oncology 42, no. 4_suppl (2024): 426. http://dx.doi.org/10.1200/jco.2024.42.4_suppl.426.
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426 Background: Dipeptidyl peptidase IV (DPP4) is a cell surface receptor with exopeptidase activity that is expressed on most cell types, and possesses numerous substrates including growth factors, chemokines, and vasoactive peptides. These effects have implicated DPP4 in tumor growth and metastasis. Prior SEER-Medicare and retrospective studies have suggested an association between DPP4 inhibition and increases in both progression-free survival (PFS) and overall survival (OS) in patients with colorectal and lung cancers. Similar studies have shown no associated OS benefit from DPP4 inhibition in breast or pancreatic cancers, and increased OS but not PFS in prostate cancer. However, no studies to date have explored the impact of DPP4 inhibitors (DPP4i) in renal cell carcinoma (RCC). Thus, in this study we present a first-time analysis examining the impact of DPP4i use on PFS in patients with metastatic RCC and type 2 diabetes mellitus. Methods: We performed a single-center retrospective analysis of patients with diabetes and metastatic RCC at University of Virginia. The control group included patients who were on metformin, a sulfonylurea or SGLT2 inhibitor during treatment for metastatic RCC, while the study group included those who were taking a DPP4i with or without metformin and other diabetes medications during treatment. The primary and secondary endpoints of this study were PFS and OS, respectively. Results: Fifty-nine patients were eligible for the study, 11 of whom were taking a DPP4i with or without other diabetic medications during RCC treatment, while 48 were taking metformin with or without other non-DPP4i medications. Cancer progression occurred in 81.8% of patients in the DPP4i group compared to 66.7% of patients in the control group with an odds ratio of 1.58 (95% CI: 0.672-3.71), p = 0.57. No statistically significant difference on PFS (HR: 1.60; 95% CI: 0.75-3.43; p = 0.24) or OS (HR of death: 0.73; 95% CI: 0.27-1.97; p = 0.52) was found in this study. Conclusions: This retrospective study explored the effect of DPP4i on outcomes in patients with metastatic RCC and diabetes. While DPP4i have been shown in previous SEER-Medicare and retrospective studies to have favorable effects on PFS and OS in certain cancers such as colorectal and lung, the results of this study suggest that DPP4i do not confer clinical benefit in patients with RCC, similar to pancreatic and breast cancers. Given the small sample size in this study, larger studies are warranted to better elucidate the effect of DPP4i in metastatic RCC as well as the mechanisms underlying differential tumor response to these agents.
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Patel, Shejal B., and James Edward Shaw. "Celiac plexus block in patients with nonpancreatic GI malignancies: Experience from a single institution." Journal of Clinical Oncology 30, no. 15_suppl (2012): e19551-e19551. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e19551.
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e19551 Background: Celiac plexus block (CPB) has been well described in the treatment of pancreatic cancer pain. A recent Cochrane Library review of the subject concluded that CPB often resulted in fewer adverse effects when compared to chronic opioid use. CPB has not been well described in non-pancreatic GI malignancies. This study sought to determine the effectiveness of CPB in non-pancreatic GI malignancies. Methods: The Virginia Commonwealth University Massey Cancer Center database was queried for all patients who had undergone celiac plexus block, 2001-2010, using specific CPT billing codes. In addition, VCU Radiology Department records were also examined. Diagnosis, physician assessment of effectiveness, pre and post procedure pain scores, complications of procedure, and pain medication dosage pre and post procedure were all assessed. Results: 68 total patients were identified. 12 patients underwent a CPB for non-pancreatic GI malignancies and 56 for pancreatic cancer patients. The most common non-pancreatic GI malignancies were colorectal cancer (50%), hepatocellular carcinoma (8%), carcinoid (8%), duodenal cancer (8%), and gastric cancer (8%). By study criteria, 7 of the 12 patients had sufficient data for exploratory analysis. By physician assessment, CPB resulted in pain relief in 5 (71%) of 7 patients. Furthermore, the post procedure pain score improved but the usage of pain medications did not change. By comparison, 26 of 56 patients with pancreatic CA had sufficient data and 15(58%) has pain relief by physician assessment. Conclusions: CPB appears to provide some pain relief for patients with non-pancreatic GI malignancies. However, the retrospective design revealed missing data including: pre and post procedure pain scores, complications of procedure and patient assessments of pain. A prospective study is being considered.
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Schrag, Deborah, Raymond U. Osarogiagbon, Sandra L. Wong, et al. "Stakeholder feedback at four ePRO-naïve healthcare institutions about the need, effectiveness, and barriers to usage of a fully EHR-integrated ePRO tool." Journal of Clinical Oncology 38, no. 29_suppl (2020): 165. http://dx.doi.org/10.1200/jco.2020.38.29_suppl.165.
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165 Background: Collecting patient-reported outcomes (PROs) is a proven method to enhance doctor-patient communication and care. With the influx of technology and usage of telehealth services, electronic PROs (ePROS) have become the mainstay for ascertaining how a patient is doing at home. Collection of ePROs is particularly valuable for providers caring for rural and vulnerable populations with limited access to high quality care. A fully EHR-integrated ePRO collection system could help bridge the gap. Methods: To inform the design, function, and deployment of a new EHR-integrated ePRO symptom management system, focus groups with stakeholders were conducted at four institutions caring for largely rural-based populations (Baptist Cancer Center, West Virginia University Cancer Institute, Dartmouth-Hitchcock Medical Center, Maine Medical Center). Sessions were conducted 2 to 3 months prior to the launch of a new ePRO platform and included oncologists, surgeons, practice nurses, tech analysts, operations staff, and institutional leadership. Each group included a 30-minute overview of the new tool followed by a 30-minute discussion with qualitative open-ended questions and clicker-enabled multiple-choice questions. Developed questions utilized the CFIR and RE-AIM implementation frameworks. Results: In total, 134 stakeholders participated from the four institutions. RNs made up nearly half of respondents (47%). 97% of participants felt a new ePRO system would complement existing healthcare initiatives and 64% felt it would be extremely effective/very effective in improving symptom management. Each group was asked to rate the barriers to patient usage of an ePRO system in the home-care setting. Computer literacy (51%) and access to an internet-enabled device (48%) ranked as the highest barriers. Other barriers perceived to be of less significance included privacy, distrust, and limited English-language proficiency. Consequently, two-thirds of respondents felt patients would only be somewhat likely/not so likely to use an ePRO system; one-third felt patients would be likely/extremely likely to utilize the system. Conclusions: From the perspective of stakeholders at four engaged institutions, an integrated ePRO tool is considered a widely acceptable symptom management solution, but uncertainty remains around patient acceptance and uptake. Future research will include post-implementation discussions with stakeholders and evaluation of patient utilization and clinical outcomes.
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Schrag, Deborah, Raymond U. Osarogiagbon, Sandra L. Wong, et al. "Development of self-management tip sheets for medical oncology and surgical patients electronically reporting symptoms in the home-care recovery setting." Journal of Clinical Oncology 38, no. 29_suppl (2020): 299. http://dx.doi.org/10.1200/jco.2020.38.29_suppl.299.
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299 Background: Patients receiving cancer treatments, including chemotherapy and surgery, often face immense morbidities. Poor symptom control frequently leads to decreased quality of life and an increased need for acute care services. For patients undergoing chemo, adverse side effects can deter them from receiving life-saving therapies. Similarly, poorly managed postoperative symptoms can delay recovery and timely receipt of adjuvant therapies. Empowering patients to proactively monitor, electronically report, and effectively treat symptoms in the home-care setting is critical to improving clinical outcomes. Methods: Through the NCI’s Moonshot-funded IMPACT consortium, 6 health systems developed a library of 70 open source symptom management tip sheets for medical oncology and surgical patients. The study team went through an iterative process with medical oncologists, surgeons, practice nurses, health educators, and patient advocates. Careful attention was paid to minimize the usage of regional dialects or idioms to ensure scalability and acceptability. The tip sheets achieved passing scores on two validated healthy literacy and readability tools. Results: Tip sheets were accessible to patients participating in the novel eSyM (electronic symptom management) program, a fully EHR-integrated ePRO model.eSyM and the incorporated tips were deployed at four health systems between fall 2019 and spring 2020 (Baptist Cancer Center, West Virginia University, Dartmouth-Hitchcock Medical Center, and Maine Medical Center). Patients enrolled in eSyM had access to the tip sheet library through their patient portal and could view them at any time. In addition, after completing an ePRO questionnaire, patients were given dedicated links to the tips for symptoms they reported. Each developed tip sheet included 4 sections: 1) things you can do on your own, 2) with over-the-counter medications, 3) with the help of your care team, 4) when to call your care team for help. This simplified structure allowed patients to determine how to manage symptoms on their own and when to seek out assistance. Conclusions: Presenting self-management tip sheets in response to patient-reported symptoms through a fully integrated patient portal platform is a novel approach to symptom management. Future efforts will include deploying the library and platform at two additional health institutions and evaluating the adoption, acceptability, and utilization of the tip sheets and their impact on clinical care outcomes.
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Jiang, Bei, Nour Daboul, Maria Hafez, et al. "Prevalence of UGT1A1 polymorphisms in gastrointestinal cancer: A single-institutional retrospective study." Journal of Clinical Oncology 41, no. 4_suppl (2023): 797. http://dx.doi.org/10.1200/jco.2023.41.4_suppl.797.
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797 Background: UGT1A1 gene polymorphisms are heterogeneously distributed among ethnicities and varying geographical regions. Patients with UGT1A1*6 and UGT1A1*28 polymorphisms have an increased risk of grade 3-4 neutropenia and diarrhea from irinotecan due to poor metabolism. This study evaluated the prevalence of UGT1A1 polymorphisms in the cancer patients in a large tertiary cancer center in the Appalachian region, in order to develop individualized institutional guidelines on the utility of UGT1A1 testing in chemotherapy dose management. Methods: This retrospective study evaluated all patients with gastrointestinal (GI) malignancies who underwent UGT1A1 testing prior to chemotherapy initiation between 1/1/2020 and 6/30/2022 at West Virginia University. All patients within this disease sub-specialty who were eligible for chemotherapy were tested for UGT1A1 *6 and UTG1A1*28 polymorphism via PCR based pharmacogenomic evaluation using OneOme RightMed comprehensive testing. Patients were excluded if they were tested for genetic alterations specifically due to previous treatment intolerances. Prevalence of the alterations along with demographic characteristics of patients are reported. Results: UGT1A1 genotyping was performed in 278 patients prior to initiating chemotherapy and 12 patients were excluded due to insufficient sample. A total of 266 patients met the inclusion criteria. The median age was 66 years (IQR: 26-92). Males constituted a higher proportion of the population compared to females (M: F = 147: 119). Colon (n-81; 30.5%) and pancreatic (n-80; 30%) cancers were the predominant GI malignancies. Fifty five percentage of patients (n-146) had metastatic disease. The distribution of the UGT1A1 variant genotype is showed in the table below. Conclusions: The prevalence of heterozygous and homozygous of UGT1A1*28 polymorphism in GI cancer patients in the Appalachian region is 51.5%, consistent with the reported literature. Homozygous and heterozygous UGT1A1 *28 alterations constituted 13.2 and 38.3% respectively. Data collection for pre-emptive chemotherapy dosage adjustments and adverse events is ongoing to integrate testing for UGT1A1 polymorphism routinely for all GI malignancies cancer patients starting irinotecan chemotherapy.[Table: see text]
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Scott, Eggener. "Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Department of Medicine; Department of Biostatistics and Computational Biology; Dana-Farber Cancer Institute, Boston; Harvard Medical School, Boston; Johns Hopkins University, Baltimore; University of Wisconsin Carbone Cancer Center; School of Medicine and Public Health; Madison; Fox Chase Cancer Center, Temple University Health System, Philadelphia; Indiana University Melvin and Bren Simon Cancer Center, Indianapolis; Mayo Clinic, Rochester, MN; University Hospitals Case Medical Center, Seidman Cancer Center; Cleveland Clinic Taussig Cancer Institute; Both in Cleveland; University of Virginia Cancer Center, Charlottesville; Comprehensive Cancer Centers of Nevada, Las Vegas; Siteman Cancer Center, Washington University School of Medicine, St. Louis; NorthShore University Health System, Evanston, IL; University of Michigan Comprehensive Cancer Center, Ann Arbor; Rutgers Cancer Institute of New Jersey, New Brunswick.N Engl J Med. 2015 Aug 20;373(8):737-46. [Epub 2015 Aug 5]. doi: 10.1056/NEJMoa1503747." Urologic Oncology: Seminars and Original Investigations 35, no. 3 (2017): 123. http://dx.doi.org/10.1016/j.urolonc.2016.12.021.
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Syed, Khajamoinuddin, William C. Sleeman, Michael Hagan, Jatinder Palta, Rishabh Kapoor, and Preetam Ghosh. "Multi-View Data Integration Methods for Radiotherapy Structure Name Standardization." Cancers 13, no. 8 (2021): 1796. http://dx.doi.org/10.3390/cancers13081796.
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Standardization of radiotherapy structure names is essential for developing data-driven personalized radiotherapy treatment plans. Different types of data are associated with radiotherapy structures, such as the physician-given text labels, geometric (image) data, and Dose-Volume Histograms (DVH). Prior work on structure name standardization used just one type of data. We present novel approaches to integrate complementary types (views) of structure data to build better-performing machine learning models. We present two methods, namely (a) intermediate integration and (b) late integration, to combine physician-given textual structure name features and geometric information of structures. The dataset consisted of 709 prostate cancer and 752 lung cancer patients across 40 radiotherapy centers administered by the U.S. Veterans Health Administration (VA) and the Department of Radiation Oncology, Virginia Commonwealth University (VCU). We used randomly selected data from 30 centers for training and ten centers for testing. We also used the VCU data for testing. We observed that the intermediate integration approach outperformed the models with a single view of the dataset, while late integration showed comparable performance with single-view results. Thus, we demonstrate that combining different views (types of data) helps build better models for structure name standardization to enable big data analytics in radiation oncology.
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Hedrick, Traci L., Rebecca P. Galloway, Shannon T. Mcelearney, et al. "Screening Practices of Patients Presenting for Resection of a Colorectal Neoplasm." American Surgeon 72, no. 1 (2006): 89–95. http://dx.doi.org/10.1177/000313480607200123.
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Multiple studies demonstrate the efficacy of colorectal cancer (CRC) screening in patients over 50 years of age. However, there is a lack of consensus regarding which screening method to use, and compliance has been poor. The objective of this study was to identify the CRC screening practices at two institutions and determine the relationship between screening and pathologic stage for patients presenting with a colorectal neoplasm. This study, conducted at the University of Virginia (UVA) Health System and the Salem Veterans Affairs Medical Center (VAMC) between October 30, 2000, and September 1, 2004, included 198 patients ≥50 years who presented for resection of a primary colorectal neoplasm. Pathologic stage and prior screening were identified retrospectively through chart review and patient response to an anonymous survey. Prior screening was demonstrated in 71 per cent of patients. Colonoscopy was the most commonly used modality. There was a higher percentage of CRC screening at VAMC compared with UVA (80% vs 62%, P < 0.0008). Patients at UVA were more likely screened with colonoscopy, whereas fecal occult blood testing (FOBT) was most common at VAMC (P < 0.0001). Prior CRC screening and cancer stage were inversely related. Ninety-one per cent of patients with benign polyps had been screened prior to diagnosis, compared with 72 per cent of patients with stage I and II cancer and 54 per cent of patients with stage III and IV cancer (P < 0.05). Of patients presenting for surgery, 71 per cent underwent CRC screening. Variability exists in the methods employed for CRC screening. CRC screening facilitates diagnosis at an early stage.
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Manjili, Masoud H., Madison Isbell, Nicholas James Koelsch, et al. "Restoration of CD4 +T helper cells without modulating the hepatic inflammatory pattern is not sufficient to prevent HCC." Journal of Immunology 210, no. 1_Supplement (2023): 245.15. http://dx.doi.org/10.4049/jimmunol.210.supp.245.15.
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Abstract Recent studies suggest that progression of nonalcoholic fatty liver disease (NAFLD) to hepatocellular carcinoma (HCC) is associated with a decreased frequency of the hepatic CD4 +T cells, as well as a predominance of the inflammatory immunological pattern. To determine whether the inhibition of chronic inflammation could prevent the progression of NAFLD to HCC, we used a novel LRP-1 agonistic peptide, SP16, during a progressive NAFLD in an animal model of NAFLD, i.e., DIAMOND mice. Tumor progression, circulating inflammatory cytokines as well as the hepatic immune cells were analyzed using 44-plex cytokine array and multi-color flow cytometry. Although SP16 restored the hepatic CD4 +T cells and slightly increased Th2 subset, it failed to modulate the CD4 +Th1 dominant pattern in the liver or prevent HCC. These data suggest that the hepatic immune pattern, which could produce a collective function independent from its cellular components, is more important than CD4 +T cell recovery during disease progression. Our data also suggest that administration of SP16 very early during NAFLD could shift a predominant Th1 pattern towards an equilibrium Th1=Th2=Th17 pattern which has been found to protect DIAMOND mice from from the progression of NAFLD to HCC. Future studies will determine if modulation of the inflammatory immune response by SP16 when administered early during NAFLD progression will prevent HCC. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Breast Cancer Research Program under Award No. W81XWH2210793, Massey Cancer Center Multi-Investigator Award, grant number 2017-MIP-02, NIH R01DK105961, and VA Merit Award 1I01BX003275. Opinions, interpretations, conclusions, and recommendations are those of the authors and are not necessarily endorsed by the U.S. Department of Defense. Services and products in support of the research project were generated by the Virginia Commonwealth University Flow Cytometry Shared Resource, supported, in part, with funding from NIH-NCI Cancer Center Support Grant P30 CA016059.
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Man, Louise, Jeremy Sen, Jeanne Giordano, et al. "Multidisciplinary Effort to Decrease Time From Admission to Chemotherapy on an Inpatient Oncology Unit." Journal of Oncology Practice 15, no. 8 (2019): e728-e732. http://dx.doi.org/10.1200/jop.18.00281.
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There are no national standards for time between patient arrival and the initiation of scheduled chemotherapy (time to chemotherapy [TTC]). Delays in this process have a negative impact on patient care and the use of health care resources. At the University of Virginia Cancer Center, mean TTC in 2015 was 12.1 hours and mean length of stay (LOS) was 5.45 days at baseline. We formed a multidisciplinary team that participated in ASCO’s Quality Training Program. We aimed to improve TTC by 10% over 6 months. We used Plan-Do-Study-Act (PDSA) cycles as quality improvement (QI) models and used XmR charts to evaluate the interventions. The first PDSA cycle involved amending the chemotherapy consent process; mean TTC and LOS improved to 9.3 hours and 4.65 days, respectively. The second PDSA cycle involved shifting pharmacist review of chemotherapy orders to before admission rather than after patient arrival. Mean TTC remained at 9.4 hours (net 22% improvement from baseline) and LOS improved to 4.33 days (net 21% improvement). Our team surpassed the 10% improvement goal for TTC. This QI project faced a few limitations. Our baseline data set was a retrospective cohort review. In addition, oncology patients have a wide range of individual clinical needs that may have an impact on TTC. Delays in TTC have an impact on oncologic care at many medical centers. Our project highlights the need for guidance on this issue. We recommend that other institutions form multidisciplinary teams and also use QI tools to assess delays and implement changes.
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Bernens, Jordan, Kara Hartman, Brendan F. Curley, Sijin Wen, Jame Abraham, and Michael David Newton. "Assessing the impact of a targeted electronic medical record intervention on growth factor usage in cancer patients." Journal of Clinical Oncology 32, no. 30_suppl (2014): 262. http://dx.doi.org/10.1200/jco.2014.32.30_suppl.262.
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262 Background: Patients receiving chemotherapy are at risk for febrile neutropenia following treatment. The American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) recommend screening patients for risk of febrile neutropenia and risk stratification based on likelihood of febrile neutropenia events. Prophylactic growth factors (G-CSF) should be in patients receiving high-risk regimens or intermediate-risk regimens with individual risk factors. The impact of electronic medical record system (EMR) implementation on compliance with G-CSF support guidelines has not been studied. Methods: At West Virginia University/Mary Babb Randolph Cancer Center we conducted an IRB approved retrospective chart review of cancer patients receiving chemotherapy from January 1, 2007 to August 1, 2008 (pre-EMR) and January 1, 2011 to December 31, 2011 (post-EMR). We reviewed the chemotherapy regimens and patient risk factors for developing febrile neutropenia, and determined if the G-CSF usage was consistent with guideline recommendations. Results: Compliance with prophylactic G-CSF guidelines was 75.6% in the post-EMR arm, compared to 67.5% in the pre-EMR arm (p=0.041, ch-square). The post EMR data of 1,042 new chemotherapy initiations showed: (see Table). The appropriateness of usage in high and low risk patients were the most compliant, as G-CSF orders were built into chemotherapy plans of high risk regimens and omitted from low risk regimens. Conclusions: Appropriate prophylactic G-CSF usage can be improved when orders are integrated into standard chemotherapy order sets in an EMR. An area of further improvement would include automatic identification of individual risk factors by the EMR. [Table: see text]
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Ezeana, Chika, Xiaohui Yu, Zhihao Wan, et al. "Abstract PO2-28-06: An on-line deep learning decision support tool, iBRISK, aimed at improving breast cancer risk estimation and reducing unnecessary biopsies for BI-RADS 4 patients." Cancer Research 84, no. 9_Supplement (2024): PO2–28–06—PO2–28–06. http://dx.doi.org/10.1158/1538-7445.sabcs23-po2-28-06.
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Abstract Probability of malignancy (POM) for Breast Imaging Reporting and Data System (BI-RADS) category 4 designated breast lesions ranges from 2% – 95% and contributes to a high unnecessary biopsy rate. This is as most clinicians often stick to the biopsy option to rule in or out breast cancer early; withholding biopsy could be risky, and biopsies of BI-RADS 4 lesions serve as a quality metric and performance standard. At 21.1%, biopsy-proven positive predictive value (PPV3) rates for BI-RADS 4 have not improved for decades, translating to high false-positive rates of mammography. Unnecessary biopsies are a big issue in the management of BI-RADS 4 lesions with negative implications including increased medical costs, healthcare wastes, unnecessary psychological burdens to the patients, and potential complications and risks. Objectives 1. Optimize the precision breast cancer risk assessment tool, iBRISK, that utilizes artificial intelligence (AI) technologies, including natural language processing (NLP), image processing, and deep learning, with clinical risk factors and imaging features. 2. Develop a user-friendly web interface for iBRISK to facilitate clinicians or insurers in estimating cancer risk and making informed biopsy decisions for BI-RADS 4 lesions. Methods Our intelligent-augmented breast cancer risk calculator (iBRISK) model was trained on multimodal data collected from 10,778 patients, including demographic factors, historical and clinical characteristics, mammographic features, and pathologic signatures. We validated iBRISK using 4,200 patients from multiple leading hospitals, including Houston Methodist Neal Cancer Center, the University of Texas MD Anderson Cancer Center, and the University of Texas Health San Antonio MD Anderson Mays Cancer Center. The iBRISK was connected to a backend server which is linked to a frontend web user interface using technologies like Hypertext Preprocessor (PHP) for the backend application running on an APACHE HTTP server and React-JavaScript for the front-end web application that communicates with the backend using Representational State Transfer Application Programming Interface (RESTful API) and JavaScript Object Notation (JSON) format. The communication was secured using Secure Sockets Layer (SSL) encryption. Results The iBRISK model demonstrated high sensitivity in malignancy prediction and achieved an accuracy of 89.5%, area under the receiver operating characteristic curve of 0.93 (95% CI: 0.92-0.95), sensitivity of 100%, and specificity of 81%. Only 0.16% of lesions determined to have low POM by the model were malignant. Our multi-center study shows that iBRISK achieves at least 50% reduction in unnecessary biopsies of BI-RADS 4 cases. Data elements for the required 20 features are entered into the interface using a variety of imputation methods including direct text, dropdown menus and radio button selections. The user-friendly web interface provides risk scores (0 – 1), risk levels (low, medium, and high), and associated biopsy recommendations. Conclusion The user-friendly iBRISK web interface is proposed as an adjunct to the BI-RADS system, enhancing the precision of BI-RADS 4 lesion cancer risk stratification. It is expected to reduce unnecessary biopsies, lower health costs, and enhance the quality of health care. This approach aims to tackle a critical issue in breast cancer diagnosis by leveraging advanced AI technologies and big data and providing clinicians with a tool to make more informed and precise biopsy decisions for BI-RADS 4 lesions. Citation Format: Chika Ezeana, Xiaohui Yu, Zhihao Wan, Tiancheng He, Tejal Patel, Virginia Kaklamani, Maryam Elmi, Erika Brigmon, Pamela Otto, Kenneth Kist, Lin Wang, Joe Ensor, Heather Speck, Ya-Chen Shih, Bumyang Kim, I-Wen Pan, David Spak, Wei Yang, Jenny Chang, Stephen Wong. An on-line deep learning decision support tool, iBRISK, aimed at improving breast cancer risk estimation and reducing unnecessary biopsies for BI-RADS 4 patients [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-28-06.
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Albandar, Heidar, Salah Ud Din Safi, Jacob Lane Fuqua, Samuel Merrill, and Patrick C. Ma. "Immune-related adverse events (irAE) to cancer immune checkpoint inhibitors (CPI) and survival outcomes: To rechallenge or not—An Appalachian experience." Journal of Clinical Oncology 38, no. 5_suppl (2020): 81. http://dx.doi.org/10.1200/jco.2020.38.5_suppl.81.
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81 Background: The adoption of immunotherapy has led to a paradigm shift in the treatment of many advanced stage malignancies. Patients with durable long term survival under cancer immunotherapy have begun to emerge. Circulating memory immune T and B-cells play a key role in the anamnestic response to future similar antigen exposure and may contribute to durable cancer immunotherapy response and benefits in patients with irAE. We hypothesized that there is increased median overall survival (mOS) in patients who had irAE under CPI therapy. Methods: We conducted a retrospective analysis with an IRB-approved study protocol of adults treated between 2011-2019 at the West Virginia University Cancer Institute, with a histopathologic diagnosis of melanoma or lung cancer, who had received CPI therapy. We collected data on demographics, histology, stage at diagnosis, immunotherapy type used, irAE and its grade, and days from immunotherapy initiation to death. Patients were stratified by irAE status and CPI rechallenge status following irAE. Results: Demographics were similar between the irAE and non-irAE groups within both cancer types. A total of 229 lung and 114 melanoma cancer patients had received CPI. Overall, there were 105/343 (30.6%) cases of irAE found of any grades: 27.5% of lung and 37.7% of melanoma patients developed irAE. The mOS for the non-irAE cohort group was 299 days, which was significantly worse than the irAE cohort (mOS not met, Log-rank, p < 0.0001). Within the irAE cohort, there was no significant survival difference between the non-rechallenged and rechallenged groups (Log-rank p = 0.6150). Conclusions: Our findings identified significantly improved survival outcomes among lung cancer/melanoma patients treated with CPI who developed irAE, including those who were rechallenged after irAE, compared to those who had no irAE. Patients who were CPI-rechallenged after irAE had comparable survival outcomes compared to those without rechallenge. Further multi-center validation studies and prospective studies are warranted to further confirm these findings and help guide clinical management in patients who experience CPI irAE.
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Gopie, Priya, Oana C. Rosca, Ayesha Chawla, et al. "Risk stratification of gastrointestinal stromal tumors by CtBP2 and CD44 analysis." Journal of Clinical Oncology 36, no. 4_suppl (2018): 48. http://dx.doi.org/10.1200/jco.2018.36.4_suppl.48.
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48 Background: C-terminal binding protein 2 (CtBP2) is an oncogenic transcription factor that promotes cancer stem cell (CSC) growth and self-renewal, and controls pathways for tumor initiation, progression, and response to therapy. Expression of CtBP2 is linked to aggressive behavior in ovarian cancer, while genetic or pharmacologic targeting of CtBP2 disrupts CSC growth and self-renewal. CD44 is a cell surface marker that has been linked to CSC populations in many solid tumors, though data is conflicting on its role as tumor suppressor or oncogene. Gastrointestinal stromal tumors (GIST) is an increasingly common malignancy where risk stratification is essential for guiding post-surgical adjuvant therapy. We hypothesized that CtBP2 and CD44 staining would enhance risk stratification of GIST which currently relies on purely non-molecular clinicopathologic criteria. Methods: We identified 149 GIST cases from 1990 to 2016 in the Virginia Commonwealth University Medical Center pathology archive. Clinical data for 121 patients was available. The Armed Forces Institute of Pathology (AFIP) criteria (Miettinen's criteria) was used to risk stratify GISTs using the size, site, and mitotic index of the primary tumor. Immunohistochemistry for CtBP2 and CD44 was then performed on GIST samples with adequate tumor (86, CD44; 87, CtBP2). Stains were scored 0 (negative) to 3 (maximum) by two independent pathologists. Statistical analysis (χ2) correlating AFIP risk category with CD44 and CtBP2 staining was performed using PRISM6. Results: Moderate and high risk GISTs, based on AFIP criteria, significantly correlated with high CtBP2 expression (score = 3, p = 0.046) and low CD44 expression (score = 0-2, p = 0.034). Conclusions: CD44 and CtBP2 staining can be used to risk stratify GIST, and may enhance and complement current clinical risk stratification systems. Our data also suggests a potential tumor suppressive role of CD44 in GIST. Additionally, based on our findings, investigation of therapeutics that target CtBP2 in GISTs should be pursued.
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Devitt, Michael Edward, Kristine E. Gade, Richard Delmar Hall, et al. "The effect of chemotherapy on the tumor immune microenvironment in non-small cell lung cancer (NSCLC): A single-institution retrospective analysis." Journal of Clinical Oncology 36, no. 5_suppl (2018): 155. http://dx.doi.org/10.1200/jco.2018.36.5_suppl.155.
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155 Background: Platinum-doublet chemotherapy (chemo) is routinely used for treatment of early stage and metastatic NSCLC. Immunotherapy is a proven treatment in these patients as well. The presence of tumor infiltrating lymphocytes (TILs) has been shown to be prognostic of this disease; however, the effect of chemo on TILs and the tumor immune microenvironment in NSCLC has not been well studied. We tested the hypothesis that chemo results in a decrease in the presence of TILs in NSCLC. Methods: We retrospectively identified patients treated with neo-adjuvant platinum-doublet chemo who underwent surgical resection from 2007-2015 at the University of Virginia. The specimens were sectioned and IHC stained for CD8, FoxP3, and PD-L1. Two independent investigators assessed a central and a peripheral high power field of tumor for number of CD8 and FoxP3 positive TILs. An independent pathologist assessed tumor cell PD-L1 expression. The nonparametric Wilcoxon Mann Whitney test was used to compare measurements of TILs in chemo-exposed tissue to a control cohort from a database of NSCLC surgical specimens that had not received pre-operative therapy. Results: Of the 17 patients who met eligibility criteria, 11 had sufficient tissue for evaluation. Results are shown in Table 1. There was a significant decrease in CD8 and FoxP3 TILs in both the center and periphery in patients exposed to chemo. There was no difference in PD-L1 expression. Conclusions: These data suggest that platinum-doublet chemo significantly decreases the presence of cytotoxic and regulatory subsets of TILs without effecting PD-L1 expression. This study is limited by the lack of pre-treatment tumor samples to compare pre- and post-treatment TILs in individual patients. Further studies are warranted to evaluate the impact of decreased TILs in the setting of concurrent or sequential immunotherapy treatment with chemo in NSCLC. [Table: see text]
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Winkfield, Karen M., Jessica L. Jones, Virginia Fuqua-Meadows, Freneka F. Minter, Calandra G. Whitted, and Alecia M. Fair. "Abstract A031: Leveraging the Meharry-Vanderbilt alliance to develop a faculty affiliate program to expand cross-collaborative research." Cancer Epidemiology, Biomarkers & Prevention 32, no. 12_Supplement (2023): A031. http://dx.doi.org/10.1158/1538-7755.disp23-a031.
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Abstract Background: Academic institutions struggle to break down research silos and boost interdisciplinary collaboration. The challenge is magnified when multiple partners seek to build research collaboratives. The Meharry-Vanderbilt-Tennessee State Cancer Partnership (MVTCP) is one of the longest-standing Comprehensive Partnerships to Advance Cancer Health Equity (U54 CPACHE) in the nation and includes faculty from 4 partner institutions, including 2 historically black institutions: Meharry Medical College (MMC), Vanderbilt University Medical Center (VUMC), Vanderbilt University, and Tennessee State University. While this partnership has been extremely productive, a 2022 MVTCP strategic planning session indicated opportunities for deeper scientific discovery and community engagement. The Meharry-Vanderbilt Alliance (MVA) is a 20+year collaboration between MMC and VUMC explicitly designed to advance clinical, translational and basic research focused on ending health disparities by developing and supporting mutually beneficial partnerships between academic centers and the community. A mixed-methods approach was employed to ascertain how the MVA could leverage its resources to further enhance the mission of the MVTCP. Methods: Semi-structured interviews were conducted with 10 MVA stakeholders (2 MMC; 5 VUMC, 3 community partners) to identify opportunities to grow cross-institutional collaborations. Emerging themes were used to develop exploratory questions for faculty-centric focus groups. Focus groups with MMC and VUMC faculty were held to elicit barriers to collaboration and explore possible solutions. A faculty survey was designed and deployed among faculty from all 4 MVTCP institutions from April to December 2022. Results: Themes from semi-structured interviews included limited networking opportunities between institutions, need for greater community engagement, and lack of awareness of faculty development resources, scholarly opportunities, and research funding. Focus group participants (6 MMC; 7 VUMC) recommended solutions that included hosting networking events, newsletters to highlight research and community partners, and developing a resource repository. Faculty respondents to the survey (n=52) indicated their willingness to support cross-institutional capacity building by mentoring students (86.5%), connecting research and clinical colleagues (63.5%), and peer mentorship (57.7%). Faculty requested connections to resources and community organizations (82.7%), support for research and grant development (63.5%), and career development opportunities (50%). Conclusion: This project informed the MVA to actualize the Faculty Affiliate Program (FAP). FAP membership is open to faculty across all MVTCP institutions and has grown to over 75 members. This centralized resource hub facilitates collaborative research and fosters cross-institutional engagement. It is hoped that with support from the FAP, the MVTCP will continue to develop more robust cross-institutional collaborations and community partnerships designed to eliminate cancer disparities. Citation Format: Karen M. Winkfield, Jessica L. Jones, Virginia Fuqua-Meadows, Freneka F. Minter, Calandra G. Whitted, Alecia M. Fair. Leveraging the Meharry-Vanderbilt alliance to develop a faculty affiliate program to expand cross-collaborative research [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A031.
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Rahma, Osama, Mathew Katz, Todd Bauer, et al. "960 Randomized multicenter study of neoadjuvant chemoradiation therapy (CRT) alone or in combination with pembrolizumab in patients with resectable or borderline resectable pancreatic cancer." Journal for ImmunoTherapy of Cancer 9, Suppl 2 (2021): A1010. http://dx.doi.org/10.1136/jitc-2021-sitc2021.960.
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BackgroundPancreatic cancer (PC) is a challenging target for immunotherapy due to its immune-suppressive microenvironment. Neoadjuvant chemoradiation (CRT) can increase the presence of tumor-infiltrating lymphocytes (TILs). We hypothesized that the combination of CRT and pembrolizumab can further expand and activate TILs.MethodsPatients with resectable or borderline resectable PC were randomized 2:1 to the investigational treatment (Arm A) of pembrolizumab 200mg IV every 3 weeks concurrently with CRT (capecitabine 825 mg/m2 orally twice daily and radiation 50.4 Gy in 28 fractions over 28 days) or CRT only (Arm B) prior to surgical resection. The primary endpoints were safety and difference in TILs density between Arm A and B assessed using multiplexed immunofluorescence on resected tumor specimens. As a correlate analysis, single cell RNA-sequencing (scRNA-seq) was performed to quantify gene expression in T cells from tumors and peripheral blood, and to track expanded T cell clonotypes in these compartments (n=4 patients Arm A; n=3 patients Arm B). The study was amended after enrollment of 37 patients to allow FOLFIRINOX prior to CRT, given changes in standard of care.Results37 patients were enrolled (24 Arm A, 13 Arm B). After neoadjuvant therapy, 13 patients had unresectable disease (9 on A, 4 on B), and 24 patients underwent surgery and were evaluable for the TILs primary endpoint (17 arm A, 7 arm B). The mean difference (A-B) in CD8+ T cell density was 36 cells/mm2 (95% CI -85 to 157, stdev 130) (p 0.48). Additional analysis did not show significant differences in activated cytotoxic T cells, regulatory T cells, M1- or M2-like polarized macrophages, or granulocytes. The median recurrence free survival (RFS) was 18.2 months on Arm A and 14.1 on Arm B (p 0.41). Overall survival was 27.8 months on Arm A and 24.3 on Arm B (p 0.68) with a median follow up of 2.2 years. The most common grade 3 treatment-related toxicities were lymphopenia reported in 29% on Arm A and 31% on Arm B, respectively followed by diarrhea in 8% on Arm A attributed to CRT. scRNA-seq revealed clonal expansion and expression of co-inhibitory markers among TIL subsets.ConclusionsThe combination of CRT and pembrolizumab is safe. Preliminary analysis shows that the addition of pembrolizumab to CRT has minimal effects on intratumoral densities of TILs and other immune cell populations. Single cell transcriptome analyses enable in-depth characterization of the functional responses of T cells to pembrolizumab in the setting of CRT.AcknowledgementsThis study was funded by MerckTrial RegistrationNCT02305186Ethics ApprovalThe study was conducted at 6 sites: University of Virginia, Dana Farber Cancer Institute, MD Anderson Cancer Center (MDACC), Mayo Clinic, Hartford Healthcare Cancer Center, and University of Miami. Written informed consent was provided by the study participants and the protocol was approved by the relevant local IRBs in each site.
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Patel, Reema, and Zhiyuan Xu. "RADT-06. IMPACT OF STATUS OF TUMOR PROGRESSION PRIOR TO STEREOTACTIC RADIOSURGERY ON LOCAL TUMOR CONTROL IN PATIENTS WITH TRIPLE-NEGATIVE BREAST CANCER BRAIN METASTASES TREATED WITH STEREOTACTIC RADIOSURGERY." Neuro-Oncology 25, Supplement_5 (2023): v49. http://dx.doi.org/10.1093/neuonc/noad179.0195.
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Abstract INTRODUCTION Prognosis in patients triple-negative breast cancer (TNBC) brain metastases remains poor owing to the lack of treatment targeting pathways. Furthermore, approaches–like surgical resection, stereotactic radiosurgery (SRS), and whole-brain radiation therapy–have variable efficacy depending on the degree of tumor burden. The cohort of patients benefit least to targeted therapy and immunotherapy, therefore, forming ideal candidates to evaluate the local tumor control attributed to SRS. This study aimed to characterize intracranial tumor response and clinical outcomes in the patient cohort. PATIENTS and METHODS This retrospective, single-center study included patients with confirmed TNBC brain metastases treated with SRS at the University of Virginia Health. Tumor response, new intracranial tumor development, and survival were investigated. 24 patients with 169 total treated lesions between 2007 and 2021 were assessed. The median age of patients at the initial treatment was 49.1 years. RESULTS One MRI within one month prior to SRS plus the treatment study MRI were evaluated. Tumor progression at the time of SRS led to worse local tumor control following the first SRS treatment (p &lt; 0.0001). 15.1% of total treated lesions demonstrated a complete response, while 48.5% had a partial response. 25.7% of lesions remained stable and 13.5% progressed. Three patients did not have any follow-up imaging to assess initial tumor response due to mortality. For patients with tumor progression, the progression-free survival was 4.93 months. Additionally, new intracranial metastases developed in ten patients over their treatment course. Median overall survival following the first SRS session was 9.83 months (range 0.9 - 37.7 months), with a 1-year and 2-year survival of 54.5% and 22.7%, respectively. CONCLUSION Tumor control in patients with TNBC treated with SRS is unfavorable. Tumor progression prior to SRS might lead to worse tumor control. Further study is warranted to evaluate this phenomenon in a large cohort of patients.
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Van Galen, Joseph, Samuel Maldonado, Leonid Volodin, and Michael Kenneth Keng. "Minimizing the risk of Clostridium difficile infection as an early complication of autologous stem cell transplantation." Journal of Clinical Oncology 39, no. 28_suppl (2021): 219. http://dx.doi.org/10.1200/jco.2020.39.28_suppl.219.
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219 Background: Clostridium difficile infection (CDI) is one of the most important affecting patients immunocompromised by autologous stem cell transplantation (ASCT), and can be associated with increased morbidity and length of stay. One precipitating factor for index CDI cases in the ASCT population is heavy antibiotic exposure, which often includes prophylaxis. A retrospective review identified 11 cases of CDI (17%) in the 30-day period following ASCT performed at the University of Virginia Medical Center (UVAMC) between about June 2016 and July 2017. Various institutional and multicenter studies have reported incidence rates in this population ranging from less than 5% to more than 10%. Methods: To decrease CDI rate, a multidisciplinary team comprised of oncology and infectious diseases physicians, pharmacists, and nurses was formed. The group used quality improvement principles to identify and target areas of greatest significance. A first PDSA cycle was conducted between approximately July 2017 and June 2018, during which time administration of standard-of-care ciprofloxacin prophylaxis between T+0 and count recovery was suspended. A second PDSA cycle was executed between approximately May 2018 and July 2019, incorporating UV light equipment into existing post-discharge cleaning practices. Data were analyzed using process control charts with 3-sigma limits for ASCT length-of-stay (LOS) and 30-day post-transplant CDI incidence. Results: Suspension of prophylactic antibiotics did not have a significant effect on CDI incidence in our first PDSA cycle. In our second improvement cycle, most of which elapsed after prophylactic ciprofloxacin had been re-implemented, CDI incidence was almost halved, from 17 to 9%. A numerical decreased in LOS was observed in each subsequent PDSA cycle. Conclusions: Our multidisciplinary team applied quality improvement methods to drive a clinically significant reduction in the 30-day CDI incidence after ASCT at UVAMC. This outcome should be associated with an improved patient experience. Future PDSA cycles are scheduled and may include other cancer patients, beyond those receiving stem cell transplantation.[Table: see text]
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Man, Louise Ming-Wai, Jeremy Sen, Jeanne Cahan, et al. "A multidisciplinary effort to decrease time from admission to chemotherapy on an inpatient oncology unit." Journal of Clinical Oncology 35, no. 8_suppl (2017): 96. http://dx.doi.org/10.1200/jco.2017.35.8_suppl.96.
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96 Background: Patients with established cancer diagnoses often experience delays in starting scheduled inpatient chemotherapy (CTX) after arrival on the University of Virginia (UVA) Medical Center oncology unit. These delays negatively impact hospital resource utilization. We formed a multidisciplinary team of physicians, nurses, and pharmacists to investigate these delays. We aim to decrease time-to-CTX (TTC) by 30% from baseline. Methods: From 340 planned inpatient CTX encounters in calendar year 2015, 100 were randomly reviewed to establish baseline retrospective data. The following were collected for each encounter: patient demographics; oncologic diagnosis; admitting team; CTX regimen and cycle; procedures and urinary parameters required prior to CTX start; times of lab orders and results, CTX signature and release, and start of intravenous fluid (IVF), premedications, and CTX; unit census data; available nursing staff; and length of stay. With guidance from ASCO’s Quality Training Program, we constructed a process map of the current state, an Ishikawa cause-and-effect diagram, a Pareto chart to assess causes of delays, and a priority matrix of potential interventions. XmR charts compared baseline and post-intervention data. Results: Baseline median TTC was 6.7 hours (range 1.5-105.3 h). Patients with pre-admission outpatient appointments started CTX 2.4 h earlier than those without appointments. Patients without urine parameters for treatment started CTX 3 h earlier than those with parameters. The Pareto chart indicated the longest delays occurred in pre-medicating patients, starting IVF, and signing CTX orders. In the first Plan-Do-Study-Act (PDSA) cycle, the CTX consent process was reformed. Post-intervention data showed no change in median TTC (7.2 h). Other PDSA cycles (setting patient arrival times and pre-admission pharmacy review of treatment plans) are ongoing; prospective data collection is pending. Conclusions: Retrospective data validate concerns that delays in starting inpatient CTX are longer than acceptable. They affect hospital length of stay, cost, and patient satisfaction. Our first PDSA cycle showed no change in TTC but additional interventions are ongoing.
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Elghawy, Omar, Bethany Horton, Shiyi Shen, and Varinder Kaur. "SDPS-10 DISPARITIES IN THE RISK OF CNS METASTASIS AND CLINICAL OUTCOMES IN PATIENTS WITH HER2- MUTATION POSITIVE (HER2+) NON-BREAST VERSUS HER2+ BREAST CANCERS." Neuro-Oncology Advances 5, Supplement_3 (2023): iii18—iii19. http://dx.doi.org/10.1093/noajnl/vdad070.070.
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Abstract BACKGROUND Risk of CNS metastases is well characterized for patients (pts) with HER2+ breast cancer (BC), however, poorly defined for pts with HER2+ non-breast solid tumors (ST). METHODS We performed a retrospective cohort analysis to characterize the frequency of CNS metastasis and clinical outcomes in pts with Her2+ ST treated at the University of Virginia Emily Couric Cancer Center between 01/2010- 01/2022. Risk of CNS metastasis, time to CNS metastasis, progression free survival (PFS) and overall survival (OS) were analyzed for each cohort and stage IV subgroups. The outcomes were further compared between HER2+ ST vs BC cohorts. RESULTS 50 pts had HER2+ ST and 383 had HER2+ BC. In the ST group, median age was 66.0 years (y), 37 (74.0%) were male, 43 (86.0%) were white and 2(4.0%) were African American. Majority (74%) of patients had gastro-esophageal tumors. Median time to CNS metastasis was 5.8 y and median PFS was 0.7 y (95% CI 0.55-0.98, p&lt;0.05). In those with CNS metastasis 5 (50%) received CNS directed plus HER2 targeted therapy and 3(30%) received CNS directed therapy alone. 24 (48%) pts had baseline CNS imaging in ST group, compared to 11 (2.9%) in the BC group. Rate of CNS metastasis was 20% (n=10) vs 6.8% (n=26) in the ST and BC cohorts (p&lt;0.0001). OS differs in ST vs BC cohorts overall (p&lt;0.0001; median OS 1.7 vs 18.5y) and in patients with metastatic disease at diagnosis (p&lt;0.0001; median OS 1 vs 6.3y). Advanced N (p=0.0445) and smoking (p=0.0868) were associated with early CNS metastasis CONCLUSIONS Pts with HER2+ ST have higher risk of CNS metastasis and shorter OS compared to BC pts. Improved understanding of disease characteristics and standardized management approaches are imminently needed to improve outcomes.
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Reddy, Sangeetha, Joyce O'Shaughnessy, Navid Sadeghi, et al. "Abstract PO1-19-08: Phase I trial of pegylated liposomal doxorubicin chemotherapy in combination with CD40 agonist and Flt3 ligand in metastatic triple-negative breast cancer." Cancer Research 84, no. 9_Supplement (2024): PO1–19–08—PO1–19–08. http://dx.doi.org/10.1158/1538-7445.sabcs23-po1-19-08.
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Abstract Background: Only a subset of patients with metastatic triple-negative breast cancers (TNBC) demonstrate response to FDA approved PD-1 immune checkpoint blockade (ICB), and few have durable responses. Data suggests that breast cancers have defects in antigen presentation and that antigen presenting cells especially the cDC1 subtype of dendritic cells (DCs) are required for response to ICB. CD40 agonists activate antigen presenting cells including DCs and B cells and repolarize macrophages to an anti-tumor phenotype. Flt3 ligand is a growth factor that increases differentiation and expansion of DCs. We recently demonstrated in pre-clinical TNBC models that the combination of liposomal doxorubicin chemotherapy, a CD40 agonist, and a Flt3 ligand improves outcomes compared to alternate combinations. Methods: This is a single arm phase I pilot study of liposomal doxorubicin, CDX-1140 (CD40 agonist monoclonal antibody), and CDX-301 (recombinant Flt3 ligand) combination therapy in patients with metastatic or unresectable locally advanced metastatic TNBC. Patients will be randomized to 3 lead-in arms (triplet therapy, doublet immunotherapy only, or liposomal doxorubicin only) for one cycle prior to receiving triplet therapy with tissue biopsies done before and after the lead-in treatment. CDX-301 will be given for only two cycles; liposomal-doxorubicin and CDX-1140 will be continued until disease progression or clinically limiting toxicities. Primary endpoint is determination of a recommended phase II dose based on treatment-related adverse events and dose-limiting toxicities. Secondary endpoints include anti-tumor immune response after triplet therapy, after immunotherapy alone, and after liposomal doxorubicin alone; median progression-free survival, overall response rate, duration of response, and clinical benefit rate. Key eligibility criteria are unresectable stage III or stage IV TNBC (ER ≤10%, PR ≤10%, HER2/neu negative), 1st to 3rd line treatment for metastatic disease (1st line patients need to be PD-L1 negative by 22C3 assay), measurable disease by RECIST 1.1 criteria, consent for pre-treatment and on-treatment biopsies of amenable soft tissue tumor lesions, no prior treatment with an anti-CD40 antibody or a Flt3 ligand, no anthracycline treatment in the metastatic setting, no prior progression while on anthracycline-based therapy or within 6 months of completing neoadjuvant chemotherapy, and no history of non-infectious pneumonitis or current pneumonitis. This trial will enroll up to 45 patients across multiple sites (NCT05029999) and is currently open at University of Texas Southwestern Medical Center, Texas Oncology, University of Chicago, University of Texas San Antonio, Sarah Cannon Research Institute, and Johns Hopkins. Citation Format: Sangeetha Reddy, Joyce O'Shaughnessy, Navid Sadeghi, Samira Syed, Cesar Santa-Maria, Virginia Kaklamani, Nan Chen, Denise Yardley, Yisheng Fang, Isaac Chan, Nisha Unni, Sarah Kashanian, Namrata Peswani, Shahbano Shakeel, Meredith Carter, Kelly Kyle, Farjana Fattah, Chul Ahn, Ina Patel, Joshua Gruber, Dawn Klemow, Glenda Delgado, Nicole Sinclair, Michael Yellin, Heather McArthur, Rita Nanda, Suzanne Conzen, Carlos Arteaga. Phase I trial of pegylated liposomal doxorubicin chemotherapy in combination with CD40 agonist and Flt3 ligand in metastatic triple-negative breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-19-08.
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Frazier, Heather, Sewanu Anjolaoluwa Toyon, DeJuana Coleman, et al. "Improved germline screening for patients with pancreatic cancer through provider driven testing." Journal of Clinical Oncology 42, no. 16_suppl (2024): e16366-e16366. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.e16366.
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e16366 Background: National guidelines recommend germline genetic screening for all pancreatic cancer patients. Results provide meaningful insights into pathogenic variants and impacts both treatment selection and family screening recommendations. We previously reported on current state and the need to improve germline screening rates. Since implementing a provider-driven approach, we have seen a significant increase in testing. Our findings demonstrate the feasibility and ongoing need for novel approaches to germline screening. Methods: This is a retrospective review of 223 patients with pancreatic adenocarcinoma evaluated at the University of Virginia Health System within the calendar year of 2022 compared to the 2021 calendar year. Primary endpoints include the rate of genetic counseling referral placement, the rate of attendance of outpatient genetic counseling, and the rate of individuals who completed germline screening. Our primary data points will be compared with outcomes obtained from a prior study evaluating 210 patients with pancreatic adenocarcinoma in the calendar year of 2021 at the same academic medical center. Results: Of the 223 patients with pancreatic adenocarcinoma, only 30% (69/223) had genetic counseling referrals present in the electronic health record system (EHR). This was an improvement from the 2021 calendar year, where 19% (39/210) had referrals present in the EHR. Of those with referrals present, an improvement in the rate of genetic counseling attendance was found, from 51% (20/39) in 2021 to 58% (40/69) in 2022. There was also an improvement in the rate of germline screening completion rates; 38% (85/223) of patients evaluated in 2022 completed testing, compared to 21% (44/210) in 2021. Six percent (5/85) of tested patients in 2022 had pathogenic findings, consistent with historical incidence rates. The main provider barriers were time and testing logistics. Conclusions: Our data shows an improvement in the rates of genetic counseling referrals, the rates of genetic counseling attendance, and the rates of germline screening completion. This modest improvement is primarily related to increased awareness by our providers. We acknowledge the need for further improvements and are developing a prospective clinical trial to better educate and empower patients to understand the need and results of germline testing.
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Mautner, Ben, Eric Pierce, Joseph Mort, et al. "The risks of thrombotic and bleeding events in patients receiving PEGylated asparaginase for treatment of acute lymphoblastic leukemia." Journal of Clinical Oncology 40, no. 16_suppl (2022): e19015-e19015. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.e19015.
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e19015 Background: The prognosis of adult patients with acute lymphoblastic leukemia (ALL) has improved with the adoption of pediatric-inspired chemotherapy regimens. PEGylated asparaginase (PEG-Asp) is essential to these regimens. Although PEG-Asp is associated with an increased risk of coagulopathy, venous thromboembolism, and depletion of antithrombin III (AT3), there is limited data evaluating the risk of thrombosis and bleeding and optimal antithrombotic interventions in these patients are unknown. Methods: We performed a single-center retrospective study of patients ≥ 18 years-old who received PEG-Asp for B- or T-ALL at the University of Virginia between 2015 and 2020. The primary outcomes were the incidence of thrombosis and bleeding events. All patients received prophylactic AT3 repletion for activity level <60% & cryoprecipitate for fibrinogen <100mg/dL. None received prophylactic anticoagulation. All received prednisone during induction at a median daily dose of 1 mg/kg. Results: We identified 57 patients who received PEG-Asp for ALL. Median age was 32 years (range 18-63). Five patients (8.8%) had a thrombotic event during induction versus five (16%) during post-induction. Four patients (7%) had a bleeding event during induction versus five (10%) during post-induction. The most common type of thrombosis was deep venous thrombosis, with the majority being catheter-associated. Pulmonary embolism and CNS thrombosis were less common. During induction, the median time to thrombotic event was 18 days after last PEG-Asp administration. 60% and 80% of patients received AT3 and cryoprecipitate, respectively. During post-induction, the median time to thrombotic event was 58 days after last PEG-Asp administration. 38% and 63% of the patients received AT3 and cryoprecipitate, respectively. There was one episode of major bleeding during induction and six during post-induction. Conclusions: Though the increase in thrombotic risk in adult patients receiving PEG-Asp is well-characterized, rates of reported thromboses vary widely. Studies examining bleeding risk associated with PEG-Asp regimens are even scarcer and with variable outcomes. There was a significant occurrence of both thrombotic and bleeding events associated with administration of PEG-Asp. More investigation into the relative thrombotic and bleeding risks associated with PEG-Asp is needed to determine optimal antithrombotic interventions in adult patients with ALL.[Table: see text]
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Ajilore, Priscilla Olabimpe, Thomas M. Fishbein, Emily R. Winslow, et al. "The roles of race and social determinants of health in pancreatic adenocarcinoma diagnosis and treatment." Journal of Clinical Oncology 41, no. 16_suppl (2023): e18565-e18565. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.e18565.
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e18565 Background: Pancreatic ductal adenocarcinoma (PDAC) is a significant health crisis in the United States and will soon become the second leading cause of death, despite being the 10th most common cancer. It is also associated with disparities in both incidence and outcomes among racial groups, socioeconomic status (SES), and insurance status.Given the dismal outcomes with advanced stage, early diagnosis is critical. The objective of this study is to evaluate the association of social determinants of health with timeframe to PDAC diagnosis (TPD) at an academic center. Methods: This study was an IRB approved retrospective analysis that utilized chart data from patients that were diagnosed with PDAC at the Georgetown University Lombardi Comprehensive Cancer Center from December 2018 to February 2022. Patient demographics were captured from patient charts. The main outcome of this study was TPD, defined as the number of days that elapsed between first symptom presentation to medical personnel and the date of histologic diagnosis. Secondary outcomes included the frequency of being offered specific cancer treatments. The Kruskal-Willis test was used to evaluate for a difference between median Time to Diagnosis among racial and insurance groups, and the Wilcoxon method used for post-hoc analysis. Results: A total of 200 patients (115 females [57%]; 85 males [43%]) were included in the analysis. There were 111 White (W, 55.5%), 71 African American (AA, 34%), 10 Asian (A, 5%), 3 Hispanic (H, 1.5%) and 5 Unknown (U, 2.5%) patients. AA patients received their diagnosis at a median of 16 [P < 0.0001], and 19 [P = 0.001] days later than W and A patients, respectively. Compared to AA, A patients were more likely to be offered clinical trials (odds ratio [OR], 5.27 [95% CI, 1.19-23.2]). Chemotherapy, surgery, and radiation therapy were offered to patients at similar rates, regardless of their racial group, sex, or insurance status. AA patients presented with unresectable PDAC at higher rates than their counterparts in other racial groups: 66.2% compared to 54% of W and 50% of A patients. There were no statistically significant correlations between health outcome rankings and TPD among patients from Virginia and Maryland. In DC communities with poor health outcome rankings were positively associated with longer TPD, with a Spearman’s correlation coefficient of 0.29 (P < 0.03). Conclusions: This study highlights disparities in TPD among racial groups. Racial groups were offered treatments at similar rates, but AA patients were less likely to be offered clinical trials. Furthermore, geographical locations with lower health outcome ratings experienced longer time to diagnosis. Our findings may inform institutional policymaking and quality measures regarding the allocation of resources to achieve better racial and geographic equities in treatment of patients with PDAC.
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Natarajan, Arjun, Erica Marie Roman Hernandez, SriVyshnavi Ramineni, et al. "Mapping incidence and survival of non-small-cell lung cancers stratified by mutation type in southern Appalachia: A single center retrospective study." Journal of Clinical Oncology 42, no. 16_suppl (2024): e20568-e20568. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.e20568.
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e20568 Background: Non-small cell lung cancer (NSCLC) is often a mutation-driven disease with variability in incidence and survival depending on location as seen in population-based cohort studies. Our study aims to delineate these differences based on molecular testing for these mutations in our study cohort at East Tennessee State University - Quillen College of Medicine, which is based on patients from east Tennessee, western North Carolina, and southwestern Virginia. Methods: We obtained pathology results of 294 patient samples with advanced/metastatic NSCLC from our cancer center/health system database over a 5 year period. PDL-1 was tested in all patients. Fluorescent in-situ hybridization (FISH) testing for common pathogenic driver mutations such as EGFR, ALK, ROS1, RET, MET and PTEN were performed as is standard of care. Molecular sequencing was performed and included over 40 genetic mutations and 2 biomarkers, several of which today are considered targetable for advanced NSCLC, per standard of care. Incidence of different mutations was measured in our patient population. Overall survival was calculated with date of diagnosis available based on pathology report and date of patient expiration obtained from electronic medical records. Data analysis was performed to ascertain which mutations carried an increased risk of death. Results: The TP53 mutation was very common, seen in 85% of squamous cell carcinoma (SCC) histology and 55% of adenocarcinoma. Similarly, incidence of PTEN deletion by FISH was noted to be 52% in SCC and 31% in adenocarcinoma. EGFR mutations were rare, seen in only 3% of tested patients. We had an incidence of KRAS G12C mutations at 11% overall, but it was present in up to 18% of adenocarcinomas. BRAF was seen in 4.8% of all cases, 8% of adenocarcinomas and 2% of SCC. Since there were more than 2 predictors, Cox proportional-hazards regression model was fit. Due to either having all negative values or very few positive values, the variables CCND1, CDKN2B, ERBB2, ERBB4, FGFR, FGFR2, MET, MSI, NRAS, PDGFRA, RET, RS01, SCR were excluded from analysis. A total of 156 samples were used in final analysis. After model building, it was found that BRAF and KRAS G12C mutation were significant predictors of survival by hazard ratios for death. Conclusions: In our unique patient population, there was a greater incidence of deleterious TP53 mutations and PTEN deletions compared to the general North American advanced/metastatic NSCLC population. Although BRAF and KRAS G12C mutations were not at a greater incidence in comparison to the rest of North America, they were notably significant predictors of survival, conferring nearly 3.4 and 2.7 times increased risk of death in our study. [Table: see text]
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Hartzell, Michelle, Laxmi Upadhyay, Rachel Salyer, et al. "Analysis of Inferior Vena Cava Filter Indications and Retrieval Rates at an Academic Medical Center in Appalachia." Blood 142, Supplement 1 (2023): 2322. http://dx.doi.org/10.1182/blood-2023-180247.
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Introduction: Inferior vena cava (IVC) filters are placed for prevention of pulmonary embolism in patients with venous thromboembolism (VTE) and a contraindication to anticoagulation. Additional clinical indications for IVC filters, such as pre-operative prophylaxis for VTE and extensive VTE, are controversial and vary across clinical guidelines. Current guidelines recommend that IVC filters be retrieved after resolution of their clinical indication. A common problem is failure to retrieve IVC filters when indicated, resulting in prolonged or indefinite placement of these devices. Failure to remove IVC filters contributes to an increased risk of filter-associated complications such as device migration, embolization to the cardiopulmonary circulation, perforation and increased risk of deep vein thrombosis (DVT). The goal of this study is to identify IVC filter indications and retrieval statistics at our academic medical center in Appalachia. We seek to compare our performance to national averages, identify the reasons for failure of retrieval in our patient population and develop quality improvement initiatives to improve our performance. Methods: An IRB-approved, single-institution, retrospective chart review was conducted for all patients who had an IVC filter placed between January 2020 and December 2022 at West Virginia University Hospital. Patient demographics, comorbidities, placement indications, retrieval statistics and filter-associated complications were obtained from the electronic medical record (EMR). Patients who had a permanent IVC filter placed were excluded from the final analysis. Statistical analysis was performed using Mann-Whitney U and Chi squared tests where appropriate to compare the retrieval and failure of retrieval groups. Results: The study sample (n=450) had a mean age of 65.3±15.4 years and was comprised of 54.2% males and 45.8% females. West Virginia residents comprised 82.4% of the study sample. The most common reported clinical indications for placement included VTE with a contraindication to anticoagulation (62.4%), preoperative prophylaxis for VTE (15.8%), extensive VTE (15.3%), pharmacomechanical thrombectomy (15.0%) or other (3.1%). The rate of IVC filter retrieval was 25.4% (n=114). The most common reasons for failure of retrieval were loss to follow-up (31.8%), other reasons including provider or patient preference (31.5%), patient death (28.3%), clinical indication remains present (5.7%) and unsuccessful retrieval (2.7%). Patients in the failure of retrieval group (n=114) were significantly older (69 vs 61 years, p&lt;0.001) and had a higher frequency of clinical indications for history of VTE with a contraindication to anticoagulation (231 vs 50 patients, p&lt;0.0001) and extensive VTE (49 vs 20 patients, p&lt;0.0001) compared to retrieval group (n=336). There was a nonsignificant trend toward greater frequency of chronic conditions in the failure of retrieval group including cancer history (101 vs 26 patients, p=0.15), heart failure (44 vs 11, p=0.41) and hypercoagulable disease (16 vs 2 patients, p=0.26). Conclusions: Our institution had a lower IVC filter retrieval rate than the estimated average of 34% reported in a systematic review by Angel et al. Patients with comorbid conditions tended to not undergo retrieval, predisposing them to a higher risk of filter-associated complications. A history of VTE with a contraindication to anticoagulation was the most common clinical indication for placement, but the other most common indications are not universally guideline recommended which identified an area of opportunity for multidisciplinary provider education. Patient loss to follow-up is the predominant reason for failure of retrieval at our institution, which is consistent with the healthcare disparity faced by our predominantly rural, Appalachian patient population of travelling long distances to our tertiary center to obtain specialty care. Quality improvement strategies to mitigate this limitation in the context of IVC filter placement through close local follow-up for timely reassessment, retrieval evaluation and removal will be developed.