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Articles de revues sur le sujet « Survival endpoint »

Auteur : Grafiati

Publié le 9 mars 2023

Mis à jour le 31 juillet 2025

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1

Bensimon, Gilbert. "Survival endpoint: Pro." Amyotrophic Lateral Sclerosis and Other Motor Neuron Disorders 3, sup1 (2002): S35—S36. http://dx.doi.org/10.1080/146608202320374237.

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Rosenfeld, Jeffrey. "Survival endpoint: Con." Amyotrophic Lateral Sclerosis and Other Motor Neuron Disorders 3, sup1 (2002): S37—S39. http://dx.doi.org/10.1080/146608202320374246.

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Meininger, Vincent. "Survival endpoint: Summary." Amyotrophic Lateral Sclerosis and Other Motor Neuron Disorders 3, sup1 (2002): S41—S44. http://dx.doi.org/10.1080/146608202320374255.

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Teuwen, Laure-Anne Marie Nicole, Joanna Alyse Young, Maria Teresa Bourlon, Eva Segelov, and Hans Prenen. "Endpoints reported in phase 3 randomized clinical trials at ASCO 2022." Journal of Clinical Oncology 41, no. 16_suppl (2023): 1570. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.1570.

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1570 Background: The goal of phase 3 randomized clinical trials (RCTs) is to show clinically meaningful benefit for patients. An analysis of phase 3 RCTs presented at the ASCO 2022 Annual Meeting (ASCO22) was undertaken to assess which endpoints were evaluated. Methods: A systematic analysis was undertaken of ASCO22 abstracts from phase 3 RCTs reporting primary, secondary, interim, updated, and subgroup analyses, as well as trials reporting methodology of currently enrolling studies. Trials that reported posthoc, exploratory, biomarker, and retrospective analyses of RCTs were excluded. Informa

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Hahn, Andreas, Andreas Podbielski, Markus M. Heimesaat, Hagen Frickmann, and Philipp Warnke. "Binary surrogate endpoints in clinical trials from the perspective of case definitions." European Journal of Microbiology and Immunology 11, no. 1 (2021): 18–22. http://dx.doi.org/10.1556/1886.2020.00031.

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AbstractIntroductionSurrogate endpoints are widely used in clinical trials, especially in situations where the endpoint of interest is not directly observable or to avoid long trial periods. A typical example for this case is frequently found in clinical trials in oncology, where overall survival (OS) as endpoint of interest and progression free survival (PFS) as surrogate endpoint are discriminated.MethodsBased on the perspective of case definitions on surrogate endpoints, we provide a formal definition of such endpoints followed by a description of the structure of surrogate endpoints.Result

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Schmidt, Rene. "INSP-04. Confirmatory adaptive designs for survival trials with several time-to-event endpoints." Neuro-Oncology 24, Supplement_1 (2022): i187. http://dx.doi.org/10.1093/neuonc/noac079.700.

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Abstract Confirmatory adaptive designs comprise a range of statistical methods that allow to modify the sample size of an ongoing trial in a data-dependent way without compromising control of the type I error rate. For short-term endpoints (e.g., 3-month response rate), comprehensive methodology of adaptive designs exists. However, clinical trials in oncology often have a special focus on long-term outcome and therefore often choose a time-to-event endpoint as the primary endpoint. Typical examples are progression-free survival (PFS) or overall survival (OS). But subtle statistical problems ar

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Narayanan, Siva, Dong Shao, Anshul Shah, and Vidya Ramesh. "Use of intermediate clinical endpoints (ICE) as a primary efficacy endpoint in malignant melanoma." Journal of Clinical Oncology 35, no. 15_suppl (2017): e21075-e21075. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e21075.

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e21075 Background: Melanoma incidence in the US has seen a considerable increase, from 17.8 (1997) to 24.0 (2013) per 100,000, with localized melanoma accounting for 84% of all cases. Early detection and treatment can improve outcomes considerably, resulting in a 99% survival rate. The FDA, within its accelerated approval program, accepts ICE as a primary endpoint, shortening time for patient access to life saving medications. Our objective was to study use of ICE as a primary endpoint for therapies targeting non-metastatic/early-stage malignant melanoma. Methods: A systematic review was condu

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Mushtaq, Muhammad Umair, Moazzam Shahzad, Ezza Tariq, et al. "Use of Endpoints in Phase III Randomized Controlled Trials for Hematopoietic Stem Cell Transplantation over the Last 15 Years: A Systematic Review." Blood 138, Supplement 1 (2021): 4910. http://dx.doi.org/10.1182/blood-2021-146218.

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Abstract Background: The use of objective endpoints is critical for the generalization and clinical implications of a study. Overall survival (OS) has traditionally been used as the gold standard for demonstrating the true clinical benefit of a therapy or intervention. Use of clinically meaningful pre-specified endpoints is essential for a successful clinical trial. In this systemic review, we aimed to investigate different primary and secondary endpoints used in phase III randomized controlled trials (RCTs) for hematopoietic stem cell transplantation (HCT), and their trends over a span of 15

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Buyse, M. E., K. J. Punt, C. H. Köhne, et al. "Endpoints in adjuvant trials: A systematic review of the literature in colon cancer and proposed definitions for future trials." Journal of Clinical Oncology 25, no. 18_suppl (2007): 4018. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.4018.

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4018 Background: Disease-free survival (DFS) is the primary endpoint of most trials testing adjuvant treatments. However many other endpoints are used. There is much confusion about these endpoints since different definitions were used among trials, or no definitions were provided at all. Moreover there is no consensus on either the definition of each endpoint or on the most relevant among these endpoints. This creates difficulties when comparing the results of various trials. Methods: Adjuvant trials in colon cancer were used as a model. A systematic review was performed on published adjuvant

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Hammel, Pascal, Ewa Carrier, Mairead Carney, Mark Eisner, and Thomas Fleming. "A novel event-free survival endpoint in locally advanced pancreatic cancer." Therapeutic Advances in Medical Oncology 13 (January 2021): 175883592110595. http://dx.doi.org/10.1177/17588359211059586.

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The treatment paradigm for locally advanced pancreatic cancer (LAPC) is evolving rapidly. The development of neoadjuvant therapies composed of combination therapies and the evaluation of their impact on conversion to borderline resectable (BR) status, resection, and ultimately overall survival (OS) are presently being pursued. These efforts justify re-visiting study endpoints in order to better predict therapeutic effects on OS, by capturing not only the achievement of R0 resection at the end of induction therapy but also the long-term reductions in the rate of local and distal recurrence. The

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Chen, Tai-Tsang. "Milestone survival (MS): An alternative survival endpoint in cancer immunotherapies." Journal of Clinical Oncology 33, no. 15_suppl (2015): e20004-e20004. http://dx.doi.org/10.1200/jco.2015.33.15_suppl.e20004.

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Uemura, Nariaki, and Shunsuke Ono. "Associations between prognosis and primary endpoint selection in phase III oncology trials in the United States." Journal of Clinical Oncology 42, no. 16_suppl (2024): e23022-e23022. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.e23022.

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e23022 Background: Overall survival (OS) is commonly used as a primary endpoint in phase III oncology trials in the United States, serving as direct evidence of clinical benefit and as an objective outcome measure. Other endpoints such as progression-free survival (PFS) and objective response rate (ORR) are also utilized. Factors such as a cancer type and treatment line are considered important for primary endpoint selection, however, the fundamental factor influencing primary endpoint selection across various cancer types or treatment lines remains unclear. I hypothesize that the prognosis of

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Emura, Takeshi, Casimir Ledoux Sofeu, and Virginie Rondeau. "Conditional copula models for correlated survival endpoints: Individual patient data meta-analysis of randomized controlled trials." Statistical Methods in Medical Research 30, no. 12 (2021): 2634–50. http://dx.doi.org/10.1177/09622802211046390.

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Correlations among survival endpoints are important for exploring surrogate endpoints of the true endpoint. With a valid surrogate endpoint tightly correlated with the true endpoint, the efficacy of a new drug/treatment can be measurable on it. However, the existing methods for measuring correlation between two endpoints impose an invalid assumption: correlation structure is constant across different treatment arms. In this article, we reconsider the definition of Kendall's concordance measure (tau) in the context of individual patient data meta-analyses of randomized controlled trials. Accord

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Gharzai, Laila A., Ralph Jiang, Elizabeth Jaworski, et al. "Candidate surrogate endpoints in advanced prostate cancer: Aggregate meta-analysis of 143 randomized trials." Journal of Clinical Oncology 40, no. 16_suppl (2022): 5039. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.5039.

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5039 Background: The Intermediate Clinical Endpoints (ICEs) in Cancer of the Prostate (ICECaP) working group identified metastasis-free survival as a valid surrogate endpoint for overall survival (OS) for patients with localized prostate cancer. No comparably validated surrogate endpoints for OS exist in advanced prostate cancer. Methods: In this meta-analysis, PubMed was searched for trials in advanced prostate cancer, defined as node positive (N1M0), metastatic castration-sensitive (mCSPC), non-metastatic (M0CRPC), or metastatic castration-resistant prostate cancer (mCRPC). Eligible randomiz

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Knox, Jennifer J. "Progression-free survival as endpoint in metastatic RCC?" Lancet 372, no. 9637 (2008): 427–29. http://dx.doi.org/10.1016/s0140-6736(08)61040-5.

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Yang, Sherry X., John Yu, and Molin Wang. "Abstract LB119: Recurrence score for recurrence over survival outcome in the landmark TAILORx trial." Cancer Research 83, no. 8_Supplement (2023): LB119. http://dx.doi.org/10.1158/1538-7445.am2023-lb119.

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Abstract Overall survival is the most relevant endpoint in clinical research and patient care. Nonetheless, cancer recurrence has been frequently utilized as a surrogate endpoint, particularly in the context of multi-gene assays and molecular signatures. The 21-gene recurrence score (RS) was originally established against distant recurrence for prognosis in breast cancer. However, it is unclear whether RS has a weight for the recurrence over survival prognosis. We investigated RS on the choice of clinical endpoints in the Trial Assigning Individualized Options for Treatment (TAILORx), which ha

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Masson-Lecomte, Alexandra, Victoire Vaillant, Mathieu Roumiguié, et al. "Oncological Outcomes of Distal Ureterectomy for High-Risk Urothelial Carcinoma: A Multicenter Study by The French Bladder Cancer Committee." Cancers 14, no. 21 (2022): 5452. http://dx.doi.org/10.3390/cancers14215452.

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Upper urinary tract urothelial carcinoma (UTUC) is an uncommon disease and its gold-standard treatment is radical nephroureterectomy (RNU). Distal ureterectomy (DU) might be an alternative for tumors of the distal ureter but its indications remain unclear. Here, we aimed to evaluate the oncological outcomes of DU for UTUC of the pelvic ureter. We performed a multicenter retrospective analysis of patients with UTUC who underwent DU. The primary endpoint was 5-year cancer-specific survival (CSS), followed by overall survival (OS), intravesical recurrence-free (IVR) and homolateral urinary tract

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Madariaga, Ainhoa, Rodrigo Sanchez-Bayona, Fernanda G. Herrera, Pedro T. Ramirez, and Antonio González Martín. "Outcomes and endpoints of relevance in gynecologic cancer clinical trials." International Journal of Gynecologic Cancer 33, no. 3 (2023): 323–32. http://dx.doi.org/10.1136/ijgc-2022-003727.

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Drug development is paramount to improve outcomes in patients with gynecologic cancers. A randomized clinical trial should measure whether a clinically relevant improvement is detected with the new intervention compared with the standard of care, using reproductible and appropriate endpoints. Clinically meaningful improvements in overall survival and/or quality of life (QoL) are the gold standards to measure benefit of new therapeutic strategies. Alternative endpoints, such as progression-free survival, provide an earlier measure of the effect of the new therapeutic drug, and are not confounde

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Eaton, Anne, Terry Therneau, and Jennifer Le-Rademacher. "Designing clinical trials with (restricted) mean survival time endpoint: Practical considerations." Clinical Trials 17, no. 3 (2020): 285–94. http://dx.doi.org/10.1177/1740774520905563.

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Background/aims: The difference in mean survival time, which quantifies the treatment effect in terms most meaningful to patients and retains its interpretability regardless of the shape of the survival distribution or the proportionality of the treatment effect, is an alternative endpoint that could be used more often as the primary endpoint to design clinical trials. The underuse of this endpoint is due to investigators’ lack of familiarity with the test comparing the mean survival times and the lack of tools to facilitate trial design with this endpoint. The aim of this article is to provid

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Heller, Glenn, Robert Thomas Mccormack, Thian Kheoh, et al. "Circulating tumor cell (CTC) number as a response endpoint in metastatic castration resistant (mCRPC) compared with PSA across five randomized phase 3 trials." Journal of Clinical Oncology 35, no. 15_suppl (2017): 5007. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.5007.

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5007 Background: Radiographic progression and overall survival (OS) are the traditional clinical benefit measures for mCRPC trials. Reliable indicators of response that occur early are a critical unmet need in practice and clinical research. We explored a week 13 CTC and prostate-specific antigen (PSA) endpoint relative to baseline in 5 prospective randomized phase 3 registration trials that enrolled 5912 pts. OS was the primary endpoint. Methods: CTC number (CellSearch) and PSA values in patients who survived at least 13 weeks were evaluated as response endpoints in COU-AA-301, AFFIRM, ELM-PC

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Grady, Connor B., Yimei Li, Shannon L. Maude, et al. "Inconsistent Reporting and Definition of Time-to-Event Endpoints in CAR T Clinical Trials: A Review of the Literature and a Call for Harmonization." Blood 144, Supplement 1 (2024): 7805. https://doi.org/10.1182/blood-2024-202597.

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Introduction: Clinical trials evaluating chimeric antigen receptor T-cell therapy (CAR T) commonly report time-to-event (TTE) endpoints. However, definitions are not necessarily comparable across studies and variability can lead to misinterpretation of results or inappropriate comparisons across products and studies. Amid the rapidly increasing number of published CAR T trials-many of which were used for regulatory approval-this study aims to summarize the variation in the use and reporting of TTE endpoints in CAR T trials. Methods: We include CAR T trials published January 2008-January 2023 o

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Sherry, Alexander Dean, Avital Miller, Jnana P. Parlapalli, et al. "Overall survival and quality of life superiority in modern phase III oncology trials." Journal of Clinical Oncology 43, no. 16_suppl (2025): 11015. https://doi.org/10.1200/jco.2025.43.16_suppl.11015.

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11015 Background: The use of alternative endpoints, such as progression-free survival, has increased over time in phase III randomized clinical trials (RCTs). However, PFS and other alternative endpoints are often not valid surrogates for overall survival (OS) and quality of life (QOL), and may be less relevant to patients. We sought to determine the proportion of phase III oncology RCTs with OS or QOL superiority. A secondary goal was to evaluate the approach of QOL analyses, since “change-from-baseline” approaches may bias results (Bland and Altman. Trials. 2011;12:264). Methods: We performe

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Buyse, Marc, Everardo D. Saad, Tomasz Burzykowski, Meredith M. Regan, and Christopher S. Sweeney. "Surrogacy Beyond Prognosis: The Importance of “Trial-Level” Surrogacy." Oncologist 27, no. 4 (2022): 266–71. http://dx.doi.org/10.1093/oncolo/oyac006.

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Abstract Many candidate surrogate endpoints are currently assessed using a 2-level statistical approach, which consists in checking whether (1) the potential surrogate is associated with the final endpoint in individual patients and (2) the effect of treatment on the surrogate can be used to reliably predict the effect of treatment on the final endpoint. In some situations, condition (1) is fulfilled but condition (2) is not. We use concepts of causal inference to explain this apparently paradoxical situation, illustrating this review with 2 contrasting examples in operable breast cancer: the

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Tuma, R. "Progression-Free Survival Remains Debatable Endpoint in Cancer Trials." JNCI Journal of the National Cancer Institute 101, no. 21 (2009): 1439–41. http://dx.doi.org/10.1093/jnci/djp399.

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Derek Li, Yuping, Jingqin Rosy Luo, Cierra Grote, et al. "CTIM-24. PHASE II TRIAL OF RHIL-7-HYFC IN PATIENTS WITH HIGH-GRADE GLIOMA DEMONSTRATED ACCEPTABLE SAFETY PROFILE AND REDUCED LYMPHOPENIA." Neuro-Oncology 26, Supplement_8 (2024): viii90—viii91. http://dx.doi.org/10.1093/neuonc/noae165.0357.

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Abstract BACKGROUND Lymphopenia, a common finding in patients with high-grade gliomas (HGGs), is associated with poor outcomes including worse survival, fatigue, and in some cases, increased opportunistic infections. Interleukin-7 (IL-7) is a cytokine crucial for lymphocyte survival and proliferation. We previously demonstrated long-acting IL-7 (rhIL-7-hyFc, efineptakin alfa, NT-I7) increases absolute lymphocyte counts (ALCs) and extends survival in preclinical murine models of HGG. Here, we report results using rhIL-7-hyFc to effectively reduce lymphopenia in patients with HGG. METHODS We per

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Shahzad, Moazzam, Muhammad Arslan, Sibgha Gull Chaudhary, et al. "Use of Endpoints in Phase III Randomized Controlled Trials for Acute Myeloid Leukemia over the Last 15 Years: A Systematic Review." Blood 138, Supplement 1 (2021): 4389. http://dx.doi.org/10.1182/blood-2021-145545.

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Abstract Background: The use of objective endpoints is critical for the generalization and clinical implications of a study. Overall survival (OS) has traditionally been used as the gold standard for demonstrating the true clinical benefit of therapy or intervention. We systematically evaluated the proportion of different primary and secondary endpoints used in phase III randomized controlled trials (RCTs) for acute myeloid leukemia (AML), and their trends over time. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, a comprehensive l

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Le Tourneau, C., S. Michiels, H. Gan, and L. Siu. "Reporting of endpoints and tracking of failures in randomized trials of radiotherapy or concurrent chemoradiotherapy for locally advanced head and neck squamous cell cancer (LA-HNSCC)." Journal of Clinical Oncology 27, no. 15_suppl (2009): 6072. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.6072.

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6072 Background: Due to their anatomical complexity, the interactive effects of multiple treatment modalities, the difficulties in differentiating scar tissues versus residual disease and second cancers versus tumor recurrence, LA-HNSCC represent a challenging disease for the reporting of endpoints and the tracking of failures. Methods: We retrieved all randomized trials that began accrual on or after 1978, and enrolled previously untreated nonmetastatic HNSCC patients receiving primary (chemo)radiotherapy. The reporting of endpoints and the tracking of failures in these trials were analyzed.

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Topkan, Erkan, Yurday Ozdemir, Ahmet Kucuk, et al. "Low Advanced Lung Cancer Inflammation Index Predicts Poor Prognosis in Locally Advanced Nasopharyngeal Carcinoma Patients Treated with Definitive Concurrent Chemoradiotherapy." Journal of Oncology 2020 (October 6, 2020): 1–10. http://dx.doi.org/10.1155/2020/3127275.

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Purpose. We aimed to retrospectively investigate the prognostic worth of pretreatment advanced lung cancer inflammation index (ALI) in locally advanced nasopharyngeal carcinoma (LA-NPC) patients treated with concurrent chemoradiotherapy (C-CRT). Patients and Methods. A total of 164 LA-NPC patients treated with cisplatinum-based definitive C-CRT were included in this retrospective cohort analysis. The convenience of ideal pre-C-CRT ALI cut-offs affecting survival results was searched by employing the receiver operating characteristic (ROC) curve analyses. The primary endpoint was the link betwe

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McCahill, Laurence E., Greg Yothers, Saima Sharif, et al. "A phase II trial of 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) chemotherapy plus bevacizumab (bev) for patients (pts) with unresectable stage IV colon cancer and a synchronous asymptomatic primary tumor: Updated results of NSABP C-10 with definitive survival analysis." Journal of Clinical Oncology 31, no. 4_suppl (2013): 468. http://dx.doi.org/10.1200/jco.2013.31.4_suppl.468.

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468 Background: Surgical resection of asymptomatic primary colon tumor for pts presenting with synchronous yet unresectable metastatic disease is controversial. We published results for the primary endpoint in JCO in September 2012. Here we update the primary endpoint and present definitive survival results. Methods: Eligible pts had ECOG Performance 0 or 1, an asymptomatic colon tumor and unresectable distant metastases. Primary endpoint (PE) was major morbidity, defined as surgical resection or death related to the intact primary tumor. Major morbidity rate of 25% was considered acceptable a

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Sági, Balázs, Tibor Vas, Botond Csiky, Judit Nagy, and Tibor József Kovács. "Does Metabolic Syndrome and Its Components Have Prognostic Significance for Renal and Cardiovascular Outcomes in IgA Nephropathy?" Biomedicines 12, no. 6 (2024): 1250. http://dx.doi.org/10.3390/biomedicines12061250.

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Background: Patients with IgA nephropathy (IgAN), a chronic kidney disease (CKD), are significantly more likely to have cardiovascular (CV) mortality and morbidity than the general population. The occurrence of metabolic syndrome (MetS) and metabolic risk factors are independent risk factors for CV disease and renal progression. The purpose of this study was to determine how metabolic characteristics in a homogeneous population of CKD patients relate to prognosis. Methods: A total of 145 patients with CKD stages 1–4 diagnosed with IgA nephropathy (92 men and 53 women, aged 54.7 ± 13 years) wer

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Vander, M. A., E. A. Lyasnikova, L. A. Belyakova, et al. "Two-year follow-up of patients with heart failure with reduced ejection fraction receiving cardiac contractility modulation." Russian Journal of Cardiology 25, no. 7 (2020): 3853. http://dx.doi.org/10.15829/1560-4071-2020-3853.

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Aim. To assess the 2-year prognosis of patients with heart failure with reduced ejection fraction (HFrEF) receiving cardiac contractility modulation (CCM).Material and methods. This single-center observational study included 55 patients (46 men, mean age 53±11 years) with NYHA class II-III HFrEF receiving optimal medical therapy, with sinus rhythm, QRS <130 ms or QRS<150 ms with nonspecific intraventricular conduction delay. NYHA class II and III were established in 76% and 24% of patients, respectively. All patients were implanted with CCM devices between October 2016 and September 2017

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Kortüm, Martin K., Sebastian Theurich, James Farrell, et al. "Symptomatic Progression Free Survival (SPFS): A New Endpoint for Multiple Myeloma (MM) Combining Patient-Reported Outcomes (PROs) and Progression-Free Survival (PFS)." Blood 144, Supplement 1 (2024): 3322. https://doi.org/10.1182/blood-2024-204074.

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BACKGROUND In other therapy areas, endpoints have been established which combine progression and its impact on patients (pts). An example of this is the ‘time to symptomatic progression’, which is considered pt-relevant in metastatic hormone-sensitive prostate cancer. We sought to combine PROs and PFS to create ‘Symptomatic Progression-Free Survival’ (SPFS), a novel endpoint in MM that allows for a pt-centric analysis of progression. METHODS First, we identified the PROs that are both important to pts and could be expected to be linked to the risk of progression. To do this a systematic litera

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Parimi, Sunil, Soundouss Raissouni, Yongtao Lin, Jose Gerard Monzon, Patricia A. Tang, and Vincent Channing Tam. "Trends in the design and interpretation of metastatic colorectal cancer phase III clinical trials." Journal of Clinical Oncology 33, no. 3_suppl (2015): 692. http://dx.doi.org/10.1200/jco.2015.33.3_suppl.692.

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692 Background: Increasing use of subsequent lines of therapy and crossover in phase III randomized clinical trials (P3 RCTs) has shifted how we perceive the effectiveness of treatments for metastatic colorectal cancer (mCRC). This study aims to characterize the evolution of P3 RCTs in mCRC with respect to clinical trial design and result interpretation. Methods: Abstracts of P3 RCTs of systemic therapy for mCRC conducted between 1980 and 2014 were identified by searching PubMed, Medline, and ASCO abstracts. Data regarding trial design, agent(s) investigated, primary endpoint, secondary endpoi

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Weiss, Emmanuel, Jean-Ralph Zahar, Jeff Alder, et al. "Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-acquired/Ventilator-associated Bacterial Pneumonia Clinical Trials." Clinical Infectious Diseases 69, no. 11 (2019): 1912–18. http://dx.doi.org/10.1093/cid/ciz093.

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Abstract Background Randomized clinical trials (RCTs) in hospital-acquired and ventilator-associated bacterial pneumonia (HABP and VABP, respectively) are important for the evaluation of new antimicrobials. However, the heterogeneity in endpoints used in RCTs evaluating treatment of HABP/VABP may puzzle clinicians. The aim of this work was to reach a consensus on clinical endpoints to consider in future clinical trials evaluating antimicrobial treatment efficacy for HABP/VABP. Methods Twenty-six international experts from intensive care, infectious diseases, and the pharmaceutical industry wer

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Wijngaarde, Camiel A., Marloes Stam, Louise A. M. Otto, et al. "Population-based analysis of survival in spinal muscular atrophy." Neurology 94, no. 15 (2020): e1634-e1644. http://dx.doi.org/10.1212/wnl.0000000000009248.

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ObjectiveTo investigate probabilities of survival and its surrogate, that is, mechanical ventilation, in patients with spinal muscular atrophy (SMA).MethodsWe studied survival in a population-based cohort on clinical prevalence of genetically confirmed, treatment-naive patients with SMA, stratified for best acquired motor milestone (i.e., none: type 1a/b; head control in supine position or rolling: type 1c; sitting independently: type 2a; standing: type 2b; walking: type 3a/b; adult onset: type 4). We also assessed the need for mechanical ventilation as a surrogate endpoint for survival.Result

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Yaeger, Rona, Qian Shi, Amylou C. Dueck, et al. "A randomized trial of consolidation-targeted adjuvant therapy with encorafenib and cetuximab versus usual care for patients with stage II/III BRAF V600E colon cancer: Alliance for Clinical Trials in Oncology A022004." Journal of Clinical Oncology 41, no. 16_suppl (2023): TPS3641. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.tps3641.

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TPS3641 Background: Patients with mismatch repair proficient (pMMR) BRAF V600E mutant high-risk stage II (T4) or stage III colon cancer have a substantial risk of recurrence despite standard adjuvant therapy. In patients with metastatic BRAF V600E mutant colorectal cancer, the combination of the RAF inhibitor encorafenib and the EGFR inhibitor cetuximab has been shown to improve overall and progression-free survival compared to standard therapy after at least one prior line of therapy. This study will evaluate if this combination improves disease-free survival (DFS) in patients with resected B

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Poad, Heather, Sam Khan, Lorna Wheaton, Anne Thomas, Michael Sweeting, and Sylwia Bujkiewicz. "The Validity of Surrogate Endpoints in Sub Groups of Metastatic Colorectal Cancer Patients Defined by Treatment Class and KRAS Status." Cancers 14, no. 21 (2022): 5391. http://dx.doi.org/10.3390/cancers14215391.

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Background and Aim: Findings from the literature suggest that the validity of surrogate endpoints in metastatic colorectal cancer (mCRC) may depend on a treatments’ mechanism of action. We explore this and the impact of Kirsten rat sarcoma (KRAS) status on surrogacy patterns in mCRC. Methods: A systematic review was undertaken to identify randomized controlled trials (RCTs) for pharmacological therapies in mCRC. Bayesian meta-analytic methods for surrogate endpoint evaluation were used to evaluate surrogate relationships across all RCTs, by KRAS status and treatment class. Surrogate endpoints

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Amit, Ohad, Will Bushnell, Lori Dodd, Nancy Roach, and Daniel Sargent. "Blinded Independent Central Review of the Progression‐Free Survival Endpoint." Oncologist 15, no. 5 (2010): 492–95. http://dx.doi.org/10.1634/theoncologist.2009-0261.

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Carlson, Robert H. "Debating Progression-Free versus Overall Survival as a Trial Endpoint." Oncology Times 34, no. 13 (2012): 32–34. http://dx.doi.org/10.1097/01.cot.0000416578.87137.66.

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ZackheimMD, Herschel S. "Overall Survival as an Endpoint in Cutaneous T-Cell Lymphoma." Blood 90, no. 5 (1997): 2117. http://dx.doi.org/10.1182/blood.v90.5.2117.

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Henkel, Gretchen. "Epoetin Alfa Study Amended to Include Survival as Additional Endpoint." Oncology Times 23, no. 7 (2001): 51–52. http://dx.doi.org/10.1097/01.cot.0000313801.47479.b3.

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Roberts, S. A. "Determination of Cell Dose–survival Relationships from Endpoint Dilution Assays." International Journal of Radiation Biology 64, no. 2 (1993): 251–55. http://dx.doi.org/10.1080/09553009314551371.

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Chen, Tai-Tsang. "Milestone Survival: A Potential Intermediate Endpoint for Immune Checkpoint Inhibitors." Journal of the National Cancer Institute 107, no. 9 (2015): djv156. http://dx.doi.org/10.1093/jnci/djv156.

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Holstein, Sarah A., Vera J. Suman, and Philip L. McCarthy. "Should Overall Survival Remain an Endpoint for Multiple Myeloma Trials?" Current Hematologic Malignancy Reports 14, no. 1 (2019): 31–38. http://dx.doi.org/10.1007/s11899-019-0495-9.

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Oulhaj, Abderrahim, Anouar El Ghouch, and Rury R. Holman. "Testing for qualitative heterogeneity: An application to composite endpoints in survival analysis." Statistical Methods in Medical Research 28, no. 1 (2017): 151–69. http://dx.doi.org/10.1177/0962280217717761.

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Composite endpoints are frequently used in clinical outcome trials to provide more endpoints, thereby increasing statistical power. A key requirement for a composite endpoint to be meaningful is the absence of the so-called qualitative heterogeneity to ensure a valid overall interpretation of any treatment effect identified. Qualitative heterogeneity occurs when individual components of a composite endpoint exhibit differences in the direction of a treatment effect. In this paper, we develop a general statistical method to test for qualitative heterogeneity, that is to test whether a given set

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Galle, Peter R. "Abstract IA15: Trial Design and Endpoint Definition in intermediate-stage HCC – a Challenge." Clinical Cancer Research 28, no. 17_Supplement (2022): IA15. http://dx.doi.org/10.1158/1557-3265.liverca22-ia15.

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Abstract Trial Design and Endpoint Definition in general is more complex in hepatocellular carcinoma compared to other solid tumors. It took decades of research until the first systemic treatment was defined in 2007 as a result of the SHARP and the ASIA-Pacific trials. The demonstration of Sorafenib’s anti-tumor efficacy in advanced HCC to a large extend was owing to the concentration on patients with good liver function, avoiding the confounding impact of liver cirrhosis. In intermediate stage HCC trial design is even more challenging: intermediate stage HCC is a heterogeneous disease with a

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Myles, Paul S. "Meaningful Outcome Measures in Cardiac Surgery." Journal of ExtraCorporeal Technology 46, no. 1 (2014): 23–27. http://dx.doi.org/10.1051/ject/201446023.

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The most common cardiac surgical procedures are coronary artery bypass graft surgery and aortic or mitral valve repair or replacement. Underlying conditions include coronary artery disease and heart failure, manifesting as exertional angina, dyspnea, and poor exercise tolerance. The major goals of surgery are to alleviate symptoms and improve patient survival. These, therefore, should inform the choice of primary outcome measures in clinical studies enrolling patients undergoing cardiac surgery. Studies focusing on surrogate outcome measures are relied on all too often. Many are of questionabl

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Duriez, Lucas. "Factors influencing the clinical added value (CAV) in France over more than a decade." Journal of Clinical Oncology 42, no. 16_suppl (2024): e23102-e23102. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.e23102.

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e23102 Background: The rise of cancer drug prices has raised alarm over the need to base pricing decisions on the clinical added value (CAV). The French National Authority for Health (HAS) is responsible for health technology assessment (HTA) in France. For each indication retained for reimbursement, the HAS assesses the CAV on a 5-point scale ranging from I (Major) to V (absence of clinical added value). This assessment is primarily based on medical evidence. The CAV score is one of the factors contributing to price negotiations between the French ministry and pharmaceutical companies. Method

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Ozols, R. F. "Treatment goals in ovarian cancer." International Journal of Gynecologic Cancer 15, Suppl 1 (2005): 3–11. http://dx.doi.org/10.1136/ijgc-00009577-200505001-00002.

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Ovarian cancer remains the number one gynecological killer in the Western world. Most ovarian cancer patients present with advanced-stage disease and are treated with cytoreductive surgery followed by combination chemotherapy. While the majority of patients respond to treatment, most will relapse such that the 5-year survival rates for advanced disease are approximately 20–25%. Overall survival and progression-free survival (PFS) are the primary endpoints in clinical trials in patients with advanced ovarian cancer. In patients with early-stage ovarian cancer, PFS may be the preferred trial end

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Pullen, Matthew F., Katherine Huppler Hullsiek, Joshua Rhein, et al. "Cerebrospinal Fluid Early Fungicidal Activity as a Surrogate Endpoint for Cryptococcal Meningitis Survival in Clinical Trials." Clinical Infectious Diseases 71, no. 7 (2020): e45-e49. http://dx.doi.org/10.1093/cid/ciaa016.

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Abstract Background In cryptococcal meningitis phase 2 clinical trials, early fungicidal activity (EFA) of Cryptococcus clearance from cerebrospinal fluid (CSF) is used as a surrogate endpoint for all-cause mortality. The Food and Drug Administration allows for using surrogate endpoints for accelerated regulatory approval, but EFA as a surrogate endpoint requires further validation. We examined the relationship between rate of CSF Cryptococcus clearance (EFA) and mortality through 18 weeks. Methods We pooled individual-level CSF data from 3 sequential cryptococcal meningitis clinical trials co

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