Journal articles: 'Modified CHOI criteria'

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Smith, Andrew D., Haowei Zhang, Frederico Souza, Manohar Roda, and Alan Penman. "Predicting survival in metastatic RCC on sunitinib using MASS criteria: Evaluation of a large multicentered prospective phase III trial." Journal of Clinical Oncology 31, no. 6_suppl (February 20, 2013): 407. http://dx.doi.org/10.1200/jco.2013.31.6_suppl.407.

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407 Background: The objective of this study is to predict progression-free survival (PFS) and overall survival (OS) in metastatic RCC on sunitinib therapy using initial post-therapy CT imaging changes as a biomarker. Methods: An IRB-approved HIPAA-compliant analysis of CT imaging and survival data from 213 randomly selected patients on sunitinib therapy from a prospective phase III trial of metastatic RCC treated with sunitinib (N=375) versus interferon-alpha (N=375) was performed. Up to 5 target lesions were identified, and response per RECIST 1.1, Choi Criteria, Modified Choi Criteria, and MASS Criteria were made in comparison with the baseline images, while blinded to clinical data. Imaging responses on the first post-therapy CT were associated with PFS and OS by log-rank test, descriptive statistics, and cox proportional hazards models. Results: All criteria had predictive capacity for PFS and OS (log-rank p < 0.0004 each). Only hazard ratios (HRs) of the best and worst response for Modified-Choi (0.60/2.60) and MASS Criteria (0.46/14.8) were both significantly different from the middle category for predicting PFS (p = 0.002/p = 0.008 and p < 0.001/p < 0.001). Only HRs of the best and worst response for RECIST (0.46/9.78) and MASS Criteria (0.56/7.18) were both significantly different from the middle category for predicting OS (p = 0.007/p < 0.001 and p = 0.001/ p <0.001). The overall accuracy for detecting a good clinic outcome (PFS > 250 days) was 51% for RECIST, 62% for Choi Criteria, 67% for Modified Choi Criteria, and 76% for MASS Criteria. The overall accuracy for detecting a poor clinical outcome (PFS<250 days) was 58% for RECIST, 57% for Choi Criteria, 58% for Modified Choi Criteria, and 58% for MASS Criteria. Conclusions: MASS Criteria had the best overall accuracy for predicting PFS and OS in metastatic RCC on sunitinib therapy.

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Baheti, Akshay D., Ashita Rastogi, Aravintho Natarajan, Anurima Patra, and Sree Harsha Tirumani. "Tumor Response Criteria in Oncoimaging: RECIST Criteria and beyond—Part 2." Journal of Gastrointestinal and Abdominal Radiology 02, no. 02 (August 6, 2019): 107–15. http://dx.doi.org/10.1055/s-0039-1692016.

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AbstractThe rapid recent advances in oncology have made the dream of precision oncology a reality, with targeted therapy available for various tumors depending on the molecular genotype. This has led to the corresponding development of personalized radiology as well, with various tumor response criteria used to characterize disease response/progression depending on chemotherapy used. In these two review articles, we review the various tumor response criteria widely applied in both research and clinical settings. These include the classic size-based criteria such as RECIST (Response Evaluation Criteria In Solid Tumors) 1.1 and the WHO (World Health Organization) criteria, as also various other criteria such as Choi and modified Choi criteria for tumors treated by targeted therapy, EASL (European Association for the Study of the Liver) and modified RECIST (mRECIST) criteria for hepatocellular carcinomas, immune-related response criteria (irRC) and immune RECIST (iRECIST) for patients on immunotherapy. Other clinically important criteria such as PERCIST (PET Response Criteria In Solid Tumors) for positron emission tomography–computed tomography (PET-CT), and the MD Anderson criteria for evaluating bone metastases are also highlighted.

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Rastogi, Ashita, Akshay D. Baheti, Anurima Patra, and Sree Harsha Tirumani. "Tumor Response Criteria in Oncoimaging: RECIST Criteria and beyond—Part 1." Journal of Gastrointestinal and Abdominal Radiology 02, no. 02 (July 22, 2019): 098–106. http://dx.doi.org/10.1055/s-0039-1692021.

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AbstractThe rapid recent advances in oncology have made the dream of precision oncology a reality, with targeted therapy available for various tumors depending on the molecular genotype. This has led to the corresponding development of personalized radiology as well, with various tumor response criteria used to characterize disease response/progression depending on chemotherapy used. In these two review articles, we review the various tumor response criteria widely applied in both research and clinical settings. These include the classic size-based criteria such as RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 and the WHO (World Health Organization) criteria, as also various other criteria such as Choi and modified Choi criteria for tumors treated by targeted therapy, EASL and modified RECIST (mRECIST) criteria for hepatocellular carcinomas, and immune-related response criteria (irRC) and immune RECIST (iRECIST) for patients on immunotherapy. Other clinically important criteria such as PERCIST (PET Response Criteria In Solid Tumors) for positron emission tomography–computed tomography (PET-CT) and the MD Anderson criteria for evaluating bone metastases are also highlighted.

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Patt, Richard H., David H. Kirn, Caroline Breitbach, James M. Burke, and Riccardo Lencioni. "Imaging approaches to assess mechanism-of-action and response in patients with advanced hepatocellular carcinoma treated with the novel oncolytic poxvirus JX-594." Journal of Clinical Oncology 31, no. 4_suppl (February 1, 2013): 210. http://dx.doi.org/10.1200/jco.2013.31.4_suppl.210.

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210 Background: The novel oncolytic virus JX-595 has demonstrated anti-cancer mechanisms of action, as defined in preclinical models, which includes cytolysis, intra-tumoral vascular disruption, and immune-mediated tumor targeting. Methods: To determine whether mechanism(s) of action (MOA) of the novel anti-cancer oncolytic virus JX-594 could be demonstrated by MRI imaging in patients with advanced hepatocellular carcinoma (HCC), dynamic contrast-enhanced MRI of the liver was performed at baseline, day 5, and week 8 following intra-tumoral injection. Images were evaluated by a central reviewer blinded to treatment and dose using both modified RECIST and Choi response criteria. 17/30 subjects underwent day 5 (D5) post-treatment imaging; 28/30 had week 8 (W8) imaging. Results: Choi responses correlated more reliably than RECIST with JX-594 MOA. Evidence of intra-tumoral vascular shutdown, manifest by areas of reduced or non-enhancement (Choi response), was observed in 6 of 17 subjects on D5 5 MRI scans. Day 5 Choi responses were a predictor of week 8 Choi responses in all but 1 subject. Of the 11/17 D5 Choi non-responders, 3 were Choi responders at 8 weeks. Increase in size at D5 of small lesions present at baseline (“unmasking”) is compatible with oncolytic flare due to intra-tumoral edema contributed to by cell lysis and immune infiltration. RECIST criteria tumor measurements did not identify MOA of JX-594, and resulted in the appearance of pseudoprogression at D5 in some subjects. Conclusions: Hyperacute MRI post-therapy can be used to detect activity of the JX-594, a novel oncolytic anti-cancer therapy. Day 5 Choi responses were a predictor of subsequent response at week 8. Clinical trial information: NCT00554372.

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Nathan, P. D., A. Vinayan, D. Stott, and V. Goh. "CT response assessment combining reduction in size and arterial enhancement correlates with time to progression in metastatic renal cancer patients treated with TKIs." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): e16062-e16062. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e16062.

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e16062 Background: Targeted therapy is now the standard of care in advanced Renal Carcinoma (RCC). Response assessment by RECIST criteria is insensitive as treated tumours often have only a modest change in size despite the induction of significant necrosis and does not correlate with time to progression (TTP). The Choi criteria (10% size reduction or 15% contrast enhancement reduction) are routinely used in the assessment of GIST tumours treated with targeted agents. We report the use of combined size and density assessment in RCC metastases treated with either sunitinib or cediranib. Methods: CT scans from 32 patients with metastatic RCC treated with either sunitinib (18) or cediranib (14) were assessed. Scans from 10 patients were not evaluable as non-contrast enhanced scans were performed due to impaired renal function. Scans from a further 2 patients were excluded as they ceased treatment due to toxicity rather than progression. Scans from 20 evaluable patients at baseline and 12 weeks on treatment were assessed using RECIST, Choi, and modified criteria in which both a 10% decrease in size and 15% decrease in enhancement in the arterial phase were required to define a response (PR). A total of 60 lesions were assessed. Response assessment was performed using each of the three methods and correlated with time to disease progression (itself RECIST defined). Statistical analysis was performed using the Mann-Whitney U test. Results: There was no difference in TTP between RECIST defined PR (346.8 days) and SD (328.5 days) (P=0.965). TTP in Choi defined PR (358.4 days) and SD (189.6 days) groups showed improved but non-significant separation of TTP duration (P=0.266). TTP in PR (421.5 days) and SD (200.3 days) groups defined by a combined assessment of reduction in size and enhancement showed greatly improved separation (P=0.064). Conclusions: A combined reduction in both size and arterial phase enhancement of RCC metastases treated with TKIs correlates with time to progression. RECIST and standard Choi criteria appear inferior. No significant financial relationships to disclose.

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Lamuraglia, M., S. Raslan, R. Elaidi, S. Oudard, B. Escudier, K. Slimane, R. Renard Penna, M. Wagner, and O. Lucidarme. "mTOR-inhibitor treatment of metastatic renal cell carcinoma: contribution of Choi and modified Choi criteria assessed in 2D or 3D to evaluate tumor response." European Radiology 26, no. 1 (May 8, 2015): 278–85. http://dx.doi.org/10.1007/s00330-015-3828-7.

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Stacchiotti, Silvia, Paolo Verderio, Antonella Messina, Carlo Morosi, Paola Collini, Antonio Llombart-Bosch, Javier Martin, et al. "Tumor response assessment by modified Choi criteria in localized high-risk soft tissue sarcoma treated with chemotherapy." Cancer 118, no. 23 (May 17, 2012): 5857–66. http://dx.doi.org/10.1002/cncr.27624.

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McNamara, Mairead Geraldine, Anne M. Horgan, Alex Aspinall, Eric Xueyu Chen, Kelly Burak, Neesha C. Dhani, Jennifer Petronis, et al. "A phase II trial of second-line axitinib following prior antiangiogenic therapy in advanced hepatocellular carcinoma (HCC)." Journal of Clinical Oncology 31, no. 4_suppl (February 1, 2013): 314. http://dx.doi.org/10.1200/jco.2013.31.4_suppl.314.

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314 Background: Second-line options in treatment of HCC are limited. Axitinib is a multi-targeted tyrosine kinase inhibitor (TKI) of VEGFRs 1, 2, and 3, PDGFR and c-KIT that warrants exploration in HCC. Methods: This is an open-label, single-arm, two-stage phase II trial of axitinib in advanced HCC. Eligible patients (pts) are Child-Pugh A/B7, with measurable progressive disease after TKIs/antiangiogenic drugs. Axitinib starts at 5 mg bid orally, titrated to 10 mg bid as tolerated. Treatment continues to progression (PD) or intolerable toxicity. Primary endpoint is response defined by reduction in size by RECIST 1.1 on CT scan at 16 wks, secondary endpoints to compare response by RECIST 1.1 to Choi criteria and modified RECIST, explore dynamic imaging models, feasibility, safety, PFS and overall survival. Results: We present results of 15 (of 29) pts enrolled from 01/11 - 09/12. Median age; 62y (range 18-78) with ECOG PS 0 (5 pts), 1 (10 pts) with prior therapy of Temsirolimus/Bevacizumab (2 pts), sorafenib (13 pts). A planned safety/futility interim analysis was passed. Most common axitinib-related AEs were hypertension (HTN) (60%), hand-foot skin reaction (HFSR) (60%), diarrhea (60%), fatigue (50%). Most common axitinib-related grade 3 (G3) AEs were HTN (20%) and diarrhea (20%). There were no G3 HFSR. There was 1 G4 hyperbilirubinaemia. 60% of pts had dose interruptions due to AEs; most common reasons included fatigue (20%), HTN (10%), and HFSR (10%). 20% required dose reductions, 14% of pts tolerated dose escalation above 5 mg bid. As of 09/12, 8 pts remain on study, 7 pts discontinued (4pts: PD, 3pts: AEs). Med duration of treatment; 4.0 mo (range 6 d - 15.5 mo). Out of 9 evaluable for response, there was 1 confirmed PR per RECIST 1.1; 3 other pts had tumor reduction; 10%, 22%, 23%, 2 PR by Choi criteria and none by modified RECIST. Early on-treatment perfusion changes were noted on functional imaging. Of the 9 pts with evaluable AFP response, 3 (33%) had >50% decrease from baseline. 11 pts are still alive, 4 pts are deceased secondary to PD. Conclusions: Axitinib is tolerated and has shown preliminary efficacy in this VEGF pretreated HCC pt population.This is early analysis and updated data will be presented. Clinical trial information: NCT01334112.

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Ragab, A. R., S. N. Samy, and Ch A. R. Saleh. "Prediction of Central Bursting in Drawing and Extrusion of Metals." Journal of Manufacturing Science and Engineering 127, no. 3 (June 23, 2004): 698–702. http://dx.doi.org/10.1115/1.1961982.

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In this work central bursting in drawing and extrusion of metals is investigated. The analysis is based on a modified stress distribution within the die zone due to Shield (Shield, R. T., 1955, J. Mech. Phys. Solids, 3, pp. 246–258) together with Gurson–Tvergaard’s yield function (Tvergaard, V., 1981, Int. J. Fract., 17, pp. 389–407) and its associated flow rule for voided solids. The effects of hardening and evolution of void shape on void growth are considered. Various fracture criteria are employed to predict the process conditions at which central bursting occurs. The first criterion is due to Avitzur (Avitzur, B., 1968, ASME J. Eng. Ind., 90, pp. 79–91 and Avitzur, B., and Choi, J. C., 1986, ASME J. Eng. Ind., 108, pp. 317–321), the second and simplest criterion is based on vanishing mean stress while a suggested third criterion depends on the current value of the void volume fraction. Two other criteria which are basically due to Thomason’s internal necking condition (Thomason, P. F., 1990, Ductile Fracture of Metals, Pergamon, Oxford) as well as McClintock’s shear band formation criterion are applied (McClintock, F. A., Kaplan, S. M., and Berg, C. S., 1966, Int. J. Fract. Mech., 2, p. 614, and McClintock, F. A., 1968, in Ductility, ASM, Metals, Park, OH). The critical process conditions are predicted and compared with the available experimental data. Comparison showed that predictions based on the vanishing mean stress and the current void volume fraction criteria are closer to experiments than those based on Thomason’s internal necking and McClintock criteria.

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Ronot, Maxime, Mohamed Bouattour, Johanna Wassermann, Onorina Bruno, Chantal Dreyer, Béatrice Larroque, Laurent Castera, et al. "Alternative Response Criteria (Choi, European Association for the Study of the Liver, and Modified Response Evaluation Criteria in Solid Tumors [RECIST]) Versus RECIST 1.1 in Patients With Advanced Hepatocellular Carcinoma Treated With Sorafenib." Oncologist 19, no. 4 (March 20, 2014): 394–402. http://dx.doi.org/10.1634/theoncologist.2013-0114.

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Gavanier, M., A. Ayav, C. Sellal, X. Orry, M. Claudon, J. P. Bronowicki, and V. Laurent. "CT imaging findings in patients with advanced hepatocellular carcinoma treated with sorafenib: Alternative response criteria (Choi, European Association for the Study of the Liver, and modified Response Evaluation Criteria in Solid Tumor (mRECIST)) versus RECIST 1.1." European Journal of Radiology 85, no. 1 (January 2016): 103–12. http://dx.doi.org/10.1016/j.ejrad.2015.10.024.

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Niu, Xiaohui, Feng Wei, Chongqi Tu, Gang Huang, Wenzhi Bi, Jianmin Li, Weitao Yao, et al. "Efficacy and safety of JMT103 in patients with giant cell tumor of bone: A multicenter, single-arm, open-label, phase Ib/II study." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): 11526. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.11526.

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11526 Background: JMT103 is a novel, fully humanized IgG4 monoclonal antibody targeting RANKL, inhibiting osteoclastogenesis and osteoclast-mediated bone resorption. A multicenter, single-arm, open-label, phase Ib/II study was conducted to evaluate the efficacy and safety of JMT103 in patients (pts) with Giant cell tumor of bone (GCTB). Methods: Eligible pts (ECOG: 0-2) were adults with pathologically confirmed unresectable GCTB or their planned surgery is associated with severe morbidity. Pts with active dental or jaw condition requiring oral surgery, other anti-tumor therapies, anti-RANKL antibody or concurrent use of bisphosphonates were excluded. 2 mg/kg JMT103 was administrated subcutaneously every 4 weeks with a loading dose on days 8 and day 15 of the first 4 week of therapy. The primary endpoint was tumor response, defined as elimination of at least 90% giant cells or objective response of the target lesion assessed by radiologic imaging as per Modified Inverse Choi density/size (ICDS) or the Modified European Organization for Research and Treatment of Cancer (EORTC) criteria within 12 weeks. Secondary endpoints included safety profile, change of pain score using Brief Pain Inventory-Short Form, and suppression of bone-resorption biomarkers. Results: 38 pts (14 males) were enrolled between June 3 and December 24, 2020. The median age was 31 years (range 18-57). Lesions sites included lower extremities (39.5%), upper extremities (31.6%), spine (21.1%) and pelvis (13.2%). Among 32 pts with at least 1 efficacy evaluation within 12 weeks, 26 (81.3%, 95% CI: 63.6-92.8) had a tumor response by at least one response criteria. All 7 pts who underwent histological assessments had a tumor response. 25 of 32 pts assessed by radiology had a tumor response. As per ICDS criteria, 23 of 32 (71.9%) had a response; as per EORTC criteria, 15 of 17 (88.2%) had a response. 21 of 26 (80.8%) pts who complained of pain at baseline experienced reduced pain during the treatment. The median reductions in bone-resorption biomarkers were 71.8% (IQR 67.7-82.4) for uNTx/Cr (p < 0.001) and 81.4% (IQR 68.3-84.7) for sCTx (p < 0.001) at day 8. Of all 38 pts who were included in safety analyses, treatment-related adverse events (TRAEs) occurred in 14 pts. The most common TRAEs were hypophosphatemia (18.4%), hypocalcemia (7.9%) and blood bilirubin increased (7.9%). 1 patient (2.6%) was reported a grade 3 AE but it was not related to the treatment; other AEs were grade 1–2. Conclusions: JMT103 demonstrated encouraging anti-tumor efficacy and manageable safety profile in pts with unresectable GCTB or at high risk of severe morbidity after surgery. Clinical trial information: NCT04255576.

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Esser, Michael, Cristopher Kloth, Wolfgang M. Thaiss, Christian P. Reinert, Mareen S. Kraus, Gabriel CC Gast, and Marius Horger. "CT-morphologic and CT-textural patterns of response in inoperable soft tissue sarcomas treated with pazopanib—a preliminary retrospective cohort study." British Journal of Radiology 92, no. 1103 (November 2019): 20190158. http://dx.doi.org/10.1259/bjr.20190158.

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Objective: To analyze patterns of response in soft tissue sarcomas exposed to pazopanib using CT-morphologic and textural features and their suitability for evaluating therapeutic response. Methods: Retrospective evaluation of CT response and texture patterns in 33 patients (23 female; mean age: 61.2 years, range, 30–85 years) with soft tissue sarcomas treated with pazopanib from October 2008 to July 2017. Response evaluation was based on modified (m)CHOI-criteria and RECISTv.1.1 and classified as partial response (PR), stable disease (SD), progressive disease (PD). The following CT-texture (CTTA)-parameters were calculated: mean, entropy and uniformity of intensity/average/skewness/entropy of co-occurrence matrix and contrast of neighboring-gray-level-dependence-matrix. Results: Following mCHOI-criteria, 12 patients achieved PR, 7 SD and 14 PD. As per RECISTv.1.1 9 patients obtained PR, 9 SD and 15 PD. Frequent patterns of response were tumor liquefaction and necrosis (n=4/33, 12.1% each). Further patterns included shrinkage and cavitation (n=2/33, 6.1% each). In responders, differences in mean heterogeneity (p=0.01), intensity (p=0.03), average (p=0.03) and entropy of skewness (p=0.01) were found at follow-up whereas in non-responders, CTTA-parameters did not change significantly. Baseline-CTTA-features differed between responders and non-responders in terms of uniformity of skewness (p=0.045). Baseline-CTTA-parameters did not correlate with any morphologic response pattern. Conclusion: Most frequent patterns of response to pazopanib were tumor liquefaction and necrosis. Single CT-textural features show strong association with the response to pazopanib—although limited in relation to specific response patterns. Advances in knowledge: Tumor liquefication and necrosis are important patterns of response to pazopanib. CT-texture analysis has limited associations with specific response patterns.

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Khan, Khurum Hayat, Mihaela Rata, Dow-Mu Koh, Nina Tunariu, David J. Collins, Ian Chau, David J. Watkins, et al. "A prospective translational study investigating molecular predictors of resistance and response to regorafenib (REG) monotherapy in RAS mutant (mt) metastatic colorectal cancer (mCRC): Initial magnetic resonance imaging (MRI) sub-study result." Journal of Clinical Oncology 34, no. 4_suppl (February 1, 2016): 580. http://dx.doi.org/10.1200/jco.2016.34.4_suppl.580.

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580 Background: REG that has single agent efficacy in patients (pts) with refractory mCRC, is known to have anti-angiogenic activities. The benefit of REG in unselected pts is modest. Thus, the identification of predictive biomarkers is critical for treatment stratification. PROSPECT-R study aims to identify genetic and radiological mechanisms of primary and acquired REG resistance in RAS mt mCRC patients. Methods: Multiparametric MRI studies including dynamic contrast enhancement (DCE)-MRI and diffusion weighted imaging (DWI) were acquired pre- and at day 15 post-treatment on a 1.5T Siemens Avanto MR scanner. Regions of interest of the entire chosen target metastatic lesion were drawn by a senior radiologist and the following imaging parameters were generated: volume transfer constant (Ktrans) derived from a pharmacokinetic analysis based on the extended Kety model and apparent diffusion coefficient (ADC) calculated using a mono-exponential fitting algorithm; median values of ADC and Ktrans were reported. Results: The first seven enrolled pts were analysed; a single target lesion per patient was chosen (5 liver and 2 pelvic metastases). At day 15 post treatment, a marked decrease (68-81%) of median tumour Ktrans was observed in 4 out of 7 pts; the remaining 3 patients showed no significant median Ktrans change (-36 to + 17%). Overall, the cohort average Ktrans decreased from 0.17 to 0.07 min-1(58%). No significant ADC changes were observed at day 15. Of the 4 pts with Ktrans reduction on day 15, 1 achieved RECIST 1.1 partial response (38% reduction in target lesions), 2 had stable disease and 1 progressed, based on CT assessments performed at 8 weeks of REG therapy; 3/7 pts with no Ktrans change progressed within 2 months of initiating REG. When modified Choi criteria were applied, 3/4 pts with Ktrans reduction were classified as responders. Conclusions: REG may have early anti-angiogenic affects; DCE-MRI could be a potential predicting biomarker in pts treated with REG. Further analysis within PROSPECT-R may elucidate genetic biomarkers to validate these findings. Clinical trial information: EUDRACT No: 2014- 003579-51.

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Ramanathan, Ramesh K., Peter Lee, Joseph W. Leach, Stephen Patrick Anthony, Glen J. Weiss, Peter J. Rosen, Vincent J. Picozzi, et al. "Phase II study of induction therapy with gemcitabine and nab-paclitaxel followed by consolidation with mFOLFIRINOX in patients with metastatic pancreatic cancer." Journal of Clinical Oncology 31, no. 4_suppl (February 1, 2013): 233. http://dx.doi.org/10.1200/jco.2013.31.4_suppl.233.

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233 Background: We designed a phase II study to evaluate the efficacy, toxicity and feasibility of administering nab-paclitaxel/gemcitabine (NabP-Gem) followed by mFOLFIRINOX in MPC. Methods: Eligible patients had evidence of untreated MPC with performance status of ECOG 0-1 and adequate organ function. Induction therapy was with Nab-P (125 mg/m2) and Gem (1000 mg/ m2) weekly x 3 every 4 weeks for a maximum of 6 months (6 cycles). mFOLFIRINOX every 2 weeks (Consolidation regimen) was initiated after 6 cycles of the Induction regimen, or earlier in case of progression, and given upto 6 months (12 cycles). The FOLFIRINOX regimen (NEJM,364:1817-25: 2011) was modified to omit the bolus 5FU and requires addition of granulocyte growth factor prophylaxis. A primary endpoint is to increase 1 year survival (n=30) to >70%, (95% confidence intervals for one year survival rate is +/- 20%). Results: As of 9/1/2012, 26 of 30 subjects have been accrued. M/F ratio is 58%/42%, median is 65 years. In 20 patients treated on the induction phase, 75% have a > 90% decrease in CA 19-9 levels. The partial response rate (PR) in the first 19 patients who have completed 4 cycles is 50%. Early image analysis on 9 subjects with concurrent CT and PET showed 44% PR (RECIST 1.1) but 89% by CHOI and PET criteria. A novel approach to interrogate tumor texture composition demonstrated substantial change in lesion texture following induction therapy. To date selected Grade > 3 adverse events are neutropenia (n=8), fatigue (n=5), thromboembolic events (n=4), peripheral neuropathy (n=3), dehydration (n=2), anemia (n=3), thrombocytopenia (n=2), febrile neutropenia (n=2) and myalgias (n=2). Among 26 patients who have received at least one cycle of NabP-Gem, ten dose reductions and four dose delays were seen. To date, 11 patients have begun the Consolidation regimen with mFOLFIRINOX. Conclusions: The induction NabP-Gem regimen shows preliminary evidence of substantial activity similar to published reports (JCO.29:4548-54: 2011). Study will now evaluate the safety, efficacy and feasibilty of the Consolidation regimen with mFOLFIRINOX. Supported by the Seena Magowitz Foundation. Clinical trial information: NCT01488552.

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Lucidarme, O., M. Lamuraglia, B. Escudier, A. Ravaud, F. Rolland, C. Chevreau, S. Negrier, B. Duclos, K. Slimane, and S. Oudard. "Interest of CHOI and modified CHOI criterion for evaluation of metastatic renal cell carcinomas (mRCC) patients treated with Everolimus." Cancer Imaging 11, no. 1A (2011): S41—S42. http://dx.doi.org/10.1102/1470-7330.2011.9052.

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Lamuraqlia, M., S. Oudard, B. Escudier, A. Ravaud, F. Rolland, C. Chevreau, S. Negrier, B. Duclos, K. Slimane, and O. Lucidarme. "1400 POSTER DISCUSSION Interest of CHOI and Modified CHOI Criterion for Evaluation of Metastatic Renal Cell Carcinomas (mRCC) Patients Treated With Everolimus." European Journal of Cancer 47 (September 2011): S169. http://dx.doi.org/10.1016/s0959-8049(11)70893-0.

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Lucidarme, Olivier, Mathilde Wagner, Paul Gillard, Stefano Kim, Jean-Baptiste Bachet, Benoit Rousseau, Thibault Mazard, et al. "RECIST and CHOI criteria in the evaluation of tumor response in patients with metastatic colorectal cancer treated with regorafenib, a prospective multicenter study." Cancer Imaging 19, no. 1 (December 2019). http://dx.doi.org/10.1186/s40644-019-0271-z.

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Abstract Background To evaluate the objective response rate (ORR) at 2 months of treatment with regorafenib according to RECIST 1.1, Choi, and modified Choi (mChoi) criteria in patients with metastatic colorectal cancer (mCRC). Methods Baseline and 2-month contrast-enhanced computed-tomography (CECT) scans of 55 patients with mCRC, prospectively enrolled in phase II TEXCAN trial, were centrally assessed. The primary endpoint was 2-month ORR by RECIST 1.1, Choi, and mChoi criteria. Final outcome was overall survival (OS). Results Of 55 patients included in this study (Intention-to-treat [ITT1] population), 35 had CECT at 2 months (ITT2 population). According to RECIST 1.1 criteria, 20 (57%) patients were SD and 15 were PD (43%) in the ITT2 population. According to Choi criteria, 18 (51%) patients were responders and 17 (48%) were non-responders. Median OS was 5.3 months (95% CI 3.7–8.6) in the ITT1 population and 8.9 months (95% CI 5.1–12.6) in the ITT2 population. In the ITT2 population, median OS was 16 months (95% CI 6.6–17.5) in SD patients (n = 20) and 4.6 months (95% CI 3.3–5.8) in PD patients (n = 15), according to RECIST 1.1 criteria (HR = 6.48). Median OS was 7.9 months (95% CI 4.2–17.5) in responders (n = 18) and 9.9 months (95% CI 3.7-NA) in non-responders (n = 17) according to Choi criteria (HR = 1.06). All patients except one were classified as non-responders with mChoi criteria. Conclusion At 2 months, unlike RECIST 1.1, Choi and mChoi criteria could not identify mCRC patients with regorafenib survival benefit. Trial registration ClinicalTrials.gov Identifier: NCT02699073.Registered March 4, 2016, Retrospectively registered.

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Dunn, Julia Passyn, Bidhan Lamicchane, Todd Braver, Tamara Hershey, and Samuel Klein. "SAT-LB59 Functional MRI Study: Weight Loss Induced Changes in Taste Receipt-Induced Activation in the Striatum and Hypothalamus." Journal of the Endocrine Society 4, Supplement_1 (April 2020). http://dx.doi.org/10.1210/jendso/bvaa046.2262.

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Abstract Background: Reward behaviors including those related to eating are influenced by output from the ventral striatum (VS), dorsal striatal [caudate(Cau) and putamen(Put)]and hypothalamus (HTH). We hypothesized that weight loss would induce modifications in activation in these regions of interest (ROI) during a consummatory reward task. Methods: We recruited metabolic abnormal obese (MAO) from the VA St.Louis Health Care System and Washington University in St.Louis (WUSTL). MAO was screened for by fasting insulin and plasma glucose, 2 hour 75 gram OGTT, and hemoglobin A1c. MAO was defined as prediabetes by ADA criteria and/ or elevated HOMA-IR. Functional magnetic resonance imaging (fMRI) scanning sessions were completed at the WUSTL Center for Clinical Imaging Research. A rapid event-related design was used to randomly deliver taste of chocolate milk (choc) or tasteless water (wat). Each taste receipt was proceeded by a cue of corresponding image of chocolate milk or a glass of water. A total of 5 runs, each with 24 trials were completed. Imaging analyses included preprocessing with fMRIprep including censoring excessive motion ≥ 0.5mm. Single subject GLM analyses were completed in AFNI. ROIs were designated bilaterally (lt and rt) except for HTH. A canonical HRF was applied to the food cue event and the AFNI tent function over 9 TRs was applied to the taste receipt event. To evaluate for an effect of weight loss (WL) on food cue and taste receipt-induced activation, repeated measures ANOVA for each region was completed with condition (choc or wat) as a covariate. Also in the model for taste receipt, repetition time (TR) was included as a covariate. Results reported as F(sign.). Results: Ten participants achieved at least 7% WL, (range 7-15%), 44±8 years, BMI 38±4kg/m2, f/m 4/6, fasting pg 105±11, 2 hour OGTT pg 132 ±49 mg/dL, HOMA-IR 3.9±1.8. One participant fulfilled criteria for T2D. For taste receipt several significant effects were found for WL: Cau_lt WL 5.9(0.02) and WL*TR 4.9(0.03), Cau_rt WL 8.6(0.004) and WL*TR 8(0.005), Put_lt WL 8.5(0.004), HTH WL*condition 5.4(0.02) and a trend for WL 3.3(0.07). All other comparisons were non-significant including all in the VS and all for food cue. Conclusions: Moderate weight loss in MAO modified taste receipt-induced activation in the Cau, Put, and HTH but not in the VS.

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Journal articles on the topic 'Modified CHOI criteria'

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