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RECIST and CHOI criteria in the evaluation of tumor response in patients with metastatic colorectal cancer treated with regorafenib, a prospective multicenter study.

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.

SUBMITTER: Lucidarme O

PROVIDER: S-EPMC6902493 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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RECIST and CHOI criteria in the evaluation of tumor response in patients with metastatic colorectal cancer treated with regorafenib, a prospective multicenter study.

Lucidarme Olivier O Wagner Mathilde M Gillard Paul P Kim Stefano S Bachet Jean-Baptiste JB Rousseau Benoit B Mazard Thibault T Louvet Christophe C Chibaudel Benoist B Cohen Romain R Garcia-Larnicol Marie-Line ML Gobert Aurelien A Henriques Julie J André Thierry T

Cancer imaging : the official publication of the International Cancer Imaging Society 20191209 1

<h4>Background</h4>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).<h4>Methods</h4>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 ou ...[more]

PMID: 31818317

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Project description:BackgroundAxitinib, a selective and potent tyrosine kinase inhibitor of vascular endothelial growth factor receptors, was available to patients from Canada and Australia, prior to regulatory approval of axitinib in these countries, for treatment of clear-cell metastatic renal cell carcinoma (mRCC) after failure of one prior systemic regimen.MethodsThis single-arm, open-label study of axitinib evaluated the efficacy, safety, and quality of life (QoL) in patients with mRCC whose disease progressed after one prior systemic first-line regimen. Primary objective was objective response rate evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) and Choi criteria. Progression-free survival, overall survival, safety, and QoL were secondary end points. Due to the small study size, analyses comprised of descriptive statistics.ResultsFifteen patients were recruited, five from Canada and ten from Australia, over a limited recruitment period. Thirteen patients received sunitinib as prior therapy. All patients had clear-cell carcinoma, eleven had prior nephrectomy. Liver, lung, and lymph nodes were the most frequent sites of metastases; one patient had brain metastasis. Median time on axitinib was 118.0 days (range: 3.5-645.0 days); estimated survival probability at 12 months was 57.8%. Two (13.3%) patients had objective responses per RECIST versus nine (60.0%) per Choi criteria. Six patients had progressive disease based on RECIST versus three per Choi criteria. Nine (60.0%) events of progression or death occurred by the end of study, and three patients continued to receive the study drug. Fatigue (33%) and diarrhea (20%) were the most common grade ≥3 all-causality, treatment-emergent adverse events. The mean change in European Quality of Life - 5 Dimensions score from baseline to end of treatment was -0.0837.ConclusionThe small number of patients and lack of a comparator arm limit the ability to draw definitive conclusions; however, safety and efficacy profiles of axitinib were consistent with reports from previous studies in patients with mRCC, and patients generally maintained QoL. The sizeable difference observed in objective response rate by RECIST versus Choi criteria merits further research.

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RECIST and CHOI criteria in the evaluation of tumor response in patients with metastatic colorectal cancer treated with regorafenib, a prospective multicenter study.

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RECIST and CHOI criteria in the evaluation of tumor response in patients with metastatic colorectal cancer treated with regorafenib, a prospective multicenter study.

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