| 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. |
Institut de Recherche en Cancérologie de
