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

Olivier Lucidarme, Mathilde Wagner, Paul Gillard, Stefano Kim, Jean-Baptiste Bachet, Benoit Rousseau, Thibault Mazard, Christophe Louvet, Benoist Chibaudel, Romain Cohen, Marie-Line Garcia-Larnicol, Aurelien Gobert, Julie Henriques, Thierry André, Olivier Lucidarme, Mathilde Wagner, Paul Gillard, Stefano Kim, Jean-Baptiste Bachet, Benoit Rousseau, Thibault Mazard, Christophe Louvet, Benoist Chibaudel, Romain Cohen, Marie-Line Garcia-Larnicol, Aurelien Gobert, Julie Henriques, Thierry André

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.

Keywords: Colorectal cancer; Computed tomography; Tumor response.

Conflict of interest statement

Some authors of this manuscript declare relationships with the following companies:

- OL: Roche, Bracco, Siemens and Intrasense.

- JBB: Amgen, Bayer, Merck Serono, Pierre Fabre, Roche, Sanofi, Servier.

- BR: Bayer, Servier, Roche, Novartis, Astellas, Gilead, Abbvie.

- TM: ROCHE and AMGEM, Sanofi, Bayer, BMS.

- CL: MSD, Roche, Halozyme, Servier, Astra-Zeneca.

- BC: Roche, Sanofi, Bayer, Servier, Takeda, Merck, Roche, Amgen.

- RC: Servier, Amgen and Sanofi.

- TA: Roche/Genentech and Ventana, Baxter, Bayer, Amgen, MSD Oncology, Sanofi, Servier, Novartis Roche/Genentech/ventana, and Bristol-Myers Squibb.

- MW, PG, SK, ML G-L, AG and JH have no conflict of interest.

Figures

Fig. 1
Fig. 1
Study flow chart
Fig. 2
Fig. 2
Waterfall plot summarizing the maximum percent change from baseline in the sum of longest diameter of target lesion and in attenuation at 2 months as measure by contrast-enhanced computed tomography
Fig. 3
Fig. 3
Overall survival as a function of (a) RECIST and (b) Choi criteria at 2 months in the ITT2 population

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