Global phase III trial of comparing mXELIRI+BV vs FOLFIRI+Bmab for 2nd line mCRC (AXEPT) Japanese population analysis

Abstract

Background: The Asian XELIRI ProjecT (AXEPT) is an East Asian (Japan, China and Korea) collaborative, open‐labelled, randomized, phase III clinical trial which was designed to demonstrate the non‐inferiority of mXELIRI+Bevacizumab versus standard FOLFIRI+Bevacizumab as second‐line chemotherapy for patients with metastatic colorectal cancer. In main analysis, mXELIRI+Bevacizumab showed the noninferiority of overall survival for FOLFIRI+Bevaicuzmab at ESMO Asia 2017 LBA #3 (median overall survival: 16.8 month vs. 15.4, HR: 0.85, 95% CI 0.71‐ 1.02, p<0.0001). Here, we are going to disclose the efficacy and safety in Japanese population according to pre‐planned subgroup analysis. Methods: Patients with histologically confirmed mCRC, ECOG performance status (PS) 0‐2, and disease progression or intolerance of the first‐line regimen were eligible. randomized (1:1) to receive standard FOLFIRI+Bevacizumab (5 mg/kg on day 1), repeated every 2 weeks (FOLIRI arm) or mXELIRI+Bevacizumab (7.5 mg/kg on day 1) repeated every 3 weeks (mXELIRI arm). The endpoints are overall survival (OS), progression free survival (PFS), overall response rate (ORR) and safety. Result: Between December 2013 and July 2015, 267 patients were enrolled and randomized either to receive mXELIRI arm (n=133) or FOLFIRI arm (n=134) from Japanese 73 centers. After a median follow‐up of 15.8 months (IQR; 8.7 ‐ 24.9), median OS was 17.9 months in the mXELIRI arm and 17.4 months in the FOLFIRI arm (HR: 1.03, 95% CI: 0.78 ‐ 1.36). The median PFS was 8.2 months and 6.7 months, respectively (HR: 0.90, 95% CI: 0.70 ‐ 1.16). Conclusion: mXELIRI+Bevacizumab showed the similar efficacy in terms of OS and the good efficacy trend against in terms of PFS for FOLFIRI+Bevacizumab in Japan. The other detailed data including safety data will be presented in this meeting.