Tumor shrinkage and overall survival (OS) from multicenter phase II study of modified FOLFOX7 (combination chemotherapy of infusional 5-FU/l-leucovorin and intermittent oxaliplatin) with bevacizumab in the first-line therapy of colorectal cancer: CRAFT trial.

Abstract

616 Background: Additional bevacizumab (BV) to FOLFOX has been established as a standard 1st-line therapy for mCRC. The intermittent administration of L-OHP can reduce the peripheral sensory neurotoxicity as reported in OPTIMOX and CONcePT study. CRAFT trial was conducted to confirm the effectiveness of stop and go strategy of mFOLFOX7+BV. We previously reported the feasibility and good progression free survival (PSF) in that study (K. Ishibashi et al. ECCO2011). This time, the overall survival (OS) and possibilities for conversion surgery were reported. Methods: We administered 8cycles of mFOLFOX7/BV followedby 8 cycles of FULV/BV as a maintenance, and reintroduction of 8 cycles of mFOLFOX7/BV until disease progression. Patients who had progressive disease during maintenance phase are allowed to receive oxaliplatin ahead of schedule. The primary endpoint is the duration from the study enrollment to disease progression (PFS I). The secondary endpoints are survival time from the study enrollment to disease progression or death plus from 1st PD in the maintenance phase to 2nd PD (PFS II), tme to treatment failure (TTF) ,OS, and safety. Results: Between March 2009 and June 2010, 52pts were enrolled. Median PFS I was 13.2 (95%CI,10.3-15.0) months. PFS II was 13.5(95%CI,12.5-15.1) months. Median, TTF was 10.3 (95%CI, 5.6-12.1) months, OS was 27.4 (95%CI, 21.0-32.8) months. There was no uncontrollable toxicity. The range of tumor shrinkage wasup to - 91.0% and 3 patients received conversion surgery. Conclusions: This study met its primary endpoint PFS I (K.Ishibashi et al. ECCO 2011.). The current data indicated that stop and go strategy is effective to prolong the duration of 1st line treatment and to improve survival in mCRC. Tumor shrinkage data also suggested mFOLFOX7+BV has possibilities to make a conversion surgery. Water fall plot for all patients will be presented at the meeting.