O1–111 - Phase II Trial of mFOLFOX6/CapeOX Plus Bevacizumab with Oxaliplatin in a Stop and Go Fashion in Advanced mCRC

Abstract

Background: Combination therapy of bevacizumab (BV) with L-OHP based regimen (such as BV +FOLFOX / BV + CapeOX) is one of the standard therapies against metastatic colorectal cancer (mCRC), however cumulative sensory neurotoxicity of L-OHP results in impairment of patient's quality of life (QoL) and discontinuation of the treatment. although CONcePT trial has shown that intermittent l-OHP administration of BV + FOLFOX7 is safe and effective, it is unknown that the intermittent l-OHP administration is also safe and effective for Japanese patients. Method: We conducted a phase II trial to evaluate the efficacy and safety of intermittent L-OHP administration in first-line BV + mFOLFOX6 or CapeOX therapies in Japanese patients with mCRC. Six cycles of bi-weekly BV + mFOLFOX6 regimen is followed by 6 cycles of bi-weekly BV + sLV5FU2 or 4 cycles of tri-weekly BV + CapeOX regimen is followed by 4 cycles of tri-weekly BV + capecitabine regimen. The choice of mFOLFOX6 or CapeOX was up to the doctor-in charge. Primary endpoint is to evaluate median progression free survival (PFS). Secondary endpoint is to estimate response rate (RR), overall survival (OS), time to treatment failure (TTF), and frequency of neurotoxity (UMIN000002042). Results: Sixty eight patients were enrolled (49 pts are allocated to BV + mFOLFOX6 and 19 pts are allocated to BV + CapeOX ). The median PFS was 347 days (95% CI 286 - 462 days) and TTF was 229days (95% CI 187 - 263days). RR is 51.8% and disease control rate is 98.3%. As the reason of treatment discontinuation, adverse events and progression disease were almost the same number. However grade 3 of peripheral sensory neurotoxicity evaluated by DEB-NTC was not observed. Conclusion: The intermittent L-OHP administration in first-line BV + mFOLFOX6 or CapeOX therapies were also safe and effective for Japanese patients.