Phase I / II study of XELOX plus bevacizumab in Japanese patients with metastatic colorectal cancer (JO19380): Evaluation of long-term treatment cases

FOLFOX plus Bevacizumab (BEV) is one of the current standard treatments for unresectable colorectal cancer. In Europe and the United States, XELOX is a regimen which replaced 5-FU/LV of FOLFOX with capecitabine (XEL), an oral prodrug of fluorouracil. Benefits of XELOX and FOLFOX are reported to be the same in Europe and the United States. XELOX+BEV is recommended as a treatment option in various guidelines. However, the safety and effectiveness data were from overseas, and unconfirmed in Japan. Therefore, we carried out a JO19380 study to evaluate the effectiveness and safety of XELOX+BEV on Japanese patients in a domestic phase I / II clinical trial. A total of 64 patients were registered in this study. The response rate was 72%, the progression free survival was 11 months, and the median survival time was 27.4 months with XELOX+ BEV. The common grade 3/4 toxicities were sensory neurotoxicity (17%) and neutropenia (16%). The effectiveness and safety equivalents of overseas reports were confirmed in Japanese patients. They suggested that XELOX+BEV has the potential to becom one of the standard treatments for unresectable colorectal cancer in Japan. In the trial, long-term disease control with XEL+BEV was reported in patients who discontinued oxaliplatin because of adverse events. Continuous treatment with XEL+BEV after XELOX+BEV is considered to be a significant first-line therapy for colorectal cancer based on that report.