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Introduction In Japan, capecitabine is mainly used in combination with oxaliplatin (XELOX) in treatment for metastatic colorectal cancer (mCRC) since its approval in 2010. The results of capecitabine plus Irinotecan (CPT) (XELIRI) with or without bevacizumab (BV) in EU patients (pts) were previously reported, but not in Japanese. Thus, we conducted this study to assess the safety and efficacy of XELIRI plus BV in Japanese pts with mCRC. Methods Pts with prior chemotherapy including oxaliplatin and BV for mCRC, wild or hetero type of UGT1A1 *6*28 were eligible for this study. Therapy consisted of capecitabine 800 mg/m2 bid on days1-15, CPT 200 mg/m2 on day 1, and BV 7.5mg/kg on day 1, q21 days. Primary endpoint was incidence of Dose limiting Toxicity (DLT) in phase I part and progression free survival (PFS) in phase II part. Results Total 34 pts (6 pts in phase I part, 28 pts in phase II part) were enrolled from May 2010 to June 2011. Baseline characteristics were median age of 60 years (range, 22-74); PS 0/1 (22/12 pts); male/female (24/10 pts), UGT1A1 wild/*6hetero/*28hetero (21/7/6 pts), prior treatments FOLFOX4+BV/mFOLFOX6+BV/XELOX+BV/others (1/15/10/8) and reasons for 2nd-line treatment progression disease/others (33/1 pts).DLT was not appeared in phase I part. The median PFS was 8.3 months (95%CI, 6.3-11.3). The best overall response rate was 18 %, and disease control rate was 88%. The most frequently related adverse event were neutropenia (any grade: 53%, grade3/4: 9%), diarrhea (any grade: 50%, grade 3/4: 9%), and hand-foot syndrome (any grade: 44%, grade 3/4: 0%). Conclusion This study suggested that XELIRI+BV regimen had shown well-tolerated and effective as 2nd-line treatment for mCRC in Japanese pts. This regimen seems to be appropriate for using for Oxaliplatin based regimen resistant. |
