Abstract 2559
Background
Triweekly capecitabine plus irinotecan (XELIRI) is not completely regarded as a valid substitute for fluorouracil, leucovorin, and irinotecan (FOLFIRI) in metastatic colorectal cancer (mCRC) because of the potential for greater toxicity. Therefore, we conducted a phase II study to assess the efficacy and safety of biweekly XELIRI plus bevacizumab (BV) as second-line chemotherapy for mCRC. High dose BV (10 mg/kg) combined biweekly XELIRI as second-line chemotherapy was one of the first trial in the world.
Methods
Patients with mCRC who had received prior chemotherapy including oxaliplatin based regimen were eligible for this study. Protocol treatment administrated capecitabine 1,000 mg/m2 twice daily from the evening of day 1 to the morning of day 8, intravenous irinotecan 150mg/m2 on day 1, and BV 10 mg/kg on day 1 every 2 weeks. The primary endpoint of this study were progression-free survival (PFS) and safety. The secondary endpoint were overall survival (OS), time to treatment failure (TTF), response rate (RR) and disease control rate (DCR).
Results
Between January 2013 and July 2015, 51 patients were enrolled in this study. The patients’ characteristics were as follows: median age, 66 years (range 41–82); male/female, 29/22; The median PFS was 5.7 months (95% confidence interval, 4.2–7.2 months). The median OS was 13.4 months (95%CI, 11.4–16.7 months). The median TTF was 5.2 months (95%CI, 3.9–7.2 months). The response rate was 14%, and the disease control rate was 78%. Grade 3 or higher adverse events were mainly febrile neutropenia in two patients and hypertension in 14 patients (28.6%). One patient had grade 4 intestinal pneumonia but improved by intensive treatment. There were no other severe adverse events or treatment-related deaths.
Conclusions
In mCRC patients, biweekly XELIRI + BV 10 mg/kg is effective and feasible as second-line chemotherapy. Biweekly XELIRI + BV is considered a useful substitute for FOLFIRI + BV in mCRC, and further study of this combination therapy is warranted.
Clinical trial identification
Legal entity responsible for the study
Japan Southwest Oncology Group
Funding
Japan Southwest Oncology Group
Disclosure
All authors have declared no conflicts of interest.