P-250Capecitabine, irinotecan, and bevacizumab in patients with previously untreated metastatic colorectal cancer: Experience of the oncology department of the university hospital of Oran, Algeria

Introduction: This study aims to investigate the effectiveness of the associated chemotherapy based on capecitabine and irinotecan (CARIPI) with anti-VEGF, the bevacizumab, in terms of progression free survival (PFS), objective response rate (ORR) and overall survival (OS), in a way to evaluate the clinical benefit and tolerance to patients with mCRC in first line. Methods: A prospective observational study was conducted in the Oncology department of the University Hospital of Oran between March 2012 and May 2015. Eligible patients were aged over 18 years, with non-pre-treated mCRC and performance status HWO ≤ 2. Patients were treated with capecitabine 1000 mg/m2 (800mg/m2 for patients over 65 years old) morning and evening during 14 days associated with irinotecan 240mg/m2 and bevacizumab 7.5mg/kg to D1 every three weeks. Stable or responder patients could receive a maintenance treatment by capecitabine-bevacizumab until the progression of the disease. Results: Fifty-two patients with mCRC were included in the study. The ratio-sex was about 2.05 with a mean age of 57.4 ±1.7 years. 84.6% of patients showed a conserved performance status (HWO of 0-1). A total of 395 cycles was administered with an average of 7.6± 0.4 cycles (CI 95%) [3-16]. Twenty-tree patients (44.2%) received a maintenance treatment by capecitabine–bevacizumab with an average of 11.6 ± 2.2 cycles (CI 95%) [3-41]. After median follow up of 40 months (CI 95%: 42-49), the median PFS in intention to treat (ITT) was about 11 months (95% CI: 7.8 to 14.2) with a PFS rate estimated to 12 months of 44.2%. The ORR in ITT was 39.2% (95% CI: 27.5 to 52.2) and the Disease Control Rate (DCR) was 82.3%. The median OS was 20.8 months (95% CI: 16.5 to 25.1) with an OS rate at 2-year of 39.2%. The main grade 3-4 toxicities were represented by diarrhea (26.9%), neutropenia (13.5%), asthenia (7.7%), vomiting (7.7%), hand-food syndrome (5.8%). Toxicity given to bevacizumab was mainly moderate and representing by thromboembolic events (7.7%), blood pressure (32.7%; G3: 1.9%) and hemorrhagic events (G3:1.9%). Dose reductions of capecitabine and irinotecan were required in 36.5% and 28.8% of patients respectively, due to toxicities. Conclusion: CAPIRI–bevacizumab in first line treatment of the mCRC is really efficient with an acceptable tolerance profile after doses adaptation of capecitabine and irinotecan.