Efficacy and safety of bevacizumab in combination with irinotecan and capecitabine in first-line treatment of metastatic colorectal carcer

Introduction/Objective: The efficacy and safety of bevacizumab (BEV) in combination with capecitabin and irinotecan in first-line therapy of patients with metastatic colorectal cancer (mCRC) were studied. In order to improve safety and efficacy of chemotherapy, as well as to reduce adverse reactions to a minimum, doses of active agents applied were changed in relation to previously employed schedules. Methods: Patients with histologically documented mCRC who have not previously received chemotherapy or had received adjuvant or neoadjuvant chemotherapy, which ended 6 months before capecitabin treatment (1000 mg/m2 per os from 2nd to 8th day of each cycle), irinotecan (175 mg/m2 every 2 weeks), plus bevacizumab (5 mg/kg i.v. every 2 weeks) were observed. Results: The study, conducted as a prospective one included 35 patients of both sexes. Overall response rate (ORR) of 28.6%, partial response (PR) of 28.6%, progressive disease (PD) of 28.6% and stable disease (SD) of 42.8% were found. Progression-free survival (PFS) of the patients analyzed was 11.3 months (95% CL: 9.1 - 12.9) while overall survival (OS) of the patients included was 25.2 months (95% CL: 17.4 - 28.4 months) and 117 adverse effects were recorded in 24 patients. Alopecia, nausea and vomiting, hemorrhage, hand-foot syndrome, diarrhea, abdominal pain, proteinuria, and hypertension (51.4%, 37.1%, 37.1%, 25.7%, 22.8%, 20.0%, 20.0% and 17.1%, respectively) were most frequently observed adverse effects. Conclusion(s): The results of this clinical trial support and recommend the use of bevacizumab plus capecitabin and irinotecan in the doses and schedule applied throughout this study as first-line treatment of mCRC patients.