First-line bevacizumab (BEV) and chemotherapy (CT) for metastatic colorectal cancer (mCRC): Results from a developing nation.

Abstract

e14082 Background: More than 2/3 of the 20 million new cases of cancer predicted to occur yearly by 2020 will be in developing nations. Access to cancer treatment is a major issue in the developing world and evidence-based programs should be used whenever possible. BEV significantly extends overall survival (OS) when added to standard first-line CT for mCRC and although previous observational studies showed that the efficacy and safety profile of BEV in routine practice was consistent with data from phase III trials, no separate results from developing nations were described until now. Here, we report the results of the Bevacizumab Expanded Access Trial (BEAT) in a cohort of Brazilian patients. Methods: Patients with unresectable and previously untreated mCRC received the physician's choice of a fluoropyrimidine-based CT in combination with BEV 5 mg/kg q2w (5- fluorouracil [5-FU] regimens) or 7.5 mg/kg q3w (capecitabine [cap] regimens). Primary objective was safety evaluation, particularly the incidence of adverse events (AEs) related to BEV. Secondary objective was efficacy assessment, including time to progression (TTP), progression free-survival (PFS) and OS. Results: This study enrolled 168 patients from 28 centers in Brazil, from May 2006 to March 2007. Final analysis included 162 patients who received ≥ 1 BEV dose (female 55%; median age 59 years; 30% ≥ 65 years; ECOG PS 0/1 75%/23%). CT regimens most commonly used with BEV included FOLFOX (44%), 5-FU/cap monotherapy (21%) and FOLFIRI (13%). Median follow-up was 17.7 months (range 0.4 to 36.5 months), and 155 patients (95.7%) were followed for > 60 days. Grade 3-4 AEs of special interest included hypertension (3.1%) and proteinuria (2.5%). There were no cases of grade 3-4 bleeding or thromboembolism. Median TTP, PFS and OS were respectively 11.4 months (95% CI: 9.5; 13.9), 11.0 months (95% CI: 9.5; 13.9) and 21.6 months (95% CI: 18.3; 25.5 months). Conclusions: The results observed with the use of BEV in a cohort of mCRC patients from a developing nation were consistent to those obtained in the United States and internationally. These data further support the addition of BEV to CT in the first-line treatment of mCRC. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Roche Roche Roche Roche