Discontinuation of bevacizumab and folfiri administered up to a maximum of 12 cycles as first-line therapy for metastatic colorectal cancer: A retrospective Italian study Full Text
Investigational New Drugs, 08/27/2011
Clinical Article
Rosati G et al. – In this retrospective analysis remarkably long PFS and OS were obtained with a first–line therapy duration limited to a maximum of 12 cycles. These data do not support a decreased PFS or increased mortality after discontinuation of bevacizumab in mCRC patients.
Methods- PFS and OS retrospectively analyzed in patients with previously untreated mCRC who received bevacizumab 5 mg/Kg and standard FOLFIRI regimen (leucovorin, infusional fluorouracil and irinotecan) to a maximum of 12 cycles
- Data from 209 patients were collected and analyzed
- Median follow–up was 24 months. Fifty–five (26.3%) patients received at least 6 administrations and 114 (54.5%) received a maximum of 12 administrations of bevacizumab
- Median exposure to bevacizumab was 148 days (4.9 months)
- Median PFS and OS were 10.7 months [95% confidence interval (CI) 9.2–12.2 months] and 31.6 months (95% CI 25.8–37.3 months), respectively
- Overall objective response rate 49.8% (95% CI 42.9–56.6) and disease control rate 81.8%
- Approximately 65% and 30% of patients received some form of second– and third–line therapy
- Toxicity profile of bevacizumab was consistent with that documented in previous trials
