Phase II Study of Bevacizumab, Capecitabine, and Oxaliplatin Followed by Bevacizumab Plus Erlotinib as First-Line Therapy in Metastatic Colorectal Cancer

Autor: Antonieta Salud, Fernando Rivera, E. Falcó, Carles Pericay, Alberto Muñoz, Iñaki Alvarez Bustos, Vicente Alonso, R. Dueñas, Luis Cirera, Carlos García-Girón
Rok vydání: 2014
Předmět:
Zdroj: Oncology Research Featuring Preclinical and Clinical Cancer Therapeutics. 21:181-191
ISSN: 0965-0407
Popis: This phase II trial investigated the efficacy of an induction regimen of bevacizumab, capecitabine plus oxaliplatin (XELOX) followed by maintenance therapy with bevacizumab plus erlotinib as first-line therapy in patients with metastatic colorectal cancer. Patients with metastatic colorectal cancer received intravenous bevacizumab 7.5 mg/kg plus oxaliplatin 130 mg/m2 on day 1 followed by oral capecitabine 1,000 mg/m2 twice daily on days 1‐14 every 3 weeks for six cycles. In the absence of disease progression, patients then received bevacizumab 7.5 mg/kg every 3 weeks plus oral erlotinib 150 mg once daily. The primary study endpoint was progression-free survival. In the intention-to-treat population (n = 90), the median progression-free survival was 9.2 [95% confidence interval (CI): 7.9‐11.9] months, and the median overall survival was 25.8 (95% CI: 18.0‐30.9) months. In the patient subpopulation who received both induction and maintenance therapy (n = 52), median progression-free survival was 11.1 (95% CI: 9.0‐15.7) months, and the median overall survival was 29.5 (95% CI: 23.7‐36.7) months. KRAS status did not predict efficacy. The most common grade 3/4 adverse events were diarrhea, asthenia, and neutropenia. XELOX‐bevacizumab for 6 cycles followed by bevacizumab‐erlotinib maintenance therapy has been shown to be a highly active and well-tolerated first-line regimen in patients with metastatic colorectal cancer.
Databáze: OpenAIRE