Abstract
Background
Before its regulatory approval in Canada, bevacizumab to treat patients with colorectal cancer (CRC) was accessed through the Bevacizumab Expanded Access Trial and a special-access program at the Jewish General Hospital. We retrospectively evaluated patient outcomes in that large cohort.
Methods
All patients (n = 196) had metastatic CRC, were bevacizumab-naive, and received bevacizumab in combination with chemotherapy at the Jewish General Hospital between 2004 and 2009. We collected patient demographics and clinical characteristics; relevant medical history, disease stage and tumour pathology at diagnosis; type, duration, and line of therapy; grades 3 and 4 adverse events (AES), time to disease progression (TTP), and overall survival (OS) from diagnosis.
Results
Median follow-up was 36.0 months. Median TTP was 8.0 months [95% confidence interval (CI): 7.0 to 9.0 months). Median os was 41.0 months (95% CI: 36.0 to 47.0 months). Of the 40 grades 3 and 4 bevacizumab-related AES experienced by 38 patients (19.4%), the most common were thrombocytopenia (n = 17), deep-vein thrombosis (n = 6), pulmonary embolism (n = 4), and hypertension (n = 3).
Conclusions
In an expanded access setting, our data reflect the efficacy and safety of bevacizumab-based therapy in the controlled post-registration clinical trial setting.