NEW YORK MAY 15, 2008 (Reuters Health) - Adding the antiangiogenic agent bevacizumab (Avastin) to oxaliplatin-based chemotherapy improves progression-free survival when given as first-line therapy for metastatic colorectal cancer, an international team reports. However, overall survival is not improved, according to the findings.
Dr. Leonard B. Saltz of Memorial-Sloan Kettering Cancer Center in New York and colleagues randomized 1401 patients with metastatic colorectal cancer to either capecitabine plus oxaliplatin (XELOX) or to fluorouracil/folinic acid plus oxaliplatin (FOLFOX-4) and then randomized them again to bevacizumab or placebo in a 2 x 2 factorial design..
"Median progression-free survival (PFS) was 9.4 months in the bevacizumab group and 8.0 months in the placebo group," for a hazard ratio of 0.83, the investigators report in the April 20 issue of the Journal of Clinical Oncology.
The trial reached its primary objective of a statistically significant increase in PFS with the addition of bevacizumab to oxaliplatin-based chemotherapy as first-line therapy for metastatic colorectal cancer.
"Median overall survival was 21.3 months in the bevacizumab group and 19.9 months in the placebo group (HR, 0.89)," a difference that did not reach statistical significance, Dr. Saltz and colleagues report.
They found that "despite protocol allowance of treatment continuation until disease progression, only 29% and 47% of bevacizumab and placebo recipients, respectively, were treated until progression."
This lack of continuation "may have blunted the contribution of bevacizumab, thereby diminishing its impact on overall survival and progression free survival in the trial," Dr. Saltz"s team concludes.
SOURCE:
J Clin Oncol 2008;26:2013-2019.