Bevacizumab, a monoclonal antibody against vascular endothelial growth factor, increases survival when combined with irinotecan-based chemotherapy in first-line treatment of metastatic colorectal cancer.
The researchers had shown in a previous combined analysis of efficacy data from 3 studies the benefits of bevacizumab plus fluorouracil and leucovorin for metastatic colorectal cancer.
Dr Kabbinavar and colleagues undertook a randomized, phase II trial comparing bevacizumab plus fluorouracil and leucovorin versus placebo.
|Survival was 17 months for combination with bevacizumab and 13 months for combination with placebo|
|Journal of Clinical Oncology|
The research team also considered fluorouracil and leucovorin as first-line therapy in nonoptimal candidates for first-line irinotecan.
The team reported that patients had metastatic colorectal cancer and were 65 years of age.
The patients had an Eastern Cooperative Oncology Group performance status 1 or 2, serum albumin of 4 g/dL, or prior abdominal/pelvic radiotherapy.
The researchers randomized 105 patients to fluorouracil,leucovorin and placebo and 104 to fluorouracil,leucovorin and bevacizumab.
The primary end point was survival, whilst secondary end points were progression-free survival, response rate, response duration, quality of life, and safety.
The team found that median survival was 17 months for the fluorouracil, leucovorin and bevacizumab group and 13 months for the fluorouracil, leucovorin and placebo group.
Median progression-free survival was 9 months with the fluorouracil, leucovorin and bevacizumab group.
The researchers noted that median progression-free survival was 6 months in the fluorouracil, leucovorin and placebo group.
The research team observed response rates of 26% in the fluorouracil, leucovorin and bevacizumab group and 15% with fluorouracil, leucovorin and placebo.
In addition, the team noted a response duration of 9 months with fluorouracil, leucovorin and bevacizumab and 7 months in fluorouracil, leucovorin and placebo.
The researchers found that hypertension was more common with bevacizumab but was controlled with oral medication, and did not cause drug discontinuation.
Dr Kabbinavar's team concludes, “Bevacizumab was added to fluorouracil and leucovorin as first-line therapy in patients with colorectal cancer who were not considered optimal candidates for first-line irinotecan treatment.”
“This provided clinically significant patient benefit, including statistically significant improvement in progression-free survival.”