An estimated 106,370 people will be diagnosed with colon cancer and an estimated 40,570 people will be diagnosed with rectal cancer in the United States in 2004.
Researchers from Philadelphia in America undertook a large, randomized trial between October 2001 and April 2003 including a total of 829 patients.
Patients previously had received a fluorouracil-based therapy and irinotecan, either alone or at the same time.
The research team randomly assigned patients to 1 of 3 treatment groups.
Group 1 received the standard FOLFOX4 treatment plus bevacizumab.
Group 2 received the standard FOLFOX4 treatment only, and Group 3 received bevacizumab alone.
In March 2003, the study investigators suspended randomization to the third treatment arm, bevacizumab alone, on the recommendation of the Data Monitoring Committee.
Review of early results had suggested that overall survival for patients in that group might be lower than that of patients treated in the other two groups.
|26 % reduction in the risk of death for patients who received bevacizumab plus FOLFOX4 compared to those who received FOLFOX4 alone|
The researchers noted that side effects included neuropathy (problems with nerve function) for FOLFOX4 and high blood pressure and bleeding for bevacizumab.
The research team found that the patients in the trial who received bevacizumab in combination with FOLFOX4 (a regimen of oxaliplatin, 5-fluorouracil and leucovorin) had a median overall survival of 12.5 months.
This was compared to patients treated with FOLFOX4 alone, who had a median overall survival of 10.7 months.
In addition, the investigators found that there was a 26 % reduction in the risk of death (hazard ratio of 0.74) for patients in this study who received bevacizumab plus FOLFOX4 compared to those who received FOLFOX4 alone.
"These results are simply more good news for people with colorectal cancer," said Study Chair Bruce J. Giantonio, M.D., of the University of Pennsylvania's Abramson Cancer Center in Philadelphia.
"We now know that bevacizumab added to second-line chemotherapy with FOLFOX4 improves survival."
"With these findings, we can now more confidently expect survival for people with advanced disease to be more than double what it was just a few years ago."