The new chemotherapy regimen called FOLFOX 4--- oxaliplatin, 5-fluorouracil, and leucovorin--- is superior to standard chemotherapy with irinotecan, 5-fluorouracil, and leucovorin (called IFL) for cases of advanced colorectal cancer, according to an article published online December 9th by the Journal of Clinical Oncology.

The findings come from a 5-year, phase III study conducted with 795 patients in the U.S. and Canada. The regimen called FOLFOX 4 resulted in a median time to progression of 8.7 months, response rate of 45 percent, and median survival time of 19.5 months. In addition, FOLFOX 4 patients also had fewer serious side effects, including fewer infections, less diarrhea and vomiting, and less frequent severe hair loss.

“This is the greatest increase in survival time recorded to date with a new treatment used by patients enrolled in a large randomized study of colorectal cancer in the United States,” said Richard Goldberg, MD, the lead author of the study. “A tingling sensation in the hands and feet that got better over time was the most commonly reported side effect of FOLFOX 4.”

Roughly 153,000 people are diagnosed with colorectal cancer annually in the United States, and 70,000 patients have an advanced stage of the disease.

Study participants enrolled between March 1999 and April 2001 and were randomized to FOLFOX 4, standard chemotherapy with IFL, or a third regimen called IROX that included both oxaliplatin and irinotecan.

“Our goal was to compare the IFL and FOLFOX4 treatments, and the IFL and IROX treatments, to determine overall survival, response rate, the length of time between when patients began their assigned treatments to when their cancer began to grow, and to establish the side effects associated with each treatment,” said Goldberg.

The results for all 3 primary endpoints with FOLFOX 4 were significantly superior to those obtained with IFL (6.9 months, 31 percent, and 15.0 months, respectively) or with IROX (6.5 months, 35 percent, and 17.4 months, respectively). In addition, FOLFOX 4 was associated with a higher 1-year survival rate (72 percent compared with 59 percent for IFL and 67 percent for IROX).

“Based on these findings, we conclude that the FOLFOX 4 treatment should be considered as a first-line treatment over IFL and IROX for patients with advanced colorectal cancer,” said Goldberg.

The full text of the article about the current study is available at http://www.asco.org .