Initial results from a large, randomized clinical trial for patients with advanced colorectal cancer show that those who received a regimen containing the investigational drug oxaliplatin lived months longer than those who received a standard therapy. Patients on the oxaliplatin regimen, known as FOLFOX4, also had a longer time before their tumors progressed, a better response rate, and fewer severe side effects.

Sponsored by the National Cancer Institute (NCI), the trial has been conducted by a network of researchers led by the North Central Cancer Treatment Group (NCCTG).* Study chair Richard Goldberg, M.D., of the Mayo Clinic Cancer Center, Rochester, Minn., presented the new data today at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Fla.

"This trial has given us important new information about the treatment of advanced colorectal cancer," said Richard Kaplan, M.D., chief of NCI's Clinical Investigations Branch, who coordinates colorectal cancer treatment trials sponsored by NCI. "The patient benefit seen with the FOLFOX4 regimen is encouraging; FOLFOX4 is a promising new option in our armamentarium of treatments for colorectal cancer."

The trial, known as N9741, compared three drug regimens: 1) a standard (control) treatment, known as IFL (irinotecan/5-fluorouracil/leucovorin) or the "Saltz regimen," 2) the experimental regimen FOLFOX4 (5-fluorouracil/leucovorin/oxaliplatin) and 3) another experimental regimen combining oxaliplatin and irinotecan.

In a planned interim analysis of the data, the researchers found that outcomes for patients receiving FOLFOX4 were significantly better than for those on the control arm, IFL. Patients on the FOLFOX4 arm lived about four months longer than those on the IFL arm (median 18.6 months vs. 14.1 months). They also had a significantly better time to tumor progression (median 8.8 months vs. 6.9 months) and higher response rates (38 percent vs. 29 perc
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Contact: NCI Press Office
ncipressofficers@mail.nih.gov
301-496-6641
NIH/National Cancer Institute
18-May-2002

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