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Oxaliplatin Plus 5-Fluorouracil and Leucovorin Combination Effective in Second-Line Metastatic Colorectal Cancer Treatment: Presented at ASCO

By Ed Susman

CHICAGO, IL -- June 2, 2003 -- Researchers presenting final data from a large clinical trial said that adding oxaliplatin to standard second-line treatment for metastatic colorectal cancer significantly increased response rates, time to progression, and symptom relief.

The study, which was the pivotal trial that resulted in licensing of oxaliplatin for treatment of advanced colorectal cancer, enrolled 821 patients who received standard second-line therapy -- infusional 5-fluorouracil (5-FU) and leucovorin -- or oxaliplatin alone, or a combination of oxaliplatin, 5-FU, and leucovorin (FOLFOX4).

"The ability of FOLFOX4 to delay tumor progression and relieve cancer-related symptoms is clinically meaningful to our patients," said Mace Rothenberg, MD, professor of medicine at the Vanderbilt-Ingram Cancer Center, in Nashville, Tennessee, at the 39^th Annual Meeting of the American Society of Clinical Oncology.

Dr. Rothenberg said the trial found that 9.6% of patients receiving FOLFOX4 showed a clinical response compared with 0.7% of patients receiving 5-FU/leucovorin (P < 0.0001).

The time to progression was 5.6 months on FOLFOX4 compared with 2.6 months on 5-FU/leucovorin, which also was significant at the P < 0.0001 level. Tumour-related symptoms such as weight loss, abdominal pain, weakness, and fatigue were relieved in about 28% of the FOLFOX4 patients compared with 15% of the patients on 5-FU/leucovorin (P = 0.002).

The use of oxaliplatin as a single agent did not prove effective in these patients, Dr. Rothenberg said.

Robert Mayer, MD, professor of medicine at Harvard Medical School and director of gastrointestinal oncology at Dana Farber Cancer Institute, in Boston, Massachusetts, said, "I think this study will have a great impact for use as a second-line treatment in these colon cancer patients."

The use of oxaliplatin was approved for second-line treatment of metastatic colorectal cancer if those patients progressed while being treated with irinotecan and a bolus injection of 5-FU/leucovorin.

The study was supported by Sanofi-Synthelabo and was conducted by the North Central Cancer Treatment Group, based at the Mayo Clinic in Rochester, Minnesota.


[Study title: Final Results of a Phase III Trial of 5-FU/Leucovorin Versus Oxaliplatin Versus the Combination in Patients With Metastatic Colorectal Cancer Following Irinotecan, 5-FU, and Leucovorin. Abstract 1011]

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