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Adjuvant Therapy with Oxaliplatin Increases Disease-Free Colorectal Cancer Survival: Presented at ASCO

By Ed Susman

CHICAGO, IL -- June 2, 2003 -- Use of the anticancer drug oxaliplatin in the adjuvant setting results in a 23% reduction in risk of relapse from colorectal cancers, according to a study in Europe.

The researchers presented the findings here June 1^st at the 39^th Annual Meeting of the American Society of Clinical Oncology (ASCO).

"We are very encouraged by these results and expect that they will change the standard of care for many patients with colorectal cancer," said Aimery de Gramont, MD, a medical oncologist at Hôpital Saint Antoine, in Paris, France, and lead investigator for the MOSAIC (Multicentre International Study of Oxaliplatin/5-Fluorouracil-Leucovorin in the Adjuvant Treatment of Colon Cancer) Trial.

About 900,000 cases of colon cancer are diagnosed around the world each year. About 80% of these patients are treated surgically and show no residual tumour following curative resection. Nevertheless, 30% to 40% of these patients later experience a relapse.

Dr. de Gramont predicted that use of this combination regimen in colorectal cancer patients would save about 3000 lives in the United States and about 5000 lives in Europe.

Researchers enrolled 2246 patients with colon cancers in a 3-year study in which tumours were removed surgically. Because these patients were at high risk of relapse, they were randomised to the standard of care for adjuvant treatment -- 5-fluorouracil (5-FU)/leucovorin -- or the combination of oxaliplatin with 5-FU/leucovorin (FOLFOX4) in equal numbers. They received treatment for 6 months.

After 3 years, 77.8% of patients who received FOLFOX4 remained disease-free compared with 72.9% of patients on 5-FU/leucovorin, a difference that "was highly statistically significant [P < 0.01]," representing a 23% risk reduction, said Dr. de Gramont.

"FOLFOX4 is safe in adjuvant colon cancer patients," he said. The main adverse event was the appearance of grade 3 sensory neuropathy in about 12% of patients on the regimen. However, the neuropathy disappeared in all but 1% of the patients after a year, Dr. de Gramont said. "FOLFOX4 is the first combination to demonstrate superiority over 5-FU/leucovorin."

He noted that 5-FU/leucovorin has been a mainstay of adjuvant therapy for colon cancer patients for at least 15 years.

"We think that the use of FOLFOX4 has enormous potential to affect cancer patients in this country and overseas," he said during a press briefing before his oral presentation at ASCO.

Robert Mayer, MD, professor of medicine at Harvard Medical School, in Boston, Massachusetts, agreed that use of FOLFOX4 could save 3000-5000 lives. "There are a host of studies looking into how high-risk patients can be helped by adjuvant treatments," he said.


[Study title: Oxaliplatin/5-FU/LV in Adjuvant Colon Cancer: Results of the International Randomized Mosaic Trial. Abstract 1015]

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