Study: FOLFOX4 Helps Some With Advanced Colorectal Cancer

A treatment regime called FOLFOX4, which adds the investigational chemotherapy drug oxaliplatin to a potent drug cocktail, helps some patients whose advanced colorectal cancer continues to progress after other therapies, according to a report in the Journal of Clinical Oncology.

The new regime combines oxaliplatin with the chemotherapy drug 5-fluorouracil and leucovorin, a widely used adjunct to chemotherapy drugs that is a compound similar to folic acid.

Between November 2000 and September 2001, 463 patients -- whose advanced colorectal cancer was continuing to progress after a treatment known as IFL combining the chemotherapy drugs irinotecan and 5-fluorouracil with leucovorin -- were randomly assigned to treatment.

"FOLFOX4 proved superior to [the combination of 5-fluorouracil and leucovorin alone] in all measures of clinical efficacy," the researchers reported. In contrast, oxaliplatin by itself was not superior in any measure.

They said the response rate to the drug combinations was 9.9 percent for the patients on the FOLFOX4 regime compared to zero for those only taking 5-fluorouracil and leucovorin.

Median time to cancer progression was 4.6 months for patients on FOLFOX4 compared to 2.7 months for those on 5-fluorouracil and leucovorin.

Relief of cancer-related symptoms occurred in one-third of the patients treated with FOLFOX4 versus 12 percent of patients treated with 5-fluorouracil and leucovorin, the researchers reported.

Patients treated with FOLFOX4 experienced a higher incidence of clinically significant toxicities than patients treated with 5-fluorouracil and leucovorin, the researchers reported, but they said these toxicities were predictable and did not result in a higher rate of treatment discontinuation or 60-day mortality rate.

"For patients with metastatic colorectal cancer, second-line treatment with FOLFOX4 is superior," the researchers concluded.

Other Sources: Journal of Clinical Oncology