Magazine article Drug Topics

New Colon Cancer Guide Features Major Changes

Magazine article Drug Topics

New Colon Cancer Guide Features Major Changes

Article excerpt

A major change in the treatment of advanced or metastatic colon cancer has been made in a new update from the National Comprehensive Cancer Network (NCCN). The network's "Clinical Practice Guidelines in Oncology: Colon Cancer," published in January, were revised to reflect new scientific data and expert judgment.

For one, the update has added the regimen CapeOx, a combination of capecitabine (Xeloda, Roche) and oxaliplatin (Eloxatin, Sanofi-Aventis), as an alternative to FOLFOX for the treatment of advanced or metastatic colon cancer. The FOLFOX regimen includes oxaliplatin, leucovorin, and 5-fluorouracil (5-FU).

"I think many physicians were already gaining experience with this regimen [CapeOx] and are comfortable giving it," said Mark Kirstein, Pharm.D., assistant professor of experimental and clinical pharmacology at the University of Minnesota's Cancer Center and College of Pharmacy. He pointed out that the European head-to-head trial of CapeOx and FOLFOX will likely provide some of the data clinicians have been lacking.

According to the guidelines, the majority of safety and efficacy data for CapeOx have come from Europe, where administration of capecitabine at a starting dose of 1000 mg/m^sup 2^ twice daily for 14 days, to be repeated every 21 days, is standard. There is some evidence that North American patients may experience greater toxicity with capecitabine, and other fluoropyrimidines, than the Europeans and may require a lower dose. However, because the efficacy of the drug at lower doses has not been evaluated in large, randomized trials, NCCN still recommends a starting dose of 1000 mg/m^sup 2^ with close monitoring in the first cycle for toxicity and possible dosage adjustments.

NCCN also recommends discontinuation of oxaliplatin from FOLFOX or CapeOx after three months of therapy-or sooner if significant neurotoxicity develops (>grade 3)-with other drugs maintained until the time of tumor progression. Oxaliplatin may then be reintroduced if it was discontinued previously for neurotoxicity rather than for disease progression.

"There is acute and chronic," said Kirstein of oxaliplatin-associated neurotoxicity. "The chronic is the one that requires a dosage adjustment or stopping the regimen. …

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