DOI: 10.1097/01.COT.0000313240.33034.06
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Issn Print: 0276-2234
Publication Date: 2004/08/10
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Excerpt
Back-to-back late-breaking clinical trials presented here at the ASCO Annual Meeting drove home that point in a good news-bad news story for oncologists and patients in the United States. Both studies found that the oral agents were at least as good as standard bolus regimens, but only one of the drugs is available in the US.
One trial compared oral uracil and tegafur (UFT) combined with oral leucovorin with the Roswell bolus-fluorouracil (5-FU)/leucovorin (LV) regimen while the other compared capecitabine with the Mayo Clinic bolus 5-FU/leucovorin regimens.
The results, according to the Discussant for the papers, Eric Van Cutsem, MD, PhD of the Department of Internal Medicine at University Hospital Gasthuisberg in Leuven, Belgium, send a clear take-home message to clinicians: “Oral agents are preferred to bolus in the adjuvant treatment of colon cancer.”
But the lead investigator of the UFT trial, Norman Wolmark, MD, Chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP), said the outcome of the study is little more than an academic exercise for US oncologists. UFT remains beyond their grasp because although the drug received a favorable recommendation from the FDA's Oncologic Drugs Advisory Committee, the Agency rejected Bristol-Myers-Squibb's application for approval of UFT. On the other hand, capecitabine, which is made by Roche, received initial FDA approval in 1998.
In Dr. Wolmark's study, NSABP Protocol C-06, the relapse-free survival rate was 76.4% in the 5-FU arm vs 74.5% in the UFT arm, while the disease-free survival rate was 68.3% in the 5-FU arm and 66.9% in the UFT arm.
The study compared the Roswell FU regimen, which is three cycles of FULV (5-FU at 500 mg/m2 IV bolus weekly x 6 and LV at 500 mg/m2 IV weekly for six followed by two weeks rest for a total treatment time of six months), with six months of treatment with UFT (tegafur at 300 mg/m2/day and uracil in a 1:4 molar ration orally or 28 days and leucovorin at 90 mg/day orally for 28 days in a 35-day cycle for five cycles).
A total of 770 patients were randomized to the bolus arm and 784 to oral treatment. Forty-six percent of the patients in both arms had Stage II disease.
