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| |  Meta-Analysis Shows Equivalence Between Capecitabine and 5-Fluorouracil: Presented at ASCO-GI By Ed Susman ORLANDO, FL -- January 27, 2008 -- A meta-analysis that compared treatment with oral capecitabine and its intravenous cousin 5-fluorouracil (5-FU) showed that the two treatments are virtually equivalent in treating colorectal or gastric cancers. "People should stop the argument that there is some kind of difference between these two drugs," said James Cassidy, MD, Professor of Medical Oncology, Glasgow University, Scotland, United Kingdom, in a poster presentation on January 26 at the American Society for Clinical Oncology's 2008 Gastrointestinal Cancers Symposium (ASCO-GI). The symposium is cosponsored by ASCO with the American Gastroenterology Association Institute, the American Society of Clinical Oncology, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology. "We think this meta-analysis that involved more than 6,000 patients shows that there are no differences in outcomes between the FOLFOX regimens -- 5-FU plus leucovorin -- and XELOX regimens -- capecitabine-based treatments -- whether the drugs are combined with oxaliplatin, cisplatin, or bevacizumab," Dr. Cassidy said. The six studies only showed significant differences in that men were more often randomized than women (P <.0001) and that better performance status at baseline resulted in better outcomes (P <.001). Oral capecitabine has been more accepted in Europe than in the United States, Dr. Cassidy said. Reimbursement issues have delayed capecitabine's acceptance in the United States, he explained. "There are always some issues that will make the intravenous drug more acceptable in some cases than the oral drug," he said. "However, we should forever just drop the myth that there is some kind of difference in outcome between patients getting one drug or the other." In the meta-analysis, median overall survival for the 3,074 patients treated with 5-FU-based regimens was 23.1 months compared with a median overall survival of 22.4 months for patients receiving capecitabine, a 4% reduction in the risk of dying earlier with capecitabine. That difference failed to reach statistical significance. Once the survival figures were adjusted through Cox regression analyses, the results were the same, a 0.96 hazard ratio in favor of capecitabine, but a.1888 P value, not close to significance. "These findings support the already extensive evidence available from individual clinical trials for therapeutic equivalence of intravenous 5-FU and oral capecitabine in colorectal and gastric cancer," Dr. Cassidy said. Funding for this study was provided by F. Hoffman-LaRoche, Basel Switzerland.
[Presentation title: Efficacy of Capecitabine Vs. 5-FU in Colorectal and Gastric Cancer: Meta-Analysis of Survival in 6 Clinical Trials. Abstract 340]
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