© 2002 by Oxford University Press
Journal of the National Cancer Institute, Vol. 94, No. 16, 1191-1193,
August 21, 2002
© 2002 Oxford University Press
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FDA Evaluating Oxaliplatin for Advanced Colorectal Cancer Treatment
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Three years ago, oxaliplatin (Eloxatine) was in the headlines as the first potential breakthrough in 30 years in the treatment of advanced metastatic colorectal cancer. Results from clinical trials suggested that the addition of oxaliplatin to standard chemotherapy regimens was associated with an improvement in median progression-free survival exceeding 8 months and in median survival to nearly 16 months.
Despite these results, in April 2000 the U.S. Food and Drug Administration declined to approve the use of oxaliplatin in combination with the standard chemotherapy regimen of 5-fluorouracil and leucovorin (5-FU/LV) as a first-line therapy for advanced and metastatic colorectal cancer because the data available at that time from multi-institutional phase III trials failed to show that the drug combination had a survival advantage
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