Superiority of Oxaliplatin and Fluorouracil-Leucovorin Compared With Either Therapy Alone in Patients With Progressive Colorectal Cancer After Irinotecan and Fluorouracil-Leucovorin: Interim Results of a Phase III Trial
作者： Mace L. Rothenberg , Amit M. Oza , Robert H. Bigelow , Jordan D. Berlin , John L. Marshall
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摘要: Purpose: In North America, no effective therapy has been available for patients with progressive metastatic colorectal cancer after front-line treatment irinotecan, bolus fluorouracil (FU), and leucovorin (IFL). Patients Methods: who progressed IFL were randomly assigned to infusional FU (LV5FU2), single-agent oxaliplatin, or the combination (FOLFOX4). This planned interim analysis evaluated objective response rate (RR), time tumor progression (TTP), alleviation of tumor-related symptoms (TRS) in an initial cohort patients. Results: Between November 2000 September 2001, 463 from 120 sites America treatment. FOLFOX4 proved superior LV5FU2 all measures clinical efficacy. Objective RRs determined by independent radiology panel 9.9% versus 0% (Fisher’s exact test, P < .0001). Median TTP was 4.6 months 2.7...
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