Data Supporting FDA Approval of Eloxatin Presented

NEW YORK—Patients with advanced colorectal cancer experienced a significantly better response rate with a combination of oxaliplatin (Eloxatin) and infusional fluorouracil (5-FU)/leucovorin (LV), compared with infusional 5-FU/LV or oxaliplatin alone, Mace Rothenberg, MD, of Vanderbilt University Medical Center, said at the Chemotherapy Foundation Symposium XX. The data, presented for the first time in the United States, were the basis for the recent FDA approval of oxaliplatin.

The multicenter, randomized, controlled clinical study was conducted at centers in the United States and Canada. The 469 participants included in this analysis had advanced colorectal cancer that had relapsed or progressed either while taking or within 6 months of treatment with bolus 5-FU/LV plus irinotecan (Camptosar). A total of 821 patients have been enrolled in this study, which is still ongoing.

Tumor response was assessed every three cycles (6 weeks). Confirmed objective tumor response was defined as a 30% or greater reduction in overall tumor size maintained for at least 4 weeks. In the oxaliplatin/5-FU/LV group, the objective tumor response rate was 9% (n = 152), compared with 0% and 1%, respectively, for the groups given infu-sional 5-FU/LV alone (n = 151) (P = .0002) and oxaliplatin alone (n = 156).

The median time to tumor progression with oxaliplatin/5-FU/LV was 4.6 months vs 2.7 and 1.6 months for infusional 5-FU/LV alone and oxaliplatin alone, respectively. At the time of the interim analysis, 49% of the radiographic progression events had occurred. Data on survival are not mature.