NEW YORKPatients 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