The trial included 463 patients with advanced colorectal
cancer whose disease had relapsed or progressed either during or within
6 months of therapy with bolus 5-FU/leucovorin plus irinotecan(Drug information on irinotecan). Accrual to
this study is completed, with 821 patients enrolled. Survival will be assessed
in all patients enrolled in the study. Tumor response was assessed every three
cycles (6 weeks) using the standard Response Eval-
uation Criteria in Solid Tumors
The confirmed rate of objective tumor responsedefined as a 30% or greater reduction in overall tumor size, maintained for 4 weeks or morewas 9% for patients receiving oxaliplatin(Drug information on oxaliplatin) plus infusional 5-FU/leucovorin (n = 152), compared with 0% for those given infusional 5-FU/leucovorin alone (n = 151, P = .0002) and 1% for those on oxaliplatin alone (n = 156).
The median time to tumor progression for oxaliplatin in combination with infusional 5-FU/leucovorin was 4.6 months, compared with 2.7 for infusional 5-FU/leucovorin alone and 1.6 months for oxaliplatin alone. This represents a 2-month increase in median time to progression compared to infusional 5-FU/leucovorin alone.
The most frequently reported adverse events with oxaliplatin in combination with infusional 5-FU/leucovorin are peripheral neurosensory events (74% overall, 56% acute, and 48% persistent), fatigue (68%), diarrhea (67%), nausea (65%), and vomiting (40%). Changes in hematology parameters were also seen: anemia (81%), leukopenia (76%), neutropenia (73%), and thrombocytopenia (64%).