A phase III study of irinotecan (CPT-11) versus best supportive care in patients with metastatic colorectal cancer who have failed 5-fluorouracil therapy. V301 Study Group.

摘要: In a prospective multicenter trial, 279 patients with metastatic colorectal cancer who had failed 5-fluorouracil therapy were randomized 2:1 to receive either best supportive care (BSC) plus treatment the topoisomerase I inhibitor, irinotecan (CPT-11; Rhone-Poulenc Rorer, Antony, France), at dose of 350 mg/m2 every 3 weeks or BSC alone. Overall survival, primary end point study, was significantly improved in receiving treatment. Only 14% alone alive 1 year compared 36% group. After adjustment for prognostic factors such as performance status, difference survival favoring remained highly significant (P = .001). The benefit also observed through longer without status deterioration, more than 5% weight loss, and duration pain-free survival. Appreciable deterioration global quality life (50% reduction from baseline) occurred later irinotecan-treated controls. Additionally, analyses all symptoms, except diarrhea, mean scores favor assigned those BSC. This is first time that second-line chemotherapy has been demonstrated by controlled trial advanced cancer.