| [ Summary ] |
Use of systemic chemotherapy for colorectal cancer has made great strides as seen in several foreign pivotal phase III studies. Irinotecan, in combination with 5-fluorouracil/Leucovorin, demonstrated superior overall survival rates, compared to 5-fuorouracil/Leucovorin alone in European and North American studies. Oxaliplatin in combination with infusional 5-fluorouracil/Leucovorin had significant survival benefits over irinotecan, in combination with bolus 5-fluorouracil/Leucovorin, in a North American Intergroup study N9471. These excellent new treatment regimens brought double or triple the survival rates to patients with minimum adverse events. Oral fluoropyrimidines were evaluated in randomized phase III studies, in relation to intravenous 5-fluorouracil/Leucovorin. Only capecitabine was approved, based on two pivotal studies demonstrating the equivalence of survival and time to progression. S-1, a new oral fluoropyrimidine derivative, is now under evaluation in phase II studies. New active drugs, including oxaliplatin, capecitabine and S-1 have not been approved in Japan. Many Japanese colorectal cancer patients can not receive the clinical benefits of new active combination chemotherapies. Clinical investigators should actively conduct and participate in well-designed clinical studies to evaluate and create new active chemotherapy regimens. |