Phase III comparison of the treatment of advanced gastrointestinal cancer with bolus weekly 5-FU vs. methyl-CCNU plus bolus weekly 5-FU. A Southwest Oncology Group study.

In a randomized and stratified study, 294 patients with advanced gastrointestinal cancer were treated either with 5-fluorouracil (5-FU) 400 mg/m2 weekly intravenously (i.v.) or 5-FU 400 mg/m2 i.v. weekly plus methyl-CCNU 175 mg/m2 orally (p.o.) every 6 weeks. The response rate in colorectal cancer with 5-FU was 9.5% while the two-drug treatment produced a response of 31.8% (p=.009). The response in all gastrointestinal cancers to 5-FU was 10.6% as compared with29.3% for the combination (p=.012). All responses were partial. The two-drug regimen is more effective and more toxic than weekly 5-FU therapy.

RCT Entities:   Population Interventions Outcomes