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/m ² weekly intravenously (i.v.) or 5 FU 400 mg/m ² i.v. weekly plus methyl CCNU 175 mg/m ² 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 with 29.3% for the combination (p=.012). All responses were partial. The two drug regimen is more effective and more toxic than weekly 5 FU therapy.