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.

A 40-year-old black male had unresectable giant condylomata acuminata of the anorectum with invasive, squamous-cell carcinoma. He was treated with intravenous 5-fluorouracil and mitomycin-C and with extended field radiation to the primary lesion. An abdominoperineal resection was performed, and the surgical specimen contained no residual cancer. Three years after diagnosis, the patient has no recurrent cancer. This case illustrates that otherwise unresectable giant condylomata acuminata with invasive carcinoma may be rendered operable with chemotherapy and radiation.

A combined intraoperative and postoperative adjuvant program of 5 minus Fluorouracil (5 FU) for patients undergoing "curative" resection for adenocarcinoma of the colon and rectum was initiated as a randomized clinical trial in January 1968. Patients at the Medical College of Virginia and the University of Virginia were randomly assigned to an intraluminal 5 FU or intraluminal control (Saline) group and were so treated at the time of surgical resection if findings at operation indicated that all gross neoplastic disease could be resected. Patients with operative findings denoting incurability were eliminated from the study after surgical exploration. Those patients receiving intraluminal 5 FU (30mg/kg) received intravenous 5 FU (10mg/kg) on each of the two first postoperative days and 5 subsequent postoperative courses of oral 5FU (90 mg/kg in each 18 day course) over a one year period. By December 31, 1973 (6 years) 156 patients undergoing "curative" resection were entered into the study. SU therapy with the control or "No Treat" group reveal no significant benefit from this intensive adjuvant course of 5 FU thus far. Continued assessment of these patient groups and their subgroups will be required to develop confidence in these findings but the data thus far suggest no potential benefit from this particular adjuvant program.