EVALUATION OF 96-HOUR INFUSION FLUOROURACIL PLUS CISPLATIN IN COMBINATION WITH ALPHA-INTERFERON FOR PATIENTS WITH ADVANCED SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK - A SOUTHWEST-ONCOLOGY-GROUP STUDY

Background. Recurrent cancer of the head and neck after primary therap y is almost always fatal. The combination of 5-fluorouracil (5-FU) and cisplatin is considered the best available therapy but complete respo nse rates remain too low to affect survival. This study was designed t o evaluate the complete response rate and toxicity of 5-FU, cisplatin, and alpha-interferon (alpha-IFN) in patients with recurrent or metast atic squamous cell carcinoma of the head and neck (SCCHN). Methods. Fi fty eligible patients with recurrent or metastatic SCCHN and no prior chemotherapy (40 men, 10 women; age range, 26-77 years; median, 59 yea rs; 82% white; 88% had prior surgery and 92% had prior radiation thera py) were treated every 21 days with 96-hour infusion of 5-FU 1000 mg/m (2)/day; cisplatin 100 mg/m(2), day 1; and alpha-IFN 5 X 10(6) units/d ay, days 1-4. Results. One hundred fifty-seven courses of chemotherapy were administered, with a median of three courses. Thirty-seven patie nts experienced Grade 3 or 4 toxicity. Of the 17 patients with Grade 4 toxicity; 12 had hematologic toxicity, 3 stomatitis, and 2 vomiting. Two additional patients died of myelosuppression-related sepsis. Of th e 50 patients, 3 (6%) achieved a complete response, five (10%) had a p artial response, 3 (6%) had unconfirmed response (1 complete and 2 par tial), 10 (20%) had stable disease, 17 (34%) progressed, and 12 (24%) were considered nonresponders owing to early death (6) or inadequate a ssessment (6). The median survival was 5 months. Conclusion. The compl ete response rate of patients with recurrent or metastatic SCCHN treat ed with 5-FU, cisplatin, and alpha-IFN does not appear to be superior to that observed for 5-FU and cisplatin. Alpha-interferon appears to a ugment hematologic and gastrointestinal toxicities associated with thi s combination.