MITOMYCIN-C, CISPLATIN, AND 5-FLUOROURACIL FOR ADVANCED AND OR RECURRENT HEAD AND NECK SQUAMOUS-CELL CARCINOMAS/

The combination of cisplatin (CDDP 100 mg/m(2) on day 1) and 5-fluorou racil (5-FU 1,000 mg/m(2) continuous intravenous (i.v.) infusion days 1-5) is the most widely used chemotherapy regimen for the treatment of advanced head and neck carcinomas, with a response rate of 70-90% but with a survival and a duration of response which are not impressive. Most patients relapse in less than or equal to 2 years and die of canc er. We evaluated the activity of a CDDP (90 mg/m(2) on day 1), 5-FU (9 00 mg/m(2)/120 h continuous i.v. infusion from day 1), and mitomycin C (MMC 6 mg/m(2) on day 1) regimen in advanced or recurrent head and ne ck squamous ce:ll carcinoma (HNSCC). Fifty-six patients were treated a nd evaluated for response and toxicity: 5 (9%) complete responses (CR) and 36 (64%) partial responses, (PR) were observed (response rate 73% ). The median duration of response was 12 months, and median survival was 15 months. At a median follow-up of 14 months, the estimated overa ll survival at 1 year was 65%; at 2 years, it was 35%. Grade 3-4 toxic ity was noted in 14 patients, mostly hematologic; overall toxicity req uired a dose-intensity decrease in 20.2% of all cycles. No treatment-r elated deaths occurred. The regimen showed a good response rate and an encouraging median duration of response with a,good tolerability prof ile.