A PHASE-II TRIAL OF MITOMYCIN-C, 5-FLUOROURACIL AND RADIATION-THERAPYIN THE TREATMENT OF UNRESECTABLE NONSMALL CELL LUNG-CANCER

We conducted a study evaluating the efficacy of simultaneous administr ation of 5-fluorouracil. mitomycin C, and X-irradiation in unresectabl e Stage III non-small cell lung cancer. Radiation was delivered in a s plit course to a total of 55 Gy. In the first course, radiation was ad ministered daily in 250 cGy fractions for 12 treatments. Following a t wo week rest, an additional 10 treatments of 200 cGy fractions were de livered. Chemotherapy consisted of 10 mg/M2 of Mitomycin C on day 1, a nd 1000 mg/M2 per day of 5 -fluorouracil by continuous infusion on day s 1 through 5 and 29 through 33. Twenty-one enrolled patients were eva luable. The overall response rate was 52% (95% confidence intervals 31 -73%), with a median duration of response of 42 weeks. There were 5 co mplete responders (24%) and four of these patients remain disease-free with follow-up between 24-54 months. The median survival time for all patients was 59 weeks. For the complete responders the median surviva l time has not yet been reached, but is in excess of 42 months. Toxici ty consisted of moderate stomatitis and myclosuppression. The sustaine d remissions obtained by 4 of 21 patients (18%) treated with concurren t mitomycin C, 5-fluorouracil and x-irradiation are encouraging and de serve further study