CHEMOTHERAPY OF ADVANCED NON-SMALL-CELL LUNG-CANCER - A COMPARISON OF3 ACTIVE REGIMENS - A RANDOMIZED TRIAL OF THE ITALIAN ONCOLOGY GROUP FOR CLINICAL RESEARCH (GOIRC)

Background: Cisplatin-based chemotherapy is generally considered the m ost active treatment for advanced non-small-cell lung cancer, The comb ination of cisplatin and etoposide had for some time been the standard treatment at our center. Of the other active regimens, cisplatin in c ombination with mitomycin-C, vindesine or ifosfamide (MW or MTC) showe d the highest response rates. We decided to perform a comparative tria l of the three 'best' regimens in order to define a possible standard regimen in advanced NSCLC. Materials and methods: From May 1989 to Apr il 1992, 393 consecutive, previously untreated NSCLC patients, stages IIIB and IV, were randomized to receive either cisplatin (120 mg/sqm d ay 1) + etoposide (100 mg/sqm days 1-3) every 3 weeks (PE) or cisplati n (120 mg/sqm every 4 weeks)+ mitomycin-C (8 mg/sqm days 1-29-71) + vi ndesine (3 mg/sqm days 1-8-15-22) (MVP) or cisplatin (120 mg/sqm day 1 ) + mitomycin-C (6 mg/sqm day 1) + ifosfamide (3 mg/sqm day 2) every 3 weeks (MIC). Of these, 382 were evaluable for survival and 360 for re sponse. Results: Response rates were statistically higher for both MIC (40%) and MVP (36%) than for the PE arm (23%). Survival estimates ana lyzed by the log-rank test showed a significant benefit (p < 0.04) for patients treated with three-drug regimens (MVP; MIG) as compared to t hose in the PE arm. The main toxicity was myelosuppression; thrombocyt openia WHO grade 3-4 was worse in the MIC arm; nephrotoxicity grade 3- 4 was also more frequent in the MIC arm. Conclusions: A three-drug cis platin-based regimen (MVP; MIC) should be considered as reference trea tment in NSCLC.