MITOMYCIN-C PLUS VINDESINE PLUS ETOPOSIDE (MEV) VERSUS MITOMYCIN-C PLUS VINDESINE PLUS CISPLATIN (MVP) IN STAGE-IV NON-SMALL-CELL LUNG-CANCER - A PHASE-III MULTICENTER RANDOMIZED TRIAL

Purpose: To compare mitomycin C plus vindesine plus etoposide (MEV) vs . mitomycin C plus vindesine plus cisplatin (MVP) in the treatment of stage IV non-small-cell lung cancer. Patients and methods: 204 patient s were entered in a phase III multicentre randomised trial from June 1 990 to December 1994 and stratified according to the ECOG performance status (0-1 vs. 2). MVP was given in the following dosages: mitomycin C 8 mg/m(2) + vindesine 3 mg/m(2) + cisplatin 100 mg/m(2) i.v. day 1 a nd vindesine 3 mg/m(2) i.v. day 8 with cycles repeated every 4 weeks. MEV was given in the following dosages: mitomycin C 8 mg/m(2) + vindes ine 3 mg/m(2) iv. day 1 and etoposide 100 mg/m(2) i.v. days 1 to 3 wit h cycles repeated every 3 weeks. For both treatments a maximum of 6 cy cles was planned. Response and toxicity were evaluated according to WH O. Subjective responses were assessed by numerical scales. Analyses we re made on the basis of intent to treat. Results: The objective respon se rate was 21.4% (1 CR + 21 PR among 103 patients) in the MEV and 28. 7% (1 CR + 28 PR among 101 patients) in the MVP arm (P = 0.48). Sympto ms were similar in the two arms. 196 patients progressed and 182 died. The median times to progression were 10 weeks (95% CI 9-12) and 12 we eks (95% CI 10-15) and median survivals were 29 weeks (95% CI 25-36) a nd 28 weeks (95% CI 25-35) in the MEV and MVP arms, respectively. The relative risks of progressing and of dying were 0.89 (95% CL 0.66-1.20 ) and 0.96 (95% CL 0.71-1.30), respectively, for patients receiving MV P as compared with those receiving MEV at multivariate analysis adjust ed by sex, age, histologic type, number of metastatic sites, performan ce status at entry, and centre. Conclusions: In the present study, no significant differences were observed in response rate, survival or pa lliation of symptoms between the MEV and MVP regimens, while toxicity was significantly more frequent and severe with MVP. Thus, MEV should be considered a reasonable alternative to the MVP regimen in the treat ment of stage IV NSCLC.