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Annals of Oncology 7:821-826, 1996
© 1996 European Society for Medical Oncology

research-article

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 multicentre randomised trial

C. Gridelli1,, F. Perron2,3, S. Palmeri4, M. D'Aprile5, F. Cognetti6, A. Rossi7, V. Gebbia8, R. Pepe7, E. Veltri5, G. Airoma7, A. Russo9, P. Incoronato7, A. F. Scinto8, G. Palazzolo7, M. Natali5, V. Leonardi4, C. Gallo3, S. De Placido3,7, A. R. Bianco7 and on behalf of the ‘Gruppo Oncologico Centro-Sud-Isole’ (G.O.C.S.I.)

1Divisione di Onwlogia Medica B
2Unità Studi Clinici Controllati, Istituto Nazionale Tumori ‘G. Pascale’
3Centro Elaborazione Dati Clinici del Mezzogiomo, CNR-ACRO Napoli
4Cattedra di Oncologia Medica, Facoltà di Medicina, Università degli Studi di Palermo
5Divisione di Oncologia Medica, Ospedale S. Maria Goretti Latina
61st Divisione di Oncologia Medica, Istituto Nazionale Tumori ‘Regina Elena’ Roma
7Cattedra di Oncologia Medica, Facoltà di Medicina, Università ‘Federico II’ di Napoli
8Cattedra di Chemioterapia, Facoltà di Medicina, Università degli Studi di Palermo
9Servizio Centralizzato di Oncologia Medica, Facoltà di Medicina, Università degli Studi di Palermo Italy

Correspondence to: Dr. Cesare Gridelli Divisione di Oncologia Medica B Istituto Nazionale Tumori ‘G. Pascale’ Via Mariano Semmola 80131 Napoli, Italy

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 patients were entered in a phase III multicentre randomised trial from June 1990 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/m2 + vindesine 3 mg/m2 + cisplatin 100 mg/m2 i.v. day 1 and vindesine 3 mg/m2 i.v. day 8 with cycles repeated every 4 weeks. MEV was given in the following dosages: mitomycin C 8 mg/m2 + vindesine 3 mg/m2 i.v. day 1 and etoposide 100 mg/m2 i.v. days 1 to 3 with cycles repeated every 3 weeks. For both treatments a maximum of 6 cycles was planned. Response and toxicity were evaluated according to WHO. Subjective responses were assessed by numerical scales. Analyses were made on the basis of intent to treat.

RESULTS:: The objective response 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). Symptoms 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 weeks (95% CI 10–15) and median survivals were 29 weeks (95% CI 25–36) and 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 CL 0.71–1.30), respectively, for patients receiving MVP as compared with those receiving MEV at multivariate analysis adjusted by sex, age, histologic type, number of metastatic sites, performance status at entry, and centre.

CONCLUSIONS:: In the present study, no significant dfferences were observed in response rate, survival or palliation 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 treatment of stage IV NSCLC.

chemotherapy, non-cisplatin-containing, regimen, stage IV NSCLC


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