Vinorelbine plus cisplatin versus cisplatin plus vindesine and mitomycin C in stage IIIB-IV non-small cell lung carcinoma: A prospective randomized study

Vittorio Gebbia, Domenico Galetta, Fernando Riccardi, Cesare Gridelli, Ernesto Durini, Nicolò Borsellino, Nicolò Gebbia, Matteo Valdesi, Michele Caruso, Roberto Valenza, Giuseppe Pezzella, Giuseppe Colucci

Research output: Contribution to journalArticle

Abstract

Purpose: To compare a regimen of vinorelbine and cisplatin (VC) to the combination of mitomycin, vindesine, and cisplatin (MVP) in patients with stage IIIB or stage IV non-small cell lung cancer (NSCLC). The main endpoits were analysis of objective response rates, toxicity, time to progression, and overall survival. Patients and methods: 247 eligible patients were randomized to receive (a) vinorelbine 25 mg/m2 intravenous bolus on days 1and 8 plus cisplatin 100 mg/m2 on day 1 every 4 weeks, or (b) mitomycin c 8 mg/m2 i.v. on day 1, vindesine 3 mg/m2 i.v. on days 1, 8, 15 and 22, plus cisplatin 100 mg/m2 on day 1 every 4 weeks. In subsequent cycles vindesine was given every other week. For both treatments a maximum of six cycles was planned. Patients with performance status 0-2 according to the ECOG scale were enrolled. Response and toxicity were evaluated according to the WHO criteria. Analysis of clinical efficacy was performed according to an intent-to-treat analysis. Results: No statistically significant differences in clinical efficacy were observed between the two chemotherapy regimens. The overall objective response rates were 39% (95% CL, 31-49%) in the VC arm and 42% (95% CL, 33-51%) in the MVP arm (P=0.13). Median time to progression was 4.2 and 4.5 months for the MVP arm and the VC arm, respectively. Median overall survival was 7 months in the VC arm and 8 months in the MVP one (log-rank test, P=0.898). These differences were not statistically significant. However, leukopenia and thrombocytopenia were significantly higher in the MVP arm than in the VC (P=0.0001; P=0.0002). Grade 3 alopecia was more frequent in the MVP arm than in the VC one (P

Original languageEnglish
Pages (from-to)179-187
Number of pages9
JournalLung Cancer
Volume37
Issue number2
DOIs
Publication statusPublished - 2002

Keywords

  • Cisplatin
  • Mitomycin
  • Non-small cell lung cancer
  • Vindesine
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology

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    Gebbia, V., Galetta, D., Riccardi, F., Gridelli, C., Durini, E., Borsellino, N., Gebbia, N., Valdesi, M., Caruso, M., Valenza, R., Pezzella, G., & Colucci, G. (2002). Vinorelbine plus cisplatin versus cisplatin plus vindesine and mitomycin C in stage IIIB-IV non-small cell lung carcinoma: A prospective randomized study. Lung Cancer, 37(2), 179-187. https://doi.org/10.1016/S0169-5002(02)00076-4