Gemcitabine plus vinorelbine in advanced non-small cell lung cancer: A phase II study of three different doses

C. Gridelli, L. Frontini, F. Perrone, C. Gallo, M. Gulisano, S. Cigolari, F. Castiglione, S. F. Robbiati, G. Gasparini, G. P. Ianniello, A. Farris, M. C. Locatelli, R. Felletti, E. Piazza

Research output: Contribution to journalArticlepeer-review


Our aim was to study the activity and toxicity of the gemcitabine plus vinorelbine (Gem Vin) combination and to identify the optimal dose. Previously untreated patients aged <70 years, with stags IV or IIIb (not candidates for radiotherapy) non-small cell lung cancer were eligible. Studied dose-levels of Gem Vin, administered on days 1 and 8 every 3 weeks, were (mg m -2): level I = 1000/25; level II = 1200/25; level III = 1000/30; level IV = 1200/30. A feasibility study was performed at each dose-level, followed by a single-stage phase II study. Dose-level IV was unfeasible because of grade 4 neutropenia. Overall, out of 126 patients enrolled in phase II studies, there were one complete and 32 partial responses (response rate 26%: 95% Cl 18-34%). Response rates were 27.9%, 21.4% and 29.3% at levels I, II and III respectively. The treatment was well tolerated. Toxicity was less frequent and severe at level I. Overall median survival was 33 weeks (95% Cl 28-40). Descriptive quality of life analysis showed that patients with a worse baseline global health status score tended to drop out of the study earlier than those with a better score. Gem Vin is feasible at different doses. It is sufficiently active and well tolerate. A phase III study to compare the effect on quality of life of Gem Vin (level I) vs cisplatin-based chemotherapy is ongoing. (C) 2000 Cancer Research Campaign.

Original languageEnglish
Pages (from-to)707-714
Number of pages8
JournalBritish Journal of Cancer
Issue number6
Publication statusPublished - 2000


  • Gemcitabine
  • Non-small cell lung cancer
  • Vinorelbine

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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