Gemcitabine plus vinorelbine as first-line chemotherapy in advanced nonsmall cell lung carcinoma A phase II trial

Emilio Bajetta, Simonetta Chiara Stani, Daniela De Candis, Paolo Bidoli, Luigi Mariani, Nicoletta Zilembo, Paola Pozzi, Giuseppe Procopio

Research output: Contribution to journalArticlepeer-review


BACKGROUND. Response and survival in patients with advanced or oside analog gemcitabine, and the semisynthetic vinca alkaloid vinorelbine, have been shown to be effective in NSCLC and to have a low-toxicity profile. METHODS. Fifty-four chemotherapy-naive patients with NSCLC Stage IIIB (any TN3M0 or T4 any NM0) or IV (any T any NM1) were enrolled in this single-institution Phase II study. Gemcitabine 1250 mg/m2 and vinorelbine 25 mg/m2 were both administered on Days 1 and 8 every 3 weeks for up to 9 courses unless disease progression or severe toxicity required their discontinuation. RESULTS. Partial tumor regression was observed in 16 patients, for an overall response rate of 30% (95% confidence interval, 18.4-46.7%) on an intent-to-treat basis. The median time to progression was 5 months (range, 3-20). The median survival was 12 months (range, 5-42+); 1-year and 2-year survival rates were 49.1% and 17%, respectively. Hematologic toxicity was mild with only 11% of the patients developing Grade 3 neutropenia. None of the patients developed any Grade 4 toxicity. CONCLUSIONS. The combination of gemcitabine plus vinorelbine is feasible on an outpatient basis. The good activity and tolerability of the regimen make it a suitable candidate for further trials, using platinum-based regimens as comparators and possibly selecting elderly and less fit patients. (C) 2000 American Cancer Society.

Original languageEnglish
Pages (from-to)763-768
Number of pages6
Issue number4
Publication statusPublished - Aug 15 2000


  • Chemotherapy
  • Gemcitabine
  • Nonsmall cell lung carcinoma (NSCLC)
  • Vinorelbine

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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