Phase I/II study of paclitaxel, gemcitabine and vinorelbine as first-line chemotherapy of non-small-cell lung cancer

V. Lorusso, E. Crucitta, N. Panza, N. Silvestris, M. Guida, F. Carpagnano, S. Mancarella, D. Sambiasi, M. De Lena

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Background: The aim of our study was to determine the maximum tolerated dose of paclitaxel combined with a fixed dose of gemcitabine and vinorelbine in the treatment of non-small-cell lung cancer (NSCLC) and to evaluate in a phase II trial the efficacy of this combination. Patients and methods: Sixty-two patients with stage IIIB/IV NSCLC were treated with paclitaxel in escalating doses from 40-80 mg/m2 combined with gemcitabine and vinorelbine at fixed doses of 1000 mg/m2 and 25 mg/m2, respectively. All drugs were given intravenously on day 1 and 8 every 3 weeks. Results: In a phase I trial, carried out on 21 patients, grade 4 neutropenia, as dose-limiting toxicity, occurred at the dosage level of paclitaxel 80 mg/m2. In a phase II trial, with paclitaxel administered at 70 mg/m2, 27 out of 41 (66%) assessable patients responded (10% complete responses and 56% partial responses). Objective response was observed in 13 of 16 patients (81%) with stage IIIB disease and in 14 of 25 (56%) with stage IV disease. The median time to treatment failure was 26 weeks (range 3-72 weeks; 32 weeks and 20 weeks for stages IIIB and IV, respectively) and median survival 62 weeks (range 4-176 weeks; 72 weeks and 56 weeks for stages IIIB and IV, respectively). One-year survival was 64% for all patients (72% for patients with stage IIIB and 52% for those with stage IV). Grade 3 and 4 neutropenia were observed in 11 (27%) and seven (17%) cases, respectively; grade 3 thrombocytopenia was observed in three patients (7%) and grade 3 anemia in four patients (10%). The most relevant non-hematological toxicity was grade 2/3 asthenia, which was observed in 12 patients (29%). Alopecia was almost universal, whereas nausea and vomiting were absent. Conclusions: The combination of paclitaxel, gemcitabine and vinorelbine is effective and tolerable in the treatment of NSCLC. The high activity and low toxicity of this regimen warrant randomized studies with platinum-containing combinations.

Original languageEnglish
Pages (from-to)1862-1867
Number of pages6
JournalAnnals of Oncology
Issue number12
Publication statusPublished - Dec 1 2002


  • Chemotherapy
  • Gemcitabine
  • Non-small-cell lung cancer
  • Paclitaxel
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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