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

Research output: Contribution to journalArticle

Abstract

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
Volume13
Issue number12
DOIs
Publication statusPublished - Dec 1 2002

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gemcitabine
Paclitaxel
Non-Small Cell Lung Carcinoma
Drug Therapy
Neutropenia
vinorelbine
Asthenia
Survival
Maximum Tolerated Dose
Alopecia

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Phase I/II study of paclitaxel, gemcitabine and vinorelbine as first-line chemotherapy of non-small-cell lung cancer. / Lorusso, V.; Crucitta, E.; Panza, N.; Silvestris, N.; Guida, M.; Carpagnano, F.; Mancarella, S.; Sambiasi, D.; De Lena, M.

In: Annals of Oncology, Vol. 13, No. 12, 01.12.2002, p. 1862-1867.

Research output: Contribution to journalArticle

Lorusso, V. ; Crucitta, E. ; Panza, N. ; Silvestris, N. ; Guida, M. ; Carpagnano, F. ; Mancarella, S. ; Sambiasi, D. ; De Lena, M. / Phase I/II study of paclitaxel, gemcitabine and vinorelbine as first-line chemotherapy of non-small-cell lung cancer. In: Annals of Oncology. 2002 ; Vol. 13, No. 12. pp. 1862-1867.
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T1 - Phase I/II study of paclitaxel, gemcitabine and vinorelbine as first-line chemotherapy of non-small-cell lung cancer

AU - Lorusso, V.

AU - Crucitta, E.

AU - Panza, N.

AU - Silvestris, N.

AU - Guida, M.

AU - Carpagnano, F.

AU - Mancarella, S.

AU - Sambiasi, D.

AU - De Lena, M.

PY - 2002/12/1

Y1 - 2002/12/1

N2 - 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.

AB - 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.

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