Gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma: A Phase II study

Rogerio Lilenbaum, Roberto Cano, Michael Schwartz, Leonard Siegel, Jose Lutzky, Mark Lewis, Elisa Krill, Luis Barreras, Enrique Davila

Research output: Contribution to journalArticle

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Abstract

BACKGROUND. The authors conducted a Phase II study to evaluate the activity of the combination of gemcitabine and vinorelbine in patients with advanced nonsmall cell lung carcinoma (NSCLC). METHODS. Patients were eligible if they had Stage IIIB (malignant pleural effusion) or Stage IV NSCLC, no prior chemotherapy, and Cancer and Leukemia Group B performance status (PS) 0-2. Patients with brain metastases were eligible if they were neurologically stable after brain irradiation. Thirty-three patients from participating institutions were enrolled. One patient was ineligible due to untreated brain metastases. Patients were treated with gemcitabine 1250 mg/m2 over 30 minutes (1000 mg/m2 for the first 6 patients) and vinorelbine 25 mg/m2 over 6 minutes, both administered intravenously on Days 1 and 8 every 21 days. Treatment was planned for a total of six cycles or more if the patient had persistent benefit. Growth factors were not allowed. RESULTS. Among all 32 eligible patients, there were 8 partial responses, for an overall response rate of 25% (95% confidence interval [CI], 11.5-43.4%). The median survival time was 8.3 months and the 1-year survival rate was 38% (95% CI, 24-59%). Patients with PS 0-1 had a median survival of 11.7 months and a 1-year survival rate of 48%. Grade 3 and 4 neutropenia was observed in 13% and 25% of the 148 treatment cycles, respectively. One patient died of neutropenic sepsis. Only 2 episodes of Grade 3 and 4 thrombocytopenia were observed. Nonhematologic toxicity was minimal. CONCLUSIONS. Gemcitabine and vinorelbine is an active and welt-tolerated regimen in patients with advanced NSCLC, with response and survival rates at least comparable to those achieved with standard platinum-based regimens. This combination may be particularly suitable for the elderly or for patients who cannot tolerate more toxic platinum-based regimens.

Original languageEnglish (US)
Pages (from-to)557-562
Number of pages6
JournalCancer
Volume88
Issue number3
DOIs
StatePublished - Feb 1 2000
Externally publishedYes

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gemcitabine
Carcinoma
Lung
Survival Rate
Platinum
vinorelbine
Brain
Confidence Intervals
Neoplasm Metastasis
Malignant Pleural Effusion

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Lilenbaum, R., Cano, R., Schwartz, M., Siegel, L., Lutzky, J., Lewis, M., ... Davila, E. (2000). Gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma: A Phase II study. Cancer, 88(3), 557-562. https://doi.org/10.1002/(SICI)1097-0142(20000201)88:3<557::AID-CNCR10>3.0.CO;2-5

Gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma : A Phase II study. / Lilenbaum, Rogerio; Cano, Roberto; Schwartz, Michael; Siegel, Leonard; Lutzky, Jose; Lewis, Mark; Krill, Elisa; Barreras, Luis; Davila, Enrique.

In: Cancer, Vol. 88, No. 3, 01.02.2000, p. 557-562.

Research output: Contribution to journalArticle

Lilenbaum, R, Cano, R, Schwartz, M, Siegel, L, Lutzky, J, Lewis, M, Krill, E, Barreras, L & Davila, E 2000, 'Gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma: A Phase II study', Cancer, vol. 88, no. 3, pp. 557-562. https://doi.org/10.1002/(SICI)1097-0142(20000201)88:3<557::AID-CNCR10>3.0.CO;2-5
Lilenbaum, Rogerio ; Cano, Roberto ; Schwartz, Michael ; Siegel, Leonard ; Lutzky, Jose ; Lewis, Mark ; Krill, Elisa ; Barreras, Luis ; Davila, Enrique. / Gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma : A Phase II study. In: Cancer. 2000 ; Vol. 88, No. 3. pp. 557-562.
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abstract = "BACKGROUND. The authors conducted a Phase II study to evaluate the activity of the combination of gemcitabine and vinorelbine in patients with advanced nonsmall cell lung carcinoma (NSCLC). METHODS. Patients were eligible if they had Stage IIIB (malignant pleural effusion) or Stage IV NSCLC, no prior chemotherapy, and Cancer and Leukemia Group B performance status (PS) 0-2. Patients with brain metastases were eligible if they were neurologically stable after brain irradiation. Thirty-three patients from participating institutions were enrolled. One patient was ineligible due to untreated brain metastases. Patients were treated with gemcitabine 1250 mg/m2 over 30 minutes (1000 mg/m2 for the first 6 patients) and vinorelbine 25 mg/m2 over 6 minutes, both administered intravenously on Days 1 and 8 every 21 days. Treatment was planned for a total of six cycles or more if the patient had persistent benefit. Growth factors were not allowed. RESULTS. Among all 32 eligible patients, there were 8 partial responses, for an overall response rate of 25{\%} (95{\%} confidence interval [CI], 11.5-43.4{\%}). The median survival time was 8.3 months and the 1-year survival rate was 38{\%} (95{\%} CI, 24-59{\%}). Patients with PS 0-1 had a median survival of 11.7 months and a 1-year survival rate of 48{\%}. Grade 3 and 4 neutropenia was observed in 13{\%} and 25{\%} of the 148 treatment cycles, respectively. One patient died of neutropenic sepsis. Only 2 episodes of Grade 3 and 4 thrombocytopenia were observed. Nonhematologic toxicity was minimal. CONCLUSIONS. Gemcitabine and vinorelbine is an active and welt-tolerated regimen in patients with advanced NSCLC, with response and survival rates at least comparable to those achieved with standard platinum-based regimens. This combination may be particularly suitable for the elderly or for patients who cannot tolerate more toxic platinum-based regimens.",
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AU - Lilenbaum, Rogerio

AU - Cano, Roberto

AU - Schwartz, Michael

AU - Siegel, Leonard

AU - Lutzky, Jose

AU - Lewis, Mark

AU - Krill, Elisa

AU - Barreras, Luis

AU - Davila, Enrique

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N2 - BACKGROUND. The authors conducted a Phase II study to evaluate the activity of the combination of gemcitabine and vinorelbine in patients with advanced nonsmall cell lung carcinoma (NSCLC). METHODS. Patients were eligible if they had Stage IIIB (malignant pleural effusion) or Stage IV NSCLC, no prior chemotherapy, and Cancer and Leukemia Group B performance status (PS) 0-2. Patients with brain metastases were eligible if they were neurologically stable after brain irradiation. Thirty-three patients from participating institutions were enrolled. One patient was ineligible due to untreated brain metastases. Patients were treated with gemcitabine 1250 mg/m2 over 30 minutes (1000 mg/m2 for the first 6 patients) and vinorelbine 25 mg/m2 over 6 minutes, both administered intravenously on Days 1 and 8 every 21 days. Treatment was planned for a total of six cycles or more if the patient had persistent benefit. Growth factors were not allowed. RESULTS. Among all 32 eligible patients, there were 8 partial responses, for an overall response rate of 25% (95% confidence interval [CI], 11.5-43.4%). The median survival time was 8.3 months and the 1-year survival rate was 38% (95% CI, 24-59%). Patients with PS 0-1 had a median survival of 11.7 months and a 1-year survival rate of 48%. Grade 3 and 4 neutropenia was observed in 13% and 25% of the 148 treatment cycles, respectively. One patient died of neutropenic sepsis. Only 2 episodes of Grade 3 and 4 thrombocytopenia were observed. Nonhematologic toxicity was minimal. CONCLUSIONS. Gemcitabine and vinorelbine is an active and welt-tolerated regimen in patients with advanced NSCLC, with response and survival rates at least comparable to those achieved with standard platinum-based regimens. This combination may be particularly suitable for the elderly or for patients who cannot tolerate more toxic platinum-based regimens.

AB - BACKGROUND. The authors conducted a Phase II study to evaluate the activity of the combination of gemcitabine and vinorelbine in patients with advanced nonsmall cell lung carcinoma (NSCLC). METHODS. Patients were eligible if they had Stage IIIB (malignant pleural effusion) or Stage IV NSCLC, no prior chemotherapy, and Cancer and Leukemia Group B performance status (PS) 0-2. Patients with brain metastases were eligible if they were neurologically stable after brain irradiation. Thirty-three patients from participating institutions were enrolled. One patient was ineligible due to untreated brain metastases. Patients were treated with gemcitabine 1250 mg/m2 over 30 minutes (1000 mg/m2 for the first 6 patients) and vinorelbine 25 mg/m2 over 6 minutes, both administered intravenously on Days 1 and 8 every 21 days. Treatment was planned for a total of six cycles or more if the patient had persistent benefit. Growth factors were not allowed. RESULTS. Among all 32 eligible patients, there were 8 partial responses, for an overall response rate of 25% (95% confidence interval [CI], 11.5-43.4%). The median survival time was 8.3 months and the 1-year survival rate was 38% (95% CI, 24-59%). Patients with PS 0-1 had a median survival of 11.7 months and a 1-year survival rate of 48%. Grade 3 and 4 neutropenia was observed in 13% and 25% of the 148 treatment cycles, respectively. One patient died of neutropenic sepsis. Only 2 episodes of Grade 3 and 4 thrombocytopenia were observed. Nonhematologic toxicity was minimal. CONCLUSIONS. Gemcitabine and vinorelbine is an active and welt-tolerated regimen in patients with advanced NSCLC, with response and survival rates at least comparable to those achieved with standard platinum-based regimens. This combination may be particularly suitable for the elderly or for patients who cannot tolerate more toxic platinum-based regimens.

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