Activity and toxicity of gemcitabine and gemcitabine+vinorelbine in advanced non-small-cell lung cancer elderly patients: Phase II data from the Multicenter Italian Lung Cancer in the Elderly Study (MILES) randomized trial

Cesare Gridelli, Silvio Cigolari, Ciro Gallo, Luigi Manzione, Giovanni Pietro Ianniello, Luciano Frontini, Francesco Ferraù, Sergio Federico Robbiati, Vincenzo Adamo, Giampietro Gasparini, Silvia Novello, Francesco Perrone

Research output: Contribution to journalArticle

Abstract

Background: Following the demonstration that vinorelbine improves survival and quality of life compared with best supportive care in elderly patients with advanced non-small-cell lung cancer (NSCLC), we started the three-arm prospective Multicenter Italian Lung Cancer in the Elderly Study (MILES) trial of vinorelbine, gemcitabine and gemcitabine+vinorelbine. Design: Within the randomized phase 3 trial, pilot single-stage phase 2 studies were planned for gemcitabine and for gemcitabine+vinorelbine. Eligible patients are aged 70 or more, with stage IV or IIIb (with metastatic supraclavear nodes or malignant pleural effusion) NSCLC. Single-agent gemcitabine is given at 1200 mg/m2 on days 1 and 8; in the combination, gemcitabine is given at 1000 mg/m2 and vinorelbine at 25 mg/m2, both on days 1 and 8, every 3 weeks. Results: As planned 49 patients were enrolled in each group. Median age was 74 in both groups. Two-thirds of patients had stage IV disease. The response rate was 18.4% (95% exact CI 8.8-32.0) with both treatments. With single-agent gemcitabine main toxicities were grade 4 thrombocytopenia and grade 2 hepatic toxicity, in one patient each, and grade 2 pulmonary toxicity in two patients. With gemcitabine+vinorelbine combination there were grade 4 neutropenia and thrombocytopenia (one patient each), grade 3 anemia requiring red blood cell transfusion (two patients), and grade 4 fever in two patients. Four patients, with severe cardiac comorbidities, suffered grade 3 heart toxicity with atrial flutter or fibrillation, followed by congestive heart failure responsive to treatment. Conclusion: Both single-agent gemcitabine and the gemcitabine+vinorelbine combination are sufficiently active and tolerable to allow continuation of the MILES study.

Original languageEnglish
Pages (from-to)277-284
Number of pages8
JournalLung Cancer
Volume31
Issue number2-3
DOIs
Publication statusPublished - 2001

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gemcitabine
Non-Small Cell Lung Carcinoma
Lung Neoplasms
vinorelbine
Malignant Pleural Effusion
Erythrocyte Transfusion
Atrial Flutter

Keywords

  • Chemotherapy
  • Elderly
  • Gemcitabine
  • NSCLC
  • Randomised phase II study
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology

Cite this

Activity and toxicity of gemcitabine and gemcitabine+vinorelbine in advanced non-small-cell lung cancer elderly patients : Phase II data from the Multicenter Italian Lung Cancer in the Elderly Study (MILES) randomized trial. / Gridelli, Cesare; Cigolari, Silvio; Gallo, Ciro; Manzione, Luigi; Ianniello, Giovanni Pietro; Frontini, Luciano; Ferraù, Francesco; Robbiati, Sergio Federico; Adamo, Vincenzo; Gasparini, Giampietro; Novello, Silvia; Perrone, Francesco.

In: Lung Cancer, Vol. 31, No. 2-3, 2001, p. 277-284.

Research output: Contribution to journalArticle

Gridelli, Cesare ; Cigolari, Silvio ; Gallo, Ciro ; Manzione, Luigi ; Ianniello, Giovanni Pietro ; Frontini, Luciano ; Ferraù, Francesco ; Robbiati, Sergio Federico ; Adamo, Vincenzo ; Gasparini, Giampietro ; Novello, Silvia ; Perrone, Francesco. / Activity and toxicity of gemcitabine and gemcitabine+vinorelbine in advanced non-small-cell lung cancer elderly patients : Phase II data from the Multicenter Italian Lung Cancer in the Elderly Study (MILES) randomized trial. In: Lung Cancer. 2001 ; Vol. 31, No. 2-3. pp. 277-284.
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abstract = "Background: Following the demonstration that vinorelbine improves survival and quality of life compared with best supportive care in elderly patients with advanced non-small-cell lung cancer (NSCLC), we started the three-arm prospective Multicenter Italian Lung Cancer in the Elderly Study (MILES) trial of vinorelbine, gemcitabine and gemcitabine+vinorelbine. Design: Within the randomized phase 3 trial, pilot single-stage phase 2 studies were planned for gemcitabine and for gemcitabine+vinorelbine. Eligible patients are aged 70 or more, with stage IV or IIIb (with metastatic supraclavear nodes or malignant pleural effusion) NSCLC. Single-agent gemcitabine is given at 1200 mg/m2 on days 1 and 8; in the combination, gemcitabine is given at 1000 mg/m2 and vinorelbine at 25 mg/m2, both on days 1 and 8, every 3 weeks. Results: As planned 49 patients were enrolled in each group. Median age was 74 in both groups. Two-thirds of patients had stage IV disease. The response rate was 18.4{\%} (95{\%} exact CI 8.8-32.0) with both treatments. With single-agent gemcitabine main toxicities were grade 4 thrombocytopenia and grade 2 hepatic toxicity, in one patient each, and grade 2 pulmonary toxicity in two patients. With gemcitabine+vinorelbine combination there were grade 4 neutropenia and thrombocytopenia (one patient each), grade 3 anemia requiring red blood cell transfusion (two patients), and grade 4 fever in two patients. Four patients, with severe cardiac comorbidities, suffered grade 3 heart toxicity with atrial flutter or fibrillation, followed by congestive heart failure responsive to treatment. Conclusion: Both single-agent gemcitabine and the gemcitabine+vinorelbine combination are sufficiently active and tolerable to allow continuation of the MILES study.",
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T1 - Activity and toxicity of gemcitabine and gemcitabine+vinorelbine in advanced non-small-cell lung cancer elderly patients

T2 - Phase II data from the Multicenter Italian Lung Cancer in the Elderly Study (MILES) randomized trial

AU - Gridelli, Cesare

AU - Cigolari, Silvio

AU - Gallo, Ciro

AU - Manzione, Luigi

AU - Ianniello, Giovanni Pietro

AU - Frontini, Luciano

AU - Ferraù, Francesco

AU - Robbiati, Sergio Federico

AU - Adamo, Vincenzo

AU - Gasparini, Giampietro

AU - Novello, Silvia

AU - Perrone, Francesco

PY - 2001

Y1 - 2001

N2 - Background: Following the demonstration that vinorelbine improves survival and quality of life compared with best supportive care in elderly patients with advanced non-small-cell lung cancer (NSCLC), we started the three-arm prospective Multicenter Italian Lung Cancer in the Elderly Study (MILES) trial of vinorelbine, gemcitabine and gemcitabine+vinorelbine. Design: Within the randomized phase 3 trial, pilot single-stage phase 2 studies were planned for gemcitabine and for gemcitabine+vinorelbine. Eligible patients are aged 70 or more, with stage IV or IIIb (with metastatic supraclavear nodes or malignant pleural effusion) NSCLC. Single-agent gemcitabine is given at 1200 mg/m2 on days 1 and 8; in the combination, gemcitabine is given at 1000 mg/m2 and vinorelbine at 25 mg/m2, both on days 1 and 8, every 3 weeks. Results: As planned 49 patients were enrolled in each group. Median age was 74 in both groups. Two-thirds of patients had stage IV disease. The response rate was 18.4% (95% exact CI 8.8-32.0) with both treatments. With single-agent gemcitabine main toxicities were grade 4 thrombocytopenia and grade 2 hepatic toxicity, in one patient each, and grade 2 pulmonary toxicity in two patients. With gemcitabine+vinorelbine combination there were grade 4 neutropenia and thrombocytopenia (one patient each), grade 3 anemia requiring red blood cell transfusion (two patients), and grade 4 fever in two patients. Four patients, with severe cardiac comorbidities, suffered grade 3 heart toxicity with atrial flutter or fibrillation, followed by congestive heart failure responsive to treatment. Conclusion: Both single-agent gemcitabine and the gemcitabine+vinorelbine combination are sufficiently active and tolerable to allow continuation of the MILES study.

AB - Background: Following the demonstration that vinorelbine improves survival and quality of life compared with best supportive care in elderly patients with advanced non-small-cell lung cancer (NSCLC), we started the three-arm prospective Multicenter Italian Lung Cancer in the Elderly Study (MILES) trial of vinorelbine, gemcitabine and gemcitabine+vinorelbine. Design: Within the randomized phase 3 trial, pilot single-stage phase 2 studies were planned for gemcitabine and for gemcitabine+vinorelbine. Eligible patients are aged 70 or more, with stage IV or IIIb (with metastatic supraclavear nodes or malignant pleural effusion) NSCLC. Single-agent gemcitabine is given at 1200 mg/m2 on days 1 and 8; in the combination, gemcitabine is given at 1000 mg/m2 and vinorelbine at 25 mg/m2, both on days 1 and 8, every 3 weeks. Results: As planned 49 patients were enrolled in each group. Median age was 74 in both groups. Two-thirds of patients had stage IV disease. The response rate was 18.4% (95% exact CI 8.8-32.0) with both treatments. With single-agent gemcitabine main toxicities were grade 4 thrombocytopenia and grade 2 hepatic toxicity, in one patient each, and grade 2 pulmonary toxicity in two patients. With gemcitabine+vinorelbine combination there were grade 4 neutropenia and thrombocytopenia (one patient each), grade 3 anemia requiring red blood cell transfusion (two patients), and grade 4 fever in two patients. Four patients, with severe cardiac comorbidities, suffered grade 3 heart toxicity with atrial flutter or fibrillation, followed by congestive heart failure responsive to treatment. Conclusion: Both single-agent gemcitabine and the gemcitabine+vinorelbine combination are sufficiently active and tolerable to allow continuation of the MILES study.

KW - Chemotherapy

KW - Elderly

KW - Gemcitabine

KW - NSCLC

KW - Randomised phase II study

KW - Vinorelbine

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