The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients

Cesare Gridelli, Ermelinda De Maio, Santi Barbera, Mirella Sannicolò, Elena Piazza, FrancoVito Piantedosi, Luigi Brancaccio, Alessandro Morabito, Paolo Maione, Francesco Renda, Giuseppe Signoriello, Francesco Perrone

Research output: Contribution to journalArticle

Abstract

Background: Gemcitabine has been widely studied in elderly patients affected by advanced non-small cell lung cancer (NSCLC). A prolonged constant infusion (10 mg/m2/min) has been proposed as a way to improve its efficacy. Aim of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion in the treatment of elderly patients with advanced NSCLC. Patients and methods: Patients aged 70 years or older, with stage IV or IIIB (effusion/supraclavicular nodes) NSCLC, good performance status (0 or 1 according to ECOG classification) who had never received chemotherapy were eligible. Gemcitabine was administered at the dose of 1200 mg/m2 by prolonged infusion (10 mg/m2/min) on days 1 and 8 of each cycle. Courses were repeated every 21 days, for a maximum of 6 cycles, unless disease progression or severe toxicity. A single stage phase 2 design was applied, with 51 patients required to estimate a 25% ± 10% response rate. Ten responses were required to define the treatment as active. Results: Fifty-one patients were enrolled, with a median age of 76 years (range 70-83). Two complete responses and seven partial responses were observed, for an overall response rate of 17.6% (95% exact C.I.: 8.4-30.9%). The median time to disease progression was 16.1 weeks (95% C.I.: 11.1-20.6) and the median overall survival was 41.3 weeks (95% C.I.: 27.6-50.6). There were 2 toxic deaths, due to bleeding and liver toxicity, and one patient had an ischemic stroke. Other non-haematological toxicities were: fatigue (44% of patients), grade 2-3 pulmonary toxicity (8%), grade 2-3 hepatic toxicity (16%). Nausea and stomatitis were mild and no cases of cardiac toxicity were observed. Haematological toxicity was mild, with no case of febrile neutropenia. Conclusion: Gemcitabine at prolonged constant infusion produced a response rate lower than that required by study design and should no longer be of interest for the treatment of elderly patients with advanced NSCLC.

Original languageEnglish
Pages (from-to)67-72
Number of pages6
JournalLung Cancer
Volume61
Issue number1
DOIs
Publication statusPublished - Jul 2008

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gemcitabine
Non-Small Cell Lung Carcinoma
Disease Progression
Febrile Neutropenia
Stomatitis
Poisons
Liver

Keywords

  • Elderly patients
  • Gemcitabine
  • NSCLC

ASJC Scopus subject areas

  • Oncology

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The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients. / Gridelli, Cesare; De Maio, Ermelinda; Barbera, Santi; Sannicolò, Mirella; Piazza, Elena; Piantedosi, FrancoVito; Brancaccio, Luigi; Morabito, Alessandro; Maione, Paolo; Renda, Francesco; Signoriello, Giuseppe; Perrone, Francesco.

In: Lung Cancer, Vol. 61, No. 1, 07.2008, p. 67-72.

Research output: Contribution to journalArticle

Gridelli, C, De Maio, E, Barbera, S, Sannicolò, M, Piazza, E, Piantedosi, F, Brancaccio, L, Morabito, A, Maione, P, Renda, F, Signoriello, G & Perrone, F 2008, 'The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients', Lung Cancer, vol. 61, no. 1, pp. 67-72. https://doi.org/10.1016/j.lungcan.2007.12.002
Gridelli, Cesare ; De Maio, Ermelinda ; Barbera, Santi ; Sannicolò, Mirella ; Piazza, Elena ; Piantedosi, FrancoVito ; Brancaccio, Luigi ; Morabito, Alessandro ; Maione, Paolo ; Renda, Francesco ; Signoriello, Giuseppe ; Perrone, Francesco. / The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients. In: Lung Cancer. 2008 ; Vol. 61, No. 1. pp. 67-72.
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abstract = "Background: Gemcitabine has been widely studied in elderly patients affected by advanced non-small cell lung cancer (NSCLC). A prolonged constant infusion (10 mg/m2/min) has been proposed as a way to improve its efficacy. Aim of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion in the treatment of elderly patients with advanced NSCLC. Patients and methods: Patients aged 70 years or older, with stage IV or IIIB (effusion/supraclavicular nodes) NSCLC, good performance status (0 or 1 according to ECOG classification) who had never received chemotherapy were eligible. Gemcitabine was administered at the dose of 1200 mg/m2 by prolonged infusion (10 mg/m2/min) on days 1 and 8 of each cycle. Courses were repeated every 21 days, for a maximum of 6 cycles, unless disease progression or severe toxicity. A single stage phase 2 design was applied, with 51 patients required to estimate a 25{\%} ± 10{\%} response rate. Ten responses were required to define the treatment as active. Results: Fifty-one patients were enrolled, with a median age of 76 years (range 70-83). Two complete responses and seven partial responses were observed, for an overall response rate of 17.6{\%} (95{\%} exact C.I.: 8.4-30.9{\%}). The median time to disease progression was 16.1 weeks (95{\%} C.I.: 11.1-20.6) and the median overall survival was 41.3 weeks (95{\%} C.I.: 27.6-50.6). There were 2 toxic deaths, due to bleeding and liver toxicity, and one patient had an ischemic stroke. Other non-haematological toxicities were: fatigue (44{\%} of patients), grade 2-3 pulmonary toxicity (8{\%}), grade 2-3 hepatic toxicity (16{\%}). Nausea and stomatitis were mild and no cases of cardiac toxicity were observed. Haematological toxicity was mild, with no case of febrile neutropenia. Conclusion: Gemcitabine at prolonged constant infusion produced a response rate lower than that required by study design and should no longer be of interest for the treatment of elderly patients with advanced NSCLC.",
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AU - De Maio, Ermelinda

AU - Barbera, Santi

AU - Sannicolò, Mirella

AU - Piazza, Elena

AU - Piantedosi, FrancoVito

AU - Brancaccio, Luigi

AU - Morabito, Alessandro

AU - Maione, Paolo

AU - Renda, Francesco

AU - Signoriello, Giuseppe

AU - Perrone, Francesco

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N2 - Background: Gemcitabine has been widely studied in elderly patients affected by advanced non-small cell lung cancer (NSCLC). A prolonged constant infusion (10 mg/m2/min) has been proposed as a way to improve its efficacy. Aim of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion in the treatment of elderly patients with advanced NSCLC. Patients and methods: Patients aged 70 years or older, with stage IV or IIIB (effusion/supraclavicular nodes) NSCLC, good performance status (0 or 1 according to ECOG classification) who had never received chemotherapy were eligible. Gemcitabine was administered at the dose of 1200 mg/m2 by prolonged infusion (10 mg/m2/min) on days 1 and 8 of each cycle. Courses were repeated every 21 days, for a maximum of 6 cycles, unless disease progression or severe toxicity. A single stage phase 2 design was applied, with 51 patients required to estimate a 25% ± 10% response rate. Ten responses were required to define the treatment as active. Results: Fifty-one patients were enrolled, with a median age of 76 years (range 70-83). Two complete responses and seven partial responses were observed, for an overall response rate of 17.6% (95% exact C.I.: 8.4-30.9%). The median time to disease progression was 16.1 weeks (95% C.I.: 11.1-20.6) and the median overall survival was 41.3 weeks (95% C.I.: 27.6-50.6). There were 2 toxic deaths, due to bleeding and liver toxicity, and one patient had an ischemic stroke. Other non-haematological toxicities were: fatigue (44% of patients), grade 2-3 pulmonary toxicity (8%), grade 2-3 hepatic toxicity (16%). Nausea and stomatitis were mild and no cases of cardiac toxicity were observed. Haematological toxicity was mild, with no case of febrile neutropenia. Conclusion: Gemcitabine at prolonged constant infusion produced a response rate lower than that required by study design and should no longer be of interest for the treatment of elderly patients with advanced NSCLC.

AB - Background: Gemcitabine has been widely studied in elderly patients affected by advanced non-small cell lung cancer (NSCLC). A prolonged constant infusion (10 mg/m2/min) has been proposed as a way to improve its efficacy. Aim of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion in the treatment of elderly patients with advanced NSCLC. Patients and methods: Patients aged 70 years or older, with stage IV or IIIB (effusion/supraclavicular nodes) NSCLC, good performance status (0 or 1 according to ECOG classification) who had never received chemotherapy were eligible. Gemcitabine was administered at the dose of 1200 mg/m2 by prolonged infusion (10 mg/m2/min) on days 1 and 8 of each cycle. Courses were repeated every 21 days, for a maximum of 6 cycles, unless disease progression or severe toxicity. A single stage phase 2 design was applied, with 51 patients required to estimate a 25% ± 10% response rate. Ten responses were required to define the treatment as active. Results: Fifty-one patients were enrolled, with a median age of 76 years (range 70-83). Two complete responses and seven partial responses were observed, for an overall response rate of 17.6% (95% exact C.I.: 8.4-30.9%). The median time to disease progression was 16.1 weeks (95% C.I.: 11.1-20.6) and the median overall survival was 41.3 weeks (95% C.I.: 27.6-50.6). There were 2 toxic deaths, due to bleeding and liver toxicity, and one patient had an ischemic stroke. Other non-haematological toxicities were: fatigue (44% of patients), grade 2-3 pulmonary toxicity (8%), grade 2-3 hepatic toxicity (16%). Nausea and stomatitis were mild and no cases of cardiac toxicity were observed. Haematological toxicity was mild, with no case of febrile neutropenia. Conclusion: Gemcitabine at prolonged constant infusion produced a response rate lower than that required by study design and should no longer be of interest for the treatment of elderly patients with advanced NSCLC.

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