A randomized phase II trial evaluating standard (50 mg/min) versus low (10 mg/min) infusion duration of gemcitabine as first-line treatment in advanced non-small-cell lung cancer patients who are not eligible for platinum-based chemotherapy

F. Cappuzzo, S. Novello, F. De Marinis, G. Selvaggi, G. V. Scagliotti, F. Barbieri, M. Maur, M. Papi, E. Pasquini, S. Bartolini, L. Marini, L. Crinò

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Abstract

Purpose: Gemcitabine is one of the most active drugs against non-small-cell lung cancer (NSCLC). Preclinical data suggested that gemcitabine efficacy could be improved by increasing the dose or by increasing the infusion duration. This study has been designed in order to explore two different approaches of gemcitabine dose intensification in patients with advanced NSCLC. Patients and methods: A total of 121 chemonaive patients with locally advanced or metastatic NSCLC not suitable for a platinum-based chemotherapy were randomly allocated to chemotherapy with gemcitabine 1500 mg/m2 on days 1 and 8 every 3 weeks by standard 30 min intravenous infusion (arm A), or gemcitabine 10 mg/m2/min for 150 min on days 1 and 8 every 3 weeks by intravenous infusion at fixed dose rate (arm B). Results: One hundred and seventeen patients were fully analyzed. No difference in response rate (16.1% versus 9.9%, p = 0.28), median time to disease progression (4 months versus 4.5 months, p = 0.34) median survival (9.8 months in both arms), and 1-year survival (42.6% versus 39.0% p = 0.98) was detected in arms A and B, respectively. No treatment-related deaths occurred. Main hematological toxicities were grade 3-4 neutropenia observed in 17.9% of patients in group A and in 49.2% of individuals in group B (p = 0.0002). The incidence of febrile neutropenia was 3.3% in arm A and 0% in arm B (p = 0.17). Grade 3-4 thrombocytopenia was more frequently observed in arm B patients (9.9% versus 1.8%, p = 0.057). Non-hematological toxicity was similar in both arms, and consisted in grade 1-2 gastrointestinal toxicity observed in 48.2% of patients in arm A and 41.0% in arm B. Conclusion: Intensification of standard doses or prolonged infusion schedule did not result in efficacy improvement. Gemcitabine infusion duration does not warrant further investigation in patients with advanced NSCLC.

Original languageEnglish
Pages (from-to)319-325
Number of pages7
JournalLung Cancer
Volume52
Issue number3
DOIs
Publication statusPublished - Jun 2006

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gemcitabine
Platinum
Non-Small Cell Lung Carcinoma
Drug Therapy
Therapeutics
Intravenous Infusions
Febrile Neutropenia
Survival
Neutropenia
Disease Progression
Appointments and Schedules

Keywords

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

ASJC Scopus subject areas

  • Oncology

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A randomized phase II trial evaluating standard (50 mg/min) versus low (10 mg/min) infusion duration of gemcitabine as first-line treatment in advanced non-small-cell lung cancer patients who are not eligible for platinum-based chemotherapy. / Cappuzzo, F.; Novello, S.; De Marinis, F.; Selvaggi, G.; Scagliotti, G. V.; Barbieri, F.; Maur, M.; Papi, M.; Pasquini, E.; Bartolini, S.; Marini, L.; Crinò, L.

In: Lung Cancer, Vol. 52, No. 3, 06.2006, p. 319-325.

Research output: Contribution to journalArticle

Cappuzzo, F. ; Novello, S. ; De Marinis, F. ; Selvaggi, G. ; Scagliotti, G. V. ; Barbieri, F. ; Maur, M. ; Papi, M. ; Pasquini, E. ; Bartolini, S. ; Marini, L. ; Crinò, L. / A randomized phase II trial evaluating standard (50 mg/min) versus low (10 mg/min) infusion duration of gemcitabine as first-line treatment in advanced non-small-cell lung cancer patients who are not eligible for platinum-based chemotherapy. In: Lung Cancer. 2006 ; Vol. 52, No. 3. pp. 319-325.
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title = "A randomized phase II trial evaluating standard (50 mg/min) versus low (10 mg/min) infusion duration of gemcitabine as first-line treatment in advanced non-small-cell lung cancer patients who are not eligible for platinum-based chemotherapy",
abstract = "Purpose: Gemcitabine is one of the most active drugs against non-small-cell lung cancer (NSCLC). Preclinical data suggested that gemcitabine efficacy could be improved by increasing the dose or by increasing the infusion duration. This study has been designed in order to explore two different approaches of gemcitabine dose intensification in patients with advanced NSCLC. Patients and methods: A total of 121 chemonaive patients with locally advanced or metastatic NSCLC not suitable for a platinum-based chemotherapy were randomly allocated to chemotherapy with gemcitabine 1500 mg/m2 on days 1 and 8 every 3 weeks by standard 30 min intravenous infusion (arm A), or gemcitabine 10 mg/m2/min for 150 min on days 1 and 8 every 3 weeks by intravenous infusion at fixed dose rate (arm B). Results: One hundred and seventeen patients were fully analyzed. No difference in response rate (16.1{\%} versus 9.9{\%}, p = 0.28), median time to disease progression (4 months versus 4.5 months, p = 0.34) median survival (9.8 months in both arms), and 1-year survival (42.6{\%} versus 39.0{\%} p = 0.98) was detected in arms A and B, respectively. No treatment-related deaths occurred. Main hematological toxicities were grade 3-4 neutropenia observed in 17.9{\%} of patients in group A and in 49.2{\%} of individuals in group B (p = 0.0002). The incidence of febrile neutropenia was 3.3{\%} in arm A and 0{\%} in arm B (p = 0.17). Grade 3-4 thrombocytopenia was more frequently observed in arm B patients (9.9{\%} versus 1.8{\%}, p = 0.057). Non-hematological toxicity was similar in both arms, and consisted in grade 1-2 gastrointestinal toxicity observed in 48.2{\%} of patients in arm A and 41.0{\%} in arm B. Conclusion: Intensification of standard doses or prolonged infusion schedule did not result in efficacy improvement. Gemcitabine infusion duration does not warrant further investigation in patients with advanced NSCLC.",
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T1 - A randomized phase II trial evaluating standard (50 mg/min) versus low (10 mg/min) infusion duration of gemcitabine as first-line treatment in advanced non-small-cell lung cancer patients who are not eligible for platinum-based chemotherapy

AU - Cappuzzo, F.

AU - Novello, S.

AU - De Marinis, F.

AU - Selvaggi, G.

AU - Scagliotti, G. V.

AU - Barbieri, F.

AU - Maur, M.

AU - Papi, M.

AU - Pasquini, E.

AU - Bartolini, S.

AU - Marini, L.

AU - Crinò, L.

PY - 2006/6

Y1 - 2006/6

N2 - Purpose: Gemcitabine is one of the most active drugs against non-small-cell lung cancer (NSCLC). Preclinical data suggested that gemcitabine efficacy could be improved by increasing the dose or by increasing the infusion duration. This study has been designed in order to explore two different approaches of gemcitabine dose intensification in patients with advanced NSCLC. Patients and methods: A total of 121 chemonaive patients with locally advanced or metastatic NSCLC not suitable for a platinum-based chemotherapy were randomly allocated to chemotherapy with gemcitabine 1500 mg/m2 on days 1 and 8 every 3 weeks by standard 30 min intravenous infusion (arm A), or gemcitabine 10 mg/m2/min for 150 min on days 1 and 8 every 3 weeks by intravenous infusion at fixed dose rate (arm B). Results: One hundred and seventeen patients were fully analyzed. No difference in response rate (16.1% versus 9.9%, p = 0.28), median time to disease progression (4 months versus 4.5 months, p = 0.34) median survival (9.8 months in both arms), and 1-year survival (42.6% versus 39.0% p = 0.98) was detected in arms A and B, respectively. No treatment-related deaths occurred. Main hematological toxicities were grade 3-4 neutropenia observed in 17.9% of patients in group A and in 49.2% of individuals in group B (p = 0.0002). The incidence of febrile neutropenia was 3.3% in arm A and 0% in arm B (p = 0.17). Grade 3-4 thrombocytopenia was more frequently observed in arm B patients (9.9% versus 1.8%, p = 0.057). Non-hematological toxicity was similar in both arms, and consisted in grade 1-2 gastrointestinal toxicity observed in 48.2% of patients in arm A and 41.0% in arm B. Conclusion: Intensification of standard doses or prolonged infusion schedule did not result in efficacy improvement. Gemcitabine infusion duration does not warrant further investigation in patients with advanced NSCLC.

AB - Purpose: Gemcitabine is one of the most active drugs against non-small-cell lung cancer (NSCLC). Preclinical data suggested that gemcitabine efficacy could be improved by increasing the dose or by increasing the infusion duration. This study has been designed in order to explore two different approaches of gemcitabine dose intensification in patients with advanced NSCLC. Patients and methods: A total of 121 chemonaive patients with locally advanced or metastatic NSCLC not suitable for a platinum-based chemotherapy were randomly allocated to chemotherapy with gemcitabine 1500 mg/m2 on days 1 and 8 every 3 weeks by standard 30 min intravenous infusion (arm A), or gemcitabine 10 mg/m2/min for 150 min on days 1 and 8 every 3 weeks by intravenous infusion at fixed dose rate (arm B). Results: One hundred and seventeen patients were fully analyzed. No difference in response rate (16.1% versus 9.9%, p = 0.28), median time to disease progression (4 months versus 4.5 months, p = 0.34) median survival (9.8 months in both arms), and 1-year survival (42.6% versus 39.0% p = 0.98) was detected in arms A and B, respectively. No treatment-related deaths occurred. Main hematological toxicities were grade 3-4 neutropenia observed in 17.9% of patients in group A and in 49.2% of individuals in group B (p = 0.0002). The incidence of febrile neutropenia was 3.3% in arm A and 0% in arm B (p = 0.17). Grade 3-4 thrombocytopenia was more frequently observed in arm B patients (9.9% versus 1.8%, p = 0.057). Non-hematological toxicity was similar in both arms, and consisted in grade 1-2 gastrointestinal toxicity observed in 48.2% of patients in arm A and 41.0% in arm B. Conclusion: Intensification of standard doses or prolonged infusion schedule did not result in efficacy improvement. Gemcitabine infusion duration does not warrant further investigation in patients with advanced NSCLC.

KW - Chemotherapy

KW - Gemcitabine

KW - Non-small-cell lung cancer

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