A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung Cancer

IntroductionIn a literature meta-analysis, we showed survival benefits for regimens including cisplatin [hazard ratio (HR) 0.61; 95% confidence interval (CI), 0.57–0.66] and for those including etoposide (HR 0.65; 0.61–0.69). That benefit was mainly observed when etoposide alone or in combination wi...

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Main Authors: Thierry Berghmans, Arnaud Scherpereel, Anne-Pascale Meert, Vicente Giner, Jacques Lecomte, Jean-Jacques Lafitte, Nathalie Leclercq, Marianne Paesmans, Jean-Paul Sculier, for the European Lung Cancer Working Party (ELCWP)
Format: Article
Language:English
Published: Frontiers Media S.A. 2017-09-01
Series:Frontiers in Oncology
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Online Access:http://journal.frontiersin.org/article/10.3389/fonc.2017.00217/full
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author Thierry Berghmans
Thierry Berghmans
Thierry Berghmans
Arnaud Scherpereel
Anne-Pascale Meert
Anne-Pascale Meert
Anne-Pascale Meert
Vicente Giner
Jacques Lecomte
Jean-Jacques Lafitte
Nathalie Leclercq
Nathalie Leclercq
Nathalie Leclercq
Marianne Paesmans
Jean-Paul Sculier
Jean-Paul Sculier
Jean-Paul Sculier
for the European Lung Cancer Working Party (ELCWP)
spellingShingle Thierry Berghmans
Thierry Berghmans
Thierry Berghmans
Arnaud Scherpereel
Anne-Pascale Meert
Anne-Pascale Meert
Anne-Pascale Meert
Vicente Giner
Jacques Lecomte
Jean-Jacques Lafitte
Nathalie Leclercq
Nathalie Leclercq
Nathalie Leclercq
Marianne Paesmans
Jean-Paul Sculier
Jean-Paul Sculier
Jean-Paul Sculier
for the European Lung Cancer Working Party (ELCWP)
A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung Cancer
Frontiers in Oncology
small-cell lung cancer
chemotherapy
cisplatin
etoposide
extensive disease
author_facet Thierry Berghmans
Thierry Berghmans
Thierry Berghmans
Arnaud Scherpereel
Anne-Pascale Meert
Anne-Pascale Meert
Anne-Pascale Meert
Vicente Giner
Jacques Lecomte
Jean-Jacques Lafitte
Nathalie Leclercq
Nathalie Leclercq
Nathalie Leclercq
Marianne Paesmans
Jean-Paul Sculier
Jean-Paul Sculier
Jean-Paul Sculier
for the European Lung Cancer Working Party (ELCWP)
author_sort Thierry Berghmans
title A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung Cancer
title_short A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung Cancer
title_full A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung Cancer
title_fullStr A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung Cancer
title_full_unstemmed A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung Cancer
title_sort phase iii randomized study comparing a chemotherapy with cisplatin and etoposide to a etoposide regimen without cisplatin for patients with extensive small-cell lung cancer
publisher Frontiers Media S.A.
series Frontiers in Oncology
issn 2234-943X
publishDate 2017-09-01
description IntroductionIn a literature meta-analysis, we showed survival benefits for regimens including cisplatin [hazard ratio (HR) 0.61; 95% confidence interval (CI), 0.57–0.66] and for those including etoposide (HR 0.65; 0.61–0.69). That benefit was mainly observed when etoposide alone or in combination with cisplatin was included in the chemotherapy regimens. Our objective was to determine if chemotherapy with both drugs improves survival in comparison to a non-platinum regimen with etoposide.MethodsExtensive small-cell lung cancer patients were randomized between cisplatin–etoposide (CE) and ifosfamide + etoposide + epirubicin regimen (IVE) between 2000 and 2013.Results176 and 170 eligible patients were allocated to CE and IVE (315 deaths were required before analysis), respectively. Objective response rates were not significantly different: 60% with CE and 59% with IVE. No statistically significant difference in median survival and 1-year and 2-year was observed with rates of 9.6 months, 31 and 5% for CE and 10 months, 39 and 9% for IVE, respectively. HR was 0.84 (95% CI 0.68–1.05, p = 0.16). Only two prognostic factors for survival were retained in multivariate analysis: sex with HR = 0.69 (95% CI 0.49–0.97, p = 0.03) and performance status with HR = 0.53 (95% CI 0.49–0.97, p < 0.0001). After adjustment for these prognostic factors, HR for survival was 0.83 (95% CI 0.65–1.08, p = 0.17). There was more thrombopenia in the CE regimen and more leukopenia with IVE.ConclusionCombination of CE failed to improve survival in comparison to an etoposide-containing regimen without cisplatin.Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT00658580?term=ELCWP+01994&rank=1, identifier NCT00658580.
topic small-cell lung cancer
chemotherapy
cisplatin
etoposide
extensive disease
url http://journal.frontiersin.org/article/10.3389/fonc.2017.00217/full
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spelling doaj-def77f8f82b74a1db40ee3da9b8c16742020-11-25T00:50:25ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2017-09-01710.3389/fonc.2017.00217285910A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung CancerThierry Berghmans0Thierry Berghmans1Thierry Berghmans2Arnaud Scherpereel3Anne-Pascale Meert4Anne-Pascale Meert5Anne-Pascale Meert6Vicente Giner7Jacques Lecomte8Jean-Jacques Lafitte9Nathalie Leclercq10Nathalie Leclercq11Nathalie Leclercq12Marianne Paesmans13Jean-Paul Sculier14Jean-Paul Sculier15Jean-Paul Sculier16for the European Lung Cancer Working Party (ELCWP)Department of Intensive Care, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, BelgiumDepartment of Oncological Emergencies, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, BelgiumDepartment of Thoracic Oncology, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, BelgiumPneumologie et Oncologie Thoracique, CHU de Lille, Université de Lille, Lille, FranceDepartment of Intensive Care, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, BelgiumDepartment of Oncological Emergencies, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, BelgiumDepartment of Thoracic Oncology, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, BelgiumHospital de Sagunto, Valencia, SpainHôpital Civil de Charleroi, Charleroi, BelgiumPneumologie et Oncologie Thoracique, CHU de Lille, Université de Lille, Lille, FranceDepartment of Intensive Care, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, BelgiumDepartment of Oncological Emergencies, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, BelgiumDepartment of Thoracic Oncology, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, BelgiumData Centre, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, BelgiumDepartment of Intensive Care, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, BelgiumDepartment of Oncological Emergencies, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, BelgiumDepartment of Thoracic Oncology, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, BelgiumIntroductionIn a literature meta-analysis, we showed survival benefits for regimens including cisplatin [hazard ratio (HR) 0.61; 95% confidence interval (CI), 0.57–0.66] and for those including etoposide (HR 0.65; 0.61–0.69). That benefit was mainly observed when etoposide alone or in combination with cisplatin was included in the chemotherapy regimens. Our objective was to determine if chemotherapy with both drugs improves survival in comparison to a non-platinum regimen with etoposide.MethodsExtensive small-cell lung cancer patients were randomized between cisplatin–etoposide (CE) and ifosfamide + etoposide + epirubicin regimen (IVE) between 2000 and 2013.Results176 and 170 eligible patients were allocated to CE and IVE (315 deaths were required before analysis), respectively. Objective response rates were not significantly different: 60% with CE and 59% with IVE. No statistically significant difference in median survival and 1-year and 2-year was observed with rates of 9.6 months, 31 and 5% for CE and 10 months, 39 and 9% for IVE, respectively. HR was 0.84 (95% CI 0.68–1.05, p = 0.16). Only two prognostic factors for survival were retained in multivariate analysis: sex with HR = 0.69 (95% CI 0.49–0.97, p = 0.03) and performance status with HR = 0.53 (95% CI 0.49–0.97, p < 0.0001). After adjustment for these prognostic factors, HR for survival was 0.83 (95% CI 0.65–1.08, p = 0.17). There was more thrombopenia in the CE regimen and more leukopenia with IVE.ConclusionCombination of CE failed to improve survival in comparison to an etoposide-containing regimen without cisplatin.Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT00658580?term=ELCWP+01994&rank=1, identifier NCT00658580.http://journal.frontiersin.org/article/10.3389/fonc.2017.00217/fullsmall-cell lung cancerchemotherapycisplatinetoposideextensive disease