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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2017-09-01
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DOAJ |
language |
English |
format |
Article |
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DOAJ |
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 |
work_keys_str_mv |
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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 |