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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.


ABSTRACT: INTRODUCTION:In 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. METHODS:Extensive small-cell lung cancer patients were randomized between cisplatin-etoposide (CE) and ifosfamide?+?etoposide + epirubicin regimen (IVE) between 2000 and 2013. RESULTS:176 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?

SUBMITTER: Berghmans T 

PROVIDER: S-EPMC5610723 | BioStudies | 2017-01-01

REPOSITORIES: biostudies

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