AUTHOR=Berghmans Thierry , Scherpereel Arnaud , Meert Anne-Pascale , Giner Vicente , Lecomte Jacques , Lafitte Jean-Jacques , Leclercq Nathalie , Paesmans Marianne , Sculier Jean-Paul ,  for the European Lung Cancer Working Party (ELCWP) 

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

JOURNAL=Frontiers in Oncology

VOLUME=7

YEAR=2017

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2017.00217

DOI=10.3389/fonc.2017.00217

ISSN=2234-943X

ABSTRACT=<sec id="ST1"><title>Introduction</title><p>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.</p></sec><sec id="ST2"><title>Methods</title><p>Extensive small-cell lung cancer patients were randomized between cisplatin–etoposide (CE) and ifosfamide + etoposide + epirubicin regimen (IVE) between 2000 and 2013.</p></sec><sec id="ST3"><title>Results</title><p>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, <italic>p</italic> = 0.16). Only two prognostic factors for survival were retained in multivariate analysis: sex with HR = 0.69 (95% CI 0.49–0.97, <italic>p</italic> = 0.03) and performance status with HR = 0.53 (95% CI 0.49–0.97, <italic>p</italic> &lt; 0.0001). After adjustment for these prognostic factors, HR for survival was 0.83 (95% CI 0.65–1.08, <italic>p</italic> = 0.17). There was more thrombopenia in the CE regimen and more leukopenia with IVE.</p></sec><sec id="ST4"><title>Conclusion</title><p>Combination of CE failed to improve survival in comparison to an etoposide-containing regimen without cisplatin.</p></sec><sec id="ST5"><title>Clinical Trial Registration</title><p><uri xlink:href="https://clinicaltrials.gov/ct2/show/NCT00658580?term=ELCWP+01994&amp;rank=1" xmlns:xlink="http://www.w3.org/1999/xlink">https://clinicaltrials.gov/ct2/show/NCT00658580?term=ELCWP+01994&amp;rank=1</uri>, identifier NCT00658580.</p></sec>