Randomized phase III trial of erlotinib vs. docetaxel in patients with advanced squamous cell non-small cell lung cancer (SqNSCLC) failing first line platinum based doublet chemotherapy stratified by VeriStrat Good vs VeriStrat Poor: The European Thoracic Oncology Platform (ETOP) EMPHASIS trial
| Autor: | Bartomeu Massuti, Robbert C. van Heemst, Javier Garde Noguera, Peter Meldgaard, Manuel Cobo Dols, Rolf A. Stahel, M. Kassapian, Urania Dafni, Santiago Ponce Aix, Ana López Martín, Irene Floriani, Christoph C. Zielinski, Oliver Gautschi, Adriana Gasca-Ruchti, Yojena Chittazhathu Kurian Kuruvilla, Solange Peters, Vanesa Gregorc, Thierry Berghmans, Egbert F. Smit, Linda Coate |
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| Rok vydání: | 2015 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 33:8049-8049 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2015.33.15_suppl.8049 |
| Popis: | 8049 Background: Docetaxel (D) or Erlotinib (E) are registered second-line treatments for EGFR wild type NSCLC. Previous studies suggested a predictive value of the serum proteomic VeriStrat test (VS), assigning a good (VSG) or poor (VSP) classification in second-line therapy of patients (pts.) with NSCLC. EMPHASIS aimed at exploring a predictive interaction in SqNSCLC pts. The trial closed prematurely due to low accrual. Methods: EMPHASIS is a randomized phase III multicenter trial exploring the differential activity of second line E vs D on progression-free survival (PFS) in VSG vs VSP SqNSCLC. The expected hazard ratio (HR) of E vs D was 0.675 for the VSG patients (median PFS, E: 4.0 and D: 2.7 mo.), and 1.23 for the VSP patients (median PFS, E: 2.2 and D: 2.7 mo.). A sample size of 500 was needed to achieve 86% power for testing the expected interaction HR of 1.82 at a two-sided p-value of 0.05. Pts were randomized to receive treatment E150 mg p.o. daily or D 75 mg/m2 i.v. on day 1 of each 21 day cycl... |
| Databáze: | OpenAIRE |
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