TORNA ALL’ELENCO

Individual patients data analysis (IPD) of three randomized studies comparing erlotinib (E) with chemotherapy (CT) in patients with advanced wild-type epidermal growth factor receptor (wtEGFR) non-small cell lung cancer (NSCLC) in Journal of Clinical Oncology

2015
AOU San Luigi di Orbassano

Tipo pubblicazione

Conference Abstract

Autori/Collaboratori (13)Vedi tutti...

Torri V

Ando M

Rulli E


et alii...

Abstract

Background: While the benefit of EGFR tyrosine kinase inhibitors in EGFR mutated NSCLC patients (pts) is undisputed, their usefulness in wtEGFR pts is still questioned. The TAILOR, DELTA and PROSE trials singularly showed a significant gain in Progression-Free Survival (PFS) favoring CT. We present here the mature results from the IPD analysis of the three studies. Methods: In each trial, pts with wtEGFR stage IIIB/IV NSCLC, progressing after first line platinum-based therapy, were randomized 1:1 to receive either E or CT at standard doses. Primary endpoints of this IPD were PFS and Overall Survival (OS); summary measures were Hazard Ratio (HR) and Difference in Mean Survival Time (DMST), which is the difference in the areas under the Kaplan-Meier curves of two treatment arms. Cox regression analyses were used to estimate the HR. All analyses were stratified by trial. Results: The analysis included all 587 pts randomized into the trials (Overall E/CT 303/284; TAILOR 109/110; DELTA 109/90; PROSE 85/84); 464 deaths and 570 progressions or deaths were observed. Compared with CT, E treatment was associated to an increased risk of both progression (40%) and death (12%) (HR-PFS: 1.40, 95%CI: 1.18-1.65, p < 0.0001; HROS: 1.12, 95%CI: 0.93-1.35; p = 0.221). Importantly, patients treated with CT gained 1.6 and 1.5 months, in progression-free and lifetime respectively (DMST-PFS 95%CI: 0.6-2.1; DMST-OS 95%CI: -0.53.4). Results were preserved after adjustment by age, gender, smoking habit, performance status and histo-type. Conclusions: The IPD analysis of TAILOR, DELTA and PROSE conclusively confirm the superiority of CT over E in the disease control of wtEGFR NSCLC patients, and corroborate the original results of each single trial.

Keywords

erlotinib; epidermal growth factor receptor; protein tyrosine kinase inhibitor; platinum; patient; human; wild type; chemotherapy; society; non small cell lung cancer; American; data analysis; oncology; death; progression free survival; overall survival; proportional hazards model; therapy; risk; hazard ratio; survival time; Kaplan Meier method; arm; regression analysis; lifespan; gender; smoking habit; disease control;