P1.01-056 Quality of Life and Clinical Outcomes of Nivolumab as 2+ Line Treatment in Advanced Refractory NSCLC Pts: Interim Analysis

Abstract

Background: We aimed to evaluate quality of life (QoL) and clinical outcomes of nivolumab (Nivo) as ≥ 2nd line treatment within the expanded access program in NSCLC pts. The QoL changes, response rates, survival and safety were studied within the multicenter prospective observational study. Method: Adult pts with advanced refractory NSCLC were enrolled in 7 centers in RF. All the pts received Nivo 3 mg/kg q2w. Tumor response was assessed using RECIST v. 1.1, adverse events (AEs) with NCI CTCAE v3.0; QoL by SF-36 and symptoms by ESAS-R at baseline, 4 and 12 weeks after treatment start. Overall survival (OS) and progression-free survival (PFS) curves were evaluated from the start of Nivo treatment by the Kaplan-Meyer method and compared by the log rank test. For QoL analysis Generalized Estimating Equations (GEE) method was used. Result: The interim analysis was performed in the group of 172 pts with the median followup - 4.7 mos (65% - males; median age - 62 (29-80); ECOG PS 0-1/ 2-3 - 81%/19%; former/current smokers - 71%; non squamous NSCLC - 65%; ≥2 lines of previous treatment - 51%). After 2 cycles of Nivo QoL improvement was registered in 53% pts, after 6 cycles - in 60% pts; mean QoL index increased by 59% and 51%, respectively. Upon GEE, significant improvement of QoL index during 6 cycles was revealed (p<0.05). The most severe and frequent baseline symptoms, fatigue and shortness of breath, decreased after 2 cycles in 44% and 33% of pts as compared to baseline, and after 6 cycles - in 54% and 46% pts, respectively. Efficacy was evaluated in 118 pts (median first evaluation - 2.2 mos): PR - 9%, SD - 44%, PD - 47%. 14 pts died before first efficacy evaluation. 40 pts were not evaluated for response on cut-off. In the group of pts who completed Nivo treatment (n=116) median PFS was 2.7 mos (95%CI 2.1-3.3), median OS - 8.4 mos (95% CI 6.2-10.7); median follow-up - 4.6 mos. Pts with brain mts (median OS 2.5 mos vs 9.0 mos) and pts with ECOG PS 2-3 (median PFS 2.5 mos vs 3.2 mos) had worse survival; p<0.05. AEs were registered in 54 pts; among them 14 had grades 3-4 AEs. Conclusion: Early data from this study supports the acceptable efficacy (53% pts had PR/SD) and safety of Nivo (11% pts with 3-4 grades AEs) in NSCLC pts. Nivo treatment leads to meaningful QoL improvement in this patient population.