We aimed to evaluate clinical and patient-reported outcomes of Nivo as ≥ 2nd line treatment in NSCLC pts within the expanded access program. The interim data on response rates, survival and safety as well as base-line QoL and its changes are presented.
Adult pts with advanced refractory NSCLC received Nivo 3 mg/kg q2w. Tumor response was assessed using RECIST v. 1.1, adverse events (AEs) with NCI CTCAE v3.0; for QoL and symptom assessment RAND SF-36 and ESAS-R were used. Progression-free survival (PFS) and overall survival (OS) from the start of Nivo treatment were evaluated using Kaplan-Meier method. Group QoL comparisons were made using Mann-Whitney and Wilcoxon tests.
At the cut-off 172 pts were enrolled in 7 centers in RF with median follow-up – 19 weeks (mean age – 60 (29 − 80); males – 65%; ECOG PS 0-1/2-3 – 81%/19%; former/current smokers – 71%; non-squamous NSCLC – 65%; ≥2 lines of previous systemic treatment – 51%). At baseline pts had dramatically compromised QoL as compared to healthy controls: Integral QoL Index (IQoLI) – 0.283 vs 0.505 (p
Early data from this study supports the acceptable efficacy and safety of Nivo (7% of pts with 3-4 grades AEs) in NSCLC pts. Nivo treatment is accompanied with noticeable QoL improvement in 51% pts.
Clinical trial identification
Legal entity responsible for the study
Multinational Center for Quality of Life Research
ISR funded by Bristol-Myers Squibb
T. Ionova: Principal Investigator of ISR sponsored by BMS. All other authors have declared no conflicts of interest.