Efficacy Of Nivolumab (Nivo) As 2+Line Treatment And Quality Of Life (Qol) In Advanced Refractory Non-Small Cell Lung Cancer (Nsclc) Patients: Interim Results Of Observational Prospective Study.

e21126 Background: We aimed to evaluate quality of life (QoL) in advanced refractory NSCLC pts and clinical outcomes of nivolumab (Nivo) as ≥ 2nd line treatment within the expanded access program in RF. We report interim analysis on response rates, survival and QoL changes during Nivo treatment. Methods: Adult pts with advanced refractory NSCLC were enrolled in 7 centers. All the pts received Nivo 3 mg/kg q2w. Tumor response was assessed using RECIST v. 1.1., QoL – by RAND SF-36 at baseline, 4 and 12 weeks after treatment start. Overall survival (OS) and progression-free survival (PFS) were evaluated by the Kaplan-Meyer method. Cox regression was performed. For longitudinal QoL analysis GEE method was used. Results: The interim analysis was performed in the group of 176 pts with the median follow-up – 7.8 mos (64% – males; median age – 61.5 (29−80); ECOG PS 0-1/2-3 – 81%/19%; former/current smokers – 70%; non squamous NSCLC – 65%; ≥2 lines of previous systemic treatment – 52%, underweight – 30% pts). Efficacy was evaluated in 154 pts (median first evaluation – 2.1 mos): PR – 9.7%, SD – 48.7%, PD – 41.6% (21 pts had clinical PD). Median OS was 10.2 mos (95%CI 6.6–13.7), median PFS – 4.2 mos (95%CI 3.7–4.7). Univariate analysis revealed that poor pretreatment ECOG PS, disease progression at the first tumor evaluation as well as impaired pretreatment QoL were associated with shorter OS and PFS; pretreatment underweight – with shorter OS (log-rank, p < 0.05). In multivariate Cox regression analysis, disease progression (OS – HR, 95%CI 0,3 (0,1–0,6), PFS – HR, 95% CI 0,04 (0,01–0,9); p < 0.001) and impaired pretreatment QoL (OS – HR, 95%CI 2.2 (1.1–4.3); PFS – HR 95%CI 0,04 (0,01–0,9); p < 0.05) were associated with shorter OS and PFS. Before treatment QoL was significantly impaired in 45% pts. Upon GEE, improvement of QoL after 6 cycles was revealed (p < 0.001). Conclusions: Interim results from this study corroborate clinical benefit of Nivo treatment observed in clinical trials. Nivo treatment leads to meaningful QoL improvement in NSCLC pts. Satisfactory pretreatment QoL and disease control at first tumor evaluation predict better OS and PFS.