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N.N. Buevich

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    P1.01 - Advanced NSCLC (ID 757)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P1.01-056 - Quality of Life and Clinical Outcomes of Nivolumab as 2+ Line Treatment in Advanced Refractory NSCLC Pts: Interim Analysis (ID 8452)

      09:30 - 16:00  |  Author(s): N.N. Buevich

      • Abstract
      • Slides

      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.

      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.

      The interim analysis was performed in the group of 172 pts with the median follow-up – 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.

      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.

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