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S.A. Protsenko

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    Poster Display Session (ID 63)

    • Event: ELCC 2017
    • Type: Poster Display Session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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      113P - Clinical outcomes and quality of life (QoL) in adults with advanced refractory non-small cell lung cancer (NSCLC) patients receiving nivolumab (Nivo) as 2+ line treatment: Interim analysis of expanded access program (ID 391)

      12:30 - 13:00  |  Author(s): S.A. Protsenko

      • Abstract

      Therapy with immune checkpoints changed the paradigm of treatment in many solid tumors including NSCLC. Recently several drugs of this group were approved in second and first line. Still the data on their use in NSCLC is quite limited. The aim of this study was to evaluate benefits/risks of Nivo treatment within the expanded access program in refractory NSCLC patients both from physician’s and patient’s perspective. We report interim analysis on response rates, safety and QoL.

      Adult pts with advanced refractory NSCLC received Nivo 3 mg/kg q2w in accordance with expanded access program. Tumor response was assessed using RECIST v. 1.1. Adverse events (AEs) were evaluated by NCI CTCAE v3.0. QoL was assessed by RAND SF-36, symptom severity – by ESAS-R. Group comparisons were made using Mann-Whitney test.

      From July of 2015 to December of 2016 with the median follow-up time of 11 weeks 141 pts were enrolled in 7 centers in RF. Clinical characteristics: 64.5% – males; median age – 60.5 (29 − 79); ECOG PS 0-1/2-3 – 78.3%/21.3%; former or current smokers – 71%; non squamous NSCLC – 65.2%; ≥2 lines of previous systemic treatment – 54%. At baseline pts had poor QoL comparing with healthy controls – 0.283 vs 0.505 (p < 0.001); 68.8% had moderate-to-severe symptoms. The most dramatic QoL worsening was observed for physical functioning and role functioning, p < 0.001. During 4 weeks of treatment Integral QoL index increased by 50% in 53% of pts. Efficacy was evaluated in 51 pts (median first evaluation – 9 weeks), PR – 6/51, SD – 30/51, PD – 15/51. Early deaths from cancer occurred in 7 pts; early deaths not related to cancer – 2 pts. 15 pts discontinued Nivo prematurely (<2 mos) because of rapid clinical worsening. 66 pts were not evaluated for response on cut-off. AEs were registered in 35 pts (median of Nivo treatment – 7 weeks); among them 8 with grade 3-4 AEs.

      QoL is dramatically compromised in advanced refractory NSCLC pts. Early data from this study supports that Nivo is effective and well tolerated by this patient population.

      Clinical trial identification:

      Legal entity responsible for the study:
      Multinational Center for QoL Research

      The study was supported by the grant of BMS

      K.K. Laktionov, L.V. Bolotina, V.V. Breder, A.S. Danilova, F.V. Moiseenko, T.P. Nikitina, R.V. Orlova, E.A. Filippova, S.A. Protsenko, T.I. Ionova: Study supported by the grant of BMS