113P - Clinical outcomes and quality of life (QoL) in adults with advanced refractory non-small cell lung cancer (NSCLC) patients receiving nivolumab (Niv...

Date 07 May 2017
Event ELCC 2017
Session Poster Display Session
Topics Immunotherapy
Thoracic malignancies
Non-small-cell lung cancer
Therapy
Presenter Konstantin Laktionov
Citation Annals of Oncology (2017) 28 (suppl_2): ii28-ii51. 10.1093/annonc/mdx091
Authors K.K. Laktionov1, L.V. Bolotina2, V.V. Breder3, A.S. Danilova4, F.V. Moiseenko5, T.P. Nikitina6, R.V. Orlova7, E.A. Filippova8, S.A. Protsenko9, T.I. Ionova6
  • 1N. N. Blokhin Russian Cancer Research Center, 115478 - Moscow/RU
  • 2Moscow Scientific Research Institute n.a. Hertzen, Moscow/RU
  • 3N. N. Blokhin Russian Cancer Research Center, Moscow/RU
  • 4Moscow City Oncology Hospital No. 62, Moscow/RU
  • 5Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncological), St. Petersburg/RU
  • 6Multinational Center for Quality of Life Research, St. Petersburg/RU
  • 7City Clinical Oncology Dispensary, St. Petersburg/RU
  • 8R.M. Gorbacheva Memorial Institute of Children Hematology and Transplantation of Pavlov Saint-Petersburg State Medical University, St. Petersburg/RU
  • 9N.N.Petrov Research Institute of Oncology of the Ministry of Health of the Russian Federation, St. Petersburg/RU

Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

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

Funding

The study was supported by the grant of BMS

Disclosure

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