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Poster display session

1600 - Multicenter observational study of the efficacy and safety of nivolumab (Nivo) as 2+ line treatment and quality of life (QoL) in advanced refractory non-small cell lung cancer (NSCLC) patients: interim analysis

Date

09 Sep 2017

Session

Poster display session

Presenters

Konstantin Laktionov

Citation

Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380

Authors

K. Laktionov1, A. Arzumanyan1, L. Bolotina2, V. Breder1, N. Buevich3, A. Danilova4, E. Filippova5, A. Kornietskaya2, M. Kramchaninov6, E. Kushniruk7, D. Latipova3, F. Moiseenko6, T. Nikitina8, S. Orlov5, R. Orlova9, S. Protsenko3, K. Sarantseva1, D. Stroyakovskiy4, T. Ionova8

Author affiliations

  • 1 Surgery Department, N.N. Blokhin Russian Cancer Research Center, 115478 - Moscow/RU
  • 2 Branch Of National Medical Research Radiological Centre Of Ministry Of Health Of The Russian Federation, Р. Hertsen Moscow Oncology Research Institute, 125284 - Moscow/RU
  • 3 Department Of Chemotherapy, N.N.Petrov Research Institute of Oncology of the Ministry of Health of the Russian Federation, 197758 - Saint-Petersburg/RU
  • 4 Department Of Chemotherapy, Moscow City Oncology Hospital №62, 143423 - Moscow/RU
  • 5 Department Of Chemotherapy, R.M. Gorbacheva Memorial Institute of Children Hematology and Transplantation of Pavlov Saint-Petersburg State Medical University, 197089 - Saint Petersburg/RU
  • 6 Department Of Chemotherapy, Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncological), 197758 - Saint-Petersburg/RU
  • 7 Department Of Chemotherapy, City Clinical Oncology Dispensary, Saint-Petersburg/RU
  • 8 Department Of Oncology And Hematology, Multinational Center for Quality of Life Research, 191014 - Saint-Petersburg/RU
  • 9 Department Of Oncology, Saint-Petersburg State University, Saint-Petersburg/RU
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Resources

Abstract 1600

Background

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.

Methods

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.

Results

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 

Conclusions

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

Funding

ISR funded by Bristol-Myers Squibb

Disclosure

T. Ionova: Principal Investigator of ISR sponsored by BMS. All other authors have declared no conflicts of interest.

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