Vol. 65 No. 1 (2019), ORIGINAL ARTICLES. A. PROTOCOLS OF CLINICAL RESEARCH

Vol. 65 No. 1 (2019)

EFFICACY OF NIVOLUMAB (NWO) DURING 2+ LINE TREATMENT AND QUALITY OF LIFE IN PATIENTS WITH ADVANCED REFRACTORY NON-SMALL CELL LUNG CANCER: INTERIM RESULTS OF PROSPECTIVE OBSERVATIONAL STUDY

ORIGINAL ARTICLES. A. PROTOCOLS OF CLINICAL RESEARCH

https://doi.org/10.37469/0507-3758-2019-65-1-99-105

Published 01.01.2019

Konstantin Laktionov

N.N. Blokhin Russian Cancer Research Center

Alla Arzumanyan

N.N. Blokhin Russian Cancer Research Center

Larisa Bolotina

P. Hertsen Moscow Oncology Research Institute - branch of National Medical Research Radiological Centre of Ministry of health of the Russian Federation

Valeriy Breder

N.N. Blokhin Russian Cancer Research Center

Natalya Buevich

N.N. Petrov Research Institute of Oncology of the Ministry of Health of the Russian Federation

A. Danilova

Moscow City Oncology Hospital №62 of Moscow Department of Health

Anna Zinkovskaya

Multinational Center for Quality of Life Research

Anna Kornietskaya

P. Hertsen Moscow Oncology Research Institute - branch of National Medical Research Radiological Centre of Ministry of health of the Russian Federation

M. Kramchaninov

Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncological)

Ye. Kushniruk

City Clinical Oncology Dispensary, Saint-Petersburg

Dilorom Latipova

N.N. Petrov Research Institute of Oncology of the Ministry of Health of the Russian Federation

Fedor Moiseenko

N.N. Petrov Research Institute of Oncology of the Ministry of Health of the Russian Federation, Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncological)

Tatyana Nikitina

Multinational Center for Quality of Life Research

Mariya Okruzhnova

N.N. Blokhin Russian Cancer Research Center

Sergey Orlov

Clinic of High Medical Technology named after N.I. Pirogov, Saint-Petersburg State University

Rashida Orlova

City Clinical Oncology Dispensary, Saint-Petersburg, R.M. Gorbacheva Memorial Institute of Children Hematology and Transplantation of Pavlov Saint-Petersburg State Medical University

N. Porfireva

Multinational Center for Quality of Life Research

Svetlana Protsenko

N.N. Petrov Research Institute of Oncology of the Ministry of Health of the Russian Federation

Kseniya Sarantseva

N.N. Blokhin Russian Cancer Research Center

Daniil Stroyakovskiy

Moscow City Oncology Hospital №62 of Moscow Department of Health

Yelena Filippova

Clinic of High Medical Technology named after N.I. Pirogov, Saint-Petersburg State University

Tatyana Ionova

Multinational Center for Quality of Life Research

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Keywords

ADVANCED REFRACTORY NSCLC
NIVOLUMAB
QUALITY OF LIFE
SURVIVAL
TUMOR RESPONSE

How to Cite

Laktionov, K., Arzumanyan, A., Bolotina, L., Breder, V., Buevich, N., Danilova, A., Zinkovskaya, A., Kornietskaya, A., Kramchaninov, M., Kushniruk, Y., Latipova, D., Moiseenko, F., Nikitina, T., Okruzhnova, M., Orlov, S., Orlova, R., Porfireva, N., Protsenko, S., Sarantseva, K., Stroyakovskiy, D., Filippova, Y., & Ionova, T. (2019). EFFICACY OF NIVOLUMAB (NWO) DURING 2+ LINE TREATMENT AND QUALITY OF LIFE IN PATIENTS WITH ADVANCED REFRACTORY NON-SMALL CELL LUNG CANCER: INTERIM RESULTS OF PROSPECTIVE OBSERVATIONAL STUDY. Voprosy Onkologii, 65(1), 99–105. https://doi.org/10.37469/0507-3758-2019-65-1-99-105

Abstract

The preliminary results of observational study focused on clinical efficacy and safety of nivolumab (Nivo) treatment as >2nd line in patients with advanced refractory NSCLC as well as on quality of life (QoL) before and during treatment are presented.

Patients and methods. Adult pts with advanced refractory NSCLC received Nivo 3 mg/kg q2w within the Expanded Access Program. Tumor response was assessed using RECIST v. 1.1, adverse events (AEs) - using NCI CTCAE v3.0. For QoL assessment pts completed RAND SF-36. For statistical analysis Mann-Whitney, Wilcoxon test and generalized estimating equations (GEE) were used. Overall survival (OS) and progression-free survival (PFS) were evaluated by the Kaplan-Meyer method.

Results. The analysis was performed in the group of 176 NSCLC pts enrolled from 7 centers in RF. Median follow-up - 7.8 mos. Tumor control was confirmed in 59% patients. Median OS was 10.2 mos (95%CI: 6.6-13.7), median PFS - 4.2 mos (95%CI: 3.7-4.7). AEs were revealed in 34% patients; among them 13 (8%) patients with grade 3-4 AEs. Significant QoL impairment was identified in patients before Nivo treatment. Within 12 weeks after treatment start QoL improvement/ stabilization was revealed. Absence of tumor control at first tumor evaluation, poor ECOG, underweight and significant base-line QoL impairment are predictive for worse survival.

Conclusion. The data obtained demonstrate satisfactory efficacy and safety of Nivo treatment as >2^ndline in patients with advanced refractory NSCLC within the Expanded Access Program. Before Nivo treatment patients have significant QoL impairment; Nivo treatment leads to meaningful QoL improvement/stabilization in NSCLC pts.

https://doi.org/10.37469/0507-3758-2019-65-1-99-105

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