How to Cite
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 >2ndline 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.
References
Бычков М.Б., Горбунова В.А. Клинические рекомендации по диагностике и лечению больных раком легкого / Ассоциация онкологов России. - М., 2014. - 26 с.
Моисеенко В.М., Волков Н.М. Важнейшие события в онкологии в 2014 году: иммунотерапия злокачественных опухолей // Практическая онкология. - 2015. -№ 16 (1). - С. 6-12.
Новик А.А., Ионова Т.И. Руководство по исследованию качества жизни в медицине (3-е издание, переработанное и дополненное) / Под ред. акад. РАМН Ю.Л. Шевченко. - М.: Издательство РАЕН, 2012. - 528 с.
Aldige С., Boerckel W., Donaldson D. et al. Improving the Quality of Life for Lung Cancer Patients. - New York, 2015. - 19 p.
Areses M.C., Campelo R.G., Gonzlez J.G. et al. The real-world experience with nivolumab in previously treated patients with advanced non small cell lung cancer (NSCLC): A Galician Lung Cancer Group clinical practice // Journal of Clinical Oncology. - 2017. - Vol. 3 (15_ Suppl). - e20564.
Blumenthal G.M., Karuri S.W., Zhang H. et al. Overall Response Rate, Progression-Free Survival, and Overall Survival With Targeted and Standard Therapies in Advanced Non-Small-Cell Lung Cancer: US Food and Drug Administration Trial-Level and Patient-Level Analyses // Journal of Clinical Oncology. - 2015. - Vol. 33. - P. 1008-1014.
Boini S., Brian on S., Guillemin F. et al. Impact of cancer occurrence on health-related quality of life: a longitudinal pre-post assessment // Health Qual. Life Outcomes. -2004. - Vol. 2. - 4 p.
Borghaei H., Paz-Ares L., Horn L. et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer // N. Engl. J. Med. - 2015. - Sep. 27. Available at: http://www.nejm.org/doi/full/10.1056/ NEJMoa1507643; DOI: 10.1056/NEJMoa1507643
Brahmer J., Reckamp K.L., Baas P. et al. Nivolumab versus Docetaxel in Advanced Squamous-Cell NonSmall-Cell Lung Cancer // N. Engl. J. Med. - 2015. -Vol. 373. - P. 123-135.
Ettinger D.S., Wood D.E., Aisner D.L. et al. Non-Small Cell Lung Cancer, NCCN Clinical Practice Guidelines in Oncology. Version 5.2017 // J. Natl. Compr. Canc. Netw. - 2017. - Vol. 15 (4). - P. 504-535.
European Medicines Agency. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. -2005.
Fiteni F., Vernerey D., Bonnetain F. et al. Prognostic value of health-related quality of life for overall survival in elderly non-small cell lung cancer patients // European Journal of cancer. - 2016. - Vol. 52. - P. 120-128.
Gralla R.J. Quality of life in lung cancer. Issues in evaluating quality of life in clinical trials and in practice // MASCC materials. - 2015.
Grossi F., Crino L. Delmonte A. et al. Italian nivolumab expanded access programme: real-world results innon-squamous non-small cell lung cancer patients // Annals of Oncology. - 2017. - Vol. 28 (Supplement 5). - 411 p.
Hays R.D., Sherbourne C.D., Mazel R.M. User's Manual for Medical Outcomes Study (MOS) Core measures of health-related quality of life // RAND Corporation. -1995. MR-162-RC (available at www.rand.org).
Misch D., de Wit M., Grah C. et al. Efficacy and safety of nivolumab in routine NSCLC treatment - an observational study in 5 lung cancer centers in Berlin, Germany // European Respiratory Journal. - 2017. - Vol. 50 (Issue suppl 61). - OA1477.
Novik A.A., Ionova T.I., Kishtovich A.V. et al. Stratification of patients using QoL parametrs by the method of integral profiles // Quality of Life Research. - 2003. - Vol. 12 (7). - 770 p.
Schwartzberg L., Chandler J., Reynold C. et al. Symptom analysis and quality of life (QoL) in patients treated with nivolumab (NIVO) as 2nd line therapy for advanced nonsmall cell lung cancer (aNSCLC) // European Journal of Cancer. - 2015. - Vol. 51 (Suppl. 3). - P. 628-629.
Shukuya T., Mori K., Amann J.M. et al. Relationship between Overall Survival and Response or Progression-Free Survival in Advanced Non-Small Cell Lung Cancer Patients Treated with Anti-PD-1/PD-L1 Antibodies // J. Thorac. Oncol. - 2016. - Vol. 11 (11). - P. 1927-1939.
Walker M.S., Goertz H.-P, Ravelo A. et al. Prospective assessment of quality of life in patients with advanced NSCLC treated in real world community oncology settings: effect of initial treatment regimen and diseases progression // J. Clin. Oncol. - 2015. - Vol. 33 (Suppl.). - Abstract e19027.
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
© АННМО «Вопросы онкологии», Copyright (c) 2019