medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/2079-701X-2021-9-18-24medsovet-6244Research ArticleИММУНОТЕРАПИЯ ОПУХОЛЕЙIMMUNOTHERAPY IN ONCOLOGYПятилетние результаты применения ниволумаба у больных с метастатическим немелкоклеточным раком легкого в реальной клинической практике ФГБУ НМИЦ онкологии им. Н.Н. Блохина МЗ РФFive-year results of nivolumab for the treatment of non-small cell lung cancer in clinical practice of the N.N. Blokhin Russian Cancer Research Centerhttps://orcid.org/0000-0002-0620-2696ЮдинД. И.YudinD. I.

Юдин Денис Иванович, кандидат медицинских наук, старший научный сотрудник

115478, Москва, Каширское шоссе, д. 24

Denis I. Yudin, Cand. Sci. (Med.), Senior Researcher

24, Kashirskoye Shosse, Moscow, 115478

yudinden@mail.ruhttps://orcid.org/0000-0003-4469-502XЛактионовК. К.LaktionovK. K.

Лактионов Константин Константинович, доктор медицинских наук, профессор кафедры онкологии и лучевой терапии лечебного факультета, Российский национальный исследовательский медицинский университет имени Н.И. Пирогова; заведующий онкологическим отделением лекарственных методов лечения (химиотерапевтическое) №17, Национальный медицинский исследовательский центр онкологии имени Н.Н. Блохина

117997, Москва, ул. Островитянова, д. 1,

115478, Москва, Каширское шоссе, д. 24

Konstantin K. Laktionov, Dr. Sci. (Med.), Professor of the Department of Oncology and Radiation Therapy of the Faculty of Medicine, Pirogov Russian National Research Medical University; Head of the Oncological Department of Medical Treatment Methods (Chemotherapeutic) №17, Blokhin National Medical Research Center of Oncology

1, Ostrovityanov St., Moscow, 117997,

24, Kashirskoye Shosse, Moscow, 115478

lkoskos@mail.ruhttps://orcid.org/0000-0002-7817-8429СаранцеваК. А.SarantsevaK. A.

Саранцева Ксения Андреевна, кандидат медицинских наук, врач-онколог

115478, Москва, Каширское шоссе, д. 24

Ksenia A. Sarantseva, Cand. Sci. (Med.), Оncologist

24, Kashirskoye Shosse, Moscow, 115478

sarantsevaka@gmail.comhttps://orcid.org/0000-0002-6244-4294БредерВ. В.BrederV. V.

Бредер Валерий Владимирович, доктор медицинских наук, ведущий научный сотрудник

115478, Москва, Каширское шоссе, д. 24

Valeriy V. Breder, Dr. Sci. (Med.), Leading Researcher

24, Kashirskoye Shosse, Moscow, 115478

vbreder@yandex.ruhttps://orcid.org/0000-0002-8967-7987АрдзинбаМ. С.ArdzinbaM. S.

Ардзинба Мераб Сергеевич, кандидат медицинских наук, врач-онколог

115478, Москва, Каширское шоссе, д. 24

Merab S. Ardzinba, Cand. Sci. (Med.), Оncologist

24, Kashirskoye Shosse, Moscow, 115478

merabii@mail.ruhttps://orcid.org/0000-0002-2154-3376РеутоваЕ. В.ReutovaE. V.

Реутова Елена Валерьевна, кандидат медицинских наук, старший научный сотрудник

115478, Москва, Каширское шоссе, д. 24

Elena V. Reutova, Cand. Sci. (Med.), Senior Researcher

24, Kashirskoye Shosse, Moscow, 115478

evreutova@rambler.ruhttps://orcid.org/0000-0002-6830-0064БорисоваО. И.BorisovaO. I.

Борисова Ольга Игоревна, врач-онколог

115478, Москва, Каширское шоссе, д. 24

Olga I. Borisova, Оncologist

24, Kashirskoye Shosse, Moscow, 115478

dr_borisova@mail.ruНациональный медицинский исследовательский центр онкологии имени Н.Н. БлохинаРоссияBlokhin National Medical Research Center of OncologyRussian FederationНациональный медицинский исследовательский центр онкологии имени Н.Н. Блохина; Российский национальный исследовательский медицинский университет имени Н.И. ПироговаРоссияBlokhin National Medical Research Center of Oncology; Pirogov Russian National Research Medical UniversityRussian Federation202106082021091824Copyright © Юдин Д.И., Лактионов К.К., Саранцева К.А., Бредер В.В., Ардзинба М.С., Реутова Е.В., Борисова О.И., 20212021Юдин Д.И., Лактионов К.К., Саранцева К.А., Бредер В.В., Ардзинба М.С., Реутова Е.В., Борисова О.И.Yudin D.I., Laktionov K.K., Sarantseva K.A., Breder V.V., Ardzinba M.S., Reutova E.V., Borisova O.I.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/6244Введение

Введение. Рак легкого остается одним из наиболее распространенных и смертельных онкологических заболеваний в мире. Долгое время химиотерапия оставалась единственной возможностью по лечению метастатического рака легкого. В настоящий момент иммунотерапия является одной из предпочтительных опций в лечении данной патологии.

Целью данной работы было оценить отдаленные результаты применения PD-1-ингибитора ниволумаба в реальной клинической практике.

Материалы и методы

Материалы и методы. В данном нерандомизированном наблюдательном исследовании были проанализированы результаты лечения 108 пациентов с метастатическим немелкоклеточным раком легкого, получивших ранее платиносодержащую химиотерапию. Были оценены общая выживаемость и выживаемость без прогрессирования, объективный ответ, некоторые клинические особенности. Медиана времени наблюдения составила 54,5 мес.

Результаты

Результаты. Медиана общей выживаемости в  анализируемой группе пациентов составила 8,8  мес. (6,74–10,65, ДИ 95%). Пятилетняя общая выживаемость составила 19,4%. Медиана выживаемости без прогрессирования  – 3,9  мес. (2,95–4,84, ДИ 95%). Пятилетняя безрецидивная выживаемость составила 7,7%. Частота объективного ответа была 18%. У пациентов с объективным ответом медиана общей выживаемости не была достигнута. Продолжение иммунотерапии после прогрессирования заболевания положительно повлияло на  общую выживаемость пациентов. Клинически значимые иммуноопосредованные нежелательные явления развились у 21% пациентов, но лишь у 7,3% отмечено развитие нежелательных явлений 3–4-й степени, потребовавших отмены иммунотерапии. К редким нежелательным явлениям, которые нам встретились, можно отнести случай энцефалопатии 3-й степени, при этом отмечается длительный полный ответ, несмотря на остановку иммунотерапии.

Выводы

Выводы. Полученные данные о выживаемости, эффективности и безопасности могут помочь в принятии решений о лечении пациентов с метастатическим НМРЛ в реальных условиях.

Introduction

Introduction. Lung cancer remains the one of the most common and fatal cancers in the world. For a long time, chemotherapy was the only treatment option for metastatic lung cancer. Currently, immunotherapy became the one of the preferred options of treatment.

The purpose of our work was to evaluate the long-term results of using the PD-1 inhibitor nivolumab in real-world settings.

Materials and methods

Materials and methods. 108 pretreated patients with metastatic NSCLC were included in this non-randomized, observational study. The median follow-up time was 54.5 months.

Results

Results. Median overall survival was 8.8 months (6-12, 95% CI). The five-year overall survival rate was 19.4%. Median progressionfree survival was 3.9 months (3-5, 95% CI). The five-year progression-free survival rate was 7.7%. Overall response rate (ORR) was 18%. In patients with ORR, the median overall survival was not achieved. Prolongation of immunotherapy after disease progression had a positive effect on the overall survival of patients. Clinically significant immuno-related adverse events developed in 21% of patients, but only 7.3% showed the development of adverse events grade 3-4 that required discontinuation of immunotherapy. A rare complication that we met was a case of encephalopathy, to which the patient achieved durable complete response despite discontinuation of immonotherapy.

Conclusion

Conclusion. Received survival, efficacy and safety data may inform treatment decisions for patients with metastatic NSCLC in real world settings.

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The authors declare that there are no conflicts of interest present.