medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/ms2024-219medsovet-8404Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL RESEARCHИнгибиторы контрольных точек иммунитета в первой или второй линии лечения у пациентов с метастатическим немелкоклеточным раком легкого: общая выживаемость в реальной клинической практикеImmune Checkpoint Inhibitors in first versus second line of metastatic non-small cell lung cancer: Real-World Overall Survivalhttps://orcid.org/0000-0002-0620-2696ЮдинД. И.YudinD. I.

Юдин Денис Иванович - к.м.н., 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.LaktionovК. К.

Лактионов Константин Константинович - д.м.н., первый заместитель директора, заведующий отделением противоопухолевой лекарственной терапии №3 отдела лекарственного лечения, НМОЦ имени Н.Н. Блохина; профессор кафедры онкологии и лучевой терапии лечебного факультета, РНИМУ имени Н.И. Пирогова.

115478, Москва, Каширское шоссе, д. 24; 119571, Москва, Ленинский проспект, д. 117

Konstantin К. Laktionov - Dr. Sci. (Med.), First Deputy Director, Head of the Department of Antitumor Drug Therapy No. 3 of the Department of Drug Treatment, Blokhin NMRCO; Professor of the Department of Oncology and Radiation Therapy of the Faculty of Medicine, Pirogov NMRU.

24, Kashirskoye Shosse, Moscow, 115478; 117, Leninskiy Ave., Moscow, 119571

lkoskos@mail.ruБредерВ. В.BrederV. V.

Бредер Валерий Владимирович - д.м.н., ведущий научный сотрудник.

115478, Москва, Каширское шоссе, д. 24

Valery V. Breder - Dr. Sci. (Med.), Leading Researcher.

24, Kashirskoye Shosse, Moscow, 115478

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

Саранцева Ксения Андреевна - к.м.н., врач-онколог, НМОЦ имени Н.Н. Блохина; доцент кафедры онкологии и лучевой терапии лечебного факультета, РНИМУ имени Н.И. Пирогова.

115478, Москва, Каширское шоссе, д. 24; 119571, Москва, Ленинский проспект, д. 117

Ksenia А. Sarantseva - Cand. Sci. (Med.), Oncologist, Blokhin NMRCO; Associate Professor of the Department of Oncology and Radiation Therapy of the Faculty of Medicine, Pirogov NMRU.

24, Kashirskoye Shosse, Moscow, 115478; 117, Leninskiy Ave., Moscow, 119571

sarantsevaka@gmail.comhttps://orcid.org/0000-0002-2154-3376РеутоваЕ. В.ReutovaE. V.

Реутова Елена Валерьевна - к.м.н., старший научный сотрудник.

115478, Москва, Каширское шоссе, д. 24

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

24, Kashirskoye Shosse, Moscow, 115478

evreutova@rambler.ruНациональный медицинский онкологический центр имени Н.Н. БлохинаРоссияBlokhin National Medical Research Center of OncologyRussian FederationНациональный медицинский онкологический центр имени Н.Н. Блохина; Российский национальный исследовательский медицинский университет имени Н.И. ПироговаРоссияBlokhin National Medical Research Center of Oncology; Pirogov National Medical Research UniversityRussian Federation202425072024010132137Copyright © Юдин Д.И., Лактионов К.К., Бредер В.В., Саранцева К.А., Реутова Е.В., 20242024Юдин Д.И., Лактионов К.К., Бредер В.В., Саранцева К.А., Реутова Е.В.Yudin D.I., Laktionov К.К., Breder V.V., Sarantseva K.A., Reutova E.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/8404Введение

Введение. Несмотря на все успехи иммунои таргетной терапии, платиносодержащая химиотерапия все еще занимает значительное место в первой линии лечения метастатического немелкоклеточного рака легкого (НМРЛ).

Цель

Цель. Сравнение общей выживаемости (ОВ) у пациентов с метастатическим НМРЛ без активирующих мутаций, получивших ингибиторы контрольных точек в первой или второй линии лечения в реальной российской практике.

Материалы и методы

Материалы и методы. В данное наблюдательное ретроспективное одноцентровое исследование было включено 232 пациента с метастатическим НМРЛ без активирующих мутаций. Все пациенты получили ингибиторы контрольных точек иммунитета в первой или второй линии лечения. В первую группу (одновременная иммунохимиотерапия) вошли 82 пациента, во вторую (платиносодержащая химиотерапия и последующая иммунотерапия во второй линии) – 150 пациентов. Также был проведен многофакторный анализ ОВ. Медиана времени наблюдения составила 38,4 мес.

Результаты

Результаты. Медиана ОВ в первой и второй группах составила 21,0 мес. (14,4–27,6; 95% ДИ) и 22,4 мес. (17,6–27,19; 95% ДИ); трехлетняя ОВ составила 40% и 36,6% соответственно. Отношение рисков (ОР) для пациентов в группе иммунохимиотерапии составило 1,02 (0,72–1,44; 95% ДИ) по сравнению с пациентами, получившими иммунотерапию во второй линии. При многофакторном анализе достоверно ассоциировался с худшей ОВ фактор несоответствия пациента общим критериям включения в клинические исследования (ECOG 2–3, значимая сопутствующая патология, активная инфекция, хроническая инфекция, необходимость в кортикостероидах) (ОР = 1,71 (1,21–2,4; 95% ДИ), наличие метастатического поражения печени (ОР = 1,76 (1,09–2,84; 95% ДИ) и мужской пол (ОР = 1,68 (1,04–2,71; 95% ДИ).

Выводы

Выводы. Общая выживаемость у пациентов, получивших иммунотерапию в первой или во второй линии лечения, не отличалась. Принципиальным моментом для пациентов без активирующих мутаций является сам факт получения иммунотерапии. Несоответствие базовым критериям включения в клинические исследования достоверно ухудшает результаты лечения.

Introduction

Introduction. Although immuneand targeted therapy have become successful in recent years, platinum-based chemotherapy continues to have a place in the up-front treatment for metastatic non-small cell lung cancer (NSCLC).

Aim

Aim. Tо evaluate the overall survival (OS) of patients with metastatic NSCLC who were treated with immune checkpoint inhibitors either as first-line or second-line treatment in clinical practice in Russia.

Materials and methods

Materials and methods. Using real-world database, we retrospectively selected 232 patients with metastatic NSCLC without driving mutations. Of these patients, 82 received chemoimmunotherapy as the initial treatment (group 1) and 150 patients were treated with platinum–based chemotherapy followed by immunotherapy as the second line (group 2). Multivariate subgroup analyses were performed. The median time from the start of treatment to data cut off was 38.4 months.

Results

Results. The median OS was the same in the first and second group, 21.0 months (14.4–27.6; 95% CI) and 22.4 months (17.6–27.19; 95% CI); estimated 3-year OS was 40% and 36.6%, respectively. The hazard ratio (HR) for patients in the immunochemotherapy group was 1.02 (0.72–1.44; 95% CI) compared with patients who received second-line immunotherapy. In multivariate analysis, non-compliance with basic inclusion criteria in clinical trials (ECOG 2–3, serious intercurrent illness, active infection, chronic infection, corticosteroids need) (HR = 1.71 (1.21–2.4; 95% CI), the liver metastasis (HR = 1.76 (1.09–2.84; 95% CI) and gender (male vs. female HR = 1.68 (1.04–2.71; 95% DI) were significantly associated with the shorter OS.

Conclusions

Conclusions. The overall survival in patients who received immunotherapy in the second line of treatment did not differ from the results of treatment for the patients after immuno-chemotherapy in the first line. The crucial is the receiving of immunotherapy regardless of the line. Failure to meet the criteria of inclusion in clinical trials significantly worsens the long-term outcomes.

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