medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/ms2023-453medsovet-8001Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL RESEARCHАдъювантная оксалиплатинсодержащая химиотерапия по сравнению с динамическим наблюдением после радикальной резекции метахронных метастазов при колоректальном раке: промежуточные результатыAdjuvant oxaliplatin-based chemotherapy comparing observation alone after radical resection of metachronous metastases of colorectal cancer: interim analysishttps://orcid.org/0000-0002-1993-3842ЕвдокимоваС. Ф.EvdokimovaS. F.

Евдокимова Сэвиндж Физулиевна – аспирант.

125284, Москва, 2-й Боткинский проезд, д. 3

Sevindzh F. Evdokimova - Postgraduate Student, Hertsen Moscow Oncology Research Institute.

3, 2nd Botkinskiy Proezd, Moscow, 125834

evdokimova.sevindzh@gmail.comhttps://orcid.org/0000-0003-4879-2687БолотинаЛ. В.BolotinaL. V.

Болотина Лариса Владимировна - д.м.н., заведующая отделением химиотерапии.

125284, Москва, 2-й Боткинский проезд, д. 3

Larisa V. Bolotina - Dr. Sci. (Med.), Head of the Chemotherapy Department, Hertsen Moscow Oncology Research Institute.

3, 2nd Botkinskiy Proezd, Moscow, 125834

lbolotina@yandex.ruhttps://orcid.org/0000-0003-0092-0459КорниецкаяА. Л.KornietskayaA. L.

Корниецкая Анна Леонидовна - к.м.н., ведущий научный сотрудник отдела лекарственного лечения опухолей.

125284, Москва, 2-й Боткинский проезд, д. 3

Аnna L. Kornietskaya - Cand. Sci. (Med.), Leading Researcher of the Department of Drug Treatment of Tumors, Hertsen Moscow Oncology Research Institute.

3, 2nd Botkinskiy Proezd, Moscow, 125834

kornietskaya@mail.ruhttps://orcid.org/0000-0002-8282-9351СидоровД. В.SidorovD. V.

Сидоров Дмитрий Владимирович - д.м.н., заведующий онкологическим отделением №7.

117152, Москва, Загородное шоссе, д. 18а, стр. 7

Dmitry V. Sidorov - Dr. Sci. (Med.), Head of Oncology Department No. 7, City Clinical Oncological Hospital No. 1.

18а, Bldg. 7, Zagorodnoye Shosse, Moscow, 117152

dvsidorov_65@mail.ruhttps://orcid.org/0000-0001-8784-8415КапринА. Д.KaprinA. D.

Каприн Андрей Дмитриевич - чл.- корр. РАН, д.м.н., профессор, генеральный директор Научного медицинского исследовательского центра радиологии, директор, МНИОИ им. П.А. Герцена; заведующий кафедрой урологии и оперативной нефрологии с курсом онкоурологии Медицинского института, РУДН.

125284, Москва, 2-й Боткинский проезд, д. 3; 117198, Москва, ул. Миклухо-Маклая, д. 6

Andrey D. Kaprin - Сorr. Member RAS, Dr. Sci. (Med.), Professor, General Director of the Scientific Medical Research Center of Radiology, Director, Hertsen Moscow Oncology Research Institute; Head of the Department of Urology and Operative Nephrology with the course of Oncourology of the Medical Institute, Peoples’ Friendship University of Russia.

3, 2nd Botkinskiy Proezd, Moscow, 125834; 6, Miklukho-Maklai St., Moscow, 117198

kaprin@mail.ruМосковский научно-исследовательский онкологический институт имени П.А. ГерценаРоссияHertsen Moscow Oncology Research InstituteRussian FederationГородская клиническая онкологическая больница №1РоссияCity Clinical Oncological Hospital No. 1Russian FederationМосковский научно-исследовательский онкологический институт имени П.А. Герцена; Российский университет дружбы народовРоссияHertsen Moscow Oncology Research Institute; Peoples’ Friendship University of RussiaRussian Federation202319012024022154160Copyright © Евдокимова С.Ф., Болотина Л.В., Корниецкая А.Л., Сидоров Д.В., Каприн А.Д., 20242024Евдокимова С.Ф., Болотина Л.В., Корниецкая А.Л., Сидоров Д.В., Каприн А.Д.Evdokimova S.F., Bolotina L.V., Kornietskaya A.L., Sidorov D.V., Kaprin A.D.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/8001Введение

Введение. Несмотря на зарегистрированный стандарт лечения пациентов после проведенного радикального хирургического лечения по поводу метахронных метастазов при колоректальном раке (КРР), целесообразность проведения адъювантной химиотерапии (АХТ) для всех больных представляется неоднозначной. В связи с появлением исследований, демонстрирующих улучшение показателей безрецидивной выживаемости при применении послеоперационной химиотерапии по сравнению с наблюдением, имелись, казалось бы, обоснованные ожидания по увеличению показателей общей выживаемости (ОВ), которые, однако, статически не отличаются между группами. В данной статье представлены промежуточные результаты собственного исследования.

Цель

Цель. Проанализировать эффективность применения АХТ по сравнению с динамическим наблюдением у пациентов после проведенного хирургического лечения по поводу метахронных метастазов при КРР.

Материалы и методы

Материалы и методы. Данное исследование является проспективно-ретроспективным нерандомизированным non-inferiority. За период с июня 2008 г. по сентябрь 2022 г. было набрано 120 пациентов. В группу АХТ включен 71 пациент. Все пациенты получали только оксалиплатинсодержащие схемы химиотерапии, группа динамического наблюдения объединила 49 больных.

Результаты

Результаты. При промежуточном анализе медиана выживаемости без признаков болезни (мВБПБ) в группе АХТ (n = 71) составила 20,9 мес. (13,7–28,3) по сравнению с группой динамического наблюдения (n = 49) – 24,4 мес. (11,1–37,7), HR: 0,76 (95% CI: 0,45–1,29), p = 0,29. Двухлетняя выживаемость без признаков болезни (ВБПБ) в группе послеоперационной химиотерапии (ХТ) (n = 50) составила 46,6%, а в экспериментальной группе (n = 31) – 55,5%, HR: 0,69 (95% CI: 0,39–1,2), p = 0,21.

Выводы

Выводы. АХТ не улучшила отдаленные результаты лечения у пациентов после радикальной резекции метахронных метастазов при КРР

Introduction

Introduction. Despite the registered standard treatment option for patients who underwent radical resection for metachronous metastases of colorectal cancer (CRC), the feasibility of adjuvant chemotherapy (ACT) for all patients seems controversial. Due to studies demonstrating improved disease-free survival rates with postoperative chemotherapy vs observation, it would seem that there is reasonable expectation of improved overall survival (OS) rates, which, however, were not statistically different between groups. This article presents the interim results of our own study.

Aim

Aim. To analyse the efficacy of ACT vs dynamic observation in patients who underwent surgery for metachronous metastases of colorectal cancer.

Materials and methods

Materials and methods. It was a prospective-retrospective, non-randomized, non-inferiority study. A total of 120 patients were recruited between June 2008 and September 2022. The ACT group included 71 patients. All patients received only oxaliplatin-based chemotherapy regimens; the dynamic observation group included 49 patients.

Results

Results. The interim analysis showed that the median disease-free survival (mDFS) in the ACT group (n = 71) was 20.9 months (13.7–28.3) vs 24.4 months in the dynamic observation group (n = 49) (11.1–37.7), HR: 0.76 (95% CI: 0.45–1.29), p = 0.29. Two-year disease-free survival (DFS) rates were 46.6% in the post-surgery chemotherapy (CT) group (n = 50) and 55.5% in the experimental group (n = 31), HR: 0.69 (95% CI: 0.39–1.2), p = 0.21.

Conclusion

Conclusion. ACT has not improved the long-term treatment outcomes in patients who underwent radical resection for metachronous metastases of CRC.

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