medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/ms2023-201medsovet-7696Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL RESEARCHАнализ региональной клинической практики применения CDK4/6 – ингибитора рибоциклиба как механизм интеграции научно-исследовательского подхода в организацию лекарственного обеспеченияAnalysis of the regional clinical use of CDK4/6 inhibitor ribociclib as a mechanism of integration of a research approach in drug provisionhttps://orcid.org/0000-0001-7127-7945ГоряиноваА. Ю.GoryainovaA. Yu.

Горяинова Алла Юрьевна, заведующий координационным отделом лекарственного обеспечения; ассистент кафедры онкологии с курсом торакальной хирургии

350040, Россия, Краснодар, ул. Димитрова, д. 146 

350063, Россия, Краснодар, ул. Митрофана Седина, д. 4 

Alla Yu. Goryainova, Medical Oncologist, Head of the Drug Supply Coordination Department; Assistant of the Department of Oncology with the course of Thoracic Surgery 

146, Dimitrov St., Krasnodar, 350040, Russia

4, Mitrofan Sedin St., Krasnodar, 350063, Russia 

mashelueva@yandex.ruhttps://orcid.org/0000-0001-8084-8770МурашкоР. А.MurashkoR. A.

Мурашко Роман Алексеевич, к.м.н., главный врач; доцент кафедры онкологии с курсом торакальной хирургии 

350040, Россия, Краснодар, ул. Димитрова, д. 146 

350063, Россия, Краснодар, ул. Митрофана Седина, д. 4 

Roman A. Murashko, Cand. Sci (Med.), Head; Associate Professor of the Department of Oncology with a Course of Thoracic Surgery

146, Dimitrov St., Krasnodar, 350040, Russia

4, Mitrofan Sedin St., Krasnodar, 350063, Russia 

kkod@kkod.ruhttps://orcid.org/0000-0002-8715-2992ШаровС. В.SharovS. V.

Шаров Сергей Викторович, к.м.н., заместитель главного врача по лекарственному обеспечению; ассистент кафедры онкологии с курсом торакальной хирургии

350040, Россия, Краснодар, ул. Димитрова, д. 146 

350063, Россия, Краснодар, ул. Митрофана Седина, д. 4 

Sergey V. Sharov, Cand. Sci (Med.), Deputy Head for Drug Supply; Assistant of the Department of Oncology with the course of Thoracic Surgery 

146, Dimitrov St., Krasnodar, 350040, Russia

4, Mitrofan Sedin St., Krasnodar, 350063, Russia 

dr_sch@mail.ruhttps://orcid.org/0009-0005-6153-3059КугаевскийД. Н.StukanA. I.

Дмитрий Николаевич Кугаевский, провизор координационного отдела лекарственного обеспечения 

350040, Россия, Краснодар, ул. Димитрова, д. 146 

Anastasia I. Stukan, Cand. Sci (Med.), Medical Oncologist, Drug Supply Coordination Department; Assistant of the Department of Oncology with the course of Thoracic Surgery

146, Dimitrov St., Krasnodar, 350040, Russia

4, Mitrofan Sedin St., Krasnodar, 350063, Russia 

lgotakuban@gmail.comhttps://orcid.org/0000-0002-0698-7710СтуканьА. И.KugaevskyD. N.

Стукань Анастасия Игоревна, к.м.н., врач-онколог координационного отдела лекарственного обеспечения; ассистент кафедры онкологии с курсом торакальной хирургии

350040, Россия, Краснодар, ул. Димитрова, д. 146 

350063, Россия, Краснодар, ул. Митрофана Седина, д. 4 

Dmitry N. Kugaevsky, Pharmacist, Drug Supply Coordination Department 

146, Dimitrov St., Krasnodar, 350040, Russia 

jolie86@bk.ruhttps://orcid.org/0000-0002-6866-1425ЛымарьЕ. В.LymarE. V.

Лымарь Елена Владимировна, врач-онколог координационного отдела лекарственного обеспечения 

350040, Россия, Краснодар, ул. Димитрова, д. 146 

Elena V. Lymar, Medical Oncologist, Drug Supply Coordination Department 

146, Dimitrov St., Krasnodar, 350040, Russia 

tsari29@mail.ruКлинический онкологический диспансер № 1; Кубанский государственный медицинский университетРоссияClinical Oncologic Dispensary No. 1; Kuban State Medical UniversityRussian FederationКлинический онкологический диспансер № 1РоссияClinical Oncologic Dispensary No. 1; Kuban State Medical UniversityRussian FederationКлинический онкологический диспансер № 1; Кубанский государственный медицинский университетРоссияClinical Oncologic Dispensary No. 1Russian FederationКлинический онкологический диспансер № 1РоссияClinical Oncologic Dispensary No. 1Russian Federation202329072023011119131Copyright © Горяинова А.Ю., Мурашко Р.А., Шаров С.В., Кугаевский Д.Н., Стукань А.И., Лымарь Е.В., 20232023Горяинова А.Ю., Мурашко Р.А., Шаров С.В., Кугаевский Д.Н., Стукань А.И., Лымарь Е.В.Goryainova A.Y., Murashko R.A., Sharov S.V., Stukan A.I., Kugaevsky D.N., Lymar 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/7696

Введение. Внедрение данных регистрационных исследований в клиническую практику зачастую представляет ряд проблем, обусловленных гетерогенностью популяции больных, отсутствием единообразия мышления клиницистов и организационными трудностями. На примере изучения алгоритма назначения рибоциклиба в когорте больных одного региона в современных реалиях и возможностях лекарственного обеспечения мы показали основные спорные моменты реализации результатов клинических исследований в повседневной практике онколога.Цель. Проанализировать предварительные результаты лечения больных гормон-рецептор-позитивным Her-2 отрицательным метастатическим раком молочной железы с использованием рибоциклиба в рутинной клинической практике с учетом влияния особенностей регионального лекарственного обеспечения.Материалы и методы. Проведен ретроспективный анализ результатов лечения больных (n = 56), принимавших рибоциклиб в плане комбинированной гормонотерапии метастатического гормонозависимого Her-2 негативного рака молочной железы, в практике онкологов Краснодарского края с 2019 по 2022 г.Результаты. На момент сбора и анализа данных при общем времени наблюдения за больными 29 месяцев медиана общей выживаемости не была достигнута, живы и продолжили наблюдение 52 пациента (92,9%). Медиана выживаемости без прогрессирования также не была достигнута: прогрессирование заболевания было зарегистрировано у 19 больных (33,9%), 37 пациентов (66,1%) продолжили лечение. Всего 14 из 56 больных (25,1%) получили терапию рибоциклибом в сочетании с препаратами для эндокринотерапии в первой и второй линиях. Наилучшие результаты продемонстрировали больные с высоким уровнем экспрессии рецепторов прогестерона в опухоли (p = 0,005), низким уровнем индекса пролиферативной активности Ki67 (p = 0,035), без метастатического висцерального поражения (p = 0,034), получившие минимальное количество линий терапии до назначения рибоциклиба (p = 0,029). Результаты клинической части исследования стали доступны благодаря своевременной оптимизации процессов регионального лекарственного обеспечения с созданием и постоянным контролем клиницистами устойчивой когорты больных в виде актуализируемых регистров.Выводы. Внедрение опыта и знаний клинических онкологов в процесс управления лекарственным обеспечением и его оптимизацией с учетом понимания данных об эффективности и токсичности препарата является перспективным направлением и требует дальнейшего обсуждения.

Introduction. Implementation of data from registration studies into clinical practice often presents a number of problems due to the heterogeneity of the patient population, the lack of uniformity of thinking among clinicians, and organizational difficulties. Using the example of studying the algorithm for prescribing ribociclib in a cohort of patients from one region in modern realities and the possibilities of drug provision, we have shown the main controversial points in the implementation of the results of clinical trials in the daily practice of an oncologist.Aim. The purpose of this study was to analyze our own preliminary results of the treatment of patients with hormone-receptorpositive Her-2-negative metastatic breast cancer using ribociclib in the routine practice of prescribing CDK4/6 inhibitors outside of clinical trials, taking into account the peculiarities of regional drug supply.Materials and methods. A retrospective analysis of the results of treatment of patients (n = 56) who took ribociclib in terms of combined hormone therapy for metastatic hormone-dependent Her-2 negative breast cancer in the practice of oncologists in the Krasnodar Territory from 2019 to 2022 was carried out.Results. At the time of data collection and analysis, with a total follow-up time of 29 months, the median overall survival was not achieved, 52 patients (92.9%) were alive and continued to follow up. The median progression-free survival was also not reached: disease progression was recorded in 19 patients (33.9%), 37 patients (66.1%) continued treatment. A total of 14 out of 56 patients (25.1%) received ribociclib therapy in combination with drugs for endocrine therapy in the first and second lines. The best results were demonstrated by patients with a high level of expression of progesterone receptors in the tumor (p = 0.005), a low level of Ki67 proliferative activity index (p = 0.035), without metastatic visceral lesions (p = 0.034), who received the minimum number of lines of therapy before the appointment of ribociclib (p = 0.029). The results of the clinical part of the study became available due to the timely optimization of regional drug supply processes with the creation and constant monitoring by clinicians of a stable cohort of patients in the form of updated registers.Conclusions. The introduction of the experience and knowledge of clinical oncologists into the process of drug supply management and its optimization, taking into account the understanding of data on drug efficacy and toxicity, is a promising direction and requires further discussion.

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