myrwdРеальная клиническая практика: данные и доказательстваReal-World Data & Evidence2782-3784Publishing House OKI10.37489/2782-3784-myrwd-076EFAKGLmyrwd-105Research ArticleОРИГИНАЛЬНОЕ ИССЛЕДОВАНИЕORIGINAL RESEARCHСТАТЬЯ ОТОЗВАНА: Исследование ICEDORA: клинико-демографическая характеристика и схемы лечения пациентов с HR+ HER2- местнораспространённым или метастатическим раком молочной железы, принимающих ингибиторы CDK4/6, в реальной клинической практикеRETRACTED: The ICEDORA study: clinical and demographic characteristics and treatment regimens of patients with HR+ HER2- locally advanced or metastatic breast cancer receiving CDK4/6 inhibitors in real clinical practicehttps://orcid.org/0000-0002-4088-8118ХатьковИ. Е.KhatkovI. E.

Игорь Евгеньевич Хатьков, д. м. н., профессор, академик РАН, зав. кафедрой, директор ГБУЗ, главныйвнештатный специалист-онколог департаментаздравоохранения Москвы, председатель РОО «Московское онкологическое общество»

лечебный факультет; кафедра факультетской хирургии № 2

Москва

Igor E. Khatkov, Dr. Sci. (Med.), Professor, Academician of the Russian Academy of Sciences, Head of the Department, Director of the Center, Chief Oncologist of the Moscow Health Department; Chairman of the Moscow Oncology Society

Medical Faculty; Department of Faculty Surgery No. 2

Moscow

i.hatkov@mknc.ruhttps://orcid.org/0000-0003-2646-499XАндреяшкинаИ. И.AndreyashkinaI. I.

Ирина Ивановна Андреяшкина, д. м. н., зам. главного внештатного специалиста-онколога департамента здравоохранения Москвы, в. н. с.

отдел общей онкологии

Москва

Irina I. Andreyashkina, Dr. Sci. (Med.), Deputy Chief Oncologist of the Moscow Healthcare Department, Leading Researcher

General Oncology Department

Moscow

i.andreyashkina@mknc.ruhttps://orcid.org/0000-0002-6667-0125ТроценкоИ. Д.TrotsenkoI. D.

Иван Дмитриевич Троценко, к. м. н., с. н. с., исполнительный директор РОО

отдел общей онкологии

Москва

Ivan D. Trotsenko, Cand. Sci. (Med.), Senior Researcher, Executive Director

Department of General Oncology

Moscow

i.trotsenko@mknc.ruhttps://orcid.org/0009-0009-0806-909XМатвееваО. Н.MatveevaO. N.

Ольга Николаевна Матвеева, к. м. н., медицинский руководитель направления Солидные опухоли

Москва

Olga N. Matveeva, Cand. Sci. (Med.), Medical Director of the Solid Tumors Department

Moscow

olga.matveeva@novartis.comhttps://orcid.org/0009-0009-6413-3244РезниковВ. А.ReznikovV. A.

Валерий Анатольевич Резников, старший медицинский советник направления Солидные опухоли

Москва

Valery A. Reznikov, Senior Medical Advisor, Solid Tumors

Moscow

valeriy.reznikov@novartis.comГБУЗ «Московский клинический научно-практический центр имени А. С. Логинова»; ФГБОУ ВО «Российский университет медицины»; РОО «Московское онкологическое общество»РоссияMoscow Clinical Research Center named after A. S. Loginov; Russian University of Medicine; Moscow Oncology SocietyRussian FederationГБУЗ «Московский клинический научно-практический центр имени А. С. Логинова»РоссияMoscow Clinical Research Center named after A. S. LoginovRussian FederationГБУЗ «Московский клинический научно-практический центр имени А. С. Логинова»; ФГБОУ ВО «Российский университет медицины»; РОО «Московское онкологическое общество»РоссияMoscow Clinical Research Center named after A. S. Loginov; Russian University of Medicine; Moscow Oncology SocietyRussian FederationООО «Новартис Фарма»РоссияNovartis PharmaRussian Federation2025300720255283100Copyright © Хатьков И.Е., Андреяшкина И.И., Троценко И.Д., Матвеева О.Н., Резников В.А., 20252025Хатьков И.Е., Андреяшкина И.И., Троценко И.Д., Матвеева О.Н., Резников В.А.Khatkov I.E., Andreyashkina I.I., Trotsenko I.D., Matveeva O.N., Reznikov V.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.myrwd.ru/jour/article/view/105СТАТЬЯ ОТОЗВАНА

СТАТЬЯ ОТОЗВАНА

   Введение

   Введение. Ингибиторы CDK4/6 в сочетании с эндокринной терапией (ЭТ) являются современным стандартом терапии пациентов с HR+ HER2- распространённым и метастатическим РМЖ (рРМЖ и мРМЖ). Доказательства клинической эффективности ингибиторов CDK4/6 были получены в нескольких рандомизированных клинических исследованиях (РКИ), но данные об их эффективности в условиях реальной клинической практики (РКП) противоречивы.

   Целью исследования ICEDORA был анализ клинико-демографических характеристик, схем лечения и клинических исходов у пациентов с HR+ HER2- мрРМЖ и мРМЖ, принимающих ингибиторы CDK4/6 в РКП в Москве.

   Материалы и методы

   Материалы и методы. ICEDORA — неинтервенционное ретроспективное исследование, основанное на анализе данных о пациентах, получавших ингибиторы CDK 4/6 в Москве. Из первичной медицинской документации (амбулаторных карт и историй болезни) путём парсинга были извлечены клинические характеристики и подробности лечения всех пациентов с HR+ HER2- РМЖ, принимавших рибоциклиб, палбоциклиб или абемациклиб с января 2020 г. до конца декабря 2022 г. Общую выживаемость (ОВ) рассчитывали от момента выявления РМЖ до смерти пациента с использованием метода Каплана-Мейера, а различия между группами лечения оценивались с помощью логрангового теста. Многофакторные модели логистической регрессии и пропорциональных рисков Кокса были построены с целью исключения влияния вмешивающихся факторов и систематических ошибок.

   Результаты

   Результаты. В анализ была включена 2051 пациентка. Палбоциклиб получали 58,7 %, рибоциклиб — 34,7 %, абемациклиб — 6,6 % пациенток. Медиана возраста в общей популяции составила 58 лет, но в группе абемациклиба она была выше (62 года). В 83,5 % случаев Her2/neu был негативным, группы однородны по этому показателю. Уровень рецепторов эстрогена (ER) Ki-67 были значительно выше в группе абемациклиба. В общей популяции пациентки с первично-метастатическим РМЖ (IV стадия) составили 42,1 %. Распределение стадий внутри каждой группы было сопоставимым. По количеству метастазов группы значимо различались за счёт большей доли пациенток с одним метастазом в группе абемациклиба (31,9 %) по сравнению с группами рибоциклиба (19,0 %) и палбоциклиба (16,6 %), где количество метастатических очагов было больше одного. Коморбидность присутствовала у 90 % пациенток. Отличия исходных характеристик пациентов, получающих разные препараты, требуют осторожности при интерпретации результатов исследования.

   Заключение

   Заключение. Исследование ICEDORA, включавшее пациентов, принимавших ингибиторы CDK4/6 в реальной клинической практике в Москве, является одним из крупнейших в России анализов клинико-демографических характеристик, схем лечения и клинических исходов у пациентов с HR+ HER2- мрРМЖ и мРМЖ, принимающих ингибиторы CDK4/6 в РКП. Сравнительный анализ эффективности рибоциклиба, палбоциклиба и абемациклиба в РКП не планировался и не проводился из-за различий в клинико-демографических характеристиках пациентов. Необходимы более крупные многоцентровые данные со сбалансированными когортами и длительным наблюдением.

RETRACTED ARTICLE

RETRACTED ARTICLE

   Introduction

   Introduction. CDK4/6 inhibitors in combination with endocrine therapy (ET) are the current standard of care for patients with HR+ HER2- advanced and metastatic breast cancer (eBC and mBC). Evidence of the clinical efficacy of CDK4/6 inhibitors has been obtained in several randomized clinical trials (RCTs), but data on their efficacy in real-world clinical practice (RCP) are contradictory.

   Objective

   Objective. The aim of the ICEDORA study was to analyze clinical and demographic characteristics, treatment regimens, and clinical outcomes in patients with HR+ HER2- mBC and mBC receiving CDK4/6 inhibitors in a real-world clinical practice in Moscow.

   Materials and methods

   Materials and methods. ICEDORA is a non-interventional retrospective study based on the analysis of data on patients receiving CDK 4/6 inhibitors in Moscow. Clinical characteristics and treatment details of all patients with HR+ HER2-breast cancer who received ribociclib, palbociclib, or abemaciclib from January 2020 to the end of December 2022 were extracted from primary medical records (outpatient charts and medical histories) by parsing. Overall survival (OS) was calculated from the date of breast cancer diagnosis until patient death using the Kaplan-Meier method, and differences between treatment groups were assessed using the log-rank test. Multivariate logistic regression and Cox proportional hazards models were built to exclude the influence of confounders and systematic errors.

   Results

   Results. The analysis included 2051 patients. 58.7 % received palbociclib, 34.7 % — ribociclib, 6.6 % — abemaciclib. The median age in the overall population was 58 years, but it was higher in the abemaciclib group (62 years). In 83.5 % of cases, Her2/neu was negative, the groups were homogeneous in this indicator. The level of estrogen receptors (ER) Ki-67 was significantly higher in the abemaciclib group. In the overall population, patients with primary metastatic breast cancer (stage IV) accounted for 42.1 %. The distribution of stages within each group was comparable. The groups differed significantly in the number of metastases due to a higher proportion of patients with one metastasis in the abemaciclib group (31.9 %) compared to the ribociclib (19.0 %) and palbociclib (16.6 %) groups, where the number of metastatic foci was more than one. Comorbidity was present in 90 % of patients. Differences in the baseline characteristics of patients receiving different drugs require caution when interpreting the study results.

   Conclusion

   Conclusion. The ICEDORA study, which included patients taking CDK4/6 inhibitors in real-world clinical practice in Moscow, is one of the largest analyses of clinical and demographic characteristics, treatment regimens, and clinical outcomes in patients with HR+ HER2- mBC and mBC taking CDK4/6 inhibitors in real-life clinical practice in Russia. Comparative analysis of the efficacy of ribociclib, palbociclib, and abemaciclib in real-life clinical practice was not planned or conducted due to differences in the clinical and demographic characteristics of patients. Larger multicenter data withbalanced cohorts and long-term follow-up are needed.

ингибиторы CDK4/6рибоциклибпалбоциклибабемациклибреальная клиническая практикаместнораспространённый рак молочной железыметастатический рак молочной железыCDK4/6 inhibitorsribociclibpalbociclibabemaciclibreal-life clinical practicelocally advanced breast cancermetastatic breast cancerДанное исследование было частично финансировано компанией ООО «Новартис Фарма»The study was partially funded by Novartis Pharma LLCReferencesСостояние онкологической помощи населению России в 2023 году. Под ред. А.Д. Каприна, В.В. Старинского, А.О. Шахзадовой. М.: МНИОИ им. П.А. Герцена − филиал ФГБУ «НМИЦ радиологии» Минздрава России, 2024. − ил. – 262 с.The state of oncological care for the population of Russia in 2023. Edited by A.D. Kaprin, V.V. Starinsky, A.O. Shakhzadova. Moscow: P.A. Herzen Moscow Oncology Research Institute – branch of the National Medical Research Center of Radiology of the Ministry of Health of the Russian Federation, 2022. – ill. – 262 p. (In Russ.)Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Frenzel M, Lin Y, Barriga S, Smith IC, Bourayou N, Llombart-Cussac A. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017;35(25):2875-2884. doi: 10.1200/JCO.2017.73.7585Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Frenzel M, Lin Y, Barriga S, Smith IC, Bourayou N, Llombart-Cussac A. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017;35(25):2875-2884. doi: 10.1200/JCO.2017.73.7585Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O'Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018;29(7):1541-1547. doi: 10.1093/annonc/mdy155Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O'Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018;29(7):1541-1547. doi: 10.1093/annonc/mdy155Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, Hurvitz SA, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, Liu MC, Carlson G, Hughes G, Diaz-Padilla I, Germa C, Hirawat S, Lu YS. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018;19(7):904-915. doi: 10.1016/S1470-2045(18)30292-4Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, Hurvitz SA, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, Liu MC, Carlson G, Hughes G, Diaz-Padilla I, Germa C, Hirawat S, Lu YS. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018;19(7):904-915. doi: 10.1016/S1470-2045(18)30292-4Rugo HS, Finn RS, Diéras V, Ettl J, Lipatov O, Joy AA, Harbeck N, Castrellon A, Iyer S, Lu DR, Mori A, Gauthier ER, Bartlett CH, Gelmon KA, Slamon DJ. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat. 2019;174(3):719-729. doi: 10.1007/s10549-018-05125-4Rugo HS, Finn RS, Diéras V, Ettl J, Lipatov O, Joy AA, Harbeck N, Castrellon A, Iyer S, Lu DR, Mori A, Gauthier ER, Bartlett CH, Gelmon KA, Slamon DJ. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat. 2019;174(3):719-729. doi: 10.1007/s10549-018-05125-4Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martín M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Sondhi M, Wang Y, Chakravartty A, Rodriguez-Lorenc K, Taran T, Jerusalem G. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382:514-524. doi: 10.1056/NEJMoa1911149Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martín M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Sondhi M, Wang Y, Chakravartty A, Rodriguez-Lorenc K, Taran T, Jerusalem G. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382:514-524. doi: 10.1056/NEJMoa1911149Johnston S, O'Shaughnessy J, Martin M, Huober J, Toi M, Sohn J, André VAM, Martin HR, Hardebeck MC, Goetz MP. Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 up-dated results in prognostic subgroups. NPJ Breast Cancer. 2021;22;7(1):80. doi: 10.1038/s41523-021-00289-7Johnston S, O'Shaughnessy J, Martin M, Huober J, Toi M, Sohn J, André VAM, Martin HR, Hardebeck MC, Goetz MP. Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 up-dated results in prognostic subgroups. NPJ Breast Cancer. 2021;22;7(1):80. doi: 10.1038/s41523-021-00289-7Abdallah HMA, Owoseni YI, Sultan A, Ahmed S, Wood J, Varadhan B, Ayodele O. 448P Real-world experience with CDK4/6 inhibitors for HR+/HER2-metastatic breast cancer (MBC). Ann Oncol. 2023;34(2):S369-S370. doi: 10.1016/j.annonc.2023.09.624Abdallah HMA, Owoseni YI, Sultan A, Ahmed S, Wood J, Varadhan B, Ayodele O. 448P Real-world experience with CDK4/6 inhibitors for HR+/HER2-metastatic breast cancer (MBC). Ann Oncol. 2023;34(2):S369-S370. doi: 10.1016/j.annonc.2023.09.624Miron AI, Anghel AV, Barnonschi AA, Mitre R, Liscu HD, Găinariu E, Pătru R, Coniac S. Real-World Outcomes of CDK4/6 Inhibitors Treatment in Metastatic Breast Cancer in Romania. Diagnostics (Basel). 2023;13(11):1938. doi: 10.3390/diagnostics13111938Miron AI, Anghel AV, Barnonschi AA, Mitre R, Liscu HD, Găinariu E, Pătru R, Coniac S. Real-World Outcomes of CDK4/6 Inhibitors Treatment in Metastatic Breast Cancer in Romania. Diagnostics (Basel). 2023;13(11):1938. doi: 10.3390/diagnostics13111938Chen BF, Tsai YF, Chao TC, Lien PJ, Lin YS, Feng CJ, Chen YJ, Cheng HF, Liu CY, Lai JI, Tseng LM, Huang CC. Real-world experience with CDK4/6 inhibitors in hormone receptor-positive metastatic and recurrent breast cancer: findings from an Asian population. Clin Exp Med. 2024;24(1):185. doi: 10.1007/s10238-024-01458-1Chen BF, Tsai YF, Chao TC, Lien PJ, Lin YS, Feng CJ, Chen YJ, Cheng HF, Liu CY, Lai JI, Tseng LM, Huang CC. Real-world experience with CDK4/6 inhibitors in hormone receptor-positive metastatic and recurrent breast cancer: findings from an Asian population. Clin Exp Med. 2024;24(1):185. doi: 10.1007/s10238-024-01458-1Gehrchen ML, Berg T, Garly R, Jensen MB, Eßer-Naumann S, Rønlev JD, Nielsen HM, Knoop A, Kümler I. Real-world effectiveness of CDK 4/6 inhibitors in estrogen-positive metastatic breast cancer. BJC Rep. 2024;2(1):44. doi: 10.1038/s44276-024-00070-wGehrchen ML, Berg T, Garly R, Jensen MB, Eßer-Naumann S, Rønlev JD, Nielsen HM, Knoop A, Kümler I. Real-world effectiveness of CDK 4/6 inhibitors in estrogen-positive metastatic breast cancer. BJC Rep. 2024;2(1):44. doi: 10.1038/s44276-024-00070-wPlavetic ND, Čular K, Gudelj D, Kaceljak K, Križić M, Popovic M, Bulimbašić S, Sirotković-Skerlev M, Bubanović S, Silovski T. Real-world comparison of the efficacy of three CDK4/6 inhibitors (CDK4/6i) in the first-line treatment of endocrine-sensitive advanced breast cancer (aBC): Single institution experience. J Clin Oncol. 2024;42(16):e13080-e13080. doi: 10.1200/JCO.2024.42.16_suppl.e13080Plavetic ND, Čular K, Gudelj D, Kaceljak K, Križić M, Popovic M, Bulimbašić S, Sirotković-Skerlev M, Bubanović S, Silovski T. Real-world comparison of the efficacy of three CDK4/6 inhibitors (CDK4/6i) in the first-line treatment of endocrine-sensitive advanced breast cancer (aBC): Single institution experience. J Clin Oncol. 2024;42(16):e13080-e13080. doi: 10.1200/JCO.2024.42.16_suppl.e13080Patel R, Mathews J, Hamm C, Kulkarni S, Gupta R, Opperman T, Chiong JD, Nasser A. Real-World Experience with CDK4/6 Inhibitors in the first-line palliative setting for HR+/HER2- advanced breast cancer. Curr Oncol. 2025;32(1):52. doi: 10.3390/curroncol32010052Patel R, Mathews J, Hamm C, Kulkarni S, Gupta R, Opperman T, Chiong JD, Nasser A. Real-World Experience with CDK4/6 Inhibitors in the first-line palliative setting for HR+/HER2- advanced breast cancer. Curr Oncol. 2025;32(1):52. doi: 10.3390/curroncol32010052Rugo HS, Layman RM, Lynce F, Liu X, Li B, McRoy L, Cohen AB, Estevez M, Curigliano G, Brufsky A. Comparative overall survival of CDK4/6 inhibitors plus an aromatase inhibitor in HR+/HER2- metastatic breast cancer in the US real-world setting. ESMO Open. 2025;10(1):104103 doi: 10.1016/j.esmoop.2024.104103Rugo HS, Layman RM, Lynce F, Liu X, Li B, McRoy L, Cohen AB, Estevez M, Curigliano G, Brufsky A. Comparative overall survival of CDK4/6 inhibitors plus an aromatase inhibitor in HR+/HER2- metastatic breast cancer in the US real-world setting. ESMO Open. 2025;10(1):104103 doi: 10.1016/j.esmoop.2024.104103Клинические рекомендации Минздрава России. Рак молочной железы. 2021. Электронный ресурс. https://oncology-association.ru/wp-content/uploads/2021/02/rak-molochnoj-zhelezy-2021.pdf (Дата последнего доступа: 19. 05. 2025).Clinical guidelines of the Ministry of Health of Russia. Breast Cancer. 2021. (In Russ.) https://oncology-association.ru/wp-content/uploads/2021/02/rak-molochnoj-zhelezy-2021.pdfТюляндин С.А., Артамонова Е.В., Жигулев А.Н., Жукова Л.Г., Королева И.А., Пароконная А.А., Семиглазова Т.Ю., Стенина М.Б., Фролова М.А. Рак молочной железы. Практические рекомендации RUSSCO, часть 1.2. Злокачественные опухоли. 2024;14(3s2):32–81. doi: 10.18027/2224-5057-2024-14-3s2-1.2-01Tyulyandin SA, Artamonova EV, Zhigulev AN, Zhukova LG, Koroleva IA, Parokonnaya AA, Semiglazova TYu, Stenina MB, Frolova MA. Breast cancer. RUSSCO practical recommendations, part 1.2. Malignant tumors. 2024;14(3s2):32–81. (In Russ.)Cardoso F, Paluch-Shimon S, Schumacher-Wulf E, Matos L, Gelmon K, Aapro MS, Bajpai J, Barrios CH, Bergh J, Bergsten-Nordström E, Biganzoli L, Cardoso MJ, Carey LA, Chavez-MacGregor M, Chidebe R, Cortés J, Curigliano G, Dent RA, El Saghir NS, Eniu A, Fallowfield L, Francis PA, Franco Millan SX, Gilchrist J, Gligorov J, Gradishar WJ, Haidinger R, Harbeck N, Hu X, Kaur R, Kiely B, Kim SB, Koppikar S, Kuper-Hommel MJJ, Lecouvet FE, Mason G, Mertz SA, Mueller V, Myerson C, Neciosup S, Offersen BV, Ohno S, Pagani O, Partridge AH, Penault-Llorca F, Prat A, Rugo HS, Senkus E, Sledge GW, Swain SM, Thomssen C, Vorobiof DA, Vuylsteke P, Wiseman T, Xu B, Costa A, Norton L, Winer EP. 6<sup>th</sup> and 7<sup>ер</sup> International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7). The Breast. 2024;76:103756. doi: 10.1016/j.breast.2024.103756Cardoso F, Paluch-Shimon S, Schumacher-Wulf E, Matos L, Gelmon K, Aapro MS, Bajpai J, Barrios CH, Bergh J, Bergsten-Nordström E, Biganzoli L, Cardoso MJ, Carey LA, Chavez-MacGregor M, Chidebe R, Cortés J, Curigliano G, Dent RA, El Saghir NS, Eniu A, Fallowfield L, Francis PA, Franco Millan SX, Gilchrist J, Gligorov J, Gradishar WJ, Haidinger R, Harbeck N, Hu X, Kaur R, Kiely B, Kim SB, Koppikar S, Kuper-Hommel MJJ, Lecouvet FE, Mason G, Mertz SA, Mueller V, Myerson C, Neciosup S, Offersen BV, Ohno S, Pagani O, Partridge AH, Penault-Llorca F, Prat A, Rugo HS, Senkus E, Sledge GW, Swain SM, Thomssen C, Vorobiof DA, Vuylsteke P, Wiseman T, Xu B, Costa A, Norton L, Winer EP. 6<sup>th</sup> and 7<sup>ер</sup> International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7). The Breast. 2024;76:103756. doi: 10.1016/j.breast.2024.103756NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Breast Cancer Version 3.2025 Invasive Breast Cancer. Электронный ресурс. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf (Дата последнего доступа: 26. 03. 2025)NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Breast Cancer Version 3.2025 Invasive Breast Cancer. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdfЗолотой стандарт профилактики, диагностики, лечения и реабилитации больных РМЖ 2025. Электронный ресурс. https://docs.google.com/document/d/14XU19rSHmmg0v8aL9msY9B1uoscVK7WS/edit#heading=h.gjdgxs (Дата последнего доступа: 19. 05. 2025)Gold standard for prevention, diagnosis, treatment and rehabilitation of patients with breast cancer 2025. (In Russ.) https://docs.google.com/document/d/14XU19rSHmmg0v8aL9msY9B1uoscVK7WS/edit#heading=h.gjdgxsSledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Conte P, Lu Y, Barriga S, Hurt K, Frenzel M, Johnston S, Llombart-Cussac A. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy – MONARCH 2. A randomized clinical trial. JAMA Oncol. 2020;6(1):116–124. doi: 10.1001/jamaoncol.2019.4782Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Conte P, Lu Y, Barriga S, Hurt K, Frenzel M, Johnston S, Llombart-Cussac A. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy – MONARCH 2. A randomized clinical trial. JAMA Oncol. 2020;6(1):116–124. doi: 10.1001/jamaoncol.2019.4782Cristofanilli M, Rugo HS, Im SA, Slamon DJ, Harbeck N, Bondarenko I, Masuda N, Colleoni M, DeMichele A, Loi S, Iwata H, O'Leary B, André F, Loibl S, Bananis E, Liu Y, Huang X, Kim S, Lechuga Frean MJ, Turner NC. Overall survival (OS) with palbociclib (PAL) + fulvestrant (FUL) in women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC): Updated analyses from PALOMA-3. J Clin Oncol. 2021;39:15_suppl:1000-1000. doi: 10.1200/JCO.2021.39.15_suppl.1000Cristofanilli M, Rugo HS, Im SA, Slamon DJ, Harbeck N, Bondarenko I, Masuda N, Colleoni M, DeMichele A, Loi S, Iwata H, O'Leary B, André F, Loibl S, Bananis E, Liu Y, Huang X, Kim S, Lechuga Frean MJ, Turner NC. Overall survival (OS) with palbociclib (PAL) + fulvestrant (FUL) in women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC): Updated analyses from PALOMA-3. J Clin Oncol. 2021;39:15_suppl:1000-1000. doi: 10.1200/JCO.2021.39.15_suppl.1000Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte PF, Cameron D, André F, Arteaga C, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB). Ann Oncol. 2021;32(suppl_5):S1283-S1346. doi: 10.1016/annonc/annonc741Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte PF, Cameron D, André F, Arteaga C, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB). Ann Oncol. 2021;32(suppl_5):S1283-S1346. doi: 10.1016/annonc/annonc741Tripathy D, Im S-A, Colleoni M, Franke F, Bardia A, Harbeck N, Hurvitz S, Chow L, Sohn J, Lee KS, Campos-Gomez S, Vazquez RV, Jung KH, Babu KG; Wheatley-Price P, De Laurentiis M, Im Y-H, Kümmel S, El-Saghir N, Liu M-C, Kaur S, Gasch C, Wang C, Wang Y, Chakravartty A, Luet Y-S. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Cancer Res. 2021;81(4_Suppl):PD2-04. doi: 10.1158/1538-7445.SABCS20-PD2-04Tripathy D, Im S-A, Colleoni M, Franke F, Bardia A, Harbeck N, Hurvitz S, Chow L, Sohn J, Lee KS, Campos-Gomez S, Vazquez RV, Jung KH, Babu KG; Wheatley-Price P, De Laurentiis M, Im Y-H, Kümmel S, El-Saghir N, Liu M-C, Kaur S, Gasch C, Wang C, Wang Y, Chakravartty A, Luet Y-S. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Cancer Res. 2021;81(4_Suppl):PD2-04. doi: 10.1158/1538-7445.SABCS20-PD2-04Finn RS, Rugo HS, Dieraset VC, Harbeck N, Im S-A, Gelmon KA, Walshe JM, Martin M, Mac Gregor MC, Bananis E, Gauthier ERd, Lu DR, Kim S, Slamon DJ. Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ER+/HER2− ABC): Analyses from PALOMA-2. J Clin Oncol. 2022;40(17_suppl):LBA1003. doi: 10.1200/JCO.2022.40.17_suppl.LBA1003Finn RS, Rugo HS, Dieraset VC, Harbeck N, Im S-A, Gelmon KA, Walshe JM, Martin M, Mac Gregor MC, Bananis E, Gauthier ERd, Lu DR, Kim S, Slamon DJ. Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ER+/HER2− ABC): Analyses from PALOMA-2. J Clin Oncol. 2022;40(17_suppl):LBA1003. doi: 10.1200/JCO.2022.40.17_suppl.LBA1003Goetz MP, Toi M, Huober J, Sohn J, Trédan O, Park IH, Campone M, Chen SC, Manso LM, Paluch-Shimon S, Freedman OC, O'Shaughnessy J, Pivot X, Tolaney SM, Hurvitz SA, Llombart-Cussac A, André V, Saha A, van Hal G, Shahir A, Iwata H, Johnston SRD. Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3. Ann Oncol. 2024;35(8):718-727. doi: 10.1016/j.annonc.2024.04.013Goetz MP, Toi M, Huober J, Sohn J, Trédan O, Park IH, Campone M, Chen SC, Manso LM, Paluch-Shimon S, Freedman OC, O'Shaughnessy J, Pivot X, Tolaney SM, Hurvitz SA, Llombart-Cussac A, André V, Saha A, van Hal G, Shahir A, Iwata H, Johnston SRD. Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3. Ann Oncol. 2024;35(8):718-727. doi: 10.1016/j.annonc.2024.04.013Slamon DJ, Diéras V, Rugo HS, Harbeck N, Im SA, Gelmon KA, Lipatov ON, Walshe JM, Martin M, Chavez-MacGregor M, Bananis E, Gauthier E, Lu DR, Kim S, Finn RS. Overall survival with palbociclib plus letrozole in advanced breast cancer. J Clin Oncol. 2024;42(9):994-1000. doi: 10.1200/JCO.23.00137Slamon DJ, Diéras V, Rugo HS, Harbeck N, Im SA, Gelmon KA, Lipatov ON, Walshe JM, Martin M, Chavez-MacGregor M, Bananis E, Gauthier E, Lu DR, Kim S, Finn RS. Overall survival with palbociclib plus letrozole in advanced breast cancer. J Clin Oncol. 2024;42(9):994-1000. doi: 10.1200/JCO.23.00137Государственный Реестр Лекарственных Средств (ГРЛС). Электронный ресурс. https://grls.rosminzdrav.ru/default.aspx (Дата последнего доступа: 23. 02. 2025).State Register of Medicines. (In Russ.) https://grls.rosminzdrav.ru/default.aspx

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