Keywords
adjuvant endocrine therapy
CDK4/6 inhibitor
ribociclib
abemaciclib
risk of recurrence
How to Cite
Abstract
Introduction. Patients with stage II–III hormone receptor-positive, HER2-negative breast cancer (HR+/HER2-BC) maintain a persistent risk of recurrence for many years despite comprehensive treatment. Identifying risk factors enables adjuvant hormone therapy intensification and recurrence prevention.
Aim. The ORCHIDEA study aimed to characterize the clinical and demographic profiles of Russian patients with stage II–III HR+/HER2– BC and evaluate real-world adjuvant treatment patterns.
Materials and Methods. This retrospective observational study analyzed data from 14 Russian clinical centers. We included patients ≥ 18 years with confirmed stage II–III HR+/HER2– BC who initiated adjuvant hormone therapy between December 1, 2022, and December 1, 2023.
Results. The cohort included 1000 patients (mean age 61 years). Most had stage II disease (76.1 %), with 42.7 % being node-negative. Among node-negative patients, 64.7 % had ≥1 high-risk feature (T3–4 tumors or T2 with grade 3 histology or grade 2 with Ki‑67 ≥ 20 %). Node-positive disease distribution was: N1 (41.6 %), N2–3 (15.7 %). Ki‑67 ≥ 20 % occurred in 61.6 % of patients; 13 % had grade 3 tumors. Endocrine therapy included aromatase inhibitors (AI) for most patients (73.0 %), tamoxifen (26.0 %), and abemaciclib combinations with AI or tamoxifen (1.0 %). Chemotherapy was prescribed for 54.8 % patients: 33.4 % of patients received neoadjuvant CT, 23.9 % — adjuvant CT.
Conclusion. The study characterizes patients with stage II–III HR+/HER2– BC, identifying high-risk populations that may benefit from treatment intensification. These data provide a foundation for optimizing BC recurrence prevention strategies in Russia.
References
Под ред. А.Д. Каприна, В.В. Старинского, А.О. Шахзадовой. Состояние онкологической помощи населению России в 2023 году. Москва: МНИОИ им. П.А. Герцена — филиал ФГБУ «НМИЦ радиологии» Минздрава России. 2024; 262.-URL: https://oncology-association.ru/wp-content/uploads/2024/06/sop-2023-elektronnaya-versiya.pdf. [Ed. by A.D. Kaprin. V.V. Starinskii. A.O. Shakhzadova. Malignant tumors in Russia in 2023 (morbidity and mortality). Moscow: P.A. Herzen Moscow State Medical Research Institute — branch of the Federal State Budgetary Institution ‘NMRC of Radiology’ of the Ministry of Health of Russia. 2024; 262.-URL: https://oncology-association.ru/wp-content/uploads/2024/06/sop-2023-elektronnaya-versiya.pdf (In Rus)].
Поддубная И.В., Колядина И.В., Калашников Н.Д., et al. Популяционный «портрет» рака молочной железы в России: анализ данных российского регистра. Современная онкология. 2015; 1: 25–29.-URL: https://modernonco.orscience.ru/1815-1434/article/view/26989. [Poddubnaya I.V., Kolyadina I.V., Kalashnikov N.D. et al. A population-based portrait of breast cancer in Russia: a Cancer Register-based analysis in Russian. Journal of Modern Oncology. 2015; 1: 25–29.-URL: https://modernonco.orscience.ru/1815-1434/article/view/26989 (In Rus)].
Артамонова Е.В., Коваленко Е.И. Системное лечение рака молочной железы. "Ре Медиа" Москва. 2021; 128(илл.).-ISBN: 978-5-6044975-1-7.-URL: https://expose.gpntbsib.ru/expose/vnp-64b55898/book/ %D0 %932021-23407976950591. [Artamonova E.V., Kovalenko E.I. Systemic treatment of breast cancer (2nd edition, revised and enlarged) M.: Re Media. 2021; 128(ill.).-ISBN: 978-5-6044975-1-7.-URL: https://expose.gpntbsib.ru/expose/vnp-64b55898/book/ %D0 %932021-23407976950591 (In Rus)].
Клинические рекомендации. Рак молочной железы. 2021.-URL: http://cr.rosminzdrav.ru/schema/379 (21.06.2025). [Clinical recommendations. Breast cancer. 2021.-URL: http://cr.rosminzdrav.ru/schema/379 (In Rus)].
Pan H., Gray R., Braybrooke J., et al. 20-Year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med. 2017; 377: 1836–46.-DOI: https://doi.org/10.1056/NEJMoa170183.
Тюляндин С.А., Артамонова Е.В., Жигулев А.Н., et al. Рак молочной железы. Практические рекомендации RUSSCO, часть 1.2. Злокачественные опухоли. 2024; 14(3s2): 32–81. https://doi.org/10.18027/2224-5057-2024-14-3s2-1.2-01. [Tyulandin S.A., Artamonova E.V., Zhigulev A.N., et al. Breast cancer. RUSSCO Practical Recommendations, Part 1.2. Malignant Tumors. 2024; 14(3s2): 32-81.-DOI: https://doi.org/10.18027/2224-5057-2024-14-3s2-1.2-01 (In Rus)].
Гордеева О.О. Оценка риска рецидива люминального HER2-отрицательного рака молочной железы и возможности интенсификации адъювантной гормонотерапии для снижения риска прогрессирования. Фарматека. 2024; 31(6): 207-211.-DOI: https://doi.org/10.18565/pharmateca.2024.6.207-211.-URL: https://pharmateca.ru/archive/article/45671. [Gordeeva O.O. Assessing the risk of recurrence of luminal HER2-negative breast cancer and the possibility of intensifying adjuvant hormonal therapy to reduce the risk of progression. Pharmateca. 2024; 31(6): 207-211.-DOI: https://doi.org/10.18565/pharmateca.2024.6.207-211.-URL: https://pharmateca.ru/archive/article/45671 (In Rus)].
Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Increasing the dose intensity of chemotherapy by more frequent administration or sequential scheduling: a patient-level meta-analysis of 37 298 women with early breast cancer in 26 randomised trials. Lancet. 2019; 393: 1440–52.-DOI: https://doi.org/10.1016/S0140-6736(18)33137-4.
Davies C., Pan H., Godwin J., et al. Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) Collaborative Group. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013; 381(9869): 805–16.-DOI: https://doi.org/10.1016/S0140-6736(12)61963-1.
Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015;386(10001): 1341–52.-DOI: https://doi.org/10.1016/S0140-6736(15)61074-1.
Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in premenopausal women with oestrogen receptor-positive early-stage breast cancer treated with ovarian suppression: a patient-level meta-analysis of 7030 women from four randomised trials. Lancet Oncol. 2022; 23(3): 382–92.-DOI: https://doi.org/10.1016/S1470-2045(21)00758-0.
Gray R.G., Bradley R., Braybrooke J., et al. Effects of ovarian ablation or suppression on breast cancer recurrence and survival: Patient-level meta-analysis of 14,993 pre-menopausal women in 25 randomized trials. J Clin Oncol. 2023; 41: 503–3.-DOI: https://doi.org/10.1200/JCO.2023.41.16_suppl.503.
Jhaveri K., Pegram M., Neven P., et al. 292P Real-world evidence on risk of recurrence (ROR) in patients (pts) with node-negative (N0) and node-positive HR+/HER2– early breast cancer (EBC) from US electronic health records (EHR). Annals of Oncology. 2024. 35:S337-S338.-DOI: https://doi.org/10.1016/j.annonc.2024.08.233.-URL: https://www.annalsofoncology.org/article/S0923-7534(24)01752-6/fulltext.
Johnston S., Martin M., O'Shaughnessy J., et al. Overall survival with abemaciclib in early breast cancer. Ann Oncol. 2025: S0923-7534(25)04948-8.-DOI: https://doi.org/10.1016/j.annonc.2025.10.005.
Hortobagyi G.N., Lacko A., Sohn J., et al. A phase III trial of adjuvant ribociclib plus endocrine therapy versus endocrine therapy alone in patients with HR-positive/HER2-negative early breast cancer: final invasive disease-free survival results from the NATALEE trial. Ann Oncol. 2025; 36(2): 149-157.-DOI: https://doi.org/10.1016/j.annonc.2024.10.015.
Crown J., Stroyakovskii D., Yardley D.A., et al. Adjuvant ribociclib plus nonsteroidal aromatase inhibitor therapy in patients with HR-positive/HER2-negative early breast cancer: 5-year follow-up of NATALEE efficacy outcomes and updated overall survival. ESMO Open. 2025; 10(11): 105858.-DOI: https://doi.org/10.1016/j.esmoop.2025.105858.-URL: https://www.esmoopen.com/article/S2059-7029(25)01727-2/fulltext.
Колядина И.В. Место рибоциклиба в лечении раннего гормонозависимого HER2 отрицательного рака молочной железы: 4 летние результаты рандомизированного контролируемого исследования III фазы NATALEE и их переосмысление для клинической практики. Опухоли женской репродуктивной системы. 2025; 21(2): 00–00.-DOI: https://doi.org/10.17650/1994-4098-2025-21-2-47-59. [Kolyadina I.V. The role of ribociclib in the treatment of early hormone receptor-positive HER2‑negative breast cancer: 4‑year results of the randomized controlled phase 3 trial NATALEE and their reconsideration for clinical practice. Opukholi zhenskoy reproduktivnoy sistemy = Tumors of Female Reproductive System. 2025; 21(2): 00–00.-DOI: https://doi.org/10.17650/1994-4098-2025-21-2-47-59 (In Rus)].
Li Q., Jiang M., Liu J., et al. Clinicopathologic features, Adjuvant Treatment Patterns and Clinical Outcomes of HR+/HER2- Early Breast Cancer in China. The Breast. 2025; 80: 104101.-DOI: https://doi.org/10.1016/j.breast.2025.104101.
Johnston S.R.D., Harbeck N., Hegg R., et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020; 38(34): 3987-3998.-DOI: https://doi.org/10.1200/JCO.20.02514.
Slamon D., Lipatov O., Nowecki Z., et al. Ribociclib plus endocrine therapy in early breast cancer. N Engl J Med. 2024; 390(12): 1080-1091.-DOI: https://doi.org/10.1056/NEJMoa2305488.
Hortobagyi G.N., Stemmer S.M., Burris H.A., et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016; 375(18): 1738-1748.-DOI: https://doi.org/10.1056/nejmoa1609709.-URL: https://www.nejm.org/doi/full/10.1056/NEJMoa1609709.
Goetz M.P., Toi M., Campone M., et al. MONARCH 3: Abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017; 35(32): 3638-3646.-DOI: https://doi.org/10.1200/JCO.2017.75.6155.
Артамонова Е.В., Владимирова Л.Ю., Жукова Л.Г., et al. Эффективность алпелисиба в реальной клинической практике: данные третьего промежуточного анализа исследования Prosperity. Газета RUSSCO. 2024; 4: 15-16.-URL: https://rosoncoweb.ru/newspaper/archive/2024/04/. [Artamonova E.V., Vladimirova L.Yu., Zhukova L.G., et al. Efficacy of alpelisib in real-world clinical practice: results of the third interim analysis of the PROSPERITY trial. RUSSCO Newsletters. 2024; 4: 15-16.-URL: https://rosoncoweb.ru/newspaper/archive/2024/04/ (In Rus)].
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Copyright (c) 2025 Ольга Викторовна Романчук, Денис Юрьевич Юкальчук, Роман Сергеевич Жихорев, Мария Сергеевна Перминова, Сергей Борисович Белоногов, Мария Ивановна Антошкина, Татьяна Валерьевна Гармарник , Надежда Витальевна Леушина, Елена Ивановна Россоха, Ирина Михайловна Радюкова, Алексей Александрович Аксарин, Олег Вячеславович Миронов, Александр Валерьевич Султанбаев, Александр Сергеевич Дергунов