Инновации в деле. 5 лет применения палбоциклиба в Российской Федерации. Обзор по итогам интернет-конференции 8 октября 2021 г.

Инновации в деле. 5 лет применения палбоциклиба в Российской Федерации. Обзор по итогам интернет-конференции 8 октября 2021 г. Современная Онкология. 2021;23(4):588–592. DOI: 10.26442/18151434.2021.4.201255

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Innovations in practice. 5 years of palbociclib experience in the Russian Federation. Overview of web-conference took place on 8 October 2021. Journal of Modern Oncology. 2021;23(4):588–592. DOI: 10.26442/18151434.2021.4.201255

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Аннотация

В рамках образовательного цикла «Венера будущего: открытия и новые традиции в лечении мРМЖ», инициированного компанией «Пфайзер» при поддержке компании «ТС Онколоджи», в 2021–2022 гг. запланирована серия мероприятий с целью обсуждения практических вопросов применения и доступности инновационных подходов в лечении пациентов с HER2-негативным мРМЖ в Российской Федерации. 8 октября 2021 г. состоялась первая интернет-конференция цикла – «Инновации в деле. 5 лет применения палбоциклиба в Российской Федерации», которая была посвящена 5-летнему юбилею регистрации палбоциклиба в РФ, ознаменовавшего появление в нашей стране нового класса препаратов – ингибиторов CDK4/6 (CDK4/6i). В мероприятии приняли участие ведущие российские эксперты в области лекарственного лечения РМЖ, которые стояли у истоков внедрения CDK4/6i в рутинную клиническую практику. По мнению экспертов, при выборе конкретного препарата из группы CDK4/6i необходимо учитывать различия между ними с точки зрения профиля переносимости и требований мониторинга, для практикующих врачей-онкологов также очень важен опыт работы с препаратом. Большим преимуществом палбоциклиба перед другими представителями класса являются значительный объем данных рандомизированных клинических исследований и реальной клинической практики, а также опыт его использования (более 5 лет) в РФ и мире.

Ключевые слова: метастатический рак молочной железы, ингибиторы CDK4/6, палбоциклиб

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The educational cycle "Venus of The Future: the discoveries and new traditions in the treatment of mBC" was initiated by Pfizer with the support of TS Oncology. During several web-conferences planned in 2021–2022 key experts discussed implementation in clinical practice and availability of innovative approaches for treatment patients with HER-negative mBC in the Russian Federation. The first web-conference of the cycle - "Innovations in practice. 5 years of palbociclib experience in the Russian Federation" took place on October 8, 2021 and was dedicated to the 5th anniversary since registration in the Russian Federation of palbociclib – 1st CDK4/6 inhibitor (CDK4/6i) in our country. Key Russian experts in oncology, who were at the forefront of introducing CDK4/6i into routine clinical practice, took part in the event and outlined the importance of considering the differences among iCDK 4/6 in terms of the tolerance profile and monitoring requirements, as well as taking into account practical experience when making desicion to choose specific product. Experts agreed that palbociclib have a great advantage over other products in the class due to significant amount of RCT and RWE data, as well as broad practical experience (more than 5 years) in the Russian Federation and in the world.

Keywords: metastatic breast cancer, CDK4/6 inhibitors, palbociclib

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Список литературы

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18. Park YH, Kim TY, Kim GM, et al.; Korean Cancer Study Group (KCSG). Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2019;20(12):1750-9. DOI:10.1016/S1470-2045(19)30565-0
19. Rugo HS, Turner NC, Finn RS, et al. Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies. Eur J Cancer. 2018;101:123-33. DOI:10.1016/j.ejca.2018.05.017
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1. DeMichele A, Cristofanilli M, Brufsky A, et al. Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2- metastatic breast cancer in US real-world clinical practice. Breast Cancer Res. 2021;23(1):37. DOI:10.1186/s13058-021-01409-8
2. Gao JJ, Cheng J, Bloomquist E, et al. CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis. Lancet Oncol. 2020;21(2):250-60. DOI:10.1016/S1470-2045(19)30804-6
3. Cardoso F, Paluch-Shimon S, Senkus E, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol. 2020;31(12):1623-49. DOI:10.1016/j.annonc.2020.09.010
4. NCCN guidelines. Available at: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1419. Accessed: 28.10.2021.
5. Rubrikator klinicheskikh rekomendatsii. Rak molochnoi zhelezy. Available at: https://cr.minzdrav.gov.ru/recomend/379_4. Accessed: 28.10.2021 (in Russian).
6. Giuliano M, Schettini F, Rognoni C, et al. Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2-negative, metastatic breast cancer: a systematic review and network meta-analysis. Lancet Oncol. 2019;20(10):1360-9. DOI:10.1016/S1470-2045(19)30420-6
7. Wang L, Gao S, Li D, et al. CDK4/6 inhibitors plus endocrine therapy improve overall survival in advanced HR+/HER2- breast cancer: A meta-analysis of randomized controlled trials. Breast J. 2020;26(7):1439-43. DOI:10.1111/tbj.13703
8. Finn RS, Rugo HS, Gelmon KA, et al. Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up. Oncologist. 2021;26(5):e749-e755. DOI:10.1002/onco.13684
9. Diéras V, Harbeck N, Joy AA, et al. Palbociclib with Letrozole in Postmenopausal Women with ER+/HER2- Advanced Breast Cancer: Hematologic Safety Analysis of the Randomized PALOMA-2 Trial. Oncologist. 2019;24(12):1514-25.
DOI:10.1634/theoncologist.2019-0019
10. Verma S, Bartlett CH, Schnell P, et al. Palbociclib in Combination With Fulvestrant in Women With Hormone Receptor-Positive/HER2-Negative Advanced Metastatic Breast Cancer: Detailed Safety Analysis From a Multicenter, Randomized, Placebo-Controlled, Phase III Study (PALOMA-3). Oncologist. 2016;21(10):1165-75. DOI:10.1634/theoncologist.2016-0097
11. Cherny NI, Dafni U, Bogaerts J, et al. ESMO-Magnitude of Clinical Benefit Scale version 1.1. Ann Oncol. 2017;28(10):2340-66. DOI:10.1093/annonc/mdx310
12. Turner NC, Finn RS, Martin M, et al. Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases. Ann Oncol. 2018;29(3):669-80. DOI:10.1093/annonc/mdx797
13. Harbeck N, Iyer S, Turner N, et al. Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial. Ann Oncol. 2016;27(6):1047-54. DOI:10.1093/annonc/mdw139
14. Kahan Z, Gil-Gil M, Ruíz-Borrego M, et al. ESMO Breast Cancer 2020. Poster 143P.
15. Im SA, Lu YS, Bardia A, et al. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. N Engl J Med. 2019;381(4):307-16.
DOI:10.1056/NEJMoa1903765
16. Loibl S, Turner NC, Ro J, et al. Palbociclib Combined with Fulvestrant in Premenopausal Women with Advanced Breast Cancer and Prior Progression on Endocrine Therapy: PALOMA-3 Results. Oncologist. 2017;22(9):1028-38. DOI:10.1634/theoncologist.2017-0072
17. Neven P, Rugo HS, Tolaney SM, et al. Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial. Breast Cancer Res. 2021;23:article 87.
18. Park YH, Kim TY, Kim GM, et al.; Korean Cancer Study Group (KCSG). Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2019;20(12):1750-9. DOI:10.1016/S1470-2045(19)30565-0
19. Rugo HS, Turner NC, Finn RS, et al. Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies. Eur J Cancer. 2018;101:123-33. DOI:10.1016/j.ejca.2018.05.017
20. Rugo H, et al. ESMO 2021. Poster 236.
21. Caillet P, et al. ASCO 2021. Abstract 1012.
22. Rugo HS, Finn RS, Diéras V, et al. 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):719-29. DOI:10.1007/s10549-018-05125-4
23. Hortobagyi G. Ribociclib for the first-line treatment of advanced hormone receptor-positive breast cancer: a review of subgroup analyses from the MONALEESA-2 trial. Breast Cancer Res. 2018;174:719-29.
24. Johnston S, Martin M, Di Leo A, et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer. 2019;5:5. DOI:10.1038/s41523-018-0097-z
25. Sostoianie onkologicheskoi pomoshchi naseleniiu Rossii v 2020 godu. Pod red. AD Kaprina, VV Starinskogo, AO Shakhzadovoi. Moscow: MNIOI im. P.A. Gertsena − filial FGBU “NMITs radiologii” Minzdrava Rossii, 2021 (in Russian).
26. Mosher CE, Johnson C, Dickler M, et al. Living with metastatic breast cancer: a qualitative analysis of physical, psychological, and social sequelae. Breast J. 2013;19(3):285-92. DOI:10.1111/tbj.12107
27. O’Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. Oncologist. 2005;10(Suppl. 3):20-9. DOI:10.1634/theoncologist.10-90003-20
28. Sostoianie onkologicheskoi pomoshchi naseleniiu Rossii v 2018 godu. Pod red. AD Kaprina, VV Starinskogo, GV Petrovoi. Moscow: MNIOI im. P.A. Gertsena – filial FGBU “NMITs radiologii” Minzdrava Rossii, 2019 (in Russian).
29. Sostoianie onkologicheskoi pomoshchi naseleniiu Rossii v 2019 godu. Pod red. AD Kaprina, VV Starinskogo, GV Petrovoi. Moscow: MNIOI im. P.A. Gertsena – filial FGBU “NMITs radiologii” Minzdrava Rossii, 2020 (in Russian).
30. Onitilo AA, Engel JM, Greenlee RT, Mukesh BN. Breast cancer subtypes based on ER/PR and Her2 expression: comparison of clinicopathologic features and survival. Clin Med Res. 2009;7(1-2):4-13. DOI:10.3121/cmr.2009.825
31. Gosudarstvennyi reestr lekarstvennykh sredstv. Available at: https://grls.rosminzdrav.ru/default.aspx. Accessed: 28.10.2021 (in Russian).

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