Ведение пациентов с гормонозависимым HER2-отрицательным метастатическим раком молочной железы: данные рандомизированных исследований и клинической практики

Ведение пациентов с гормонозависимым HER2-отрицательным метастатическим раком молочной железы: данные рандомизированных исследований и клинической практики. Современная Онкология. 2022;24(1):24–29. DOI: 10.26442/18151434.2022.1.201466

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Management of patients with hormone receptor-positive HER2-negative metastatic breast cancer: data of randomized trials and real-world evidence. Journal of Modern Oncology. 2022;24(1):24–29.
DOI: 10.26442/18151434.2022.1.201466

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Аннотация

28 января 2022 г. в рамках Большой конференции RUSSCO «Рак молочной железы» состоялся сателлитный симпозиум компании «Новартис», посвященный вопросам лечения пациентов с гормонозависимым HER2-отрицательным распространенным раком молочной железы [HR+ HER2(-)-рРМЖ]. Была представлена информация о двух новых наблюдательных исследованиях: ретроспективный анализ последовательности лечения пациентов с РМЖ в Москве и исследование PROSPERITY. Предварительные результаты анализа данных московских пациентов с РМЖ указывают на широкую практику применения гормонотерапии в ранних линиях лечения HR+ HER2(-)-рРМЖ. Отдельное внимание было уделено новым данным по использованию препарата алпелисиб (Пикрэй) для лечения HR+ HER2(-)-рРМЖ с мутацией гена PIK3CA. Сделан обзор новых результатов, полученных в клинических исследованиях и реальной клинической практике ГБУЗ г. Москвы «МКНЦ им. А.С. Логинова». Рассмотренные результаты свидетельствуют о том, что алпелисиб в комбинации с фулвестрантом эффективен после прогрессирования на ингибиторах CDK4/6 независимо от длительности их применения, а также у больных, ранее получавших фулвестрант. Длительность лечения алпелисибом может быть увеличена за счет грамотного подхода к предотвращению и контролю нежелательных явлений.

Ключевые слова: гормонозависимый HER2-негативный рак молочной железы, мутация PIK3CA, алпелисиб, Пикрэй, ингибиторы CDK4/6, фулвестрант

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The Satellite Symposium of Novartis Pharma was held on January 28th, 2022, within the framework of the RUSSCO Big Conference "Breast Cancer". It was dedicated to the diagnostics and treatment of patients with hormone receptor-positive HER2-negative advanced breast cancer (HR+/HER2- aBC). The information concerning two new observational studies was showed during the symposium: the retrospective analysis of the sequence of BC patients’ treatment in Moscow and the PROSPERITY study. The preliminary results of the data analysis concerning Moscow patients with breast cancer indicated the widespread practice of using endocrine therapy as an early-line treatment for HR+/HER2- aBC. Special attention was paid to new data concerning the use of Piqray (alpelisib) for the treatment of HR+/HER2- aBC with a PIK3CA mutation. The review of new results obtained in clinical trials and in clinical practice of the Loginov Moscow Clinical Research Center (Moscow) was made. The obtained data results indicate that alpelisib in combination with fulvestrant is effective after disease progression on CDK4/6 inhibitors, regardless of the duration of prior CDK4/6i therapy, as well as in patients who previously received fulvestrant. The duration of alpelisib treatment can be prolonged due to the competent approach to prevent and to control the adverse events.

Keywords: hormone receptor-positive HER2-negative breast cancer, a PIK3CA mutation, Piqray, alpelisib, CDK4/6 inhibitors, fulvestrant

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Список литературы

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3. Rajadurai P, Semiglazova T, Hegmane A, et al. PIK3CA Registry: A Noninterventional, Descriptive, Retrospective Cohort Study of PIK3CA Mutations in Patients With Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Advanced Breast Cancer (ABC). Cancer Res. 2022;82(4 Suppl.):P5-13-25.
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9. NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. Version 8. September 13, 2021. Available at: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1419. Accessed: 21.03.2022.
10. Burstein HJ, Somerfield MR, Barton DL, et al. Endocrine Treatment and Targeted Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: ASCO Guideline Update. J Clin Oncol. 2021;39(35):3959-77. DOI:10.1200/JCO.21.01392
11. Andre F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019;380:1929-40. DOI:10.1056/NEJMoa1813904
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15. Ciruelos E, Lerebours F, Rugo HS, et al. Alpelisib + Fulvestrant in Patients With Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-), PIK3CA-Mutated Advanced Breast Cancer (ABC) Previously Treated With Cyclin-Dependent Kinase 4/6 Inhibitor (CDK4/6i) + Aromatase Inhibitor (AI): 18-Month Follow-up of BYLieve Cohort A. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7–10; San Antonio, TX. Philadelphia (PA): AACR. Cancer Res. 2022;82(4 Suppl.):P1-18-03. DOI:10.1158/1538-7445.SABCS21-P1-18-03
16. Chia SKL, Ruiz-Borrego M, Drullinsky P, et al. Impact of duration of prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy on alpelisib (ALP) benefit in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-), PIK3CA-mutated advanced breast cancer (ABC) from BYLieve. J Clin Oncol. 2021;39(15 Suppl.):abstr1060. DOI:10.1200/JCO.2021.39.15_suppl.1060
17. Chia S, Ciruelos E, Rugo HS, et al. Effect of Duration of Prior Cyclin-Dependent Kinase 4/6 Inhibitor (CDK4/6i) Therapy (≤6 mo or >6 mo) on Alpelisib Benefit in Patients With Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-), PIK3CA-Mutated Advanced Breast Cancer (ABC) From BYLieve. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7–10; San Antonio, TX. Poster P1-18-08. Available at: https://www.medicalcongress.novartisoncology.com/SABCS/BC/pdf/Alpelisib/Chia_Poster_P1-18-08.pdf#too.... Accessed: 21.03.2022.
18. Ciruelos E, Delea T, Moynahan A, et al. Population-Adjusted Comparison of SOLAR-1 and BOLERO-2: PFS With Second-Line Alpelisib + Fulvestrant vs Everolimus + Exemestane in Postmenopausal Patients With PIK3CA-Mut Hormone Receptor-Positive. In: European Society for Medical Oncology Breast Cancer Virtual Meeting, 23–24 May, 2020. DOI:10.1016/j.annonc.2020.03.263
19. Juric D, Janku F, Rodon J, et al. Alpelisib Plus Fulvestrant in PIK3CA-Altered and PIK3CA-Wild-Type Estrogen Receptor-Positive Advanced Breast Cancer: A Phase 1b Clinical Trial. JAMA Oncol. 2019;5(2):e184475. DOI:10.1001/jamaoncol.2018.4475
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22. Мазурина Н.В., Артамонова Е.В., Белоярцева М.Ф., и др. Консенсус по профилактике и коррекции гипергликемии у пациентов, получающих терапию препаратом алпелисиб. Современная Онкология. 2020;22(4):56-9 [Mazurina NV, Artamonova EV, Beloyartseva MF, et al. The consensus on the prevention and correction of hyperglycemia in patients with HR+ HER2- metastatic breast cancer treated with alpelisib. Journal of Modern Oncology. 2020;22(4):56-9 (in Russian)]. DOI:10.26442/18151434.2020.4.200568
23. Шливко И.Л., Гаранина О.Е., Артамонова Е.В., и др. Консенсус по профилактике и коррекции сыпи у пациентов, получающих терапию препаратом алпелисиб. Современная Онкология. 2021;23(4):572-6 [Shlivko IL, Garanina OE, Artamonova EV, et al. The consensus on the prevention and correction of rash in patients with HR+ HER2- metastatic breast cancer treated with alpelisib. Journal of Modern Oncology. 2021;23(4):572-6 (in Russian)]. DOI:10.26442/18151434.2021.4.201275
24. Rodon J, Demanse D, Rugo HS, et al. Pooled analysis of X2101 and SOLAR-1: A risk analysis of ALP-induced HG using baseline factors in patients with advanced solid tumors and BC. In: ESMO-BC, May 8, 2021. Ann Oncol. 2021;32(Suppl. 2): S60-78. DOI:10.1016/annonc/annonc508
25. Study Protocol CLEE011ARU01: A prospective observational study to describe clinical outcomes, treatment patterns, patients characteristics among patients with HR+/HER2- advanced BC initiating treatment with Risarg® (ribociclib), Piqray® (alpelisib), endocrine therapy or chemotherapy in routine clinical practice in Russia (PROSPERITY). Available at: https://clinicaltrials.gov/ct2/show/NCT04943497. Accessed: 21.03.2022.

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1. Nunnery SE, Mayer IA. Targeting the PI3K/AKT/mTOR pathway in hormone-positive breast cancer. Drugs. 2020;80(16):1685-97. DOI:10.1007/s40265-020-01394-w
2. Mosele F, Stefanovska B, Lusque A, et al. Outcome and molecular landscape of patients with PIK3CA-mutated metastatic breast cancer. Ann Oncol. 2020;31(3):377-86. DOI:10.1016/j.annonc.2019.11.006
3. Rajadurai P, Semiglazova T, Hegmane A, et al. PIK3CA Registry: A Noninterventional, Descriptive, Retrospective Cohort Study of PIK3CA Mutations in Patients With Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Advanced Breast Cancer (ABC). Cancer Res. 2022;82(4 Suppl.):P5-13-25.
DOI:10.1158/1538-7445.SABCS21-P5-13-25
4. Sokolova TN, Aleksakhina SN, Yanus GA, et al. The frequency and spectrum of PIK3CA mutations in patients with estrogen receptor-positive HER2-negative advanced breast cancer residing in various regions of Russia. Journal of Modern Oncology. 2021;23(1):61-67 (in Russian). DOI:10.26442/18151434.2021.1.200744
5. Tiuliandin SA, Zhukova LG, Koroleva IA, et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu raka molochnoi zhelezy. Malignant Tumours. 2021;11(3s2-1):119-57 (in Russian). DOI:10.18027/2224-5057-2021-11-3s2-09
6. Klinicheskie rekomendatsii. Rak molochnoi zhelezy. 2021. Available at: https://cr.minzdrav.gov.ru/recomend/379_4. Accessed: 21.03.2022 (in Russian).
7. 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
8. Gennari A, Andre F, Barrios CH, et al. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol. 2021;32(12):1475-95. DOI:10.1016/j.annonc.2021.09.019
9. NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. Version 8. September 13, 2021. Available at: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1419. Accessed: 21.03.2022.
10. Burstein HJ, Somerfield MR, Barton DL, et al. Endocrine Treatment and Targeted Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: ASCO Guideline Update. J Clin Oncol. 2021;39(35):3959-77. DOI:10.1200/JCO.21.01392
11. Andre F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019;380:1929-40. DOI:10.1056/NEJMoa1813904
12. Andre F, Ciruelos EM, Juric D, et al. LBA18 – Overall survival (os) results from SOLAR-1, a phase III study of alpelisib (ALP) + fulvestrant (FUL) for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Ann Oncol. 2020;31(Suppl. 4):S1142-215. DOI:10.1016/annonc/annonc325
13. Rugo H, Lerebours F, Ciruelos E, et al. Alpelisib (ALP) + fulvestrant (FUL) in patients (pts) with PIK3CA-mutated (mut) hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) previously treated with cyclin-dependent kinase 4/6 inhibitor (CDKi) + aromatase inhibitor (AI): BYLieve study results. J Clin Oncol. 2020;38(15 Suppl.):abstr1006. DOI:10.1200/JCO.2020.38.15_suppl.1006
14. Turner S, Chia SKL, Kanakamedala H, et al. Real-world effectiveness of alpelisib (ALP) + fulvestrant (FUL) compared with standard treatment among patients (Pts) with hormone-receptor positive (HR+) human epidermal growth factor receptor-2 negative (HER2-) PIK3CA-mutated (Mut) advanced breast cancer (ABC). Ann Oncol. 2020;31(Suppl. 4): S348-S395. DOI:10.1016/annonc/annonc268
15. Ciruelos E, Lerebours F, Rugo HS, et al. Alpelisib + Fulvestrant in Patients With Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-), PIK3CA-Mutated Advanced Breast Cancer (ABC) Previously Treated With Cyclin-Dependent Kinase 4/6 Inhibitor (CDK4/6i) + Aromatase Inhibitor (AI): 18-Month Follow-up of BYLieve Cohort A. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7–10; San Antonio, TX. Philadelphia (PA): AACR. Cancer Res. 2022;82(4 Suppl.):P1-18-03. DOI:10.1158/1538-7445.SABCS21-P1-18-03
16. Chia SKL, Ruiz-Borrego M, Drullinsky P, et al. Impact of duration of prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy on alpelisib (ALP) benefit in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-), PIK3CA-mutated advanced breast cancer (ABC) from BYLieve. J Clin Oncol. 2021;39(15 Suppl.):abstr1060. DOI:10.1200/JCO.2021.39.15_suppl.1060
17. Chia S, Ciruelos E, Rugo HS, et al. Effect of Duration of Prior Cyclin-Dependent Kinase 4/6 Inhibitor (CDK4/6i) Therapy (≤6 mo or >6 mo) on Alpelisib Benefit in Patients With Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-), PIK3CA-Mutated Advanced Breast Cancer (ABC) From BYLieve. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7–10; San Antonio, TX. Poster P1-18-08. Available at: https://www.medicalcongress.novartisoncology.com/SABCS/BC/pdf/Alpelisib/Chia_Poster_P1-18-08.pdf#too.... Accessed: 21.03.2022.
18. Ciruelos E, Delea T, Moynahan A, et al. Population-Adjusted Comparison of SOLAR-1 and BOLERO-2: PFS With Second-Line Alpelisib + Fulvestrant vs Everolimus + Exemestane in Postmenopausal Patients With PIK3CA-Mut Hormone Receptor-Positive. In: European Society for Medical Oncology Breast Cancer Virtual Meeting, 23–24 May, 2020. DOI:10.1016/j.annonc.2020.03.263
19. Juric D, Janku F, Rodon J, et al. Alpelisib Plus Fulvestrant in PIK3CA-Altered and PIK3CA-Wild-Type Estrogen Receptor-Positive Advanced Breast Cancer: A Phase 1b Clinical Trial. JAMA Oncol. 2019;5(2):e184475. DOI:10.1001/jamaoncol.2018.4475
20. Rugo H, Neven P, Saffie I, et al. Alpelisib + Fulvestrant in Patients With PIK3CA-Mutated, HR+, HER2– Advanced Breast Cancer (ABC) Who Received Chemotherapy or Endocrine Therapy (ET) as Immediate Prior Treatment: BYLieve Cohort C Primary Results and Exploratory Biomarker Analyses. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7–10; San Antonio, TX. Poster PD13-05. Available at: https://www.medicalcongress.novartisoncology.com/SABCS/BC/pdf/Alpelisib/Rugo_Poster_PD13-05.pdf#tool.... Accessed: 21.03.2022
21. Filonenko DA, Ibragimova TM, Polshina NI, et al. Target therapy of luminal HER2-negative advanced breast cancer with PIK3CA mutation: combination of alpelisib plus fulvestrant in real clinical practice. Meditsinskiy sovet = Medical Council. 2021;(20):75-82 (in Russian). DOI:10.21518/2079-701X-2021-20-75-82
22. Mazurina NV, Artamonova EV, Beloyartseva MF, et al. The consensus on the prevention and correction of hyperglycemia in patients with HR+ HER2- metastatic breast cancer treated with alpelisib. Journal of Modern Oncology. 2020;22(4):56-9 (in Russian). DOI:10.26442/18151434.2020.4.200568
23. Shlivko IL, Garanina OE, Artamonova EV, et al. The consensus on the prevention and correction of rash in patients with HR+ HER2- metastatic breast cancer treated with alpelisib. Journal of Modern Oncology. 2021;23(4):572-6 (in Russian). DOI:10.26442/18151434.2021.4.201275
24. Rodon J, Demanse D, Rugo HS, et al. Pooled analysis of X2101 and SOLAR-1: A risk analysis of ALP-induced HG using baseline factors in patients with advanced solid tumors and BC. In: ESMO-BC, May 8, 2021. Ann Oncol. 2021;32(Suppl. 2): S60-78. DOI:10.1016/annonc/annonc508
25. Study Protocol CLEE011ARU01: A prospective observational study to describe clinical outcomes, treatment patterns, patients characteristics among patients with HR+/HER2- advanced BC initiating treatment with Risarg® (ribociclib), Piqray® (alpelisib), endocrine therapy or chemotherapy in routine clinical practice in Russia (PROSPERITY). Available at: https://clinicaltrials.gov/ct2/show/NCT04943497. Accessed: 21.03.2022.

Авторы

Эксперты:
Стенина Марина Борисовна – д-р мед. наук, вед. науч. сотр. отд-ния химиотерапии №1 ФГБУ «НМИЦ онкологии им. Н.Н. Блохина»
Фролова Мона Александровна – д-р мед. наук, вед. науч. сотр. онкологического отд-ния лекарственных методов лечения №1
ФГБУ «НМИЦ онкологии им. Н.Н. Блохина»
Жукова Людмила Григорьевна – д-р мед. наук, проф. РАН, зам. дир. по онкологии ГБУЗ г. Москвы «МКНЦ им. А.С. Логинова»

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Experts:
Marina B. Stenina – D. Sci. (Med.), Leading Res. Officer, Blokhin National Medical Research Center of Oncology
Mona A. Frolova – D. Sci. (Med.), Leading Res. Officer, Blokhin National Medical Research Center of Oncology
Liudmila G. Zhukova – D. Sci. (Med.), Prof of RAS, Loginov Moscow Clinical Research Center

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