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Итоги обсуждения вопросов оптимального планирования терапии метастатического HER2‑негативного рака молочной железы: место ингибиторов CDK4/6 и ингибиторов PARP
Итоги обсуждения вопросов оптимального планирования терапии метастатического HER2‑негативного рака молочной железы: место ингибиторов CDK4/6 и ингибиторов PARP
Итоги обсуждения вопросов оптимального планирования терапии метастатического HER2-негативного рака молочной железы: место ингибиторов CDK4/6 и ингибиторов PARP. Современная Онкология. 2021; 23 (3): 470–476. DOI: 10.26442/18151434.2021.3.201122
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Аннотация
Для обсуждения особенностей применения ингибиторов CDK4/6 и ингибиторов PARP, а также их места в стратегии лекарственной терапии пациенток с HR+/HER2- метастатическим раком молочной железы (мРМЖ) и BRCA-ассоциированным HER2- мРМЖ в современных условиях Российской Федерации компанией «Пфайзер» при поддержке компании «ТС Онколоджи» было проведено 3 региональных интерактивных образовательно-дискуссионных мероприятия на базе платформы «Онкофорум». В работе онкофорумов приняли участие 35 специалистов федеральных и региональных онкологических центров из 7 федеральных округов. В обзоре представлены итоги обсуждения участниками онкофорумов практических вопросов, связанных с определением оптимальных профилей пациенток с HR+/HER2- мРМЖ и BRCA-ассоциированным HER2- мРМЖ для назначения CDK4/6-ингибиторов и PARP-ингибиторов, с оценкой доступных данных эффективности и профилей переносимости для каждого из CDK4/6-ингибиторов и PARP-ингибиторов и их влияния на выбор определенного препарата, а также возможностей и особенностей обеспечения ингибиторами CDK4/6 пациенток с HR+/HER2- мРМЖ и ингибиторами PARP – пациенток с gBRCA-ассоциированным HER2- мРМЖ в различных регионах РФ.
Ключевые слова: HR+/HER2- метастатический рак молочной железы, ингибиторы CDK4/6, палбоциклиб, BRCA-ассоциированный метастатический рак молочной железы, PARP-ингибиторы, талазопариб
Keywords: HR+/HER2-negative metastatic breast cancer, CDK4/6 inhibitors, palbociclib, BRCA1/2-mutated HER2-negative metastatic breast cancer, PARP inhibitors, talazoparib
Ключевые слова: HR+/HER2- метастатический рак молочной железы, ингибиторы CDK4/6, палбоциклиб, BRCA-ассоциированный метастатический рак молочной железы, PARP-ингибиторы, талазопариб
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Keywords: HR+/HER2-negative metastatic breast cancer, CDK4/6 inhibitors, palbociclib, BRCA1/2-mutated HER2-negative metastatic breast cancer, PARP inhibitors, talazoparib
Полный текст
Список литературы
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2. Cardoso F, Spence D, Mertz S, et al. Global analysis of advanced/metastatic breast cancer: Decade report (2005–2015). Breast. 2018;39:131-8.
DOI:10.1016/j.breast.2018.03.002
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6. NCCN Guidelines. Breast cancer, Version 5.2021 – June 28, 2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed: 15.09.2021.
7. Keung MYT, Wu Y, Vadgama JV. PARP Inhibitors as a Therapeutic Agent for Homologous Recombination Deficiency in Breast Cancers. J Clin Med. 2019;8(4):435. DOI:10.3390/jcm8040435
8. Poggio F, Bruzzone M, Ceppi M, et al. Single-agent PARP inhibitors for the treatment of patients with BRCA mutated HER2-negative metastatic breast cancer: A systematic review and meta-analysis. ESMO Open. 2018;3(4):e000361. DOI:10.1136/esmoopen-2018-000361
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10. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379(8):753-63.
11. Finn RS, Martin M, Rugo HS, et al. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016;375(20):1925-36. DOI:10.1056/NEJMoa1607303
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DOI:10.1056/NEJMoa1903765
17. Cristofanilli M, Turner NC, Bondarenko I, et al. 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):425-39. DOI:10.1016/S1470-2045(15)00613-0
18. Turner NC, Slamon DJ, Ro J, et al. Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2018;379(20):1926-36.
19. Sledge GW Jr, Toi M, Neven P, et al. 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):2875-84. DOI:10.1200/JCO.2017.73.7585
20. Sledge GW Jr, Toi M, Neven P, et al. 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):116-24. DOI:10.1001/jamaoncol.2019.4782
21. Slamon D, Neven P, Chia S, et al. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol. 2018;36(24):2465-72. DOI:10.1200/JCO.2018.78.9909
22. Slamon D, Neven P, Chia S, et al. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020;382(6):514-24.
23. Стенина М. Б., Жукова Л. Г., Королева И. А., и др. Практические рекомендации по лекарственному лечению рака молочной железы. Злокачественные опухоли: Практические рекомендации RUSSCO. 2020;10(3s2). Режим доступа: https://www.rosoncoweb.ru/standarts/RUSSCO/2020/2020-09.pdf. Ссылка активна на 15.09.2021 [Stenina M B, Zhukova LG, Koroleva I A, et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu raka molochnoi zhelezy. Zlokachestvennye opukholi: Prakticheskie rekomendatsii RUSSCO. 2020;10(3s2). Available at: https://www.rosoncoweb.ru/standarts/RUSSCO/2020/2020-09.pdf. Accessed: 15.09.2021 (in Russian)].
24. Artamonova EV, Kovalenko LV, Bolotina MB, et al. Ingibitory CDK 4/6 v terapii metastaticheskogo raka molochnoi zhelezy. Vybor optimal'noi terapii estrogen-retseptor-polozhitel’nogo HER2-otritsatel’nogo metastaticheskogo raka molochnoi zhelezy: obshcherossiiskii analiz predpochtenii vrachei (“Prometei”) – pervye rezul’taty oprosa. Opukholi zhenskoi reproduktivnoi sistemy. 2020;16(3):37-45 (in Russian)
25. 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.
26. Tung N, Lin NU, Kidd J, et al. Frequency of germline mutations in 25 cancer susceptibility genes in a sequential series of patients with breast cancer. J Clin Oncol. 2016;34(13):1460-8.
27. Hennes ER, Dow-Hillgartner EN, Bergsbaken JJ, Piccolo JK. PARP-inhibitor potpourri: A comparative review of class safety, efficacy, and cost. J Oncol Pharm Pract. 2020;26(3):718-29.
2. Cardoso F, Spence D, Mertz S, et al. Global analysis of advanced/metastatic breast cancer: Decade report (2005–2015). Breast. 2018;39:131-8.
DOI:10.1016/j.breast.2018.03.002
3. Hattori M, Iwata H. Advances in treatment and care in metastatic breast cancer (MBC): Are there MBC patients who are curable? Chin Clin Oncol. 2018;7(3):23.
4. Рекомендации Российского общества онкомаммологов: «Золотой стандарт» диагностики и лечения рака молочной железы. 2021, вер. 2.0. Режим доступа: http://www.abvpress.ru/project/www.abvpress.ru/KR_ROOM_2021_Zolotoy_standart_NEW.pdf. Ссылка активна на 15.09.2021 [Rekomendatsii Rossiiskogo obshchestva onkomammologov: “Zolotoi standart” diagnostiki i lecheniia raka molochnoi zhelezy. 2021, ver. 2.0. Available at: http://www.abv-press.ru/project/www.abvpress.ru/KR_ROOM_2021_Zolotoy_standart_NEW.pdf. Accessed: 15.09.2021 (in Russian)].
5. Клинические рекомендации Минздрава России. Рак молочной железы. 2021 (КР379). Режим доступа: http://cr.rosminzdrav.ru/clin_recomend. Ссылка активна на 15.09.2021 [Klinicheskie rekomendatsii Minzdrava Rossii. Rak molochnoi zhelezy. 2021 (KR379). Available at: http://cr.rosminzdrav.ru/clin_recomend. Accessed: 15.09.2021 (in Russian)].
6. NCCN Guidelines. Breast cancer, Version 5.2021 – June 28, 2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed: 15.09.2021.
7. Keung MYT, Wu Y, Vadgama JV. PARP Inhibitors as a Therapeutic Agent for Homologous Recombination Deficiency in Breast Cancers. J Clin Med. 2019;8(4):435. DOI:10.3390/jcm8040435
8. Poggio F, Bruzzone M, Ceppi M, et al. Single-agent PARP inhibitors for the treatment of patients with BRCA mutated HER2-negative metastatic breast cancer: A systematic review and meta-analysis. ESMO Open. 2018;3(4):e000361. DOI:10.1136/esmoopen-2018-000361
9. Robson ME, Tung N, Conte P, et al. OlympiAD final overall survival and tolerability results: Olaparib versus chemotherapy treatment of physician’s choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Ann Oncol. 2019;30(4):558-66.
10. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379(8):753-63.
11. Finn RS, Martin M, Rugo HS, et al. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016;375(20):1925-36. DOI:10.1056/NEJMoa1607303
12. 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
13. 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
14. Hortobagyi GN, Stemmer SM, Burris HA, et al. 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):1541-7. DOI:10.1093/annonc/mdy155
15. Tripathy D, Im SA, Colleoni M, et al. 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):904‑15. DOI:10.1016/S1470-2045(18)30292-4
16. 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
17. Cristofanilli M, Turner NC, Bondarenko I, et al. 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):425-39.
DOI:10.1016/S1470-2045(15)00613-0
18. Turner NC, Slamon DJ, Ro J, et al. Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2018;379(20):1926-36.
19. Sledge GW Jr, Toi M, Neven P, et al. 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):2875-84. DOI:10.1200/JCO.2017.73.7585
20. Sledge GW Jr, Toi M, Neven P, et al. 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):116-24. DOI:10.1001/jamaoncol.2019.4782
21. Slamon D, Neven P, Chia S, et al. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol. 2018;36(24):2465-72. DOI:10.1200/JCO.2018.78.9909
22. Slamon D, Neven P, Chia S, et al. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020;382(6):514-24.
23. Стенина М. Б., Жукова Л. Г., Королева И. А., и др. Практические рекомендации по лекарственному лечению рака молочной железы. Злокачественные опухоли: Практические рекомендации RUSSCO. 2020;10(3s2). Режим доступа: https://www.rosoncoweb.ru/standarts/RUSSCO/2020/2020-09.pdf. Ссылка активна на 15.09.2021 [Stenina M B, Zhukova LG, Koroleva I A, et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu raka molochnoi zhelezy. Zlokachestvennye opukholi: Prakticheskie rekomendatsii RUSSCO. 2020;10(3s2). Available at: https://www.rosoncoweb.ru/standarts/RUSSCO/2020/2020-09.pdf. Accessed: 15.09.2021 (in Russian)].
24. Артамонова Е.В., Коваленко Л.В., Болотина М.Б., и др. Ингибиторы CDK 4/6 в терапии метастатического рака молочной железы. Выбор оптимальной терапии эстроген-рецептор-положительного НЕR2-отрицательного метастатического рака молочной железы: общероссийский анализ предпочтений врачей («Прометей») – первые результаты опроса. Опухоли женской репродуктивной системы. 2020;16(3):37-45 [Artamonova EV, Kovalenko LV, Bolotina MB, et al. Ingibitory CDK 4/6 v terapii metastaticheskogo raka molochnoi zhelezy. Vybor optimal'noi terapii estrogen-retseptor-polozhitel’nogo HER2-otritsatel’nogo metastaticheskogo raka molochnoi zhelezy: obshcherossiiskii analiz predpochtenii vrachei (“Prometei”) – pervye rezul’taty oprosa. Opukholi zhenskoi reproduktivnoi sistemy. 2020;16(3):37-45 (in Russian)].
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26. Tung N, Lin NU, Kidd J, et al. Frequency of germline mutations in 25 cancer susceptibility genes in a sequential series of patients with breast cancer. J Clin Oncol. 2016;34(13):1460-8.
27. Hennes ER, Dow-Hillgartner EN, Bergsbaken JJ, Piccolo JK. PARP-inhibitor potpourri: A comparative review of class safety, efficacy, and cost. J Oncol Pharm Pract. 2020;26(3):718-29.
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18. Turner NC, Slamon DJ, Ro J, et al. Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2018;379(20):1926-36.
19. Sledge GW Jr, Toi M, Neven P, et al. 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):2875-84. DOI:10.1200/JCO.2017.73.7585
20. Sledge GW Jr, Toi M, Neven P, et al. 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):116-24. DOI:10.1001/jamaoncol.2019.4782
21. Slamon D, Neven P, Chia S, et al. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol. 2018;36(24):2465-72. DOI:10.1200/JCO.2018.78.9909
22. Slamon D, Neven P, Chia S, et al. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020;382(6):514-24.
23. Стенина М. Б., Жукова Л. Г., Королева И. А., и др. Практические рекомендации по лекарственному лечению рака молочной железы. Злокачественные опухоли: Практические рекомендации RUSSCO. 2020;10(3s2). Режим доступа: https://www.rosoncoweb.ru/standarts/RUSSCO/2020/2020-09.pdf. Ссылка активна на 15.09.2021 [Stenina M B, Zhukova LG, Koroleva I A, et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu raka molochnoi zhelezy. Zlokachestvennye opukholi: Prakticheskie rekomendatsii RUSSCO. 2020;10(3s2). Available at: https://www.rosoncoweb.ru/standarts/RUSSCO/2020/2020-09.pdf. Accessed: 15.09.2021 (in Russian)].
24. Artamonova EV, Kovalenko LV, Bolotina MB, et al. Ingibitory CDK 4/6 v terapii metastaticheskogo raka molochnoi zhelezy. Vybor optimal'noi terapii estrogen-retseptor-polozhitel’nogo HER2-otritsatel’nogo metastaticheskogo raka molochnoi zhelezy: obshcherossiiskii analiz predpochtenii vrachei (“Prometei”) – pervye rezul’taty oprosa. Opukholi zhenskoi reproduktivnoi sistemy. 2020;16(3):37-45 (in Russian)
25. 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.
26. Tung N, Lin NU, Kidd J, et al. Frequency of germline mutations in 25 cancer susceptibility genes in a sequential series of patients with breast cancer. J Clin Oncol. 2016;34(13):1460-8.
27. Hennes ER, Dow-Hillgartner EN, Bergsbaken JJ, Piccolo JK. PARP-inhibitor potpourri: A comparative review of class safety, efficacy, and cost. J Oncol Pharm Pract. 2020;26(3):718-29.
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