Не дайте ей исчезнуть: новые возможности продления жизни пациенток с HR+ HER2- распространенным раком молочной железы. Обзор сателлитного симпозиума, состоявшегося в рамках большой конференции RUSSCO «Рак молочной железы» (в онлайн-формате).

Не дайте ей исчезнуть: новые возможности продления жизни пациенток с HR+ HER2- распространенным раком молочной железы. Современная Онкология. 2021; 23 (1): 53–60.
DOI: 10.26442/18151434.2021.1.200764

________________________________________________

Don't let it disappear: new opportunities to prolong the life of HR+ HER2- advanced breast cancer patients. Journal of Modern Oncology. 2021; 23 (1): 53–60. DOI: 10.26442/18151434.2021.1.200764

Читать PDF

Аннотация

Увеличение продолжительность жизни и сохранение ее качества являются основными целями терапии гормонозависимого HER2-отрицательного распространенного рака молочной железы (HR+ HER2- рРМЖ). 28 января 2021 г. в рамках Большой конференции RUSSCO «Рак молочной железы» состоялся сателлитный симпозиум компании «Новартис Фарма», посвященный преимуществам терапии препаратом Рисарг (рибоциклиб) в комбинации с гормонотерапией. Эксперты-онкологи поделились актуальными данными и своим опытом применения рибоциклиба. Ингибиторы CDK4/6 в комбинации с гормонотерапией стали «золотым стандартом» 1-й линии терапии HR+ HER2- рРМЖ, а выбор конкретного препарата проводится на основании данных клинических исследований и с учетом индивидуальных особенностей пациентки. Результаты исследований рибоциклиба (MONALEESA-3 и MONALEESA-7) демонстрируют достоверное увеличение медианы общей выживаемости и снижение риска смерти на 28 и 30%. Профиль переносимости рибоциклиба является хорошо изученным и управляемым, поэтому благодаря грамотному мониторингу можно снизить риск развития нежелательных явлений и провести необходимую модификацию дозы, что позволяет сохранить высокоэффективную терапию большинству пациентов. Применение рибоциклиба позволяет достичь главные цели терапии – продлить жизнь пациентки и сохранить или улучшить качество жизни.

Ключевые слова: гормонозависимый HER2-отрицательный распространенный рак молочной железы, ингибиторы CDK4/6, рибоциклиб, общая выживаемость, качество жизни

________________________________________________

Increasing life expectancy and maintaining its quality are the main goals of the hormone-dependent HER2-negative advanced breast cancer (HR+ HER2- аBC) therapy. A Satellite Symposium of Novartis Pharma was held on January 28th, 2021, within the framework of the RUSSCO Big Conference "Breast Cancer". It was dedicated to the benefits of Risarg (ribociclib) therapy in combination with hormone therapy (HT). Experts-oncologists shared current data and their experience with ribociclib. The combination of CDK4/6 inhibitors with HT became a gold standard for the 1st line therapy for HR+ HER2- aBC. And the choice of a specific drug is based on the data of clinical studies and is made taking into account the individual characteristics of the patient. The results of ribociclib studies (MONALEESA-3 and MONALEESA-7) demonstrate a significant increase in the median overall survival and a decrease in the risk of death by 28 and 30%. The tolerance profile of ribociclib is well studied and controlled, therefore the risks of adverse events can be reduced by the competent monitoring, and the necessary dose modification can be made, which allows most patients to maintain highly effective therapy. The use of ribociclib allows to achieve the main goals of therapy – to prolong the patient's life and maintain or improve its quality.

Keywords: hormone-dependent HER2-negative advanced breast cancer, CDK4/6 inhibitors, ribociclib, overall survival, quality of life

Полный текст

Материалы доступны только для специалистов сферы здравоохранения.
Чтобы посмотреть материал полностью Авторизуйтесь или зарегистрируйтесь.

Список литературы

1. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 2020; 382: 514–24. DOI: 10.1056/NEJMoa1911149
2. 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
3. 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
4. Состояние онкологической помощи населению России в 2019 году. Под ред. А.Д. Каприна, В.В. Старинского, А.О. Шахзадовой. М.: МНИОИ им. П.А. Герцена – филиал ФГБУ «НМИЦ радиологии» Минздрава России, 2020 [The state of cancer care for the population of Russia in 2019. Ed. AD Kaprina, VV Starinsky, AO Shahzadova. Moscow: MNIOI them. PA Herzen – branch of the Federal State Budgetary Institution "NMRC of Radiology" of the Ministry of Health of Russia, 2020 (in Russian)].
5. Slamon DJ, 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
6. Tripathy D, Im S-A, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomized phase III trial. Lancet Oncol 2018; 19 (7): 904–15. DOI: 10.1016/S1470-2045(18)30292-4
7. Tripathy D, Im S-A, Colleoniet M, et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. SABCS 2020; abstr PD2-04.
8. Yardley DA, Nusch A, Yap YS, et al. Overall survival (OS) in patients (pts) with advanced breast cancer (ABC) with visceral metastases (mets), including those with liver mets, treated with ribociclib (RIB) plus endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials. J Clin Oncol 2020; 38 (Suppl. 15): abstr 1054. DOI: 10.1200/JCO.2020.38.15_suppl.1054
9. De Laurentiis M, Borstnar S, Campone M, et al. Updated results from the phase IIIb complement-1 study of ribociclib (RIB) plus letrozole (LET) in the treatment of HR+, HER2-advanced breast cancer (ABC). J Clin Oncol 2020; 38(Suppl. 15): abstr 1055. DOI: 10.1200/JCO.2020.38.15_suppl.1055
10. Cottu PH, Ring A, Marchetti P, et al. 333P. Ribociclib (RIB) + letrozole (LET) in subgroups of special clinical interest with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): Subgroup analysis from the CompLEEment-1 trial. Ann Oncol 2020; 31 (Suppl. 4): S379–S380. DOI: 10.1016/j.annonc.2020.08.435
11. Razeq HA, Cottu P, Ring A, et al. Ribociclib + letrozole in premenopausal patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): Subgroup analysis of the phase IIIb CompLEEment-1 trial. SABCS 2020; abstr PS10–10.
12. Beck JT, Neven P, Sohn J, et al. Ribociclib treatment benefit in patients with advanced breast cancer with ≥1 dose reduction: Data from the MONALEESA-2, -3, and -7 trials. Cancer Res 2018; 79 (Suppl. 4): abstr P6-18-06-P6-18-06. DOI: 10.1158/1538-7445.SABCS18-P6-18-06
13. Lange CA, Yee D. Killing the second messenger: targeting loss of cell cycle control in endocrine-resistant breast cancer. Endocr Relat Cancer. 2011; 18 (4): C19–24. DOI: 10.1530/ERC-11-0112
14. Knudsen ES, Witkiewicz AK. The strange case of CDK4/6 inhibitors: mechanisms, resistance, and combination strategies. Trends Cancer 2017; 3 (1): 39–55. DOI: 10.1016/j.trecan.2016.11.006
15. Otto T, Sicinski P. Cell cycle proteins as promising targets in cancer therapy. Nat Rev Cancer 2017; 17 (2): 93–115. DOI: 10.1038/nrc.2016.138
16. Corona SP, Generali D. Abemaciclib: a CDK4/6 inhibitor for the treatment of HR+/HER2- advanced breast cancer. Drug Des Devel Ther 2018; 12: 321–30. DOI: 10.2147/DDDT.S137783
17. Tripathy D, Bardia A, Sellers WR. Ribociclib (LEE011): Mechanism of Action and Clinical Impact of This Selective Cyclin-Dependent Kinase 4/6 Inhibitor in Various Solid Tumors. Clin Cancer Res 2017; 23 (13): 3251–62. DOI: 10.1158/1078-0432.CCR-16-3157
18. Kim S, Tiedt R, Loo A, et al. The potent and selective cyclin-dependent kinases 4 and 6 inhibitor ribociclib (LEE011) is a versatile combination partner in preclinical cancer models. Oncotarget 2018; 9 (81): 35226–40. DOI: 10.18632/oncotarget.26215
19. Rossi V, Berchialla P, Giannarelli D, et al. Should all patients with HR-positive HER2-negative metastatic breast cancer receive CDK 4/6 inhibitor as first-line based therapy? A network meta-analysis of data from the PALOMA 2, MONALEESA 2, MONALEESA 7, MONARCH 3, FALCON, SWOG and FACT trials. Cancers 2019; 11(11): 1661. DOI: 10.3390/cancers11111661
20. 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
21. 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): 425-439. DOI: 10.1016/S1470-2045(15)00613-0
22. Palbociclib PI.
23. 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). The Oncologist 2016; 21 (10): 1165–75. DOI: 10.1634/theoncologist.2016-0097
24. Ettl J, Im S-A, Ro J, et al. Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies. Breast Cancer Res 2020; 22: 27. DOI: 10.1186/s13058-020-01263-0
25. Schwartzberg L, Kanakamedala H, Thuerigen A, et al. 332P. Treatment-emergent (TE) neutropenia and related hospitalizations and medication discontinuations in patients (pts) with metastatic breast cancer (MBC) treated with palbociclib (PAL) or ribociclib (RIB): A real-world analysis. Ann Oncol 2020; 31 (Suppl. 4), S379. DOI: 10.1016/j.annonc.2020.08.434
26. Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH 1, a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR+/HER2–metastatic breast cancer. Clin Cancer Res 2017; 23 (17): 5218–4. DOI: 10.1158/1078-0432.ccr-17-0754
27. 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 (1). DOI: 10.1038/s41523-018-0097-z
28. 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
29. Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol 2017; 35 (32): 3638–46. DOI: 10.1200/JCO.2017.75.6155
30. Lu J, Cottu P, Martin M, et al. Ribociclib + letrozole in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC): Expanded safety analysis of the phase IIIb CompLEEment-1 trial. SABCS 2020; abstr PS10-05.
31. Cottu P, De Laurentiis M, Marchetti P, et al. Ribociclib + letrozole in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC) and central nervous system metastases: Subgroup analysis of the phase IIIb CompLEEment-1 trial. SABCS 2020; abstr PS14-07.
32. Hortobagyi GN, Stemmer SM, Burris HA, et al. 3552 – First-line ribociclib + letrozole for postmenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2-), advanced breast cancer (ABC). Ann Oncol 2016; 27 (Suppl. 6): 1–36. DOI: 10.1093/annonc/mdw435
33. De Laurentiis M, de la Cruz Merino L, Hart L, et al. 331P. Impact of ribociclib (RIB) dose reduction on overall survival (OS) in patients (pts) with HR+/HER2L advanced breast cancer (ABC) in MONALEESA (ML) -3 and -7. Ann Oncol 2020; 31 (Suppl. 4): S378–S379. DOI: 10.1016/j.annonc.2020.08.433
34. Hortobagyi GN, et al. Ann Oncol 2016; 27 (Suppl. 6): abstr. LBA 3552.
35. Harbeck N, Franke F, Villanueva-Vazquez R, et al. Health-related quality of life in premenopausal women with hormone-receptor-positive, HER2-negative advanced breast cancer treated with ribociclib plus endocrine therapy: results from a phase III randomized clinical trial (MONALEESA-7). Ther Adv Med Oncol 2020; 12: 1–8. DOI: 10.1177/1758835920943065

________________________________________________

Авторы

Эксперты:
Елена Владимировна Артамонова – д-р мед. наук, проф., зав. отд-нием химиотерапии ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава России, Москва, Россия
Ирина Владимировна Колядина – д-р мед. наук, проф., проф. каф. онкологии и паллиативной медицины им. акад. А.И. Савицкого ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России на базе ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава России, Москва

________________________________________________

Experts:
Elena V. Artamonova – D. Sci. (Med.), Prof., Blokhin National Medical Research Center of Oncology, Moscow, Russia
Irina V. Kolyadina – D. Sci. (Med.), Prof., Russian Medical Academy of Continuous Professional Education on the basis of Blokhin National Medical Research Center of Oncology, Moscow, Russia

Назад к списку

Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.