Алгоритм диагностики и системной терапии метастатического гормон-чувствительного HER2-отрицательного рака молочной железы


DOI: https://dx.doi.org/10.18565/pharmateca.2024.7.33-43

Дашян Г.А., Олчонова А.А., Джелялов Э.С., Ахмедов Р.М., Середа О.А., Вац А.Б., Журов А.С., Шайхелисламова Л.Ф., Пушкарук Г.А., Белоусов А.М.

Клиника высоких медицинских технологий им. Н.И. Пирогова, Санкт-Петербургский государственный университет, Санкт-Петербург, Россия
Современные методы системной терапии метастатического рака молочной железы (мРМЖ) включают в себя применение различных комбинаций химиотерапии, гормональной терапии, таргетной и иммунотерапии. Разработка и внедрение новых терапевтических агентов продолжают изменять стандарты лечения и открывают новые горизонты для индивидуализированного подхода в терапии. В статье прпедставлены особенности диагностики, доступные варианты лечения гормон-чувствительного HER2-отрицательного мРМЖ и перспективные новые методы лечения.

Литература


1. World Health Organization (WHO). Breast Cancer. WHO; 2021. Accessed April 18, 2022. URL: https://www.who.int/news-room/fact-sheets/detail/breast-cancer.


2. Daily K., Douglas E., Romitti P.A., Thomas A. Epidemiology of de novo metastatic breast cancer. Clin Breast Cancer. 2021;21(4):302–8. doi: 10.1016/j.clbc.2021.01.017.


3. Criscitiello C., André F., Thompson A.M., et al. Biopsy confirmation of metastatic sites in breast cancer patients: clinical impact and future perspectives. Breast Cancer Res. 2020;16(2):205. doi: 10.1186/bcr3630.


4. Ma C.X., Sparano J.A. Treatment for hormone receptor-positive, HER2-negative advanced breast cancer UpToDate. 2024.


5. Cardoso F., Paluch-Shimon S., Schumacher-Wulf E., et al. 6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7). Breast. 2024;76:103756. doi: 10.1016/j.breast.2024.103756.


6. Gabe S. Sonke, et al. Primary outcome analysis of the phase 3 SONIA trial (BOOG 2017-03) on selecting the optimal position of CDK4/6 inhibitors for patients with HR+, HER2 advanced breast cancer (ABC); Meeting Abstract LBA1000, 2023 ASCO Annual Meeting.


7. Yan Y., Wu B., Wang L. A real-world pharmacovigilance study of QT interval prolongation and Torsades de Pointes associated with CDK4/6 inhibitors in breast cancer patients: findings from the FDA adverse event reporting system. Expert Opin Drug Saf. 2024;23(9):1191–8. doi: 10.1080/14740338.2024.2307375.


8. 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 randomised phase 3 trial. Lancet Oncol. 2018;19(7):904–15. doi: 10.1016/S1470-2045(18)30292-4.


9. Gelmon K., Walshe J.M., Mahtani R., et al. Efficacy and safety of palbociclib in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with preexisting conditions: A post hoc analysis of PALOMA-2. Breast. 2021;59:321–6. doi: 10.1016/j.breast.2021.07.017.


10. 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):3638–46. doi: 10.1200/JCO.2017.75.6155.


11. Singh S. Review on Natural Agents as Aromatase Inhibitors: Management of Breast Cancer. Comb Chem High Throughput Screen. 2024;27(18):2623–38. doi: 10.2174/0113862073269599231009115338.


12. Turner N.C., Ro J., Andre F., et al.; PALOMA3 Study Group. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2015;373(3):209–19. doi: 10.1056/NEJMoa1505270.


13. Llombart-Cussac A., Perez-Garcia J.M., Bellet M., et al.; PARSIFAL Steering Committee and Trial Investigators. Fulvestrant-Palbociclib vs Letrozole-Palbociclib as Initial Therapy for Endocrine-Sensitive, Hormone Receptor-Positive, ERBB 2-Negative Advanced Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021;7(12):1791–9. doi: 10.1001/jamaoncol.2021.4301.


14. Cristofanilli M., Turner N.C., 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.


15. Andrade M.O., Bonadio R.R.D.C.C., Diz M.D.P.E., Testa L. Visceral crisis in metastatic breast cancer: an old concept with new perspectives. Clinics (Sao Paulo). 2024;79:100362. doi: 10.1016/j.clinsp.2024.100362.


16. Mogrovejo E., Manickam P., Amin M., Cappell .S. Characterization of the syndrome of acute liver failure caused by metastases from breast carcinoma. Dig Dis Sci. 2014;59(4):724–36. doi: 10.1007/s10620-013-2943-z.


17. Sbitti Y., Slimani K., Debbagh A., et al. Visceral Crisis Means Short Survival Among Patients With Luminal A Metastatic Breast Cancer: A Retrospective Cohort Study. World J Oncol. 2017;8(4):105–9. doi: 10.14740/wjon1043w.


18. Franzoi M.A., Saude-Conde R., Ferreira S.C., et al. Clinical outcomes of platinum-based chemotherapy in patients with advanced breast cancer: An 11-year single institutional experience. Breast. 2021;57:86–94. doi: 10.1016/j.breast.2021.03.002.


19. Lu Y.S., Mahidin E.I.B.M., Azim H., et al. Final Results of RIGHT Choice: Ribociclib Plus Endocrine Therapy Versus Combination Chemotherapy in Premenopausal Women With Clinically Aggressive Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer. J Clin Oncol. 2024;42(23):2812–21. doi: 10.1200/JCO.24.00144.


20. Modi S., Jacot W., Yamashita T., et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387(1):9–20. doi: 10.1056/NEJMoa2203690.


21. Rugo H.S., Bardia A., Marme F., et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022;40(29):3365–76. doi: 10.1200/JCO.22.01002.


22. Saatci O., Huynh-Dam K.T., Sahin O. Endocrine resistance in breast cancer: from molecular mechanisms to therapeutic strategies. J Mol Med (Berl). 2021;99(12):1691–710. doi: 10.1007/ s00109-021-02136-5.


23. Rasha F., Sharma M., Pruitt K. Mechanisms of endocrine therapy resistance in breast cancer. Mol Cell Endocrinol. 2021;532:111322. doi: 10.1016/j.mce.2021.111322.


24. Toy W., Shen Y., Won H., et al. ESR1 ligand-binding domain mutations in hormone-resistant breast cancer. Nat Genet. 2013;45(12):1439–45. doi: 10.1038/ng.2822.


25. Andre F., Ciruelos E., Rubovszky G., et al.; SOLAR-1 Study Group. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019;380(20):1929–40. doi: 10.1056/NEJMoa1813904.


26. Howell S.J., Casbard A., Carucci M., et al. Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive, HER2-negative breast cancer (FAKTION): overall survival, updated progression-free survival, and expanded biomarker analysis from a randomised, phase 2 trial. Lancet Oncol. 2022;23(7):851–64. doi: 10.1016/S1470-2045(22)00284-4.


27. Robson M., Im S.A., Senkus E., et al. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med. 2017;377(6):523–33. doi: 10.1056/NEJMoa1706450.


28. Oliveira M., Rugo H.S., Howell S.J., et al.; CAPItello-291 study group. Capivasertib and fulvestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer (CAPItello-291): patient-reported outcomes from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2024;25(9):1231–44. doi: 10.1016/S1470-2045(24)00373-5.


29. Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature 2012;490:61.


30. Ogitani Y., Aida T., Hagihara K., et al. DS-8201a, a novel HER2-targeting ADC with a novel DNA topoisomerase I inhibitor, demonstrates a promising antitumor efficacy with differentiation from T-DM1. Clin Cancer Res. 2016;22:5097–108.


31. Ogitani Y., Hagihara K., Oitate M., et al. Bystander killing effect of DS-8201a, a novel anti-human epidermal growth factor receptor 2 antibody-drug conjugate, in tumors with human epidermal growth factor receptor 2 heterogeneity. Cancer Sci. 2016;107:1039–46.


32. Modi S., Jacot W., Yamashita T., et al. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022;387:9.


33. Litton J.K., Rugo H.S., 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. doi: 10.1056/NEJMoa1802905.


34. Chan S., Friedrichs K., Noel D., et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol. 1999;17(8):2341–54.


35. Paridaens R., Biganzoli L., Bruning P., et al. Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: a European Organization for Research and Treatment of Cancer Randomized Study with cross-over. J Clin Oncol 2000;18(4):724–33.


36. Jones S.E., Erban J., Overmoyer B., et al. Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J. Clin Oncol. 2005;23(24):5542–51.


37. Mauri D., Kamposioras K., Tsali L., et al. Overall survival benefit for weekly vs. three-weekly taxanes regimens in advanced breast cancer: A meta-analysis. Cancer Treat Rev. 2010;36(1):69–74. doi: 10.1016/j.ctrv.2009.10.006.


38. Cortes J., O’Shaughnessy J., Loesch D., et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet 2011;377(9769):914–23.


39. Kaufman P.A., Awada A., Twelves C., et al. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2015;33(6):594–601.


40. Pflumio C., Carton M., Debled M., et al. Is Capecitabine the best treatment option for estrogen receptor-positive HER2-negative metastatic breast cancer after progression on endocrine treatment: an analysis of the ESME real-world database. ESMO 2024.


41. Rugo H.S., Bardia A., Marmé F., et al. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023;402:1423.


Об авторах / Для корреспонденции


Автор для связи: Гарик Альбертович Дашян, д.м.н., врач-онколог, заведующий онкологическим отделением №1, Клиника высоких медицинских технологий им. Н.И. Пирогова, Санкт-Петербургский государственный университет, Санкт-Петербург, Россия; dgarik@mail.ru


ORCID / SPIN-код: 
Г.А. Дашян (G.A. Dashyan), ORCID: https://orcid.org/0000-0003-3348-4251; SPIN-код: 6989-7148
А.А. Олчонова (A.A. Olchonova), ORCID: https://orcid.org/0009-0007-3112-8081; SPIN-код: 6144-1590
Э.С. Джелялов (E.S. Dzhelyalov), ORCID: https://orcid.org/0000-00020-2751-243X; SPIN-код: 7261-2325
Р.М. Ахмедов (R.M. Akhmedov), ORCID: https://orcid.org/0000-0003-3348-4251; SPIN-код: 5361-5059
О.А. Середа (O.A. Sereda), ORCID: https://orcid.org/0000-0001-7553-2026  
А.Б. Вац (A.B. Vats), ORCID: https://orcid.org/0009-0000-0450-0166 
А.С. Журов (A.S. Zhurov), ORCID: https://orcid.org/0009-0004-7511-2952  
Л.Ф. Шайхелисламова (L.F. Shaikhelislamova), ORCID: https://orcid.org/0000-0001-9623-3877; SPIN-код: 2166-8716
Г.А. Пушкарук (G.A. Pushkaruk), ORCID: https://orcid.org/0009-0000-8348-0633  
А.М. Белоусов (A.M. Belousov), ORCID: https://orcid.org/0000-0002-2274-8170; SPIN-код: 2842-7325


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