Противоопухолевый эффект и качество жизни: есть ли необходимость жертвовать? Клиническое наблюдение: длительный и безопасный контроль над болезнью при помощи комбинации рибоциклиба с летрозолом

Гречухина К.С., Воронцова К.А., Филоненко Д.А., Тютюнник П.С., Щадрова В.В., Жукова Л.Г. Противоопухолевый эффект и качество жизни: есть ли необходимость жертвовать? Клиническое наблюдение: длительный и безопасный контроль над болезнью при помощи комбинации рибоциклиба с летрозолом. Современная Онкология. 2022;24(3):373–379. DOI: 10.26442/18151434.2022.3.201895

© ООО «КОНСИЛИУМ МЕДИКУМ», 2022 г.

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Grechukhina KS, Vorontsova KA, Filonenko DA, Tyutyunnik PS, Shchadrova VV, Zhukova LG. Antitumor response and quality of life: is there a need to sacrifice? Clinical observation: long-term and safe control of the disease using a combination of ribociclib with letrozole. Case report. Journal of Modern Oncology. 2022;24(3):373–379.
DOI: 10.26442/18151434.2022.3.201895

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Аннотация

Метастатический люминальный В HER2-негативный рак молочной железы (HR+/HER2- мРМЖ) является одним из наиболее распространенных подтипов РМЖ, занимая одно из ведущих мест в мировой структуре заболеваемости и смертности среди женщин. Текущим «золотым стандартом» лечения 1-й линии определена комбинация ингибиторов CDK4/6 с ингибиторами ароматазы, среди которых выделяют рибоциклиб с летрозолом – единственную на сегодняшний день комбинацию, подтвердившую увеличение общей выживаемости при использовании в 1-й линии. По данным исследования MONALEESA-2, добавление рибоциклиба к летрозолу достоверно увеличило медиану общей выживаемости до 63,9 мес, снижая относительный риск смерти на 24%. Комбинация имеет благоприятный профиль безопасности, токсичность предсказуема и управляема. Развитие нежелательных явлений привело к прерыванию терапии только в 7,5% случаев. Безопасность и эффективность комбинации подтверждена и в исследовании реальной клинической практики CompLEEment-1. Сохранение и улучшение качества жизни является одной из главенствующих задач в лечении пациенток с HR+/HER2- мРМЖ. По данным исследования MONALEESA-2, добавление рибоциклиба значимо влияет на длительность сохранения качества жизни и приводит к уменьшению интенсивности болевого синдрома. Опубликованные данные позволили присвоить комбинации рибоциклиба и летрозола 4 балла по шкале ESMO-MCBS. Безопасность длительного применения комбинации в 1-й линии лечения иллюстрирована множеством собственных клинических наблюдений, одно из которых приведено в данной публикации. Выживаемость без прогрессирования на фоне терапии у пациентки составила 40 мес, что значительно превышает данные исследований MONALEESA-2 и CompLEEment-1. Максимальный эффект – частичный ответ по RECIST 1.1 (-40%), достигнут через 24 нед и сохранялся на протяжении 24 мес. Клинически пациентка отметила уменьшение выраженности болевого синдрома уже через 8 нед терапии. На фоне терапии удалось поддержать качество жизни, не жертвуя при этом противоопухолевой эффективностью.

Ключевые слова: рак молочной железы, люминальный подтип, качество жизни, рибоциклиб, летрозол

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Metastatic luminal B HER2-negative breast cancer (HR+/HER2- mBC) occupies a leading place in the global structure of morbidity and mortality among women. The current gold standard of first-line treatment is the combination of CDK4/6 inhibitors with aromatase inhibitors, among which ribociclib with letrozole is distinguished. According to the MONALEESA-2 study, the addition of ribociclib to letrozole significantly increased the median overall survival to 63.9 months, reducing the risk of death by 24%. The safety profile of the combination is manageable, and the development of adverse events led to the interruption of therapy only in 7.5% of cases. A study of the actual clinical practice of CompLEEment-1 also confirmed the safety and effectiveness of the combination. Maintaining and improving the quality of life is one of the main tasks in the treatment of patients with HR+/HER2- mBC. According to the MONALEESA-2 study, the addition of ribociclib significantly affects the maintenance of quality of life and leads to a decrease in the intensity of pain syndrome. The published data allowed us to assign a combination of ribociclib and letrozole 4 points on the ESMO-MCBS scale. The safety of long-term use of the combination in the first line of treatment illustrated by clinical observation. The patient's progression-free survival during therapy was 40 months, which significantly exceeds the data of the MONALEESA-2 and CompLEEment-1 studies. The maximum effect (partial response according to RECIST 1.1 -40%) achieved after 24 weeks and persisted for 24 months. Clinically, the patient noted a decrease in the severity of the pain syndrome after 8 weeks of therapy. Against the background of therapy, it was possible to maintain the quality of life without sacrificing antitumor efficacy.

Keywords: breast cancer, luminal subtype, quality of life, ribociclib, letrozole

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1. Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: Cancer J Clin. 2018;68:394-424. DOI:10.3322/caac.21492
2. Gnant M. The role of mammalian target of Rapamycin (mTOR) inhibition in the treatment of advanced breast cancer. Curr Oncol Rep. 2013;15:14-23. DOI:10.1007/s11912-012-0277-1
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DOI:10.1530/ERC-11-0112
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15. Thangavel C, Dean JL, Ertel A, et al. Therapeutically activating RB: Reestablishing cell cycle control in endocrine therapy-resistant breast cancer. Endocr Relat Cancer. 2011;18:333-45. DOI:10.1530/ERC-10-0262
16. Miller TW, Balko JM, Fox EM, et al. ERα-dependent E2F transcription can mediate resistance to estrogen deprivation in human breast cancer. Cancer Discov. 2011;1:338-51. DOI:10.1158/2159-8290.CD-11-0101
17. Slamon DJ, Neven P, Chia S, et al. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. New Engl J Med. 2020;382:514-24. DOI:10.1056/nejmoa1911149
18. Im S-A, Lu Y-S, Bardia A, et al. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. New Engl J Med. 2019;381:307-16. DOI:10.1056/NEJMOA1903765
19. Hortobagyi GN, Stemmer SM, Burris HA. LBA17 Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal. Ann Oncol. 2021;32:S1283-346.
20. 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;23:3251. DOI:10.1158/1078-0432.CCR-16-3157
21. ClinicalTrials.gov n.d. Available at: https://clinicaltrials.gov/ Accessed: 29.03.2022.
22. 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;29:1541-7. DOI:10.1093/ANNONC/MDY155
23. Hortobagyi GN. 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;20(1):123. DOI:10.1186/S13058-018-1050-7
24. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. New Engl J Med. 2016;375:1738-48. DOI:10.1056/nejmoa1609709
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Авторы

К.С. Гречухина*, К.А. Воронцова, Д.А. Филоненко, П.С. Тютюнник, В.В. Щадрова, Л.Г. Жукова

ГБУЗ «Московский клинический научно-практический центр им. А.С. Логинова» Департамента здравоохранения г. Москвы, Москва, Россия
*dr.grechukhina@gmail.com

________________________________________________

Katerina S. Grechukhina*, Karina A. Vorontsova, Daria A. Filonenko, Pavel S. Tyutyunnik, Victoria V. Shchadrova, Liudmila G. Zhukova

Loginov Moscow Clinical Scientific Center, Moscow, Russia
*dr.grechukhina@gmail.com

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