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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Список литературы

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
3. Gnant M. Overcoming endocrine resistance in breast cancer: Importance of mTOR inhibition. Expert Rev Anticancer Ther. 2012;12:1579-89. DOI:10.1586/era.12.138
4. Тюляндин С.А., Жукова Л.Г., Королева И.А., и др. Практические рекомендации по лекарственному лечению рака молочной железы. Злокачественные Опухоли. 2021;11:119-57 [Tiuliandin SA, Zhukova LG, Koroleva IA, et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu raka molochnoi zhelezy. Zlokachestvennye Opukholi. 2021;11:119-57 (in Russian)]. DOI:10.18027/2224-5057-2021-11-3s2-09
5. Gennari A, André F, Barrios CH, et al. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol. 2021;32:1475‑95. DOI:10.1016/j.annonc.2021.09.019
6. Finn RS, Martin M, Rugo HS, et al. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016;375:1925-36. DOI:10.1056/NEJMOA1607303
7. Goetz MP, Toi M, Campone M, et al. MONARCH 3: Abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35:3638-46. DOI:10.1200/JCO.2017.75.6155
8. Hortobagyi G, Stemmer S, Burris H, 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. 2019;30(11):1842. doi:10.1093/annonc/mdz215
9. Fox EM, Arteaga CL, Miller TW. Abrogating endocrine resistance by targeting ERα and PI3K in breast cancer. Front Oncol. 2012;2:145. DOI:10.3389/FONC.2012.00145
10. Osborne CK, Schiff R. Mechanisms of Endocrine Resistance in Breast Cancer. Annu Rev Med. 2011;62:233-47. DOI:10.1146/ANNUREV-MED-070909-182917
11. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) B-Cell Lymphomas. Version 12022. 2022. Available at: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1419. Accessed: 29.03.2022.
12. 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
13. Caldon CE, Daly RJ, Sutherland RL, Musgrove EA. Cell cycle control in breast cancer cells. J Cell Biochem. 2006;97:261-74. DOI:10.1002/jcb.20690
14. Shapiro GI. Cyclin-dependent kinase pathways as targets for cancer treatment. J Clin Oncol. 2006;24:1770-83. DOI:10.1200/JCO.2005.03.7689
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
25. Burris HA, Chan A, Bardia A, et al. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021;125:679-86. DOI:10.1038/s41416-021-01415-9
26. Aapro MS, Köhne C-H, Cohen HJ, Extermann M. Never too old? Age should not be a barrier to enrollment in cancer clinical trials. Oncologist. 2005;10:198-204. DOI:10.1634/THEONCOLOGIST.10-3-198
27. Lin NU, Amiri-Kordestani L, Palmieri D, et al. CNS metastases in breast cancer: Old challenge, new frontiers. Clin Cancer Res. 2013;19:6404-18. DOI:10.1158/1078-0432.CCR-13-0790
28. de Laurentiis M, Borstnar S, Campone M, et al. Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population. Breast Cancer Res Treat. 2021;189:689‑99. DOI:10.1007/s10549-021-06334-0
29. 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;12:1758835920943065. DOI:10.1177/1758835920943065
30. 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
31. Petrelli F, Ghidini A, Pedersini R, et al. Comparative efficacy of palbociclib, ribociclib and abemaciclib for ER+ metastatic breast cancer: an adjusted indirect analysis of randomized controlled trials. Breast Cancer Res Treat. 2019;174:597-604. DOI:10.1007/S10549-019-05133-Y/FIGURES/5
32. Extramiana F, Maison-Blanche P, Badilini F, et al. Circadian modulation of QT rate dependence in healthy volunteers: Gender and age differences. J Electrocardiol. 1999;32:33‑43. DOI:10.1016/S0022-0736(99)90019-5
33. Yap YG, Camm AJ. Drug induced QT prolongation and torsades de pointes. Heart. 2003;89:1363-72. DOI:10.1136/heart.89.11.1363
34. Sonke GS, Hart LL, Campone M, et al. Ribociclib with letrozole vs letrozole alone in elderly patients with hormone receptor-positive, HER2-negative breast cancer in the randomized MONALEESA-2 trial. Breast Cancer Res Treat. 2018;167:659-69. DOI:10.1007/s10549-017-4523-y
35. Yardley DA. MONALEESA clinical program: A review of ribociclib use in different clinical settings. Future Oncol. 2019;15:2673-86. DOI:10.2217/fon-2019-0130
36. Miles D, Minckwitz G, Seidman AD. Combination Versus Sequential Single-Agent Therapy in Metastatic Breast Cancer. Oncologist. 2002;7:13-9. DOI:10.1634/theoncologist.2002-0013
37. Montazeri A. Health-related quality of life in breast cancer patients: A bibliographic review of the literature from 1974 to 2007. J Exp Clin Cancer Res. 2008;27(1):32. DOI:10.1186/1756-9966-27-32
38. Kovic B, Guyatt G, Brundage M, et al. Association between progression-free survival and health-related quality of life in oncology: a systematic review protocol. BMJ Open. 2016;6:e012909. DOI:10.1136/bmjopen-2016-012909
39. Fasching PA, Harbeck N, Jerusalem G, et al. 233P Association of quality of life (QOL) with overall survival (OS) in patients (pts) with HR+/HER2- advanced breast cancer (ABC) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA-3 (ML-3) and ML-7 trials. Ann Oncol. 2021;32:S460. DOI:10.1016/j.annonc.2021.08.516
40. Villacampa G, Paré L, Hernando C, et al. Abstract P4-10-04: Health-related quality of life (HRQoL) in hormone receptor-positive, HER2-negative, luminal B breast cancer patients treated with ribociclib plus letrozole or chemotherapy. Cancer Res. 2022;82:P4‑10‑04-P4-10–04. DOI:10.1158/1538-7445.sabcs21-p4-10-04
41. Aaronson NK, Ahmedzai S, Bergman B, et al. The European organization for research and treatment of cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365-76. DOI:10.1093/jnci/85.5.365
42. Sprangers MA, Groenvold M, Arraras JI, et al. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: First results from a three-country field study. J Clin Oncol. 1996;14:2756-68. DOI:10.1200/JCO.1996.14.10.2756
43. Verma S, O’Shaughnessy J, Burris HA, et al. Health-related quality of life of postmenopausal women with hormone receptor–positive, HER2- advanced breast cancer treated with ribociclib + letrozole: Results from MONALEESA-2. J Clin Oncol. 2017;35:133. DOI:10.1200/JCO.2017.35.31_SUPPL.133
44. Verma S, O’Shaughnessy J, Burris HA, et al. Health-related quality of life (HRQoL) of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) treated with ribociclib + letrozole: Results from MONALEESA-2. J Clin Oncol. 2017;35:1020. DOI:10.1200/jco.2017.35.15_suppl.1020
45. Verma S, O’Shaughnessy J, Burris HA, et al. Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2. Breast Cancer Res Treat. 2018;170:535-45. DOI:10.1007/s10549-018-4769-z
46. Hollen PJ, Msaouel P, Gralla RJ. Determining issues of importance for the evaluation of quality of life and patient-reported outcomes in breast cancer: results of a survey of 1072 patients. Breast Cancer Res Treat. 2015;151:679-86. DOI:10.1007/s10549-015-3420-5
47. Janni W, Alba E, Bachelot T, et al. First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2− advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial. Breast Cancer Res Treat. 2018;169:469-79. DOI:10.1007/s10549-017-4658-x
48. Yardley DA, Hart L, Favret A, et al. Efficacy and Safety of Ribociclib With Letrozole in US Patients Enrolled in the MONALEESA-2 Study. Clin Breast Cancer. 2019;19:268-77.e1. DOI:10.1016/j.clbc.2019.02.007
49. Fasching PA, Beck JT, Chan A, et al. Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study. Breast. 2020;54:148-54. DOI:10.1016/j.breast.2020.09.008
50. Pernas S, Villagrasa P, Vivancos A, et al. Patient-reported outcomes (PROs) in advanced breast cancer (ABC) treated with ribociclib + fulvestrant: Results from MONALEESA-3. Ann Oncol. 2018;29:viii90. DOI:10.1093/ANNONC/MDY272.282
51. Lu Y-S, Bardia A, Vázquez RV, et al. Updated overall survival (OS) and quality of life (QoL) in premenopausal patients (pts) with advanced breast cancer (ABC) who received ribociclib (RIB) or placebo (PBO) plus goserelin and a nonsteroidal aromatase inhibitor (NSAI) in the MONALEESA-7 (ML-7). Ann Oncol. 2019;30:v106. DOI:10.1093/annonc/mdz242.003
52. scorecard 9 1 | ESMO n.d. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-9-1. Accessed: 01.04.2022.
53. scorecard 161 1 | ESMO n.d. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-161-1. Accessed: 01.04.2022.
54. scorecard 160 1 | ESMO n.d. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-160-1. Accessed: 01.04.2022.
55. scorecard 159 1 | ESMO n.d. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-159-1. Accessed: 01.04.2022.
56. scorecard 6 1 | ESMO n.d. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-6-1. Accessed: 01.04.2022.
57. scorecard 7 1 | ESMO n.d. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-7-1. Accessed: 01.04.2022.

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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
3. Gnant M. Overcoming endocrine resistance in breast cancer: Importance of mTOR inhibition. Expert Rev Anticancer Ther. 2012;12:1579-89. DOI:10.1586/era.12.138
4. Tiuliandin SA, Zhukova LG, Koroleva IA, et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu raka molochnoi zhelezy. Zlokachestvennye Opukholi. 2021;11:119-57 (in Russian). DOI:10.18027/2224-5057-2021-11-3s2-09
5. Gennari A, André F, Barrios CH, et al. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol. 2021;32:1475‑95. DOI:10.1016/j.annonc.2021.09.019
6. Finn RS, Martin M, Rugo HS, et al. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016;375:1925-36. DOI:10.1056/NEJMOA1607303
7. Goetz MP, Toi M, Campone M, et al. MONARCH 3: Abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35:3638-46. DOI:10.1200/JCO.2017.75.6155
8. Hortobagyi G, Stemmer S, Burris H, 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. 2019;30(11):1842. doi:10.1093/annonc/mdz215
9. Fox EM, Arteaga CL, Miller TW. Abrogating endocrine resistance by targeting ERα and PI3K in breast cancer. Front Oncol. 2012;2:145. DOI:10.3389/FONC.2012.00145
10. Osborne CK, Schiff R. Mechanisms of Endocrine Resistance in Breast Cancer. Annu Rev Med. 2011;62:233-47. DOI:10.1146/ANNUREV-MED-070909-182917
11. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) B-Cell Lymphomas. Version 12022. 2022. Available at: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1419. Accessed: 29.03.2022.
12. 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
13. Caldon CE, Daly RJ, Sutherland RL, Musgrove EA. Cell cycle control in breast cancer cells. J Cell Biochem. 2006;97:261-74. DOI:10.1002/jcb.20690
14. Shapiro GI. Cyclin-dependent kinase pathways as targets for cancer treatment. J Clin Oncol. 2006;24:1770-83. DOI:10.1200/JCO.2005.03.7689
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
25. Burris HA, Chan A, Bardia A, et al. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021;125:679-86. DOI:10.1038/s41416-021-01415-9
26. Aapro MS, Köhne C-H, Cohen HJ, Extermann M. Never too old? Age should not be a barrier to enrollment in cancer clinical trials. Oncologist. 2005;10:198-204. DOI:10.1634/THEONCOLOGIST.10-3-198
27. Lin NU, Amiri-Kordestani L, Palmieri D, et al. CNS metastases in breast cancer: Old challenge, new frontiers. Clin Cancer Res. 2013;19:6404-18. DOI:10.1158/1078-0432.CCR-13-0790
28. de Laurentiis M, Borstnar S, Campone M, et al. Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population. Breast Cancer Res Treat. 2021;189:689‑99. DOI:10.1007/s10549-021-06334-0
29. 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;12:1758835920943065. DOI:10.1177/1758835920943065
30. 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
31. Petrelli F, Ghidini A, Pedersini R, et al. Comparative efficacy of palbociclib, ribociclib and abemaciclib for ER+ metastatic breast cancer: an adjusted indirect analysis of randomized controlled trials. Breast Cancer Res Treat. 2019;174:597-604. DOI:10.1007/S10549-019-05133-Y/FIGURES/5
32. Extramiana F, Maison-Blanche P, Badilini F, et al. Circadian modulation of QT rate dependence in healthy volunteers: Gender and age differences. J Electrocardiol. 1999;32:33‑43. DOI:10.1016/S0022-0736(99)90019-5
33. Yap YG, Camm AJ. Drug induced QT prolongation and torsades de pointes. Heart. 2003;89:1363-72. DOI:10.1136/heart.89.11.1363
34. Sonke GS, Hart LL, Campone M, et al. Ribociclib with letrozole vs letrozole alone in elderly patients with hormone receptor-positive, HER2-negative breast cancer in the randomized MONALEESA-2 trial. Breast Cancer Res Treat. 2018;167:659-69. DOI:10.1007/s10549-017-4523-y
35. Yardley DA. MONALEESA clinical program: A review of ribociclib use in different clinical settings. Future Oncol. 2019;15:2673-86. DOI:10.2217/fon-2019-0130
36. Miles D, Minckwitz G, Seidman AD. Combination Versus Sequential Single-Agent Therapy in Metastatic Breast Cancer. Oncologist. 2002;7:13-9. DOI:10.1634/theoncologist.2002-0013
37. Montazeri A. Health-related quality of life in breast cancer patients: A bibliographic review of the literature from 1974 to 2007. J Exp Clin Cancer Res. 2008;27(1):32. DOI:10.1186/1756-9966-27-32
38. Kovic B, Guyatt G, Brundage M, et al. Association between progression-free survival and health-related quality of life in oncology: a systematic review protocol. BMJ Open. 2016;6:e012909. DOI:10.1136/bmjopen-2016-012909
39. Fasching PA, Harbeck N, Jerusalem G, et al. 233P Association of quality of life (QOL) with overall survival (OS) in patients (pts) with HR+/HER2- advanced breast cancer (ABC) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA-3 (ML-3) and ML-7 trials. Ann Oncol. 2021;32:S460. DOI:10.1016/j.annonc.2021.08.516
40. Villacampa G, Paré L, Hernando C, et al. Abstract P4-10-04: Health-related quality of life (HRQoL) in hormone receptor-positive, HER2-negative, luminal B breast cancer patients treated with ribociclib plus letrozole or chemotherapy. Cancer Res. 2022;82:P4‑10‑04-P4-10–04. DOI:10.1158/1538-7445.sabcs21-p4-10-04
41. Aaronson NK, Ahmedzai S, Bergman B, et al. The European organization for research and treatment of cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365-76. DOI:10.1093/jnci/85.5.365
42. Sprangers MA, Groenvold M, Arraras JI, et al. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: First results from a three-country field study. J Clin Oncol. 1996;14:2756-68. DOI:10.1200/JCO.1996.14.10.2756
43. Verma S, O’Shaughnessy J, Burris HA, et al. Health-related quality of life of postmenopausal women with hormone receptor–positive, HER2- advanced breast cancer treated with ribociclib + letrozole: Results from MONALEESA-2. J Clin Oncol. 2017;35:133. DOI:10.1200/JCO.2017.35.31_SUPPL.133
44. Verma S, O’Shaughnessy J, Burris HA, et al. Health-related quality of life (HRQoL) of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) treated with ribociclib + letrozole: Results from MONALEESA-2. J Clin Oncol. 2017;35:1020. DOI:10.1200/jco.2017.35.15_suppl.1020
45. Verma S, O’Shaughnessy J, Burris HA, et al. Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2. Breast Cancer Res Treat. 2018;170:535-45. DOI:10.1007/s10549-018-4769-z
46. Hollen PJ, Msaouel P, Gralla RJ. Determining issues of importance for the evaluation of quality of life and patient-reported outcomes in breast cancer: results of a survey of 1072 patients. Breast Cancer Res Treat. 2015;151:679-86. DOI:10.1007/s10549-015-3420-5
47. Janni W, Alba E, Bachelot T, et al. First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2− advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial. Breast Cancer Res Treat. 2018;169:469-79. DOI:10.1007/s10549-017-4658-x
48. Yardley DA, Hart L, Favret A, et al. Efficacy and Safety of Ribociclib With Letrozole in US Patients Enrolled in the MONALEESA-2 Study. Clin Breast Cancer. 2019;19:268-77.e1. DOI:10.1016/j.clbc.2019.02.007
49. Fasching PA, Beck JT, Chan A, et al. Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study. Breast. 2020;54:148-54. DOI:10.1016/j.breast.2020.09.008
50. Pernas S, Villagrasa P, Vivancos A, et al. Patient-reported outcomes (PROs) in advanced breast cancer (ABC) treated with ribociclib + fulvestrant: Results from MONALEESA-3. Ann Oncol. 2018;29:viii90. DOI:10.1093/ANNONC/MDY272.282
51. Lu Y-S, Bardia A, Vázquez RV, et al. Updated overall survival (OS) and quality of life (QoL) in premenopausal patients (pts) with advanced breast cancer (ABC) who received ribociclib (RIB) or placebo (PBO) plus goserelin and a nonsteroidal aromatase inhibitor (NSAI) in the MONALEESA-7 (ML-7). Ann Oncol. 2019;30:v106. DOI:10.1093/annonc/mdz242.003
52. scorecard 9 1 | ESMO n.d. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-9-1. Accessed: 01.04.2022.
53. scorecard 161 1 | ESMO n.d. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-161-1. Accessed: 01.04.2022.
54. scorecard 160 1 | ESMO n.d. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-160-1. Accessed: 01.04.2022.
55. scorecard 159 1 | ESMO n.d. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-159-1. Accessed: 01.04.2022.
56. scorecard 6 1 | ESMO n.d. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-6-1. Accessed: 01.04.2022.
57. scorecard 7 1 | ESMO n.d. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-7-1. Accessed: 01.04.2022.

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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