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Современные аспекты лечения гормонозависимого ERBB2-отрицательного метастатического рака молочной железы. Результаты общей выживаемости
Современные аспекты лечения гормонозависимого ERBB2-отрицательного метастатического рака молочной железы. Результаты общей выживаемости
Снеговой А.В., Кононенко И.Б. Современные аспекты лечения гормонозависимого ERBB2-отрицательного метастатического рака молочной железы. Результаты общей выживаемости. Современная Онкология. 2022;24(2):226-233. DOI: 10.26442/18151434.2022.2.201702
DOI: 10.26442/18151434.2022.2.201702
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DOI: 10.26442/18151434.2022.2.201702
Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Аннотация
В обзоре представлен анализ общей выживаемости у пациенток с гормонозависимым ERBB2-отрицательным метастатическим раком молочной железы (мРМЖ) при использовании ингибиторов CDK4/6 в комбинации с эндокринотерапией (ЭТ). Приведены данные исследований MONALESSA-2, 3, 7, PALOMA-2, 3, MONARCH-2, 3. Появление нового класса препаратов – ингибиторов CDK4/6 позволило пересмотреть алгоритм лечения пациенток с HR+/HER2- мРМЖ. Сегодня и в 1-й, и во 2-й линиях лечения предпочтительно использование комбинации ингибиторов CDK4/6 c ЭТ. Доказанное преимущество общей выживаемости в 1 и 2-й линиях лечения, а также данные подгруппового поискового анализа демонстрируют эффективность рибоциклиба в комбинации с ЭТ. Результаты исследований подтверждают целесообразность применения комбинированной терапии в рутинной практике для лечения HR+/HER2- мРМЖ независимо от возраста, менопаузального статуса пациентки, варианта ЭТ и распространенности болезни.
Ключевые слова: общая выживаемость, метастатический рак молочной железы, CDK4/6, рибоциклиб, ингибиторы циклинзависимой киназы, iCDK4/6, ингибиторы CDK4/6
The emergence of a new class of drugs, CDK4/6 inhibitors, opened the way to revise the treatment algorithm for patients with HR+/HER2- mBC. Currently, in treatment lines 1 and 2, the combination of CDK4/6 inhibitors with ET is preferable. The proven overall survival advantage in treatment lines 1 and 2, and data from an exploratory analysis subgroup, demonstrate the efficacy of ribociclib in combination with ET. The results of the studies confirm the benefits of combination therapy in routine practice to treat HR+/HER2- mBC regardless of the patient's age, menopausal status, ET variant, and disease prevalence.
Keywords: overall survival, metastatic breast cancer, CDK4/6, ribociclib, cyclin-dependent kinase, iCDK4/6, CDK 4/6 inhibitors
Ключевые слова: общая выживаемость, метастатический рак молочной железы, CDK4/6, рибоциклиб, ингибиторы циклинзависимой киназы, iCDK4/6, ингибиторы CDK4/6
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The emergence of a new class of drugs, CDK4/6 inhibitors, opened the way to revise the treatment algorithm for patients with HR+/HER2- mBC. Currently, in treatment lines 1 and 2, the combination of CDK4/6 inhibitors with ET is preferable. The proven overall survival advantage in treatment lines 1 and 2, and data from an exploratory analysis subgroup, demonstrate the efficacy of ribociclib in combination with ET. The results of the studies confirm the benefits of combination therapy in routine practice to treat HR+/HER2- mBC regardless of the patient's age, menopausal status, ET variant, and disease prevalence.
Keywords: overall survival, metastatic breast cancer, CDK4/6, ribociclib, cyclin-dependent kinase, iCDK4/6, CDK 4/6 inhibitors
Полный текст
Список литературы
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14. Finn RS, Crown JP, Lang I, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015;16(1):25-35. DOI:10.1016/S1470-2045(14)71159-3
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16. 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, phas. Lancet Oncol. 2016;17(4):425-39.
DOI:10.1016/S1470-2045(15)00613-0
17. 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. DOI:10.1056/NEJMoa1810527
18. 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
19. 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):5218-24. DOI:10.1158/1078-0432.CCR-17-0754
20. Sledge GW, 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
21. 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
22. Di Leo A, O’Shaughnessy J, Sledge GW, et al. Prognostic characteristics in hormone receptor-positive advanced breast cancer and characterization of abemaciclib efficacy. NPJ Breast Cancer. 2018;4(1):41. DOI:10.1038/s41523-018-0094-2
23. Gao JJ, Cheng J, Bloomquist E, et al. CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis. Lancet Oncol. 2020;21(2):250-60. DOI:10.1016/S1470-2045(19)30804-6
24. Zhuang SH, Xiu L, Elsayed YA. Overall survival: a gold standard in search of a surrogate: the value of progression-free survival and time to progression as end points of drug efficacy. Cancer J. 2009;15(5):395-400. DOI:10.1097/PPO.0b013e3181be231d
25. Flaherty KT, Hennig M, Lee SJ, et al. Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials. Lancet Oncol. 2014;15(3):297-304. DOI:10.1016/S1470-2045(14)70007-5
26. 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
27. Finn RS, Rugo HS, Dieras VC, et al. Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer (ER+/HER2− ABC): Analyses from PALOMA-2. J Clin Oncol. 2022;40 (Suppl. 17):LBA1003. DOI:10.1200/JCO.2022.40.17
28. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB). Ann Oncol. 2021;32(5):S1283-346. DOI:10.1016/annonc/annonc741
29. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival (OS) results from the Phase III MONALEESA-2 (ML)-2 trial of postmenopausal patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB); Presentation # LBA17_PR Sept 19, 2021.
30. Johnston S, O’Shaughnessy J, Martin M, et al. Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 updated results in prognostic subgroups. NPJ Breast Cancer. 2021;7:80. DOI:10.1038/s41523-021-00289-7
31. Tripathy D, Im S-A, Colleoni M, et al. Abstract PD2-04: 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) treate. Poster Spotlight Session Abstracts. 2021:PD2-04-PD2-04. DOI:10.1158/1538-7445.SABCS20-PD2-04
32. Nabieva N, Fasching PA. Endocrine Treatment for Breast Cancer Patients Revisited – History, Standard of Care, and Possibilities of Improvement. Cancers (Basel). 2021;13(22):5643. DOI:10.3390/cancers13225643
33. Im S-A, Lu Y-S, 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
34. Lu YS, El-Saghir N, Hurvitz S, et al. Overall survival results by age subgroup from the phase III MONALEESA-7 trial of premenopausal patients with HR+/HER2- advanced breast cancer treated with endocrine therapy ± ribociclib. Presented at: 2021 ESMO Breast Cancer Virtual Congress; May 5-8, 2021. Abstract 93MO.
35. Slamon DJ, Neven P, Chia SKL, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382:514-24. DOI:10.1056/NEJMoa1911149
36. Slamon DJ, Neven P, Chia S, et al. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol. 2021;32(8):1015-24. DOI:10.1016/j.annonc.2021.05.353
37. Neven P, Fasching PA, Chia S, et al. LBA4 Updated overall survival (OS) results from the first-line (1L) population in the phase III MONALEESA-3 trial of postmenopausal patients (PTS) with HR+/HER2− advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL). Ann Oncol. 2022;33(Suppl. 3):S194. DOI:10.1016/j.annonc.2022.03.280
38. 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
39. Cristofanilli M, Rugo HS, Im S-A, et al. Overall survival (OS) with palbociclib (PAL) + fulvestrant (FUL) in women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC): Updated analyses from PALOMA-3. J Clin Oncol. 2021;39(15):1000. DOI:10.1200/JCO.2021.39.15_suppl.1000
40. Piccart M, Hortobagyi GN, Campone M, et al. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2. Ann Oncol. 2014;25(12):2357-62. DOI:10.1093/annonc/mdu456
41. FAQ: What are the differences between one-tailed and two-tailed tests? Available at: https://stats.oarc.ucla.edu/other/mult-pkg/faq/general/faq-what-are-the-differences-between-one-tail.... Accessed: 08.05.2022.
42. 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(15):1054.
DOI:10.1200/JCO.2020.38.15_suppl.1054
43. O’Shaughnessy J. Overall survival subgroup analysis by metastatic site from the phase 3 MONALEESA-2 study of first-line ribociclib + letrozole in postmenopausal patients with advanced HR+/HER2- breast cancer. Presentation # GS2-01 – Oral Home SABCS 2021. Accessed: 12.12.2021.
44. Carey L. Correlative analysis of overall survival by intrinsic subtype across the MONALEESA-2, -3, and -7 studies of ribociclib + endocrine therapy in patients with HR+/HER2- advanced breast cancer, Presentation # GS2-00 – Oral. Available at: https://www.sabcs.org/ Accessed: 08.05.2022.
45. 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(12):1475-1495. doi:10.1016/j.annonc.2021.09.019
2. Ayyagari R, Tang D, Patterson-Lomba O, et al. Progression-free survival with endocrine-based therapies following progression on non-steroidal aromatase inhibitor among postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative metastatic breast cancer: a network meta-analysis. Curr Med Res Opin. 2018;34(9):1645-52. DOI:10.1080/03007995.2018.1479246
3. 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
4. Yap YS, Tseng LM, Blackwell KL, et al. First-line ribociclib plus letrozole in postmenopausal Asian women with hormone receptor-positive (HR plus), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): a subgroup analysis from MONALEESA-2. Abstract presented at: ESMO (European Society for Medical Oncology) Asia 2016 Congress; December 18, 2016; Singapore, Republic of Singapore. Presidential Symposium.
5. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375(18):1738-48. DOI:10.1056/NEJMoa1609709
6. Shohdy KS, Lasheen S, Kassem L, Abdel-Rahman O. Gastrointestinal adverse effects of cyclin-dependent kinase 4 and 6 inhibitors in breast cancer patients: a systematic review and meta-analysis. Ther Adv Drug Saf. 2017;8(11):337-47. DOI:10.1177/2042098617722516
7. Guo Q, Lin X, Ye L, et al. Comparative efficacy of CDK4/6 inhibitors plus aromatase inhibitors versus fulvestrant for the first-line treatment of hormone receptor-positive advanced breast cancer: a network meta-analysis. Target Oncol. 2019;14(2):139-48. DOI:10.1007/S11523-019-00633-9
8. Malumbres M, Barbacid M. Cellcycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009;9(3):153-66. DOI:10.1038/nrc2602
9. Bertoli C, Skotheim JM, de Bruin RAM. Control of cell cycle transcription during G1 and S phases. Nat Rev Mol Cell Biol. 2013;14(8):518-28. DOI:10.1038/nrm3629
10. Finn RS, Aleshin A, Slamon DJ. Targeting the cyclin-dependent kinases (CDK) 4/6 in estrogen receptor-positive breast cancers. Breast Cancer Res. 2016;18(1):17. DOI:10.1186/s13058-015-0661-5
11. Palbociclib (IBRANCE). US FDA. 2019. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/palbociclib-ibrance. Accessed: 08.05.2022.
12. US FDA. FDA expands ribociclib indication in HR-positive, HER2-negative advanced or metastatic breast cancer. 2020. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-ribociclib-indication-hr-.... Accessed: 08.05.2022.
13. US FDA. FDA approves abemaciclib for HR-positive, HER2-negative breast cancer. 2020. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abemaciclib-hr-positive-.... Accessed: 08.05.2022.
14. Finn RS, Crown JP, Lang I, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015;16(1):25-35. DOI:10.1016/S1470-2045(14)71159-3
15. 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
16. 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, phas. Lancet Oncol. 2016;17(4):425-39.
DOI:10.1016/S1470-2045(15)00613-0
17. 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. DOI:10.1056/NEJMoa1810527
18. 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
19. 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):5218-24. DOI:10.1158/1078-0432.CCR-17-0754
20. Sledge GW, 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
21. 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
22. Di Leo A, O’Shaughnessy J, Sledge GW, et al. Prognostic characteristics in hormone receptor-positive advanced breast cancer and characterization of abemaciclib efficacy. NPJ Breast Cancer. 2018;4(1):41. DOI:10.1038/s41523-018-0094-2
23. Gao JJ, Cheng J, Bloomquist E, et al. CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis. Lancet Oncol. 2020;21(2):250-60. DOI:10.1016/S1470-2045(19)30804-6
24. Zhuang SH, Xiu L, Elsayed YA. Overall survival: a gold standard in search of a surrogate: the value of progression-free survival and time to progression as end points of drug efficacy. Cancer J. 2009;15(5):395-400. DOI:10.1097/PPO.0b013e3181be231d
25. Flaherty KT, Hennig M, Lee SJ, et al. Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials. Lancet Oncol. 2014;15(3):297-304. DOI:10.1016/S1470-2045(14)70007-5
26. 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
27. Finn RS, Rugo HS, Dieras VC, et al. Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer (ER+/HER2− ABC): Analyses from PALOMA-2. J Clin Oncol. 2022;40 (Suppl. 17):LBA1003. DOI:10.1200/JCO.2022.40.17
28. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB). Ann Oncol. 2021;32(5):S1283-346. DOI:10.1016/annonc/annonc741
29. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival (OS) results from the Phase III MONALEESA-2 (ML)-2 trial of postmenopausal patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB); Presentation # LBA17_PR Sept 19, 2021.
30. Johnston S, O’Shaughnessy J, Martin M, et al. Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 updated results in prognostic subgroups. NPJ Breast Cancer. 2021;7:80. DOI:10.1038/s41523-021-00289-7
31. Tripathy D, Im S-A, Colleoni M, et al. Abstract PD2-04: 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) treate. Poster Spotlight Session Abstracts. 2021:PD2-04-PD2-04. DOI:10.1158/1538-7445.SABCS20-PD2-04
32. Nabieva N, Fasching PA. Endocrine Treatment for Breast Cancer Patients Revisited – History, Standard of Care, and Possibilities of Improvement. Cancers (Basel). 2021;13(22):5643. DOI:10.3390/cancers13225643
33. Im S-A, Lu Y-S, 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
34. Lu YS, El-Saghir N, Hurvitz S, et al. Overall survival results by age subgroup from the phase III MONALEESA-7 trial of premenopausal patients with HR+/HER2- advanced breast cancer treated with endocrine therapy ± ribociclib. Presented at: 2021 ESMO Breast Cancer Virtual Congress; May 5-8, 2021. Abstract 93MO.
35. Slamon DJ, Neven P, Chia SKL, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382:514-24. DOI:10.1056/NEJMoa1911149
36. Slamon DJ, Neven P, Chia S, et al. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol. 2021;32(8):1015-24. DOI:10.1016/j.annonc.2021.05.353
37. Neven P, Fasching PA, Chia S, et al. LBA4 Updated overall survival (OS) results from the first-line (1L) population in the phase III MONALEESA-3 trial of postmenopausal patients (PTS) with HR+/HER2− advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL). Ann Oncol. 2022;33(Suppl. 3):S194. DOI:10.1016/j.annonc.2022.03.280
38. 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
39. Cristofanilli M, Rugo HS, Im S-A, et al. Overall survival (OS) with palbociclib (PAL) + fulvestrant (FUL) in women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC): Updated analyses from PALOMA-3. J Clin Oncol. 2021;39(15):1000. DOI:10.1200/JCO.2021.39.15_suppl.1000
40. Piccart M, Hortobagyi GN, Campone M, et al. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2. Ann Oncol. 2014;25(12):2357-62. DOI:10.1093/annonc/mdu456
41. FAQ: What are the differences between one-tailed and two-tailed tests? Available at: https://stats.oarc.ucla.edu/other/mult-pkg/faq/general/faq-what-are-the-differences-between-one-tail.... Accessed: 08.05.2022.
42. 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(15):1054.
DOI:10.1200/JCO.2020.38.15_suppl.1054
43. O’Shaughnessy J. Overall survival subgroup analysis by metastatic site from the phase 3 MONALEESA-2 study of first-line ribociclib + letrozole in postmenopausal patients with advanced HR+/HER2- breast cancer. Presentation # GS2-01 – Oral Home SABCS 2021. Accessed: 12.12.2021.
44. Carey L. Correlative analysis of overall survival by intrinsic subtype across the MONALEESA-2, -3, and -7 studies of ribociclib + endocrine therapy in patients with HR+/HER2- advanced breast cancer, Presentation # GS2-00 – Oral. Available at: https://www.sabcs.org/ Accessed: 08.05.2022.
45. 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(12):1475-1495. doi:10.1016/j.annonc.2021.09.019
________________________________________________
2. Ayyagari R, Tang D, Patterson-Lomba O, et al. Progression-free survival with endocrine-based therapies following progression on non-steroidal aromatase inhibitor among postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative metastatic breast cancer: a network meta-analysis. Curr Med Res Opin. 2018;34(9):1645-52. DOI:10.1080/03007995.2018.1479246
3. 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
4. Yap YS, Tseng LM, Blackwell KL, et al. First-line ribociclib plus letrozole in postmenopausal Asian women with hormone receptor-positive (HR plus), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): a subgroup analysis from MONALEESA-2. Abstract presented at: ESMO (European Society for Medical Oncology) Asia 2016 Congress; December 18, 2016; Singapore, Republic of Singapore. Presidential Symposium.
5. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375(18):1738-48. DOI:10.1056/NEJMoa1609709
6. Shohdy KS, Lasheen S, Kassem L, Abdel-Rahman O. Gastrointestinal adverse effects of cyclin-dependent kinase 4 and 6 inhibitors in breast cancer patients: a systematic review and meta-analysis. Ther Adv Drug Saf. 2017;8(11):337-47. DOI:10.1177/2042098617722516
7. Guo Q, Lin X, Ye L, et al. Comparative efficacy of CDK4/6 inhibitors plus aromatase inhibitors versus fulvestrant for the first-line treatment of hormone receptor-positive advanced breast cancer: a network meta-analysis. Target Oncol. 2019;14(2):139-48. DOI:10.1007/S11523-019-00633-9
8. Malumbres M, Barbacid M. Cellcycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009;9(3):153-66. DOI:10.1038/nrc2602
9. Bertoli C, Skotheim JM, de Bruin RAM. Control of cell cycle transcription during G1 and S phases. Nat Rev Mol Cell Biol. 2013;14(8):518-28. DOI:10.1038/nrm3629
10. Finn RS, Aleshin A, Slamon DJ. Targeting the cyclin-dependent kinases (CDK) 4/6 in estrogen receptor-positive breast cancers. Breast Cancer Res. 2016;18(1):17. DOI:10.1186/s13058-015-0661-5
11. Palbociclib (IBRANCE). US FDA. 2019. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/palbociclib-ibrance. Accessed: 08.05.2022.
12. US FDA. FDA expands ribociclib indication in HR-positive, HER2-negative advanced or metastatic breast cancer. 2020. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-ribociclib-indication-hr-.... Accessed: 08.05.2022.
13. US FDA. FDA approves abemaciclib for HR-positive, HER2-negative breast cancer. 2020. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abemaciclib-hr-positive-.... Accessed: 08.05.2022.
14. Finn RS, Crown JP, Lang I, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015;16(1):25-35. DOI:10.1016/S1470-2045(14)71159-3
15. 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
16. 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, phas. Lancet Oncol. 2016;17(4):425-39.
DOI:10.1016/S1470-2045(15)00613-0
17. 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. DOI:10.1056/NEJMoa1810527
18. 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
19. 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):5218-24. DOI:10.1158/1078-0432.CCR-17-0754
20. Sledge GW, 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
21. 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
22. Di Leo A, O’Shaughnessy J, Sledge GW, et al. Prognostic characteristics in hormone receptor-positive advanced breast cancer and characterization of abemaciclib efficacy. NPJ Breast Cancer. 2018;4(1):41. DOI:10.1038/s41523-018-0094-2
23. Gao JJ, Cheng J, Bloomquist E, et al. CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis. Lancet Oncol. 2020;21(2):250-60. DOI:10.1016/S1470-2045(19)30804-6
24. Zhuang SH, Xiu L, Elsayed YA. Overall survival: a gold standard in search of a surrogate: the value of progression-free survival and time to progression as end points of drug efficacy. Cancer J. 2009;15(5):395-400. DOI:10.1097/PPO.0b013e3181be231d
25. Flaherty KT, Hennig M, Lee SJ, et al. Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials. Lancet Oncol. 2014;15(3):297-304. DOI:10.1016/S1470-2045(14)70007-5
26. 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
27. Finn RS, Rugo HS, Dieras VC, et al. Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer (ER+/HER2− ABC): Analyses from PALOMA-2. J Clin Oncol. 2022;40 (Suppl. 17):LBA1003. DOI:10.1200/JCO.2022.40.17
28. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB). Ann Oncol. 2021;32(5):S1283-346. DOI:10.1016/annonc/annonc741
29. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival (OS) results from the Phase III MONALEESA-2 (ML)-2 trial of postmenopausal patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB); Presentation # LBA17_PR Sept 19, 2021.
30. Johnston S, O’Shaughnessy J, Martin M, et al. Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 updated results in prognostic subgroups. NPJ Breast Cancer. 2021;7:80. DOI:10.1038/s41523-021-00289-7
31. Tripathy D, Im S-A, Colleoni M, et al. Abstract PD2-04: 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) treate. Poster Spotlight Session Abstracts. 2021:PD2-04-PD2-04. DOI:10.1158/1538-7445.SABCS20-PD2-04
32. Nabieva N, Fasching PA. Endocrine Treatment for Breast Cancer Patients Revisited – History, Standard of Care, and Possibilities of Improvement. Cancers (Basel). 2021;13(22):5643. DOI:10.3390/cancers13225643
33. Im S-A, Lu Y-S, 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
34. Lu YS, El-Saghir N, Hurvitz S, et al. Overall survival results by age subgroup from the phase III MONALEESA-7 trial of premenopausal patients with HR+/HER2- advanced breast cancer treated with endocrine therapy ± ribociclib. Presented at: 2021 ESMO Breast Cancer Virtual Congress; May 5-8, 2021. Abstract 93MO.
35. Slamon DJ, Neven P, Chia SKL, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382:514-24. DOI:10.1056/NEJMoa1911149
36. Slamon DJ, Neven P, Chia S, et al. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol. 2021;32(8):1015-24. DOI:10.1016/j.annonc.2021.05.353
37. Neven P, Fasching PA, Chia S, et al. LBA4 Updated overall survival (OS) results from the first-line (1L) population in the phase III MONALEESA-3 trial of postmenopausal patients (PTS) with HR+/HER2− advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL). Ann Oncol. 2022;33(Suppl. 3):S194. DOI:10.1016/j.annonc.2022.03.280
38. 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
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Авторы
А.В. Снеговой*, И.Б. Кононенко
НИИ урологии и интервенционной радиологии им. Н.А. Лопаткина – филиал ФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава России, Москва, Россия
*anvs2012@gmail.com
Lopatkin Scientific Research Institute of Urology and Interventional Radiology - branch of the National Medical Research Radiological Centre, Moscow, Russia
*anvs2012@gmail.com
НИИ урологии и интервенционной радиологии им. Н.А. Лопаткина – филиал ФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава России, Москва, Россия
*anvs2012@gmail.com
________________________________________________
Lopatkin Scientific Research Institute of Urology and Interventional Radiology - branch of the National Medical Research Radiological Centre, Moscow, Russia
*anvs2012@gmail.com
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