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Новые возможности терапии гормоноположительного HER2-отрицательного метастатического рака молочной железы с альтерациями сигнального пути АКТ. Резолюция совета экспертов
Новые возможности терапии гормоноположительного HER2-отрицательного метастатического рака молочной железы с альтерациями сигнального пути АКТ. Резолюция совета экспертов
Новые возможности терапии гормоноположительного HER2-отрицательного метастатического рака молочной железы с альтерациями сигнального пути AKT. Резолюция совета экспертов. Современная Онкология. 2024;26(3):262–268. DOI: 10.26442/18151434.2024.3.203012
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
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Аннотация
20 мая 2024 г. в г. Москве в рамках совета экспертов состоялось обсуждение ключевых вопросов диагностики альтераций сигнального пути AKT, эффективности и безопасности таргетной терапии гормоноположительного (HR+) HER2-отрицательного метастатического рака молочной железы (РМЖ) в связи с появлением нового селективного ингибитора AKT – капивасертиба. Представлены результаты исследования CAPItello-291. Экспертами сделан вывод о том, что в арсенале онкологов появилась новая эффективная линия лечения больных гормонорезистентным распространенным гормоноположительным HER2-отрицательным РМЖ с наличием генетических альтераций в сигнальном пути AKT, с развитием рецидива на предшествующей адъювантной эндокринотерапии ингибиторами ароматазы или в течение первого года после ее окончания либо с прогрессированием во время предшествующей терапии ингибиторами ароматазы по поводу метастатического РМЖ. Современные методы генетического тестирования на наличие альтераций в сигнальном пути AKT позволят подтвердить наличие в опухоли данной ключевой биологической мишени для назначения эффективной таргетной терапии.
Ключевые слова: метастатический рак молочной железы, распространенный рак молочной железы, гормонорезистентный рак молочной железы, селективный ингибитор AKT, таргетная терапия, капивасертиб
Keywords: metastatic breast cancer, advanced breast cancer, hormone-resistant breast cancer, selective AKT inhibitor, targeted therapy, capivasertib
Ключевые слова: метастатический рак молочной железы, распространенный рак молочной железы, гормонорезистентный рак молочной железы, селективный ингибитор AKT, таргетная терапия, капивасертиб
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Keywords: metastatic breast cancer, advanced breast cancer, hormone-resistant breast cancer, selective AKT inhibitor, targeted therapy, capivasertib
Полный текст
Список литературы
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12. Wang Q, Chen X, Hay N. Akt as a target for cancer therapy: more is not always better (lessons from studies in mice). Br J Cancer. 2017;117(2):159-63. DOI:10.1038/bjc.2017.153
13. Andrikopoulou A, Chatzinikolaou S, Panourgias E, et al. The emerging role of capivasertib in breast cancer. Breast. 2022;63:157-67. DOI:10.1016/j.breast.2022.03.018
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15. Davies BR, Greenwood H, Dudley P, et al. Preclinical pharmacology of AZD5363, an inhibitor of AKT: pharmacodynamics, antitumor activity, and correlation of monotherapy activity with genetic background. Mol Cancer Ther. 2012;11(4):873-7. DOI:10.1158/1535-7163.MCT-11-0824-T
16. Ribas R, Pancholi S, Guest SK, et al. AKT Antagonist AZD5363 Influences Estrogen Receptor Function in Endocrine-Resistant Breast Cancer and Synergizes with Fulvestrant (ICI182780) In Vivo. Mol Cancer Ther. 2015;14(9):2035-48. DOI:10.1158/1535-7163.MCT-15-0143
17. Jones RH, Casbard A, Carucci M, et al. Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive breast cancer (FAKTION): a multicentre, randomised, controlled, phase 2 trial. Lancet Oncol. 2020;21(3):345-57. DOI:10.1016/S1470-2045(19)30817-4
18. Howell SJ, 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
19. Rugo HS. Capivasertib and fulvestrant (F) for patients (pts) with aromatase inhibitor (AI)-resistant HR+/HER2- advanced breast cancer (ABC): Second progression-free survival (PFS2) and time to first subsequent chemotherapy (TFSC) in the CAPItello-291 trial. Annals of Oncology. 2024;9(suppl. 4):1-47.
2. Tiuliandin SA, Artamonova EV, Zhigulev AN, et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu raka molochnoi zhelezy. Prakticheskie rekomendatsii RUSSCO #3s2, chast' 1. Zlokachestvennye opukholi. 2023;13:157-200 (in Russian). DOI:10.18027/2224-5057-2023-13-3s2-1-157-200
3. Huang J, Zheng L, Sun Z, Li J. CDK4/6 inhibitor resistance mechanisms and treatment strategies (Review). Int J Mol Med. 2022;50(4). DOI:10.3892/ijmm.2022.5184
4. Millis SZ, Ikeda S, Reddy S, et al. Landscape of Phosphatidylinositol-3-Kinase Pathway Alterations Across 19 784 Diverse Solid Tumors. JAMA Oncol. 2016;2(12):1565-53. DOI:10.1001/jamaoncol.2016.0891
5. O'Leary B, Cutts RJ, Liu Y, et al. The Genetic Landscape and Clonal Evolution of Breast Cancer Resistance to Palbociclib plus Fulvestrant in the PALOMA-3 Trial. Cancer Discov. 2018;8(11):1390-403. DOI:10.1158/2159-8290.CD-18-0264
6. Wander SA, Cohen O, Gong X, et al. The Genomic Landscape of Intrinsic and Acquired Resistance to Cyclin-Dependent Kinase 4/6 Inhibitors in Patients with Hormone Receptor-Positive Metastatic Breast Cancer. Cancer Discov. 2020;10(8):1174-13. DOI:10.1158/2159-8290.CD-19-1390
7. Turner NC, Oliveira M, Howell SJ, et al. Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2023;388(22):2058-70. DOI:10.1056/NEJMoa2214131
8. Ma CX, Reinert T, Chmielewska I, Ellis MJ. Mechanisms of aromatase inhibitor resistance. Nat Rev Cancer. 2015;15(5):261-75. DOI:10.1038/nrc3920
9. Pereira B, Chin SF, Rueda OM, et al. The somatic mutation profiles of 2,433 breast cancers refines their genomic and transcriptomic landscapes. Nat Commun. 2016;7:11479. DOI:10.1038/ncomms11479
10. Frogne T, Jepsen JS, Larsen SS, et al. Antiestrogen-resistant human breast cancer cells require activated protein kinase B/Akt for growth. Endocr Relat Cancer. 2005;12(3):599-614. DOI:10.1677/erc.1.00946
11. Miller TW, Hennessy BT, González-Angulo AM, et al. Hyperactivation of phosphatidylinositol-3 kinase promotes escape from hormone dependence in estrogen receptor-positive human breast cancer. J Clin Invest. 2010;120(7):2406-13. DOI:10.1172/JCI41680
12. Wang Q, Chen X, Hay N. Akt as a target for cancer therapy: more is not always better (lessons from studies in mice). Br J Cancer. 2017;117(2):159-63. DOI:10.1038/bjc.2017.153
13. Andrikopoulou A, Chatzinikolaou S, Panourgias E, et al. The emerging role of capivasertib in breast cancer. Breast. 2022;63:157-67. DOI:10.1016/j.breast.2022.03.018
14. Rugo HS, Lerebours F, Ciruelos E, et al. Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study. Lancet Oncol. 2021;22(4):489-98. DOI:10.1016/S1470-2045(21)00034-6
15. Davies BR, Greenwood H, Dudley P, et al. Preclinical pharmacology of AZD5363, an inhibitor of AKT: pharmacodynamics, antitumor activity, and correlation of monotherapy activity with genetic background. Mol Cancer Ther. 2012;11(4):873-7. DOI:10.1158/1535-7163.MCT-11-0824-T
16. Ribas R, Pancholi S, Guest SK, et al. AKT Antagonist AZD5363 Influences Estrogen Receptor Function in Endocrine-Resistant Breast Cancer and Synergizes with Fulvestrant (ICI182780) In Vivo. Mol Cancer Ther. 2015;14(9):2035-48. DOI:10.1158/1535-7163.MCT-15-0143
17. Jones RH, Casbard A, Carucci M, et al. Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive breast cancer (FAKTION): a multicentre, randomised, controlled, phase 2 trial. Lancet Oncol. 2020;21(3):345-57. DOI:10.1016/S1470-2045(19)30817-4
18. Howell SJ, 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
19. Rugo HS. Capivasertib and fulvestrant (F) for patients (pts) with aromatase inhibitor (AI)-resistant HR+/HER2- advanced breast cancer (ABC): Second progression-free survival (PFS2) and time to first subsequent chemotherapy (TFSC) in the CAPItello-291 trial. Annals of Oncology. 2024;9(suppl. 4):1-47.
2. Тюляндин С.А., Артамонова Е.В., Жигулев А.Н., и др. Практические рекомендации по лекарственному лечению рака молочной железы. Практические рекомендации RUSSCO #3s2, часть 1. Злокачественные опухоли. 2023;13:157-200 [Tiuliandin SA, Artamonova EV, Zhigulev AN, et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu raka molochnoi zhelezy. Prakticheskie rekomendatsii RUSSCO #3s2, chast' 1. Zlokachestvennye opukholi. 2023;13:157-200 (in Russian)]. DOI:10.18027/2224-5057-2023-13-3s2-1-157-200
3. Huang J, Zheng L, Sun Z, Li J. CDK4/6 inhibitor resistance mechanisms and treatment strategies (Review). Int J Mol Med. 2022;50(4). DOI:10.3892/ijmm.2022.5184
4. Millis SZ, Ikeda S, Reddy S, et al. Landscape of Phosphatidylinositol-3-Kinase Pathway Alterations Across 19 784 Diverse Solid Tumors. JAMA Oncol. 2016;2(12):1565-53. DOI:10.1001/jamaoncol.2016.0891
5. O'Leary B, Cutts RJ, Liu Y, et al. The Genetic Landscape and Clonal Evolution of Breast Cancer Resistance to Palbociclib plus Fulvestrant in the PALOMA-3 Trial. Cancer Discov. 2018;8(11):1390-403. DOI:10.1158/2159-8290.CD-18-0264
6. Wander SA, Cohen O, Gong X, et al. The Genomic Landscape of Intrinsic and Acquired Resistance to Cyclin-Dependent Kinase 4/6 Inhibitors in Patients with Hormone Receptor-Positive Metastatic Breast Cancer. Cancer Discov. 2020;10(8):1174-13. DOI:10.1158/2159-8290.CD-19-1390
7. Turner NC, Oliveira M, Howell SJ, et al. Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2023;388(22):2058-70. DOI:10.1056/NEJMoa2214131
8. Ma CX, Reinert T, Chmielewska I, Ellis MJ. Mechanisms of aromatase inhibitor resistance. Nat Rev Cancer. 2015;15(5):261-75. DOI:10.1038/nrc3920
9. Pereira B, Chin SF, Rueda OM, et al. The somatic mutation profiles of 2,433 breast cancers refines their genomic and transcriptomic landscapes. Nat Commun. 2016;7:11479. DOI:10.1038/ncomms11479
10. Frogne T, Jepsen JS, Larsen SS, et al. Antiestrogen-resistant human breast cancer cells require activated protein kinase B/Akt for growth. Endocr Relat Cancer. 2005;12(3):599-614. DOI:10.1677/erc.1.00946
11. Miller TW, Hennessy BT, González-Angulo AM, et al. Hyperactivation of phosphatidylinositol-3 kinase promotes escape from hormone dependence in estrogen receptor-positive human breast cancer. J Clin Invest. 2010;120(7):2406-13. DOI:10.1172/JCI41680
12. Wang Q, Chen X, Hay N. Akt as a target for cancer therapy: more is not always better (lessons from studies in mice). Br J Cancer. 2017;117(2):159-63. DOI:10.1038/bjc.2017.153
13. Andrikopoulou A, Chatzinikolaou S, Panourgias E, et al. The emerging role of capivasertib in breast cancer. Breast. 2022;63:157-67. DOI:10.1016/j.breast.2022.03.018
14. Rugo HS, Lerebours F, Ciruelos E, et al. Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study. Lancet Oncol. 2021;22(4):489-98. DOI:10.1016/S1470-2045(21)00034-6
15. Davies BR, Greenwood H, Dudley P, et al. Preclinical pharmacology of AZD5363, an inhibitor of AKT: pharmacodynamics, antitumor activity, and correlation of monotherapy activity with genetic background. Mol Cancer Ther. 2012;11(4):873-7. DOI:10.1158/1535-7163.MCT-11-0824-T
16. Ribas R, Pancholi S, Guest SK, et al. AKT Antagonist AZD5363 Influences Estrogen Receptor Function in Endocrine-Resistant Breast Cancer and Synergizes with Fulvestrant (ICI182780) In Vivo. Mol Cancer Ther. 2015;14(9):2035-48. DOI:10.1158/1535-7163.MCT-15-0143
17. Jones RH, Casbard A, Carucci M, et al. Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive breast cancer (FAKTION): a multicentre, randomised, controlled, phase 2 trial. Lancet Oncol. 2020;21(3):345-57. DOI:10.1016/S1470-2045(19)30817-4
18. Howell SJ, 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
19. Rugo HS. Capivasertib and fulvestrant (F) for patients (pts) with aromatase inhibitor (AI)-resistant HR+/HER2- advanced breast cancer (ABC): Second progression-free survival (PFS2) and time to first subsequent chemotherapy (TFSC) in the CAPItello-291 trial. Annals of Oncology. 2024;9(suppl. 4):1-47.
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2. Tiuliandin SA, Artamonova EV, Zhigulev AN, et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu raka molochnoi zhelezy. Prakticheskie rekomendatsii RUSSCO #3s2, chast' 1. Zlokachestvennye opukholi. 2023;13:157-200 (in Russian). DOI:10.18027/2224-5057-2023-13-3s2-1-157-200
3. Huang J, Zheng L, Sun Z, Li J. CDK4/6 inhibitor resistance mechanisms and treatment strategies (Review). Int J Mol Med. 2022;50(4). DOI:10.3892/ijmm.2022.5184
4. Millis SZ, Ikeda S, Reddy S, et al. Landscape of Phosphatidylinositol-3-Kinase Pathway Alterations Across 19 784 Diverse Solid Tumors. JAMA Oncol. 2016;2(12):1565-53. DOI:10.1001/jamaoncol.2016.0891
5. O'Leary B, Cutts RJ, Liu Y, et al. The Genetic Landscape and Clonal Evolution of Breast Cancer Resistance to Palbociclib plus Fulvestrant in the PALOMA-3 Trial. Cancer Discov. 2018;8(11):1390-403. DOI:10.1158/2159-8290.CD-18-0264
6. Wander SA, Cohen O, Gong X, et al. The Genomic Landscape of Intrinsic and Acquired Resistance to Cyclin-Dependent Kinase 4/6 Inhibitors in Patients with Hormone Receptor-Positive Metastatic Breast Cancer. Cancer Discov. 2020;10(8):1174-13. DOI:10.1158/2159-8290.CD-19-1390
7. Turner NC, Oliveira M, Howell SJ, et al. Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2023;388(22):2058-70. DOI:10.1056/NEJMoa2214131
8. Ma CX, Reinert T, Chmielewska I, Ellis MJ. Mechanisms of aromatase inhibitor resistance. Nat Rev Cancer. 2015;15(5):261-75. DOI:10.1038/nrc3920
9. Pereira B, Chin SF, Rueda OM, et al. The somatic mutation profiles of 2,433 breast cancers refines their genomic and transcriptomic landscapes. Nat Commun. 2016;7:11479. DOI:10.1038/ncomms11479
10. Frogne T, Jepsen JS, Larsen SS, et al. Antiestrogen-resistant human breast cancer cells require activated protein kinase B/Akt for growth. Endocr Relat Cancer. 2005;12(3):599-614. DOI:10.1677/erc.1.00946
11. Miller TW, Hennessy BT, González-Angulo AM, et al. Hyperactivation of phosphatidylinositol-3 kinase promotes escape from hormone dependence in estrogen receptor-positive human breast cancer. J Clin Invest. 2010;120(7):2406-13. DOI:10.1172/JCI41680
12. Wang Q, Chen X, Hay N. Akt as a target for cancer therapy: more is not always better (lessons from studies in mice). Br J Cancer. 2017;117(2):159-63. DOI:10.1038/bjc.2017.153
13. Andrikopoulou A, Chatzinikolaou S, Panourgias E, et al. The emerging role of capivasertib in breast cancer. Breast. 2022;63:157-67. DOI:10.1016/j.breast.2022.03.018
14. Rugo HS, Lerebours F, Ciruelos E, et al. Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study. Lancet Oncol. 2021;22(4):489-98. DOI:10.1016/S1470-2045(21)00034-6
15. Davies BR, Greenwood H, Dudley P, et al. Preclinical pharmacology of AZD5363, an inhibitor of AKT: pharmacodynamics, antitumor activity, and correlation of monotherapy activity with genetic background. Mol Cancer Ther. 2012;11(4):873-7. DOI:10.1158/1535-7163.MCT-11-0824-T
16. Ribas R, Pancholi S, Guest SK, et al. AKT Antagonist AZD5363 Influences Estrogen Receptor Function in Endocrine-Resistant Breast Cancer and Synergizes with Fulvestrant (ICI182780) In Vivo. Mol Cancer Ther. 2015;14(9):2035-48. DOI:10.1158/1535-7163.MCT-15-0143
17. Jones RH, Casbard A, Carucci M, et al. Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive breast cancer (FAKTION): a multicentre, randomised, controlled, phase 2 trial. Lancet Oncol. 2020;21(3):345-57. DOI:10.1016/S1470-2045(19)30817-4
18. Howell SJ, 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
19. Rugo HS. Capivasertib and fulvestrant (F) for patients (pts) with aromatase inhibitor (AI)-resistant HR+/HER2- advanced breast cancer (ABC): Second progression-free survival (PFS2) and time to first subsequent chemotherapy (TFSC) in the CAPItello-291 trial. Annals of Oncology. 2024;9(suppl. 4):1-47.
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