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Мутация PIK3CA: изменяя парадигму терапии гормонозависимого HER2-отрицательного метастатического рака молочной железы. Обзор симпозиума
Мутация PIK3CA: изменяя парадигму терапии гормонозависимого HER2-отрицательного метастатического рака молочной железы. Обзор симпозиума
Мутация PIK3CA: изменяя парадигму терапии гормонозависимого HER2-отрицательного метастатического рака молочной железы. Современная Онкология. 2021; 23 (2): 269–274.
DOI: 10.26442/18151434.2021.2.200923
DOI: 10.26442/18151434.2021.2.200923
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Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Аннотация
23 апреля 2021 г. прошел виртуальный форум, посвященный вопросам диагностики и лечения пациентов с гормонозависимым HER2-отрицательным распространенным раком молочной железы с мутацией гена PIK3CA с использованием таргетного препарата алпелисиб. Эксперты-онкологи из Франции и России обсудили значение мутации PIK3CA, необходимость и методы ее диагностики, а также обменялись информацией и опытом применения препарата алпелисиб в том числе у пациенток, ранее получавших ингибитор CDK4/6 и резистентных к эндокринной терапии. На клиническом примере эксперты также обсудили вопросы профилактики и коррекции нежелательных явлений.
Ключевые слова: гормонозависимый HER2-отрицательный распространенный рак молочной железы, мутация PIK3CA, ингибитор PI3K, алпелисиб
Keywords: hormone receptor positive HER2-negative advanced breast cancer, PIK3CA mutation, PI3K inhibitor, alpelisib
Ключевые слова: гормонозависимый HER2-отрицательный распространенный рак молочной железы, мутация PIK3CA, ингибитор PI3K, алпелисиб
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Keywords: hormone receptor positive HER2-negative advanced breast cancer, PIK3CA mutation, PI3K inhibitor, alpelisib
Полный текст
Список литературы
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27. 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
28. Rugo HS, Lerebours F, Ciruelos E, et al. Alpelisib (ALP) + fulvestrant (FUL) in patients (pts) with PIK3CA-mutated (mut) hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) previously treated with cyclin-dependent kinase 4/6 inhibitor (CDKi) + aromatase inhibitor (AI): BYLieve study results. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(Suppl.):abstr. 1006.
29. Andre F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019;380:1929-40. DOI:10.1056/NEJMoa1813904
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DOI:10.1001/jamaoncol.2018.4475
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34. Batalini F, Moulder SL, Winer EP, et al. Response of brain metastases from PIK3CA-mutant breast cancer to alpelisib. JCO Precis Oncol. 2020;4:PO.19.00403. DOI:10.1200/PO.19.00403
35. Bergen ES, Berghoff AS, Medjedovic M, et al. Continued endocrine therapy is associated with improved survival in patients with breast cancer brain metastases. Clin Cancer Res. 2019;25(9):2737-44. DOI:10.1158/1078-0432
36. Arthur LM, Turnbull AK, Renshaw L, et al. Changes in PIK3CA mutation status are not associated with recurrence, metastatic disease or progression in endocrine-treated breast cancer. Breast Cancer Res Treat. 2014;147(1):211-9. DOI:10.1007/s10549-014-3080-x
2. Miller TW, Balko JM, Arteaga CL. Phosphatidylinositol 3-kinase and antiestrogen resistance in breast cancer. J Clin Oncol. 2011;29(33):4452-61. DOI:10.1200/JCO.2010.34.4879
3. Bosch A, Li Z, Bergamaschi A, et al. PI3K inhibition results in enhanced estrogen receptor function and dependence in hormone receptor-positive breast cancer. Sci Transl Med. 2015;7(283):283ra51. DOI:10.1126/scitranslmed.aaa4442
4. Janku F, Yap TA, Meric-Bernstam F. Targeting the PI3K pathway in cancer: are we making headway? Nat Rev Clin Oncol. 2018;15(5):273-91. DOI:10.1038/nrclinonc.2018.28
5. Prat A, Baselga J. The role of hormonal therapy in the management of hormonal-receptor-positive breast cancer with co-expression of HER2. Nat Clin Pract Oncol. 2008;5(9):531-42. DOI:10.1038/ncponc1179
6. Toska E, Osmanbeyoglu HU, Castel P, et al. PI3K pathway regulates ER-dependent transcription in breast cancer through the epigenetic regulator KMT2D. Science. 2017;355(6331):1324-30. DOI:10.1126/science.aah6893
7. Vanhaesebroeck B, Guillermet-Guibert J, Graupera M, et al. The emerging mechanisms of isoform-specific PI3K signalling. Nat Rev Mol Cell Biol. 2010;11(5):329-41. DOI:10.1038/nrm2882
8. Criscitiello C, Marra A, Curigliano G. PIK3CA mutation assessment in HR+/HER2- metastatic breast cancer: overview for oncology clinical practice. J Mol Pathol. 2021;2:42-54. DOI:10.3390/jmp2010005
9. The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61-70. DOI:10.1038/nature11412
10. Zardavas D, Te Marvelde L, Milne RL, et al. Tumor PIK3CA genotype and prognosis in early-stage breast cancer: a pooled analysis of individual patient data. J Clin Oncol. 2018;36(10):981-90. DOI:10.1200/JCO.2017.74.8301
11. Mayer IA, Prat A, Egle D, et al. A phase II randomized study of neoadjuvant letrozole plus alpelisib for hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer (NEO-ORB). Clin Cancer Res. 2019;25(10):2975-87. DOI:10.1158/1078-0432.CCR-18-3160
12. Bertucci F, Ng CKY, Patsouris A, et al. Genomic characterization of metastatic breast cancers. Nature. 2019;569(7757):560-4. DOI:10.1038/s41586-019-1056-z
13. Razavi P, Chang MT, Xu G, et al. The Genomic landscape of endocrine-resistant advanced breast cancers. Cancer Cell. 2018;34(3):427-38.e6. DOI:10.1016/j.ccell.2018.08.008
14. Mosele F, Stefanovska B, Lusque A, et al. Outcome and molecular landscape of patients with PIK3CA-mutated metastatic breast cancer. Ann Oncol. 2020;31(3):377-86. DOI:10.1016/j.annonc.2019.11.006
15. Baselga J, Im SA, Iwata H, et al. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(7):904-16. DOI:10.1016/S1470-2045(17)30376-5
16. Andre F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019;380:1929-40. DOI:10.1056/NEJMoa1813904
17. Juric D, Ciruelos E, Rubovszky G, et al. Alpelisib + fulvestrant for advanced breast cancer: Subgroup analyses from the phase III SOLAR-1 trial [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4–8; San Antonio, TX. Philadelphia (PA): AACR. Cancer Res. 2019;79(4 Suppl.):Abstract GS3-08. DOI:10.1158/1538-7445.SABCS18-GS3-08
18. Rugo H, Mayer I, Conte P, et al. Prevalence of PIK3CA mutations in patients with hormone receptor-positive, human epidermal growth factor-2-negative advanced breast cancer from the SOLAR-1 trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29 – Apr 3; Atlanta, GA. Philadelphia (PA): AACR. Cancer Res. 2019;79(13 Suppl.):Abstract CT142.
19. Mollon L, et al. AACR 2018. Abstract 1207 [poster].
20. Qin H, Liu L, Sun S, et al. The impact of PI3K inhibitors on breast cancer cell and its tumor microenvironment. PeerJ. 2018;6:e5092. DOI:10.7717/peerj.5092
21. Ligresti G, Militello L, Steelman LS, et al. PIK3CA mutations in human solid tumors: role in sensitivity to various therapeutic approaches. Cell Cycle. 2009;8(9):352-8. DOI:10.4161/cc.8.9.8255
22. Samuels Y, Wang Z, Bardelli A, et al. High frequency of mutations of the PIK3CA gene in human cancers. Science. 2004;304(5670):554. DOI:10.1126/science.1096502
23. Ciruelos EM., Loibl S, Mayer IA, et al. Clinical outcomes of alpelisib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer with PIK3CA alterations detected in plasma ctDNA by next-generation sequencing: Biomarker analysis from the SOLAR-1 study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8–11; San Antonio, TX. Philadelphia (PA): AACR. Cancer Res. 2021;81(4 Suppl.):Abstract PD2-06. DOI:10.1158/1538-7445.SABCS20-PD2-06
24. Vasan N, Razavi P, Johnson JL, et al. Double PIK3CA mutations in cis increase oncogenicity and sensitivity to PI3Kα inhibitors. Science. 2019;366(6466):714-23. DOI:10.1126/science.aaw9032
25. Sokolova TN, Aleksakhina SN, Yanus GA, et al. The frequency and spectrum of PIK3CA mutations in patients with estrogen receptor-positive HER2-negative advanced breast cancer residing in various regions of Russia. Journal of Modern Oncology. 2021;23(1):61-7 (in Russian) DOI:10.26442/18151434.2021.1.200744
26. Cardoso F, Senkus E, Costa A, et al. 4th ESO-ESMO International Consensus Guidelines for advanced breast cancer (ABC 4). Ann Oncol. 2018;29(8):1634-57. DOI:10.1093/annonc/mdy192
27. 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
28. Rugo HS, Lerebours F, Ciruelos E, et al. Alpelisib (ALP) + fulvestrant (FUL) in patients (pts) with PIK3CA-mutated (mut) hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) previously treated with cyclin-dependent kinase 4/6 inhibitor (CDKi) + aromatase inhibitor (AI): BYLieve study results. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(Suppl.):abstr. 1006.
29. Andre F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019;380:1929-40. DOI:10.1056/NEJMoa1813904
30. Rugo H, Lerebours F, Juric D, et al. Alpelisib + letrozole in patients with PIK3CA-mutated, hormone-receptor positive (HR+), human epidermal growth factor receptor-2-negative previously treated with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) + fulvestrant: BYLieve study results. Abstracts: 2020 San Antonio Breast Cancer Virtual Symposium; December 8-11, 2020; San Antonio, Texas. Poster PD2-07. DOI: 10.1158/1538-7445.SABCS20-PD2-07
31. Juric D, Janku F, Rodón J, et al. Alpelisib plus fulvestrant in PIK3CA-altered and PIK3CA-wild-type estrogen receptor-positive advanced breast cancer: a phase 1b clinical trial. JAMA Oncol. 2019;5(2):e184475. DOI:10.1001/jamaoncol.2018.4475
32. Andre F et al. Overall survival (os) results from SOLAR-1, a phase III study of alpelisib (ALP) + fulvestrant (FUL) for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC). Ann Oncol. 2020;31(Suppl. 4):S1142-215.
33. Fitzgerald DM, Muzikansky A, Pinto C, et al. 318P. Association between PIK3CA mutation status and development of brain metastases in HR+/HER2- metastatic breast cancer. Ann Oncol. 2019;30(Suppl. 5):v110. DOI:10.1093/annonc/mdz242.013
34. Batalini F, Moulder SL, Winer EP, et al. Response of brain metastases from PIK3CA-mutant breast cancer to alpelisib. JCO Precis Oncol. 2020;4:PO.19.00403. DOI:10.1200/PO.19.00403
35. Bergen ES, Berghoff AS, Medjedovic M, et al. Continued endocrine therapy is associated with improved survival in patients with breast cancer brain metastases. Clin Cancer Res. 2019;25(9):2737-44. DOI:10.1158/1078-0432
36. Arthur LM, Turnbull AK, Renshaw L, et al. Changes in PIK3CA mutation status are not associated with recurrence, metastatic disease or progression in endocrine-treated breast cancer. Breast Cancer Res Treat. 2014;147(1):211-9. DOI:10.1007/s10549-014-3080-x
2. Miller TW, Balko JM, Arteaga CL. Phosphatidylinositol 3-kinase and antiestrogen resistance in breast cancer. J Clin Oncol. 2011;29(33):4452-61. DOI:10.1200/JCO.2010.34.4879
3. Bosch A, Li Z, Bergamaschi A, et al. PI3K inhibition results in enhanced estrogen receptor function and dependence in hormone receptor-positive breast cancer. Sci Transl Med. 2015;7(283):283ra51. DOI:10.1126/scitranslmed.aaa4442
4. Janku F, Yap TA, Meric-Bernstam F. Targeting the PI3K pathway in cancer: are we making headway? Nat Rev Clin Oncol. 2018;15(5):273-91. DOI:10.1038/nrclinonc.2018.28
5. Prat A, Baselga J. The role of hormonal therapy in the management of hormonal-receptor-positive breast cancer with co-expression of HER2. Nat Clin Pract Oncol. 2008;5(9):531-42. DOI:10.1038/ncponc1179
6. Toska E, Osmanbeyoglu HU, Castel P, et al. PI3K pathway regulates ER-dependent transcription in breast cancer through the epigenetic regulator KMT2D. Science. 2017;355(6331):1324-30. DOI:10.1126/science.aah6893
7. Vanhaesebroeck B, Guillermet-Guibert J, Graupera M, et al. The emerging mechanisms of isoform-specific PI3K signalling. Nat Rev Mol Cell Biol. 2010;11(5):329-41. DOI:10.1038/nrm2882
8. Criscitiello C, Marra A, Curigliano G. PIK3CA mutation assessment in HR+/HER2- metastatic breast cancer: overview for oncology clinical practice. J Mol Pathol. 2021;2:42-54. DOI:10.3390/jmp2010005
9. The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61-70. DOI:10.1038/nature11412
10. Zardavas D, Te Marvelde L, Milne RL, et al. Tumor PIK3CA genotype and prognosis in early-stage breast cancer: a pooled analysis of individual patient data. J Clin Oncol. 2018;36(10):981-90. DOI:10.1200/JCO.2017.74.8301
11. Mayer IA, Prat A, Egle D, et al. A phase II randomized study of neoadjuvant letrozole plus alpelisib for hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer (NEO-ORB). Clin Cancer Res. 2019;25(10):2975-87. DOI:10.1158/1078-0432.CCR-18-3160
12. Bertucci F, Ng CKY, Patsouris A, et al. Genomic characterization of metastatic breast cancers. Nature. 2019;569(7757):560-4. DOI:10.1038/s41586-019-1056-z
13. Razavi P, Chang MT, Xu G, et al. The Genomic landscape of endocrine-resistant advanced breast cancers. Cancer Cell. 2018;34(3):427-38.e6. DOI:10.1016/j.ccell.2018.08.008
14. Mosele F, Stefanovska B, Lusque A, et al. Outcome and molecular landscape of patients with PIK3CA-mutated metastatic breast cancer. Ann Oncol. 2020;31(3):377-86. DOI:10.1016/j.annonc.2019.11.006
15. Baselga J, Im SA, Iwata H, et al. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(7):904-16. DOI:10.1016/S1470-2045(17)30376-5
16. Andre F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019;380:1929-40. DOI:10.1056/NEJMoa1813904
17. Juric D, Ciruelos E, Rubovszky G, et al. Alpelisib + fulvestrant for advanced breast cancer: Subgroup analyses from the phase III SOLAR-1 trial [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4–8; San Antonio, TX. Philadelphia (PA): AACR. Cancer Res. 2019;79(4 Suppl.):Abstract GS3-08. DOI:10.1158/1538-7445.SABCS18-GS3-08
18. Rugo H, Mayer I, Conte P, et al. Prevalence of PIK3CA mutations in patients with hormone receptor-positive, human epidermal growth factor-2-negative advanced breast cancer from the SOLAR-1 trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29 – Apr 3; Atlanta, GA. Philadelphia (PA): AACR. Cancer Res. 2019;79(13 Suppl.):Abstract CT142.
19. Mollon L, et al. AACR 2018. Abstract 1207 [poster].
20. Qin H, Liu L, Sun S, et al. The impact of PI3K inhibitors on breast cancer cell and its tumor microenvironment. PeerJ. 2018;6:e5092. DOI:10.7717/peerj.5092
21. Ligresti G, Militello L, Steelman LS, et al. PIK3CA mutations in human solid tumors: role in sensitivity to various therapeutic approaches. Cell Cycle. 2009;8(9):352-8. DOI:10.4161/cc.8.9.8255
22. Samuels Y, Wang Z, Bardelli A, et al. High frequency of mutations of the PIK3CA gene in human cancers. Science. 2004;304(5670):554. DOI:10.1126/science.1096502
23. Ciruelos EM., Loibl S, Mayer IA, et al. Clinical outcomes of alpelisib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer with PIK3CA alterations detected in plasma ctDNA by next-generation sequencing: Biomarker analysis from the SOLAR-1 study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8–11; San Antonio, TX. Philadelphia (PA): AACR. Cancer Res. 2021;81(4 Suppl.):Abstract PD2-06. DOI:10.1158/1538-7445.SABCS20-PD2-06
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28. Rugo HS, Lerebours F, Ciruelos E, et al. Alpelisib (ALP) + fulvestrant (FUL) in patients (pts) with PIK3CA-mutated (mut) hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) previously treated with cyclin-dependent kinase 4/6 inhibitor (CDKi) + aromatase inhibitor (AI): BYLieve study results. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(Suppl.):abstr. 1006.
29. Andre F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019;380:1929-40. DOI:10.1056/NEJMoa1813904
30. Rugo H, Lerebours F, Juric D, et al. Alpelisib + letrozole in patients with PIK3CA-mutated, hormone-receptor positive (HR+), human epidermal growth factor receptor-2-negative previously treated with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) + fulvestrant: BYLieve study results. Abstracts: 2020 San Antonio Breast Cancer Virtual Symposium; December 8-11, 2020; San Antonio, Texas. Poster PD2-07. DOI: 10.1158/1538-7445.SABCS20-PD2-07
31. Juric D, Janku F, Rodón J, et al. Alpelisib plus fulvestrant in PIK3CA-altered and PIK3CA-wild-type estrogen receptor-positive advanced breast cancer: a phase 1b clinical trial. JAMA Oncol. 2019;5(2):e184475.
DOI:10.1001/jamaoncol.2018.4475
32. Andre F et al. Overall survival (os) results from SOLAR-1, a phase III study of alpelisib (ALP) + fulvestrant (FUL) for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC). Ann Oncol. 2020;31(Suppl. 4):S1142-215.
33. Fitzgerald DM, Muzikansky A, Pinto C, et al. 318P. Association between PIK3CA mutation status and development of brain metastases in HR+/HER2- metastatic breast cancer. Ann Oncol. 2019;30(Suppl. 5):v110.
DOI:10.1093/annonc/mdz242.013
34. Batalini F, Moulder SL, Winer EP, et al. Response of brain metastases from PIK3CA-mutant breast cancer to alpelisib. JCO Precis Oncol. 2020;4:PO.19.00403. DOI:10.1200/PO.19.00403
35. Bergen ES, Berghoff AS, Medjedovic M, et al. Continued endocrine therapy is associated with improved survival in patients with breast cancer brain metastases. Clin Cancer Res. 2019;25(9):2737-44. DOI:10.1158/1078-0432
36. Arthur LM, Turnbull AK, Renshaw L, et al. Changes in PIK3CA mutation status are not associated with recurrence, metastatic disease or progression in endocrine-treated breast cancer. Breast Cancer Res Treat. 2014;147(1):211-9. DOI:10.1007/s10549-014-3080-x
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25. Sokolova TN, Aleksakhina SN, Yanus GA, et al. The frequency and spectrum of PIK3CA mutations in patients with estrogen receptor-positive HER2-negative advanced breast cancer residing in various regions of Russia. Journal of Modern Oncology. 2021;23(1):61-7 (in Russian) DOI:10.26442/18151434.2021.1.200744
26. Cardoso F, Senkus E, Costa A, et al. 4th ESO-ESMO International Consensus Guidelines for advanced breast cancer (ABC 4). Ann Oncol. 2018;29(8):1634-57. DOI:10.1093/annonc/mdy192
27. 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
28. Rugo HS, Lerebours F, Ciruelos E, et al. Alpelisib (ALP) + fulvestrant (FUL) in patients (pts) with PIK3CA-mutated (mut) hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) previously treated with cyclin-dependent kinase 4/6 inhibitor (CDKi) + aromatase inhibitor (AI): BYLieve study results. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(Suppl.):abstr. 1006.
29. Andre F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019;380:1929-40. DOI:10.1056/NEJMoa1813904
30. Rugo H, Lerebours F, Juric D, et al. Alpelisib + letrozole in patients with PIK3CA-mutated, hormone-receptor positive (HR+), human epidermal growth factor receptor-2-negative previously treated with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) + fulvestrant: BYLieve study results. Abstracts: 2020 San Antonio Breast Cancer Virtual Symposium; December 8-11, 2020; San Antonio, Texas. Poster PD2-07. DOI: 10.1158/1538-7445.SABCS20-PD2-07
31. Juric D, Janku F, Rodón J, et al. Alpelisib plus fulvestrant in PIK3CA-altered and PIK3CA-wild-type estrogen receptor-positive advanced breast cancer: a phase 1b clinical trial. JAMA Oncol. 2019;5(2):e184475. DOI:10.1001/jamaoncol.2018.4475
32. Andre F et al. Overall survival (os) results from SOLAR-1, a phase III study of alpelisib (ALP) + fulvestrant (FUL) for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC). Ann Oncol. 2020;31(Suppl. 4):S1142-215.
33. Fitzgerald DM, Muzikansky A, Pinto C, et al. 318P. Association between PIK3CA mutation status and development of brain metastases in HR+/HER2- metastatic breast cancer. Ann Oncol. 2019;30(Suppl. 5):v110. DOI:10.1093/annonc/mdz242.013
34. Batalini F, Moulder SL, Winer EP, et al. Response of brain metastases from PIK3CA-mutant breast cancer to alpelisib. JCO Precis Oncol. 2020;4:PO.19.00403. DOI:10.1200/PO.19.00403
35. Bergen ES, Berghoff AS, Medjedovic M, et al. Continued endocrine therapy is associated with improved survival in patients with breast cancer brain metastases. Clin Cancer Res. 2019;25(9):2737-44. DOI:10.1158/1078-0432
36. Arthur LM, Turnbull AK, Renshaw L, et al. Changes in PIK3CA mutation status are not associated with recurrence, metastatic disease or progression in endocrine-treated breast cancer. Breast Cancer Res Treat. 2014;147(1):211-9. DOI:10.1007/s10549-014-3080-x
Авторы
Эксперты:
Арнедос Моника – д-р мед. наук, проф. отд. медицинской онкологии Института онкологии Гюстава Русси, Вильжюиф, Франция
Ганьшина Инна Петровна – канд. мед. наук, вед. науч. сотр. онкологического отд-ния лекарственных методов лечения (химиотерапевтическое) №1 отд. лекарственного лечения ФГБУ «НМИЦ онкологии им. Н.Н. Блохина», Москва, Россия
Фролова Мона Александровна – д-р мед. наук, ст. науч. сотр. онкологического отд-ния лекарственных методов лечения (химиотерапевтическое) №1 отд. лекарственного лечения ФГБУ «НМИЦ онкологии им. Н.Н. Блохина», Москва, Россия
Глузман Марк Игоревич – канд. мед. наук, зав. химиотерапевтическим отд-нием №12 СПбГУЗ «Городской клинический онкологический диспансер», Санкт-Петербург, Россия
Monica Arnedos – D. Sci. (Med.), Prof., Gustave Roussy Institute of Oncology, Villejuif, France
Inna P. Ganshina – Cand. Sci. (Med.), Blokhin National Medical Research Center of Oncology, Moscow, Russia
Mona A. Frolova – D. Sci. (Med.), Blokhin National Medical Research Center of Oncology, Moscow, Russia
Mark I. Gluzman – Cand. Sci. (Med.), Saint Petersburg City Clinical Oncology Dispensary, Saint Petersburg, Russia
Арнедос Моника – д-р мед. наук, проф. отд. медицинской онкологии Института онкологии Гюстава Русси, Вильжюиф, Франция
Ганьшина Инна Петровна – канд. мед. наук, вед. науч. сотр. онкологического отд-ния лекарственных методов лечения (химиотерапевтическое) №1 отд. лекарственного лечения ФГБУ «НМИЦ онкологии им. Н.Н. Блохина», Москва, Россия
Фролова Мона Александровна – д-р мед. наук, ст. науч. сотр. онкологического отд-ния лекарственных методов лечения (химиотерапевтическое) №1 отд. лекарственного лечения ФГБУ «НМИЦ онкологии им. Н.Н. Блохина», Москва, Россия
Глузман Марк Игоревич – канд. мед. наук, зав. химиотерапевтическим отд-нием №12 СПбГУЗ «Городской клинический онкологический диспансер», Санкт-Петербург, Россия
________________________________________________
Monica Arnedos – D. Sci. (Med.), Prof., Gustave Roussy Institute of Oncology, Villejuif, France
Inna P. Ganshina – Cand. Sci. (Med.), Blokhin National Medical Research Center of Oncology, Moscow, Russia
Mona A. Frolova – D. Sci. (Med.), Blokhin National Medical Research Center of Oncology, Moscow, Russia
Mark I. Gluzman – Cand. Sci. (Med.), Saint Petersburg City Clinical Oncology Dispensary, Saint Petersburg, Russia
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