CYCLIN-DEPENDENT KINASE INHIBITOR, PALBOCICLIB – A NEW DRUG FOR THE TREATMENT OF METASTATIC BREAST CANCER
https://doi.org/10.17650/1994-4098-2017-13-4-34-43
Abstract
The sequential use of several lines of endocrine therapy is considered the standard for the treatment of metastatic breast cancer, expressing estrogen or progesterone receptors. PALOMA-1, -2 and -3 studies showed that the combination of the inhibitor of CDK4/6, palbociclib, with endocrine therapy significantly increases the time to progression compared to the use of monotherapy with antagonists of the estrogen signaling cascade.
About the Authors
E. N. Imyanitov
N.N. Petrov National Medical Research Center of Onclology, Ministry of Health of Russia; Saint Petersburg State Pediatric Medical University, Ministry of Health of Russia
Russian Federation
Russian Federation
68 Leningradskaya St., Pesochnyi Settlement, Saint Petersburg 197758; 41 Kirochnaya St., Saint Petersburg 191015; 2 Litovskaya St., Saint Petersburg 194100
T. Yu. Semiglazova
N.N. Petrov National Medical Research Center of Onclology, Ministry of Health of Russia; I.I. Mechnikov North-Western State Medical University Ministry of Health of Russia
Russian Federation
68 Leningradskaya St., Pesochnyi Settlement, Saint Petersburg 197758; 41 Kirochnaya St., Saint Petersburg 191015
Russian Federation
68 Leningradskaya St., Pesochnyi Settlement, Saint Petersburg 197758; 41 Kirochnaya St., Saint Petersburg 191015
References
1. Mohammed H., Russell I.A., Stark R. et al. Progesterone receptor modulates ERα action in breast cancer. Nature 2015;523(7560):313–7. DOI: 10.1038/nature14583.
2. Groenendijk F.H., Zwart W., Floore A. et al. Estrogen receptor splice variants as a potential source of false-positive estrogen receptor status in breast cancer diagnostics. Breast Cancer Res Treat 2013;140(3):475–84. DOI: 10.1007/s10549-013-2648-1.
3. Iyevleva A.G., Imyanitov E.N. Cytotoxic and targeted therapy for hereditary cancers. Hered Cancer Clin Pract 2016;14(1):17. DOI: 10.1186/s13053-016-0057-2.
4. Rugo H.S., Rumble R.B., Macrae E. et al. Endocrine therapy for hormone-receptor-positive metastatic breast cancer: American Society of Clinical Oncology Guideline. J Clin Oncol 2016;34(25):3069–103. DOI: 10.1200/JCO.2016.67.1487.
5. Curigliano G., Burstein H., Winer E. et al. De-escalating end escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol 2017;28(8):1700–12. DOI: 10.1093/annonc/mdx308.
6. Cтуков А.Н., Бланк М.А., Семиглазова Т.Ю. и др. Фармакотерапия опухолей (Посвящается памяти М.Л. Гершановича). Под ред. А.Н. Стукова, М.А. Бланка, Т.Ю. Семиглазовой, А.М. Беляева. СПб.: Вопросы онкологии, 2017. С. 238–69. [Stukov A.N., Blanc M.A., Semiglazova T.Y. et al. Pharmacotherapy of tumors (Dedicated to the memory of M.L. Gershanovich). Eds.: A.N. Stukov, M.A. Blanc, T.Y. Semiglazova, A.M. Belyaev. SPb.: Voprosy onkologii, 2017. Р. 238–69. (In Russ.)].
7. Llombart-Cussac A., Pivot X.B., Biganzoli L. et al. A prognostic factor (PF) index for overall survival in a HER2-negative endocrine resistant metastatic breast cancer (MBC) population: analysis from the ATHENA trial. ASCO 2013. J Clin Oncol 2013;31(suppl):555.
8. Llombart-Cussac A., Pivot X.B., Biganzoli L. et al. A prognostic factor index for overall survival in patients receiving first-line chemotherapy for HER2-negative advanced breast cancer: an analysis of the ATHENA trial. Breast 2014;23(5):656–62. DOI: 10.1016/j.breast.2014.06.017.
9. Theriault R.L., Litton J.K., Mittendorf E.A. et al. Age and survival estimates in patients who have node-negative T1ab breast cancer by breast cancer subtype. Clin Breast Cancer 2011;11(5):325–231. DOI: 10.1016/j.clbc.2011.05.002.
10. Colzani E., Liljegren A., Johansson A.L. et al. Prognosis of patients with breastcancer: causes of death and effects of time since diagnosis, age and tumor characteristics. J Clin Oncol 2011;29(30):4014–21. DOI: 10.1200/JCO.2010.32.6462.
11. Kim I.K., Park S., Hwang H. et al. Clinical significance of age at the time of diagnosis among young breast cancer patients. J Breast Cancer 2011;14(4): 314–21. DOI: 10.4048/jbc.2011.14.4.314.
12. Van de Water W., Bastiaannet E., Hille E.T. et al. Age-specific nonpersistence of endocrine therapy in postmenopausal patients diagnosed with hormone-receptor-positive breast cancer: a TEAM study analysis. Oncologist 2012;17(1):55–63. DOI: 10.1634/theoncologist.2011-0037.
13. Gazet J.C., Sutcliffe R. A randomized trial comparing tamoxifen versus surgery in patients over the age of 70 with operable breast cancer – final results after 28 years of follow-up. Eur J Surg Oncol 2011;37(9):754–7. DOI: 10.1016/j.ejso.2011.06.011.
14. СтенинаМ.Б., ЖуковаЛ.Г., Королева И.А. и др. Практические рекомендации по лекарственному лечению инвазивного рака молочной железы. М.: Практические рекомендации RUSSCO, версия 2016. C. 97–122. [Stenina M.B., Zhukova L.G., Koroleva I.A. et al. Practical recommendations on the medicinal treatment of invasive breast cancer. Moscow: Practical recommendations of RUSSCO, version 2016. Pp. 97–122. (In Russ.)].
15. Lobbezoo D.J., van Kampen R.J., Voogd A.C. et al. In real life, one-quarter of patients with hormone-receptorpositive metastatic breast cancer receive chemotherapy as initial palliative therapy: a study of the Southeast Netherlands Breast Cancer Consortium. Ann Oncol 2016;27(2):256–62. DOI: 10.1093/annonc/mdv544.
16. Cardoso F., Costa A., Norton L. et al. ESO/ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Ann Oncol 2014;25(10): 1871–88. DOI: 10.1093/annonc/mdu385.
17. NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. Version 2.2017. Available at: https://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
18. Robertson J.F.R., Bondarenko I.M., Trishkina E. et al. Fulvestrant 500 mg versus anastrozole 1 mg for hormonereceptor-positive advanced breast cancer (FALCON): an international, randomized, double-blind, phase 3 trial. Lancet 2016;388(10063):2997–3005. DOI: 10.1016/S0140-6736(16)32389-3.
19. Pritchard K.I. Combining endocrine agents with chemotherapy: which patients and what sequence? Cancer 2008;112(3 suppl):718–22. DOI: 10.1002/cncr.23189.
20. Baselga J., Campone M., Piccart M. et al. Everolimus in postmenopausal hormonereceptor-positive advanced breast cancer. N Engl J Med 2012;366(6):520–9. DOI: 10.1056/NEJMoa1109653.
21. Finn R.S., Crown J.P., Lang I. et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of estrogen-receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomized phase 2 study. Lancet Oncol 2015;16(1):25–35. DOI: 10.1016/S1470-2045(14)71159-3.
22. Finn R.S., Martin M., Rugo H.S. et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med 2016;375(20):1925–36. DOI: 10.1056/NEJMoa1607303.
23. Finn R.S., Crown J.P., Ettl J. et al. Efficacy and safety of palbociclib in combination with letrozole as first-line treatment of ER-positive, HER2-negative, advanced breast cancer: expanded analyses of subgroups from randomized pivotal trial PALOMA-1/TRIO-18. Breast Cancer Res 2016;18(1):67. DOI: 10.1186/s13058-016-0721-5.
24. Clinical Review IBRANCE (Palbociclib) Beaver (efficacy) and Amiri (safety) NDA 207,103. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207103Orig1s000MedR.pdf.
25. Finn R.S., Martin M., Rugo H.S. et al. PALOMA-2: primary results from a phase III trial of palbociclib (P) with letrozole (L) compared with letrozole alone in postmenopausal women with ER+/HER2–-advanced breast cancer (ABC). J Clin Oncol 2016;34(suppl):507.
26. Turner N.C., Ro J., Andre F. et al. Palbociclib in hormone-receptor-positive advanced breast cancer. N Engl J Med 2015;373(3):209–19. DOI: 10.1056/NEJMoa1505270.
27. Cristofanilli M., Turner N.C., 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 multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol 2016;17(4):425–39. DOI: 10.1016/S1470-2045(15)00613-0.
28. Cristofanilli M., Bondarenko I., Ro J. et al. PALOMA3: phase 3 trial of fulvestrant with or without palbociclib in preand postmenopausal women with hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on prior endocrine therapy – confirmed efficacy and safety. Poster presented at SABCS 2015, San Antonio, Texas, USA (Abstract 4-13-01).
29. Verma S., Bartlett C.H., Schnell P. et al. Palbociclib in combination with fulvestrant in women with hormone-receptor-positive/HER2-negative advanced metastatic breast cancer: detailed safety analysis from a multicenter, randomized, placebocontrolled, phase III study (PALOMA-3). Oncologyst 2016;21(10):1165–75. DOI: 10.1634/theoncologist.2016-0097.
30. Diéras V., Rugo H.S., Gelmon K. et al. Long-term safety of palbociclib in combination with endocrine therapy in treatment-naive and previously treated women with HR+HER2–-advanced breast cancer: A pooled analysis from randomized phase 2 and 3 studies. Poster presented at SABCS 2016 (Abstract P4-22-07).
31. Harbeck N., Iyer S., Cristofanilli M. et al. Quality of life with palbociclib plus fulvestrant in previously treated hormone-receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial. Ann Oncol 2016;27(6):1047–54. DOI: 10.1093/annonc/mdw139.
32. Finn R.S., Crown J.P., Lang I. et al. Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2–-advanced breast cancer (PALOMA-1, TRIO-18). J Clin Oncol 2017;35(suppl):1001. DOI: 10.1200/JCO.2017.35.15_suppl.1001.
Review
For citations:
Imyanitov E.N., Semiglazova T.Yu. CYCLIN-DEPENDENT KINASE INHIBITOR, PALBOCICLIB – A NEW DRUG FOR THE TREATMENT OF METASTATIC BREAST CANCER. Tumors of female reproductive system. 2017;13(4):34-43. (In Russ.) https://doi.org/10.17650/1994-4098-2017-13-4-34-43
Views:
833
Email this article 