Abemacyclib is a unique representative of the class of CDK4/6 inhibitors in the treatment of HR+/HER2- metastatic breast cancer
- 作者: Grechukhina K.S1,2, Vorontsova K.A1, Kuko T.M1, Prosvirnov A.A1, Ganshina I.P3, Lubennikova E.V3, Kolyadina I.V4,5, Zhukova L.G1
-
隶属关系:
- A.S. Loginov Moscow Clinical Research Center
- Lomonosov Moscow State University
- N.N. Blokhin National Medical Research Center of Oncology
- National Medical Research Center for Obstetrics, Gynecology and Perinatology n.a. Acad. V.I. Kulakov
- Russian Medical Academy of Continuous Professional Education
- 期: 卷 28, 编号 7 (2021)
- 页面: 15-27
- 栏目: Articles
- URL: https://journals.eco-vector.com/2073-4034/article/view/313174
- DOI: https://doi.org/10.18565/pharmateca.2021.7.15-27
- ID: 313174
如何引用文章
详细
全文:
作者简介
K. Grechukhina
A.S. Loginov Moscow Clinical Research Center; Lomonosov Moscow State University
Email: dr.grechukhina@gmail.com
Moscow, Russia
K. Vorontsova
A.S. Loginov Moscow Clinical Research CenterMoscow, Russia
T. Kuko
A.S. Loginov Moscow Clinical Research CenterMoscow, Russia
A. Prosvirnov
A.S. Loginov Moscow Clinical Research CenterMoscow, Russia
I. Ganshina
N.N. Blokhin National Medical Research Center of OncologyMoscow, Russia
E. Lubennikova
N.N. Blokhin National Medical Research Center of OncologyMoscow, Russia
I. Kolyadina
National Medical Research Center for Obstetrics, Gynecology and Perinatology n.a. Acad. V.I. Kulakov; Russian Medical Academy of Continuous Professional EducationMoscow, Russia
L. Zhukova
A.S. Loginov Moscow Clinical Research CenterMoscow, Russia
参考
- Fry D.W., Bedford D.C., Harvey P.H., et al. Cell cycle and biochemical effects of PD 0183812. A potent inhibitor of the cyclin D-dependent kinases CDK4 and CDK6. J boil Chem. 2001;276(20):16617- 23. doi: 10.1074/jbc.M008867200
- Lallemand L., Duhoux F.P. CDK4/6 inhibitors in the treatment of advanced breast cancer. Belg J Med Oncol. 2017;11(5):234-41
- Prall O.W., Sarcevic B., Musgrove E.A., et al. Estrogen-induced activation of Cdk4 and Cdk2 during G1-S phase progression is accompanied by increased cyclin D1 expression and decreased cyclin-dependent kinase inhibitor association with cyclinE-Cdk2.JBoilChem.1997;272(16):10882- 94. doi: 10.1074/jbc.272.16.10882
- Finn R.S.,Dering J., Conklin D., et al. PD0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptorpositive human breast cancer cell lines in vitro. Breast Cancer res. 2009;11(5):R77. doi: 10.1186/bcr2419
- Vidula N., Rugo H.S. Cyclin-Dependent Kinase 4/6 Inhibitors for the Treatment of Breast Cancer: A Review of Preclinical and Clinical Data. Clin Breast Cancer. 2016;16(1):8-17. Doi: 10.1016/j. clbc.2015.07.005
- Giuliano M., Schettini F., RognoniC., et al. Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2- negative, metastatic breast cancer: a systematic review and network meta-analysis. Lancet. Oncol. 2019;20(10):1360-69. doi: 10.1016/S1470- 2045(19)30420-6
- Gebbia V., Valerio M.R., Firenze A., et al. Abemaciclib: safety and effectiveness of a unique cyclin-dependent kinase inhibitor. Expert Opin Drug Saf. 2020;19(8):945-54. doi: 10.1080/14740338.2020.1781814
- Lallena M.J., Boehnke K., Torres R., et al. Abstract 3101: In-vitro characterization of Abemaciclib pharmacology in ER+ breast cancer cell lines. Cancer Res. 2015;75(Suppl. 15):3101. doi: 10.1158/1538-7445.AM2015-3101
- Robert M., Frenel J.S., Bourbouloux E., et al. Pharmacokinetic drug evaluation of abemaciclib for advanced breast cancer. Expert Opin Drug Metab Toxicol. 2019;15(2):85-91. doi: 10.1080/17425255.2019.1559816
- Goel S., DeCristo M.J., Watt A.C., et al. CDK4/6 inhibition triggers anti-tumour immunity. Nature. 2017;548(7668):471-75. Doi: 10.1038/ nature23465
- DeMichele A., Clark A.S., Tan K.S., et al. CDK 4/6 inhibitor palbociclib (PD0332991) in Rb+ advanced breast cancer: phase II activity, safety, and predictive biomarker assessment. Clin Cancer Res. 2015;21(5):995-1001. doi: 10.1158/1078- 0432.CCR-14-2258
- Infante J.R., Cassier P.A., Gerecitano J.F., et al. A phase I study of the cyclin-dependent kinase 4/6 inhibitor ribociclib (LEE011) in patients with advanced solid tumors and lymphomas. Clin Cancer Res. 2016;22(23):5696-705. doi: 10.1158/1078-0432.CCR-16-1248
- Yamada Y., Ishikawa N., Kakizume T., et al. Abstract B31: a phase I study of single-agent ribociclib in Japanese patients with advanced solid tumors. Mol Cancer Ther. 2015;14(12 suppl 2):B31. doi: 10.1111/cas.13428
- Dickler M.N., Tolaney S.M., Rugo H.S., 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
- Rugo H.S., Tolaney M., Cortes J., et al. Abstract CT044: MONARCH 1: Final overall survival analysis of a phase 2 study of abemaciclib, a CDK4 and CDK6 inhibitor, as monotherapy, in patients with HR+/HER2- breast cancer, after chemotherapy for advanced disease. Cancer Res. 2017;77(Suppl.13) CT044. doi: 10.1158/1538-7445.AM2017- CT044
- Hamilton E., Cortes J., Ozyilkan O., et al. nextMONARCH: Abemaciclib Monotherapy or Combined With Tamoxifen for Metastatic Breast Cancer. Clin Breast Cancer. 2020: doi: 10.1016/j. clbc.2020.09.011
- Palumbo A., Lau G., Saraceni M. Abemaciclib: The NewestCDK4/6InhibitorfortheTreatmentofBreast Cancer. Ann Pharmacother. 2019;53(2):178-85. doi: 10.1177/1060028018795146
- Gelbert L.M., Cai S., Lin X., et al. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/ independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014;32(5):825-37. doi: 10.1007/s10637- 014-0120-7
- Corona S.P., Generali D. Abemaciclib: a CDK4/6 inhibitor for the treatment of HR+/HER2- advanced breast cancer. Drug Des Devel Ther. 2018;12:321-30. doi: 10.2147/DDDT. S137783
- Sledge G.W. Jr, 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
- Sledge G.W., 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. 2019;6(1):116-24. doi: 10.1001/ jamaoncol.2019.4782
- Goetz M.P., 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
- Johnston S., Martin M., Di Leo A., et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ. Breast Cancer. 2019;5:5. doi: 10.1038/s41523- 018-0097-z
- Di Leo A., Toi M., Campone M., et al. Ann. Oncol. 2017;28(Suppl. 5):v605-v649. Doi: 10.1093/ annonc/mdx440
- Sanchez-Martinez C., Gelbert L.M., Shannon H., et al. Abstract B234: LY2835219, a potent oral inhibitor of the cyclin-dependent kinases 4 and 6 (CDK4/6) that crosses the blood-brain barrier and demonstrates in vivo activity against intracranial human brain tumor xenografts. Mol Cancer Ther. 2011;10(Suppl. 11):B234. doi: 10.1158/1535- 7163.TARG-11-B234
- Patnaik A., Rosen L.S., Tolaney S.M., et al. Efficacy and safety of abemaciclib, an inhibitor of CDK4 and CDK6, for patients with breast cancer, non-small cell lung cancer, and other solid tumors. Cancer Discov. 2016;6(7):740-53. doi: 10.1158/2159- 8290.CD-16-0095
- Tolaney S.M., Lin N.U., Thornton D., et al. Abemaciclib for the treatment of brain metastases (BM) secondary to hormone receptor positive (HR+), HER2 negative breast cancer. J Clin Oncol. 2017;35(Suppl. 15):1019. Doi: 10.1200/ JCO.2017.35.15_suppl.1019
- Kotake T., Toi M. Abemaciclib for the treatment of breast cancer. Expert Opin Pharmacother. 2018;19(5):517-24. doi: 10.1080/14656566.2018.1448787
- Tolaney S.M., Sahebjam S., Le Rhun E., et al. A Phase II Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor-Positive Breast Cancer. Clin Cancer Res. 2020;26(20):5310-19. doi: 10.1158/1078- 0432.CCR-20-1764
- Howlett S., Harvey-Jones E., Smith D., et al. Does Concurrent Use of CDK4/6 Inhibitors During Palliative Radiotherapy Increase Toxicity in Patients With Metastatic Breast Cancer? Clin Oncol. (R Coll Radiol). 2021;33(1):e99. Doi: 10.1016/j. clon.2020.10.005
- 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(3):597-604. doi: 10.1007/s10549-019-05133-y
- Messina C., Messina M., Zanardi E. Risks and benefits from CDK inhibitors for advanced HR+ Her 2- breast cancer. Ann Oncol. 2017;28(12):3099- 100. doi: 10.1093/annonc/mdx530
- Ramos-Esquivel A., Hernández-Steller H., Savard M.F., et al. Cyclin-dependent kinase 4/6 inhibitors as first-line treatment for post-menopausal metastatic hormone receptor-positive breast cancer patients: a systematic review and meta-analysis of phase III randomized clinical trials. Breast Cancer. 2018;25(4):479-88. doi: 10.1007/s12282- 018-0848-6
- Ribnikar D., Volovat S.R., Cardoso F. Targeting CDK4/6 pathways and beyond in breast cancer. Breast. 2019;43:8-17. doi: 10.1016/j. breast.2018.10.001
- Scheicher R., Hoelbl-Kovacic A., Bellutti F., et al. CDK6 as a key regulator of hematopoietic and leukemic stem cell activation. Blood. 2015;125(1):90-101. doi: 10.1182/blood2014-06-584417
- Desnoyers A., Nadler M.B., Kumar V., et al. Comparison of treatment-related adverse events of different Cyclin-dependent kinase 4/6 inhibitors in metastatic breast cancer: A network metaanalysis. Cancer Treat Rev. 2020;90:102086. doi: 10.1016/j.ctrv.2020.102086
- Tamura K. Differences of cyclin-dependent kinase 4/6 inhibitor, palbociclib and abemaciclib, in breast cancer. Jpn J Clin Oncol. 2019;49(11):993-98. doi: 10.1093/jjco/hyz151
- Sledge G.W. Abemaciclib Plus Fulvestrant Delays Breast Cancer Progression in MONARCH 2. ASCO Ann Meeting. 2017;Abstract 1000. Doi: 10.199/ Abst_199_180696
- Goetz M.P., Martin M., Tokunaga E., et al. Health-Related Quality of Life in MONARCH 3: Abemaciclib plus an Aromatase Inhibitor as Initial Therapy in HR+, HER2- Advanced Breast Cancer. Оncol. 2020;25(9):e1346-54. Doi: 10.1634/ theoncologist.2020-0084
- Omori Y., Enatsu S., Cai Z., et al. Patients’ preferences forpostmenopausalhormone receptorpositive, human epidermal growth factor receptor 2-negative advanced breast cancer treatments in Japan. Breast Cancer. 2019;26(5):652-62. doi: 10.1007/s12282-019-00965-4
- Bossi P., Antonuzzo A., Cherny N.I., et al. ESMO Guidelines Committee. Diarrhoea in adult cancer patients: ESMO Clinical Practice Guidelines. Ann Oncol. 2018;29(Suppl. 4):iv126-42. doi: 10.1093/annonc/mdy145
- Hurvitz S.A., Martin M., Press M.F., et al. Potent Cell-Cycle Inhibition and Upregulation of Immune Response with Abemaciclib and Anastrozole in neoMONARCH, Phase II Neoadjuvant Study in HR+/HER2- Breast Cancer. Clin Cancer Res. 2020;26(3):566-80. doi: 10.1158/1078-0432. CCR-19-1425
- Johnston S.R., Harbeck N., Hegg R., et al. monarchE Committee Members and Investigators. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020;38(34):3987- 98. doi: 10.1200/JCO.20.02514
- Tolaney S.M., Wardley A.M., Zambelli S., et al. Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standardof-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, openlabel, phase 2 trial. Lancet. Oncol. 2020;21(6): 763-75. doi: 10.1016/S1470-2045(20) 30112-1