Cyclin Dependent Kinases 4/6 Inhibitors: A New Hope for Breast Cancer Therapy
Keywords:
Breast cancer; cell cycle; cyclin; cyclin dependent kinaseAbstract
The limitless of self-renewal and replication of cancer cells, one of cancer hallmarks, is supported by various molecular mechanisms. Overexpression of cyclins and cyclin-dependent kinases, a group of cell cycle machinery proteins, is one of the underlying mechanisms that promotes cell proliferation in several cancers, especially in breast cancer. Breast cancer is the highest prevalent cancer among female patients in Thailand and globally. Many studies revealed the overexpression of cyclin D1, a partner of cyclin-dependent kinase 4/6 (CDK4/6), in more than 30% of breast cancer cases. These proteins are indicated to be essential for survival of breast cancer cells but are disputable for normal mammary cells. These findings, thus, led to the development of CDK4/6 inhibitors which arrest the cell cycle at G1 phase and inhibit cell division. These inhibitors have been tested for their efficacy both preclinical studies in breast cancer cells and clinical trials in breast cancer patients. Patients who supplemented with these drugs had almost double longer survival times compared with those who received the placebo. The efficiency of CDK4/6 inhibitors, hence, urged the approval and implementation of the CDK4/6 inhibitors into the clinical practice. The discovery of CDK4/6 inhibitors is one of the successful translations of basic medical research to the clinical study which finally implemented in the clinical practice of breast cancer treatment at present.
References
1. Hanahan D, Weinberg RA. The hallmarks of cancer. Cell 2000; 100: 57-70.
2. Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell 2011; 144: 646-674.
3. Singh D, Attri BK, Gill RK, Bariwal J. Review on EGFR Inhibitors: Critical Updates. Mini Rev Med Chem 2016; 16: 1134-1166.
4. Liu L, Michowski W, Inuzuka H, Shimizu K, Nihira NT, Chick JM, et al. G1 cyclins link proliferation, pluripotency and differentiation of embryonic stem cells. Nat Cell Biol 2017; 19: 177-188.
5. Liu L, Michowski W, Kolodziejczyk A, Sicinski P. The cell cycle in stem cell proliferation, pluripotency and differentiation. Nat Cell Biol 2019; 21: 1060-1067.
6. Lipsick J. A History of Cancer Research: Tumor Suppressor Genes. Cold Spring Harb Perspect Biol. 2020; 12: a035907.
7. Otto T, Sicinski P. Cell cycle proteins as promising targets in cancer therapy. Nat Rev Cancer 2017; 17: 93-115.
8. Kwapisz D. Cyclin-dependent kinase 4/6 inhibitors in breast cancer: palbociclib, ribociclib, and abemaciclib. Breast Cancer Res Treat 2017; 166: 41-54.
9. Eggersmann TK, Degenhardt T, Gluz O, Wuerstlein R, Harbeck N. CDK4/6 Inhibitors Expand the Therapeutic Options in Breast Cancer: Palbociclib, Ribociclib and Abemaciclib. BioDrugs 2019; 33: 125-135.
10. Chen Z, Xu L, Shi W, Zeng F, Zhuo R, Hao X, et al. Trends of female and male breast cancer incidence at the global, regional, and national levels, 1990-2017. Breast Cancer Res Treat 2020.
11. สถาบันมะเร็งแห่งชาติ. ทะเบียนมะเร็งระดับโรงพยาบาล พ.ศ. 2561. กรุงเทพมหานคร: บริษัท นิวธรรมดาการพิมพ์ (ประเทศไทย) จำกัด, 2562.
12. Martin P, Bartlett NL, Blum KA, Park S, Maddocks K, Ruan J, et al. A phase 1 trial of ibrutinib plus palbociclib in previously treated mantle cell lymphoma. Blood 2019; 133: 1201-1204.
13. Whittaker S, Madani D, Joshi S, Chung SA, Johns T, Day B, et al. Combination of palbociclib and radiotherapy for glioblastoma. Cell Death Discov 2017; 3: 17033.
14. Sittithumcharee G, Suppramote O, Vaeteewoottacharn K, Sirisuksakun C, Jamnongsong S, Laphanuwat P, et al. Dependency of Cholangiocarcinoma on Cyclin D-Dependent Kinase Activity. Hepatology 2019; 70: 1614-1630.
15. John RR, Malathi N, Ravindran C, Anandan S. Mini review: Multifaceted role played by cyclin D1 in tumor behavior. Indian J Dent Res 2017; 28: 187-192.
16. Dickson C, Fantl V, Gillett C, Brookes S, Bartek J, Smith R, et al. Amplification of chromosome band 11q13 and a role for cyclin D1 in human breast cancer. Cancer Lett 1995; 90: 43-50.
17. Bartkova J, Lukas J, Muller H, Lutzhoft D, Strauss M, Bartek J. Cyclin D1 protein expression and function in human breast cancer. Int J Cancer 1994; 57: 353-361.
18. Gillett C, Fantl V, Smith R, Fisher C, Bartek J, Dickson C, et al. Amplification and overexpression of cyclin D1 in breast cancer detected by immunohistochemical staining. Cancer Res 1994; 54: 1812-7.
19. McIntosh GG, Anderson JJ, Milton I, Steward M, Parr AH, Thomas MD, et al. Determination of the prognostic value of cyclin D1 overexpression in breast cancer. Oncogene. 1995;11:885-91.
20. Yu Q, Geng Y, Sicinski P. Specific protection against breast cancers by cyclin D1 ablation. Nature 2001; 411: 1017-1021.
21. Yu Q, Sicinska E, Geng Y, Ahnstrom M, Zagozdzon A, Kong Y, et al. Requirement for CDK4 kinase function in breast cancer. Cancer Cell 2006; 9: 23-32.
22. Anders L, Ke N, Hydbring P, Choi YJ, Widlund HR, Chick JM, et al. A systematic screen for CDK4/6 substrates links FOXM1 phosphorylation to senescence suppression in cancer cells. Cancer Cell 2011; 20: 620-634.
23. Carthon BC, Neumann CA, Das M, Pawlyk B, Li T, Geng Y, et al. Genetic replacement of cyclin D1 function in mouse development by cyclin D2. Mol Cell Biol 2005; 25: 1081-1088.
24. Ciemerych MA, Kenney AM, Sicinska E, Kalaszczynska I, Bronson RT, Rowitch DH, et al. Development of mice expressing a single D-type cyclin. Genes Dev 2002; 16: 3277-3289.
25. Sicinska E, Aifantis I, Le Cam L, Swat W, Borowski C, Yu Q, et al. Requirement for cyclin D3 in lymphocyte development and T cell leukemias. Cancer Cell 2003; 4: 451-461.
26. Landis MW, Pawlyk BS, Li T, Sicinski P, Hinds PW. Cyclin D1-dependent kinase activity in murine development and mammary tumorigenesis. Cancer Cell 2006; 9: 13-22.
27. Choi YJ, Li X, Hydbring P, Sanda T, Stefano J, Christie AL, et al. The requirement for cyclin D function in tumor maintenance. Cancer Cell 2012; 22: 438-451.
28. Hydbring P, Malumbres M, Sicinski P. Non-canonical functions of cell cycle cyclins and cyclin-dependent kinases. Nat Rev Mol Cell Biol 2016; 17: 280-292.
29. Wang H, Nicolay BN, Chick JM, Gao X, Geng Y, Ren H, et al. The metabolic function of cyclin D3-CDK6 kinase in cancer cell survival. Nature 2017; 546: 426-430.
30. Senderowicz AM. Flavopiridol: the first cyclin-dependent kinase inhibitor in human clinical trials. Invest New Drugs 1999; 17: 313-320.
31. Bisol Â, de Campos PS, Lamers ML. Flavonoids as anticancer therapies: A systematic review of clinical trials. Phytotherapy Research.n/a.
32. Toogood PL, Harvey PJ, Repine JT, Sheehan DJ, VanderWel SN, Zhou H, et al. Discovery of a potent and selective inhibitor of cyclin-dependent kinase 4/6. J Med Chem 2005; 48: 2388-2406.
33. Fry DW, Harvey PJ, Keller PR, Elliott WL, Meade M, Trachet E, et al. Specific inhibition of cyclin-dependent kinase 4/6 by PD 0332991 and associated antitumor activity in human tumor xenografts. Mol Cancer Ther 2004; 3: 1427-1438.
34. Niu Y, Xu J, Sun T. Cyclin-Dependent Kinases 4/6 Inhibitors in Breast Cancer: Current Status, Resistance, and Combination Strategies. J Cancer 2019; 10: 5504-5517.
35. Finn RS, Dering J, Conklin D, Kalous O, Cohen DJ, Desai AJ, et al. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res 2009; 11: R77.
36. Guarducci C, Bonechi M, Boccalini G, Benelli M, Risi E, Di Leo A, et al. Mechanisms of Resistance to CDK4/6 Inhibitors in Breast Cancer and Potential Biomarkers of Response. Breast Care (Basel) 2017; 12: 304-308.
37. Bosco EE, Knudsen ES. RB in breast cancer: at the crossroads of tumorigenesis and treatment. Cell Cycle 2007; 6: 667-671.
38. Dhillon S. Palbociclib: first global approval. Drugs 2015; 75: 543-551.
39. Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, 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: 25-35.
40. Malorni L, Curigliano G, Minisini AM, Cinieri S, Tondini CA, D'Hollander K, et al. Palbociclib as single agent or in combination with the endocrine therapy received before disease progression for estrogen receptor-positive, HER2-negative metastatic breast cancer: TREnd trial. Ann Oncol 2018; 29: 1748-1754.
41. Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, et al. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med 2016; 375: 1925-1936.
42. Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, 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, phase 3 randomised controlled trial. Lancet Oncol 2016; 17: 425-439.
43. Loibl S, Turner NC, Ro J, Cristofanilli M, Iwata H, Im SA, et al. Palbociclib Combined with Fulvestrant in Premenopausal Women with Advanced Breast Cancer and Prior Progression on Endocrine Therapy: PALOMA-3 Results. Oncologist 2017; 22: 1028-1038.
44. Infante JR, Cassier PA, Gerecitano JF, Witteveen PO, Chugh R, Ribrag V, 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: 5696-5705.
45. Curigliano G, Gomez Pardo P, Meric-Bernstam F, Conte P, Lolkema MP, Beck JT, et al. Ribociclib plus letrozole in early breast cancer: A presurgical, window-of-opportunity study. Breast 2016; 28: 191-198.
46. Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, et al. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med 2016; 375: 1738-1748.
47. Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, 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: 2465-2472.
48. Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, 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: 904-915.
49. Torres-Guzman R, Calsina B, Hermoso A, Baquero C, Alvarez B, Amat J, et al. Preclinical characterization of abemaciclib in hormone receptor positive breast cancer. Oncotarget 2017; 8: 69493-69507.
50. Raub TJ, Wishart GN, Kulanthaivel P, Staton BA, Ajamie RT, Sawada GA, et al. Brain Exposure of Two Selective Dual CDK4 and CDK6 Inhibitors and the Antitumor Activity of CDK4 and CDK6 Inhibition in Combination with Temozolomide in an Intracranial Glioblastoma Xenograft. Drug Metab Dispos 2015; 43: 1360-1371.
51. Tate SC, Sykes AK, Kulanthaivel P, Chan EM, Turner PK, Cronier DM. A Population Pharmacokinetic and Pharmacodynamic Analysis of Abemaciclib in a Phase I Clinical Trial in Cancer Patients. Clin Pharmacokinet 2018; 57: 335-344.
52. Dickler MN, Tolaney SM, Rugo HS, Cortes J, Dieras V, Patt D, 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: 5218-5224.
53. Sledge GW, Jr., Toi M, Neven P, Sohn J, Inoue K, Pivot X, 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: 2875-2884.
54. Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, et al. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J Clin Oncol 2017; 35: 3638-3646.
55. Johnston S, Martin M, Di Leo A, Im SA, Awada A, Forrester T, et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer 2019; 5: 5.
56. Harbeck N, Iyer S, Turner N, Cristofanilli M, Ro J, Andre F, 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: 1047-1054.
57. สำนักงานคณะกรรมการอาหารและยา. ระบบค้นหาข้อมูลผลิตภัณฑ์ยา. [เข้าถึงข้อมูลเมื่อวันที่ 27 มีนาคม 2563]. Available from: http://pertento.fda.moph.go.th/FDA_SEARCH_DRUG/SEARCH_DRUG/FRM_SEARCH_DRUG.aspx.
58. กรมบัญชีกลาง. แนวทางการกำกับการเบิกจ่ายยา Ribociclib ในโรคมะเร็งเต้านมระยะแพร่กระจาย ชนิด postmenopausal hormone receptor positive, HER2 negative metastatic breast cancer. [เข้าถึงข้อมูลเมื่อวันที่ 27 มีนาคม 2563]. Available from: http://www.thethaicancer.com/PDF/Drug/OCPAprotocol/62-07-12_%E0%B8%A7340/Ribociclib_Breast.pdf.
59. Herrera-Abreu MT, Palafox M, Asghar U, Rivas MA, Cutts RJ, Garcia-Murillas I, et al. Early Adaptation and Acquired Resistance to CDK4/6 Inhibition in Estrogen Receptor-Positive Breast Cancer. Cancer Res 2016; 76: 2301-2313.
60. Patel P, Asbach B, Shteyn E, Gomez C, Coltoff A, Bhuyan S, et al. Brk/Protein tyrosine kinase 6 phosphorylates p27KIP1, regulating the activity of cyclin D-cyclin-dependent kinase 4. Mol Cell Biol 2015; 35: 1506-1522.
61. Yang C, Li Z, Bhatt T, Dickler M, Giri D, Scaltriti M, et al. Acquired CDK6 amplification promotes breast cancer resistance to CDK4/6 inhibitors and loss of ER signaling and dependence. Oncogene 2017; 36: 2255-2264.
62. Patel P, Tsiperson V, Gottesman SRS, Somma J, Blain SW. Dual Inhibition of CDK4 and CDK2 via Targeting p27 Tyrosine Phosphorylation Induces a Potent and Durable Response in Breast Cancer Cells. Mol Cancer Res 2018; 16: 361-377.
2. Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell 2011; 144: 646-674.
3. Singh D, Attri BK, Gill RK, Bariwal J. Review on EGFR Inhibitors: Critical Updates. Mini Rev Med Chem 2016; 16: 1134-1166.
4. Liu L, Michowski W, Inuzuka H, Shimizu K, Nihira NT, Chick JM, et al. G1 cyclins link proliferation, pluripotency and differentiation of embryonic stem cells. Nat Cell Biol 2017; 19: 177-188.
5. Liu L, Michowski W, Kolodziejczyk A, Sicinski P. The cell cycle in stem cell proliferation, pluripotency and differentiation. Nat Cell Biol 2019; 21: 1060-1067.
6. Lipsick J. A History of Cancer Research: Tumor Suppressor Genes. Cold Spring Harb Perspect Biol. 2020; 12: a035907.
7. Otto T, Sicinski P. Cell cycle proteins as promising targets in cancer therapy. Nat Rev Cancer 2017; 17: 93-115.
8. Kwapisz D. Cyclin-dependent kinase 4/6 inhibitors in breast cancer: palbociclib, ribociclib, and abemaciclib. Breast Cancer Res Treat 2017; 166: 41-54.
9. Eggersmann TK, Degenhardt T, Gluz O, Wuerstlein R, Harbeck N. CDK4/6 Inhibitors Expand the Therapeutic Options in Breast Cancer: Palbociclib, Ribociclib and Abemaciclib. BioDrugs 2019; 33: 125-135.
10. Chen Z, Xu L, Shi W, Zeng F, Zhuo R, Hao X, et al. Trends of female and male breast cancer incidence at the global, regional, and national levels, 1990-2017. Breast Cancer Res Treat 2020.
11. สถาบันมะเร็งแห่งชาติ. ทะเบียนมะเร็งระดับโรงพยาบาล พ.ศ. 2561. กรุงเทพมหานคร: บริษัท นิวธรรมดาการพิมพ์ (ประเทศไทย) จำกัด, 2562.
12. Martin P, Bartlett NL, Blum KA, Park S, Maddocks K, Ruan J, et al. A phase 1 trial of ibrutinib plus palbociclib in previously treated mantle cell lymphoma. Blood 2019; 133: 1201-1204.
13. Whittaker S, Madani D, Joshi S, Chung SA, Johns T, Day B, et al. Combination of palbociclib and radiotherapy for glioblastoma. Cell Death Discov 2017; 3: 17033.
14. Sittithumcharee G, Suppramote O, Vaeteewoottacharn K, Sirisuksakun C, Jamnongsong S, Laphanuwat P, et al. Dependency of Cholangiocarcinoma on Cyclin D-Dependent Kinase Activity. Hepatology 2019; 70: 1614-1630.
15. John RR, Malathi N, Ravindran C, Anandan S. Mini review: Multifaceted role played by cyclin D1 in tumor behavior. Indian J Dent Res 2017; 28: 187-192.
16. Dickson C, Fantl V, Gillett C, Brookes S, Bartek J, Smith R, et al. Amplification of chromosome band 11q13 and a role for cyclin D1 in human breast cancer. Cancer Lett 1995; 90: 43-50.
17. Bartkova J, Lukas J, Muller H, Lutzhoft D, Strauss M, Bartek J. Cyclin D1 protein expression and function in human breast cancer. Int J Cancer 1994; 57: 353-361.
18. Gillett C, Fantl V, Smith R, Fisher C, Bartek J, Dickson C, et al. Amplification and overexpression of cyclin D1 in breast cancer detected by immunohistochemical staining. Cancer Res 1994; 54: 1812-7.
19. McIntosh GG, Anderson JJ, Milton I, Steward M, Parr AH, Thomas MD, et al. Determination of the prognostic value of cyclin D1 overexpression in breast cancer. Oncogene. 1995;11:885-91.
20. Yu Q, Geng Y, Sicinski P. Specific protection against breast cancers by cyclin D1 ablation. Nature 2001; 411: 1017-1021.
21. Yu Q, Sicinska E, Geng Y, Ahnstrom M, Zagozdzon A, Kong Y, et al. Requirement for CDK4 kinase function in breast cancer. Cancer Cell 2006; 9: 23-32.
22. Anders L, Ke N, Hydbring P, Choi YJ, Widlund HR, Chick JM, et al. A systematic screen for CDK4/6 substrates links FOXM1 phosphorylation to senescence suppression in cancer cells. Cancer Cell 2011; 20: 620-634.
23. Carthon BC, Neumann CA, Das M, Pawlyk B, Li T, Geng Y, et al. Genetic replacement of cyclin D1 function in mouse development by cyclin D2. Mol Cell Biol 2005; 25: 1081-1088.
24. Ciemerych MA, Kenney AM, Sicinska E, Kalaszczynska I, Bronson RT, Rowitch DH, et al. Development of mice expressing a single D-type cyclin. Genes Dev 2002; 16: 3277-3289.
25. Sicinska E, Aifantis I, Le Cam L, Swat W, Borowski C, Yu Q, et al. Requirement for cyclin D3 in lymphocyte development and T cell leukemias. Cancer Cell 2003; 4: 451-461.
26. Landis MW, Pawlyk BS, Li T, Sicinski P, Hinds PW. Cyclin D1-dependent kinase activity in murine development and mammary tumorigenesis. Cancer Cell 2006; 9: 13-22.
27. Choi YJ, Li X, Hydbring P, Sanda T, Stefano J, Christie AL, et al. The requirement for cyclin D function in tumor maintenance. Cancer Cell 2012; 22: 438-451.
28. Hydbring P, Malumbres M, Sicinski P. Non-canonical functions of cell cycle cyclins and cyclin-dependent kinases. Nat Rev Mol Cell Biol 2016; 17: 280-292.
29. Wang H, Nicolay BN, Chick JM, Gao X, Geng Y, Ren H, et al. The metabolic function of cyclin D3-CDK6 kinase in cancer cell survival. Nature 2017; 546: 426-430.
30. Senderowicz AM. Flavopiridol: the first cyclin-dependent kinase inhibitor in human clinical trials. Invest New Drugs 1999; 17: 313-320.
31. Bisol Â, de Campos PS, Lamers ML. Flavonoids as anticancer therapies: A systematic review of clinical trials. Phytotherapy Research.n/a.
32. Toogood PL, Harvey PJ, Repine JT, Sheehan DJ, VanderWel SN, Zhou H, et al. Discovery of a potent and selective inhibitor of cyclin-dependent kinase 4/6. J Med Chem 2005; 48: 2388-2406.
33. Fry DW, Harvey PJ, Keller PR, Elliott WL, Meade M, Trachet E, et al. Specific inhibition of cyclin-dependent kinase 4/6 by PD 0332991 and associated antitumor activity in human tumor xenografts. Mol Cancer Ther 2004; 3: 1427-1438.
34. Niu Y, Xu J, Sun T. Cyclin-Dependent Kinases 4/6 Inhibitors in Breast Cancer: Current Status, Resistance, and Combination Strategies. J Cancer 2019; 10: 5504-5517.
35. Finn RS, Dering J, Conklin D, Kalous O, Cohen DJ, Desai AJ, et al. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res 2009; 11: R77.
36. Guarducci C, Bonechi M, Boccalini G, Benelli M, Risi E, Di Leo A, et al. Mechanisms of Resistance to CDK4/6 Inhibitors in Breast Cancer and Potential Biomarkers of Response. Breast Care (Basel) 2017; 12: 304-308.
37. Bosco EE, Knudsen ES. RB in breast cancer: at the crossroads of tumorigenesis and treatment. Cell Cycle 2007; 6: 667-671.
38. Dhillon S. Palbociclib: first global approval. Drugs 2015; 75: 543-551.
39. Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, 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: 25-35.
40. Malorni L, Curigliano G, Minisini AM, Cinieri S, Tondini CA, D'Hollander K, et al. Palbociclib as single agent or in combination with the endocrine therapy received before disease progression for estrogen receptor-positive, HER2-negative metastatic breast cancer: TREnd trial. Ann Oncol 2018; 29: 1748-1754.
41. Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, et al. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med 2016; 375: 1925-1936.
42. Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, 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, phase 3 randomised controlled trial. Lancet Oncol 2016; 17: 425-439.
43. Loibl S, Turner NC, Ro J, Cristofanilli M, Iwata H, Im SA, et al. Palbociclib Combined with Fulvestrant in Premenopausal Women with Advanced Breast Cancer and Prior Progression on Endocrine Therapy: PALOMA-3 Results. Oncologist 2017; 22: 1028-1038.
44. Infante JR, Cassier PA, Gerecitano JF, Witteveen PO, Chugh R, Ribrag V, 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: 5696-5705.
45. Curigliano G, Gomez Pardo P, Meric-Bernstam F, Conte P, Lolkema MP, Beck JT, et al. Ribociclib plus letrozole in early breast cancer: A presurgical, window-of-opportunity study. Breast 2016; 28: 191-198.
46. Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, et al. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med 2016; 375: 1738-1748.
47. Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, 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: 2465-2472.
48. Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, 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: 904-915.
49. Torres-Guzman R, Calsina B, Hermoso A, Baquero C, Alvarez B, Amat J, et al. Preclinical characterization of abemaciclib in hormone receptor positive breast cancer. Oncotarget 2017; 8: 69493-69507.
50. Raub TJ, Wishart GN, Kulanthaivel P, Staton BA, Ajamie RT, Sawada GA, et al. Brain Exposure of Two Selective Dual CDK4 and CDK6 Inhibitors and the Antitumor Activity of CDK4 and CDK6 Inhibition in Combination with Temozolomide in an Intracranial Glioblastoma Xenograft. Drug Metab Dispos 2015; 43: 1360-1371.
51. Tate SC, Sykes AK, Kulanthaivel P, Chan EM, Turner PK, Cronier DM. A Population Pharmacokinetic and Pharmacodynamic Analysis of Abemaciclib in a Phase I Clinical Trial in Cancer Patients. Clin Pharmacokinet 2018; 57: 335-344.
52. Dickler MN, Tolaney SM, Rugo HS, Cortes J, Dieras V, Patt D, 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: 5218-5224.
53. Sledge GW, Jr., Toi M, Neven P, Sohn J, Inoue K, Pivot X, 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: 2875-2884.
54. Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, et al. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J Clin Oncol 2017; 35: 3638-3646.
55. Johnston S, Martin M, Di Leo A, Im SA, Awada A, Forrester T, et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer 2019; 5: 5.
56. Harbeck N, Iyer S, Turner N, Cristofanilli M, Ro J, Andre F, 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: 1047-1054.
57. สำนักงานคณะกรรมการอาหารและยา. ระบบค้นหาข้อมูลผลิตภัณฑ์ยา. [เข้าถึงข้อมูลเมื่อวันที่ 27 มีนาคม 2563]. Available from: http://pertento.fda.moph.go.th/FDA_SEARCH_DRUG/SEARCH_DRUG/FRM_SEARCH_DRUG.aspx.
58. กรมบัญชีกลาง. แนวทางการกำกับการเบิกจ่ายยา Ribociclib ในโรคมะเร็งเต้านมระยะแพร่กระจาย ชนิด postmenopausal hormone receptor positive, HER2 negative metastatic breast cancer. [เข้าถึงข้อมูลเมื่อวันที่ 27 มีนาคม 2563]. Available from: http://www.thethaicancer.com/PDF/Drug/OCPAprotocol/62-07-12_%E0%B8%A7340/Ribociclib_Breast.pdf.
59. Herrera-Abreu MT, Palafox M, Asghar U, Rivas MA, Cutts RJ, Garcia-Murillas I, et al. Early Adaptation and Acquired Resistance to CDK4/6 Inhibition in Estrogen Receptor-Positive Breast Cancer. Cancer Res 2016; 76: 2301-2313.
60. Patel P, Asbach B, Shteyn E, Gomez C, Coltoff A, Bhuyan S, et al. Brk/Protein tyrosine kinase 6 phosphorylates p27KIP1, regulating the activity of cyclin D-cyclin-dependent kinase 4. Mol Cell Biol 2015; 35: 1506-1522.
61. Yang C, Li Z, Bhatt T, Dickler M, Giri D, Scaltriti M, et al. Acquired CDK6 amplification promotes breast cancer resistance to CDK4/6 inhibitors and loss of ER signaling and dependence. Oncogene 2017; 36: 2255-2264.
62. Patel P, Tsiperson V, Gottesman SRS, Somma J, Blain SW. Dual Inhibition of CDK4 and CDK2 via Targeting p27 Tyrosine Phosphorylation Induces a Potent and Durable Response in Breast Cancer Cells. Mol Cancer Res 2018; 16: 361-377.
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Published
2021-04-07
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Saengboonmee C, Sanlung T, Wongkham S. Cyclin Dependent Kinases 4/6 Inhibitors: A New Hope for Breast Cancer Therapy. SRIMEDJ [Internet]. 2021 Apr. 7 [cited 2024 Apr. 24];36(2):229-3. Available from: https://li01.tci-thaijo.org/index.php/SRIMEDJ/article/view/249589
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Review Articles
