Palbociclib: A Novel Cyclin-Dependent Kinase Inhibitor for Hormone Receptorã¢â€œPositive Advanced Breast Cancer

Annals of Pharmacotherapy

Volumn 49, Issue 11, 2015, Pages 1252-1260

  Mangini, Neha S ^a   Wesolowski, Robert ^a   Ramaswamy, Bhuvaneswari ^a   Lustberg, Maryam B ^a   Berger, Michael J ^a  

^a OHIO STATE UNIVERSITY   (United States)

Author keywords

advanced breast cancer; CDK inhibitor; fulvestrant; letrozole; palbociclib; PD 0332991

Indexed keywords

ANTINEOPLASTIC AGENT; CYCLIN DEPENDENT KINASE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ERBB2 PROTEIN, HUMAN; ESTRADIOL; FULVESTRANT; LETROZOLE; NITRILE; PALBOCICLIB; PIPERAZINE DERIVATIVE; PYRIDINE DERIVATIVE; TRIAZOLE DERIVATIVE;

ANALOGS AND DERIVATIVES; ANTAGONISTS AND INHIBITORS; BREAST NEOPLASMS; DISEASE FREE SURVIVAL; FEMALE; HUMAN; METABOLISM; NEOPLASMS, HORMONE-DEPENDENT; PATHOLOGY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); UNITED STATES;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; CYCLIN-DEPENDENT KINASES; DISEASE-FREE SURVIVAL; ESTRADIOL; FEMALE; HUMANS; NEOPLASMS, HORMONE-DEPENDENT; NITRILES; PIPERAZINES; PYRIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTOR, ERBB-2; TRIAZOLES; UNITED STATES;

EID: 84961684491     PISSN: 10600280     EISSN: 15426270     Source Type: Journal    
DOI: 10.1177/1060028015602273     Document Type: Review

References (35)

1. National Cancer Institute. SEER database. http://seer.cancer. gov/statfacts/html/breast.html. Accessed March 4, 2015.
2. Goldhirsch A, Wood WC, Coates AS, et al. Strategies for subtypes—dealing with the diversity of breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann Oncol. 2011;22:1736–1747. doi:10.1093/annonc/mdr304.
3. Cardoso F, Bischoff J, Brain E, et al. A review of the treatment of endocrine responsive metastatic breast cancer in postmenopausal women. Cancer Treat Rev. 2013;39:457–465. doi:10.1016/j.ctrv.2012.06.011.
4. Buzdar AU. Endocrine therapy in the treatment of metastatic breast cancer. Semin Oncol. 2001;28:291–304.
5. Nabholtz JM, Buzdar A, Pollak M, et al. Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. Arimidex Study Group. J Clin Oncol. 2000;18:3758–3767.
6. Mouridsen H, Gershanovich M, Sun Y, et al. Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: analysis of survival and update of efficacy from the International Letrozole Breast Cancer Group. J Clin Oncol. 2003;21:2101–2109. doi:10.1200/JCO.2003.04.194.
7. Paridaens RJ, Dirix LY, Beex LV, et al. Phase III study comparing exemestane with tamoxifen as first-line hormonal treatment of metastatic breast cancer in postmenopausal women: the European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group. J Clin Oncol. 2008;26:4883–4890. doi:10.1200/JCO.2007.14.4659.
8. Thurlimann B, Hess D, Koberle D, et al. Anastrozole (“Arimidex”) versus tamoxifen as first-line therapy in postmenopausal women with advanced breast cancer: results of the double-blind cross-over SAKK trial 21/95—a sub-study of the TARGET (Tamoxifen or “Arimidex” Randomized Group Efficacy and Tolerability) trial. Breast Cancer Res Treat. 2004;85:247–254. doi:10.1023/B:BREA.0000025420. 78346.f9.
9. Robertson JF, Osborne CK, Howell A, et al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women: a prospective combined analysis of two multicenter trials. Cancer. 2003; 98: 229–238. doi:10.1002/cncr.11468.
10. Robertson JF, Llombart-Cussac A, Rolski J, et al. Activity of fulvestrant 500 mg versus anastrozole 1 mg as first-line treatment for advanced breast cancer: results from the FIRST study. J Clin Oncol. 2009;27:4530–4535. doi:10.1200/JCO.2008.21.1136.
11. Robertson JF, Lindemann JP, Llombart-Cussac A, et al. Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of advanced breast cancer: follow-up analysis from the randomized “FIRST” study. Breast Cancer Res Treat. 2012;136:503-511. doi:10.1007/s10549-012-2192-4.
12. Bergh J, Jonsson PE, Lidbrink EK, et al. FACT: an open-label randomized phase III study of fulvestrant and anastrozole in combination compared with anastrozole alone as first-line therapy for patients with receptor-positive postmenopausal breast cancer. J Clin Oncol. 2012;30:1919–1925. doi:10.1200/JCO.2011.38.1095.
13. Mehta RS, Barlow WE, Albain KS, et al. Combination anastrozole and fulvestrant in metastatic breast cancer. N Engl J Med. 2012;367:435–444. doi:10.1056/NEJMoa 1201622.
14. National Comprehensive Cancer Network. Breast cancer (version 1.2015). http://www.nccn.org/professionals/physician_ gls/pdf/breast.pdf. Accessed March 4, 2015.
15. Fedele P, Orlando L, Schiavone P, et al. Recent advances in the treatment of hormone receptor positive HER2 negative metastatic breast cancer. Crit Rev Oncol Hematol. 2015;94:291–301. doi:10.1016/j.critrevonc.2015.01.001.
16. Finn RS, Crown JP, Lang I, 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. doi:10.1016/S1470-2045 (14)71159-3.
17. US Food and Drug Administration. Palbociclib. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm432886.htm. Accessed March 4, 2015.
18. Finn RS, Dering J, Conklin D, 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. doi:10.1186/bcr2419.
19. Shapiro GI. Cyclin-dependent kinase pathways as targets for cancer treatment. J Clin Oncol. 2006;24:1770–1783. doi:10.1200/JCO.2005.03.7689.
20. Musgrove EA, Caldon CE, Barraclough J, Stone A, Sutherland RL. Cyclin D as a therapeutic target in cancer. Nat Rev Cancer. 2011;11:558–572. doi:10.1038/nrc3090.
21. Dickson MA. Molecular pathways: CDK4 inhibitors for cancer therapy. Clin Cancer Res. 2014;20:3379–3383. doi:10.1158/1078-0432.CCR-13-1551.
22. Roberts PJ, Bisi JE, Strum JC, et al. Multiple roles of cyclindependent kinase 4/6 inhibitors in cancer therapy. J Natl Cancer Inst. 2012;104:476–487. doi:10.1093/jnci/djs002.
23. Ibrance (R) (palbociclib) [prescribing information]. New York, NY: Pfizer Laboratories, Inc; 2015.
24. Parrish KE, Pokorny JL, Mittapalli RK, et al. BBB efflux pump activity limits brain penetration of palbociclib (PD0332991) in glioblastoma. Mol Cancer Ther. 2013;12(11, suppl):C81.
25. Schultz KA, Petronio J, Bendel A, Patterson R, Vaughn DJ. PD0332991 (palbociclib) for treatment of pediatric intracranial growing teratoma syndrome. Pediatr Blood Cancer. 2015;62:1072–1074. doi:10.1002/pbc.25338.
26. Michaud K, Solomon DA, Oermann E, et al. Pharmacologic inhibition of cyclin-dependent kinases 4 and 6 arrests the growth of glioblastoma multiforme intracranial xenografts. Cancer Res. 2010;70:3228–3238. doi:10.1158/0008-5472. CAN-09-4559.
27. Schwartz GK, LoRusso PM, Dickson MA, et al. Phase I study of PD 0332991, a cyclin-dependent kinase inhibitor, administered in 3-week cycles (Schedule 2/1). Br J Cancer. 2011;104:1862–1868. doi:10.1038/bjc.2011.177.
28. Flaherty KT, Lorusso PM, Demichele A, et al. Phase I, doseescalation trial of the oral cyclin-dependent kinase 4/6 inhibitor PD 0332991, administered using a 21-day schedule in patients with advanced cancer. Clin Cancer Res. 2012;18:568– 576. doi:10.1158/1078-0432.CCR-11-0509.
29. Slamon DJ, Hurvitz SA, Applebaum S, et al. Phase I study of PD 0332991, cyclin-D kinase (CDK) 4/6 inhibitor in combination with letrozole for first-line treatment of patients with ER-positive, Her2-negative breast cancer [abstract 3060]. J Clin Oncol. 2010;28(suppl):15s.
30. Turner NC, Ro J, Andre F, et al. Palbociclib in hormonereceptor- positive advanced breast cancer. N Engl J Med. 2015;373:209–219. doi:10.1056/NEJMoa1505270.
31. Johnson SM, Torrice CD, Bell JF, et al. Mitigation of hematologic radiation toxicity in mice through pharmacological quiescence induced by CDK4/6 inhibition. J Clin Invest. 2010;120:2528–2536. doi:10.1172/JCI41402.
32. DeMichele A, Clark AS, Tan KS, 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;21:995–1001. doi:10.1158/1078-0432. CCR-14-2258.
33. Clark AS, O'Dwyer PJ, Heitjan D, et al. A phase I trial of palbociclib and paclitaxel in metastatic breast cancer [abstract 527]. J Clin Oncol. 2014;32(suppl):5s.
34. Clinicaltrials.gov.https://clinicaltrials.gov/ct2/results?term= palbociclib+AND+breast+cancer&Search=Search. Accessed March 4, 2015.
35. Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012;366:520–529. doi:10.1056/NEJMoa1109653.