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Clin Cancer Res. 2015 Aug 15;21(16):3591-6. doi: 10.1158/1078-0432.CCR-15-0390. Epub 2015 Jun 22.

Palbociclib for the Treatment of Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer.

Author information

1
Department of Internal Medicine, Division of Hematology/Oncology, University of Michigan, Ann Arbor, Michigan.
2
Department of Internal Medicine, Division of Hematology/Oncology, University of Michigan, Ann Arbor, Michigan. norahh@med.umich.edu.

Abstract

Palbociclib is a selective inhibitor of cyclin-dependent kinases 4 and 6 that acts by reducing phosphorylation of the tumor suppressor gene retinoblastoma. When added to the aromatase inhibitor letrozole in a randomized phase II trial for first-line therapy of estrogen receptor-positive, HER2-negative metastatic breast cancer, palbociclib significantly increased progression-free survival compared with letrozole alone [palbociclib + letrozole: 20.2 months; 95% confidence interval (CI), 13.8-27.5; letrozole: 10.2 months; 95% CI, 5.7-12.6; HR, 0.49; 95% CI, 0.32-0.75; P = 0.0004]. On the basis of these results, the drug was recently granted accelerated approval by the FDA, and confirmatory studies are ongoing. Because this drug has a rational target in an oncologic pathway, concurrent biomarker development is of interest. In breast cancer, the most useful predictive biomarkers identified thus far are estrogen receptor and HER2 receptor status, although additional studies are ongoing. In this article, we review the development of palbociclib and its use in treatment of hormone receptor-positive metastatic breast cancer in the context of other FDA-approved agents in this setting.

PMID:
26100274
PMCID:
PMC4537809
DOI:
10.1158/1078-0432.CCR-15-0390
[Indexed for MEDLINE]
Free PMC Article

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