NDLI: Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Turner, Nicholas C. Zhang, Ke Verma, Sunil Randolph, Sophia Huang Bartlett, Cynthia André, Fabrice Loi, Sherene Loibl, Sibylle Koehler, Maria Iwata, Hiroji Harbeck, Nadia Ro, Jungsil Giorgetti, Carla Cristofanilli, Massimo
Description	Author Affiliation: Turner NC ( From Royal Marsden Hospital, London (N.C.T.))
Abstract	BACKGROUND: Growth of hormone-receptor-positive breast cancer is dependent on cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), which promote progression from the G1 phase to the S phase of the cell cycle. We assessed the efficacy of palbociclib (an inhibitor of CDK4 and CDK6) and fulvestrant in advanced breast cancer. METHODS: This phase 3 study involved 521 patients with advanced hormone-receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that had relapsed or progressed during prior endocrine therapy. We randomly assigned patients in a 2:1 ratio to receive palbociclib and fulvestrant or placebo and fulvestrant. Premenopausal or perimenopausal women also received goserelin. The primary end point was investigator-assessed progression-free survival. Secondary end points included overall survival, objective response, rate of clinical benefit, patient-reported outcomes, and safety. A preplanned interim analysis was performed by an independent data and safety monitoring committee after 195 events of disease progression or death had occurred. RESULTS: The median progression-free survival was 9.2 months (95% confidence interval [CI], 7.5 to not estimable) with palbociclib-fulvestrant and 3.8 months (95% CI, 3.5 to 5.5) with placebo-fulvestrant (hazard ratio for disease progression or death, 0.42; 95% CI, 0.32 to 0.56; P<0.001). The most common grade 3 or 4 adverse events in the palbociclib-fulvestrant group were neutropenia (62.0%, vs. 0.6% in the placebo-fulvestrant group), leukopenia (25.2% vs. 0.6%), anemia (2.6% vs. 1.7%), thrombocytopenia (2.3% vs. 0%), and fatigue (2.0% vs. 1.2%). Febrile neutropenia was reported in 0.6% of palbociclib-treated patients and 0.6% of placebo-treated patients. The rate of discontinuation due to adverse events was 2.6% with palbociclib and 1.7% with placebo. CONCLUSIONS: Among patients with hormone-receptor-positive metastatic breast cancer who had progression of disease during prior endocrine therapy, palbociclib combined with fulvestrant resulted in longer progression-free survival than fulvestrant alone. (Funded by Pfizer; PALOMA3 ClinicalTrials.gov number, NCT01942135.).
ISSN	00284793
Issue Number	3
Volume Number	373
e-ISSN	15334406
Journal	New England Journal of Medicine
Language	English
Publisher	Massachusetts Medical Society (United States)
Publisher Date	2015-07-16
Publisher Place	United States
Access Restriction	Subscribed
Subject Keyword	Antineoplastic Combined Chemotherapy Protocols Therapeutic Use Breast Neoplasms Drug Therapy Piperazines Protein Kinase Inhibitors Pyridines Adult Aged Aged, 80 And Over Adverse Effects Biological Markers Analysis Cyclin-Dependent Kinase 4 Antagonists & Inhibitors Cyclin-Dependent Kinase 6 Disease-Free Survival Double-Blind Method Estradiol Analogs & Derivatives Female Humans Middle Aged Receptor, ErbB-2 Receptors, Estrogen Receptors, Progesterone Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Medicine
Content Type	Text
Resource Type	Article
Subject	Medicine

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