Palbociclib in hormone-receptor–positive advanced breast cancer

Turner, Nicholas C., Ro, Jungsil, André, Fabrice, Loi, Sherene, Verma, Sunil, Iwata, Hiroji, Harbeck, Nadia, Loibl, Sibylle, Huang Bartlett, Cynthia, Zhang, Ke, Giorgetti, Carla, Randolph, Sophia, Koehler, Maria and Cristofanilli, Massimo 2015, Palbociclib in hormone-receptor–positive advanced breast cancer, New England journal of medicine, vol. 373, no. 3, pp. 209-219, doi: 10.1056/NEJMoa1505270.

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Title Palbociclib in hormone-receptor–positive advanced breast cancer
Author(s) Turner, Nicholas C.
Ro, Jungsil
André, Fabrice
Loi, Sherene
Verma, Sunil
Iwata, Hiroji
Harbeck, Nadia
Loibl, Sibylle
Huang Bartlett, Cynthia
Zhang, Ke
Giorgetti, Carla
Randolph, Sophia
Koehler, Maria
Cristofanilli, Massimo
Journal name New England journal of medicine
Volume number 373
Issue number 3
Start page 209
End page 219
Total pages 11
Publisher Massachusetts Medical Society
Place of publication Waltham, Mass.
Publication date 2015-07-16
ISSN 0028-4793
Summary BackgroundGrowth 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.MethodsThis 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.ResultsThe 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.ConclusionsAmong 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 number, NCT01942135.)
Language eng
DOI 10.1056/NEJMoa1505270
Field of Research 111299 Oncology and Carcinogenesis not elsewhere classified
Socio Economic Objective 920102 Cancer and Related Disorders
HERDC Research category C1.1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2015, Massachusestts Medical Society
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