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Palbociclib for Residual High-Risk Invasive HR-Positive and HER2-Negative Early Breast Cancer-The Penelope-B Trial

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Abstract
PURPOSE About one third of patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who have residual invasive disease after neoadjuvant chemotherapy (NACT) will relapse. Thus, additional therapy is needed. Palbociclib is a cyclin-dependent kinase 4 and 6 inhibitor demonstrating efficacy in the metastatic setting.

PATIENTS AND METHODS PENELOPE-B (NCT01864746) is a double-blind, placebo-controlled, phase III study in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative primary breast cancer without a pathological complete response after taxane-containing NACT and at high risk of relapse (clinical pathological staging-estrogen receptor grading score >= 3 or 2 and ypN+). Patients were randomly assigned (1:1) to receive 13 cycles of palbociclib 125 mg once daily or placebo on days 1-21 in a 28-day cycle in addition to endocrine therapy (ET). Primary end point is invasive disease-free survival (iDFS). Final analysis was planned after 290 iDFS events with a two-sided efficacy boundary P < .0463 because of two interim analyses.

RESULTS One thousand two hundred fifty patients were randomly assigned. The median age was 49.0 years (range, 19-79), and the majority were ypN+ with Ki-67 <= 15%; 59.4% of patients had a clinical pathological staging-estrogen receptor grading score >= 3. 50.1% received aromatase inhibitor, and 33% of premenopausal women received a luteinizing hormone releasing hormone analog in addition to either tamoxifen or an aromatase inhibitor. After a median follow-up of 42.8 months (92% complete), 308 events were confirmed. Palbociclib did not improve iDFS versus placebo added to ET-stratified hazard ratio, 0.93 (95% repeated CI, 0.74 to 1.17) and two-sided weighted log-rank test (Cui, Hung, and Wang) P = .525. There was no difference among the subgroups. Most common related serious adverse events were infections and vascular disorders in 113 (9.1%) patients with no difference between the treatment arms. Eight fatal serious adverse events (two palbociclib and six placebo) were reported.

CONCLUSION Palbociclib for 1 year in addition to ET did not improve iDFS in women with residual invasive disease after NACT. (C) 2021 by American Society of Clinical Oncology.
Author(s)
김성배Andreas MakrisCarsten DenkertCatherine M KellyCynthia Huang-BartelettFrederik MarmeGunter von MinckwitzGustavo WerutskyHarry BearHerve BonnefoiHope S RugoJose Garcia-SaenzKaren GelmonMarco ColleoniMaria Jose Lechuga FreanMaria KoehlerMasakazu ToiMichael GnantMichael UntchMig
Issued Date
2021
Type
Article
DOI
10.1200/JCO.20.03639
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8425
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_proquest_miscellaneous_2508570128&amp;context=PC&amp;vid=ULSAN&amp;lang=ko_KR&amp;search_scope=default_scope&amp;adaptor=primo_central_multiple_fe&amp;tab=default_tab&amp;query=any,contains,Palbociclib%20for%20Residual%20High-Risk%20Invasive%20HR-Positive%20and%20HER2-Negative%20Early%20Breast%20Cancer-The%20Penelope-B%20Trial&amp;offset=0&amp;pcAvailability=true
Publisher
JOURNAL OF CLINICAL ONCOLOGY
Location
미국
Language
영어
ISSN
0732-183X
Citation Volume
39
Citation Number
14
Citation Start Page
1518
Citation End Page
1518
Appears in Collections:
Medicine > Medicine
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