KLI

Implications of Tamoxifen Resistance in Palbociclib Efficacy for Patients with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer: Subgroup Analyses of KCSG-BR15-10 (YoungPEARL)

Metadata Downloads
Abstract
Purpose YoungPEARL (KCSG-BR15-10) trial demonstrated a significant progression-free survival (PFS) benefit for premenopausal patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (MBC) for palbociclib plus exemestane with ovarian function suppression compared to capecitabine. However, the number of tamoxifen-sensitive premenopausal patients was small because most recurrences occurred early during adjuvant endocrine therapy (ET), with tamoxifen being the only drug used; hence, the data for these patients were limited. Here we present a subgroup analysis according to tamoxifen sensitivity from the YoungPEARL study.

Materials and Methods Patients were randomized 1:1 to receive palbociclib+ET (oral exemestane 25 mg/day for 28 days, palbociclib 125 mg/day for 21 days, plus leuprolide 3.75 mg subcutaneously every 4 weeks) or chemotherapy (oral capecitabine 1,250 mg/m(2) twice daily for 14 days every 3 weeks). Tamoxifen resistance was defined as: relapse while on adjuvant tamoxifen, relapse within 12 months of completing adjuvant tamoxifen, or progression while on first-line tamoxifen within 6 months for MBC.

Results In total, 184 patients were randomized and 178 were included in the modified intention-to-treat population. PFS improvement in the palbociclib+ET group was observed in tamoxifen-sensitive patients (hazard ratio, 0.38; 95% confidence interval, 0.12 to 1.19). Furthermore, palbociclib+ET prolonged median PFS compared with capecitabine in tamoxifen-sensitive (20.5 months vs. 12.6 months) and tamoxifen-resistant (20.1 months vs. 14.5 months) patients. Palbociclib+ET demonstrated a higher rate of objective response, disease control, and clinical benefit in tamoxifen-sensitive patients.

Conclusion This post hoc exploratory analysis suggests that palbociclib+ET is a promising therapeutic option for premenopausal HR+/HER2- MBC patients irrespective of tamoxifen sensitivity.
Author(s)
강석윤김건민김지현박연희박인해안희경이지윤임석아정경해
Issued Date
2021
Type
Article
Keyword
Breast neoplasmsCDK4/6 inhibitorEndocrine therapyPalbociclibTamoxifen.
DOI
10.4143/crt.2020.1246
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8474
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_nrf_kci_oai_kci_go_kr_ARTI_9843757&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Implications%20of%20Tamoxifen%20Resistance%20in%20Palbociclib%20Efficacy%20for%20Patients%20with%20Hormone%20Receptor-Positive,%20HER2-Negative%20Metastatic%20Breast%20Cancer:%20Subgroup%20Analyses%20of%20KCSG-BR15-10%20(YoungPEARL)&offset=0&pcAvailability=true
Publisher
CANCER RESEARCH AND TREATMENT
Location
대한민국
Language
영어
ISSN
1598-2998
Citation Volume
53
Citation Number
3
Citation Start Page
695
Citation End Page
702
Appears in Collections:
Medicine > Medicine
Authorize & License
  • Authorize공개
Files in This Item:
  • There are no files associated with this item.

Items in Repository are protected by copyright, with all rights reserved, unless otherwise indicated.