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폐경 후 한국인 여성에서 호르몬 수용체 양성, HER2 음성 전이성 유방암에 대한 1차 내분비 요법으로 palbociclib 과 letrozole 병합 치료의 효과 및 안정성에 대한 후향적 분석

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Abstract
Background: Palbociclib selectively inhibits cyclin-dependent kinase 4/6 to regulate cell cycle. Based on the results of the PALOMA-2 study which showed palbociclib plus letrozole combination therapy was effective for postmenopausal women with hormone receptor (HR)-positive and HER2-negative advanced breast cancer (ABC), palbociclib was approved in Korea in June 2017. We report the real-world outcomes of palbociclib plus letrozole combination therapy for Korean patients.
Material and Methods: This study is a retrospective cohort study of patients treated with palbociclib plus letrozole for postmenopausal women with HR-positve, HER2-negative ABC at the Asan Medical Center, Seoul, Korea between June 2017 and August 2019. Primary endpoint was progression-free survival (PFS) and secondary endpoints included overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), and safety.
Results: A total of 204 patients (pts) were enrolled with median age of 53 years (range, 29-82), 135 (66.2%) with visceral metastases and 80 (39.2%) received bilateral salpingo-oophorectomy (BSO) . Median follow-up period was 19.2 months (mo) (range, 1.4 to 39.8). The median PFS was 26.0 mo (95% confidence interval [CI], 19.9 to 26.1) and the median OS was not reached. The median PFS of pts who underwent BSO was 26.0 mo (95% CI, 19.9 to 26.0) and was not reached in those with natural menopause. ORR was 38.2% (95% CI, 31.5 to 45.2), and CBR was 81.9% (95% CI, 75.8 to 86.8). The most common adverse events of any grade were neutropenia (95.0%), followed by anemia (51.4%), thrombocytopenia (33.3%), stomatitis (22.5%), fatigue (18.1%). The most frequently reported grade ≥3 adverse events were neutropenia (83.3%, 170/204), but febrile neutropenia occurred only in 4 (2.0%) pts. Dose reduction of palbociclib was required in 164 (80.4%) pts due to neutropenia and was stopped in 2 pts due to grade 4 neutropenia and thrombocytopenia.
Conclusions: Palbociclib plus letrozole in Korean pts with HR-positive, HER2-negative ABC demonstrated comparable efficacy to pivotal phase 3 trial. Although dose reductions of palbociclib due to hematologic toxicities were required more frequently in this population, dose adjustments seemed not affect the treatment outcome.
Author(s)
김혜영
Issued Date
2021
Awarded Date
2021-02
Type
Dissertation
Keyword
breast cancerHR+HER2-letrozolepalbociclib
URI
https://oak.ulsan.ac.kr/handle/2021.oak/5916
http://ulsan.dcollection.net/common/orgView/200000369258
Alternative Author(s)
Hyeyeong Kim
Affiliation
울산대학교
Department
일반대학원 의학과의학전공
Advisor
정경해
Degree
Master
Publisher
울산대학교 일반대학원 의학과의학전공
Language
eng
Rights
울산대학교 논문은 저작권에 의해 보호받습니다.
Appears in Collections:
Medicine > 1. Theses (Master)
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