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Patient-Reported Outcomes of Palbociclib Plus Exemestane with GnRH Agonist versus Capecitabine in Premenopausal Women with Hormone Receptor-Positive Metastatic Breast Cancer: A Prospective, Open-Label, Randomized Phase ll Trial (KCSG-BR 15-10)

Authors
Lee, SoohyeonIm, Seock-AhKim, Gun MinJung, Kyung HaeKang, Seok YunPark, In HaeKim, Jee HyunLee, Kyoung EunAhn, Hee KyungLee, Moon HeeKim, Hee-JunKim, Han JoLee, Jong InKoh, Su-JinPark, Yeon Hee
Issue Date
11월-2020
Publisher
MDPI
Keywords
palbociclib; capecitabine; breast neoplasm; premenopause; patient-reported outcome measures
Citation
CANCERS, v.12, no.11
Indexed
SCIE
SCOPUS
Journal Title
CANCERS
Volume
12
Number
11
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/52007
DOI
10.3390/cancers12113265
ISSN
2072-6694
Abstract
In the era of CDK4/6 inhibitors in hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, few trials have been specifically studied to compare quality of life between palbociclib plus endocrine therapy (ET) and cytotoxic chemotherapy exclusively in premenopausal women. We aimed to evaluate differences of patient report outcomes (PROs) between palbociclib plus ET and capecitabine. PROs were assessed using EORTC QLQ-C30 at baseline, every 6 weeks, and the end of treatment. All EORTC QLQ-30 scores were maintained from baseline to the end of treatment. Patients treated palbociclib plus ET arm experienced delay in time-to-deterioration of physical functioning (HR = 0.58, 95% CI, 0.36 to 0.84, p = 0.0058), nausea and vomiting (HR = 0.48; 95% CI, 0.32 to 0.73, p = 0.0005), and diarrhea (HR = 0.42; 95% CI, 0.27 to 0.65, p = 0.001). There was a numeric trend for worsening of insomnia (HR = 1.43; 95% CI, 0.96 to 2.16, p = 0.079) and favoring of appetite loss (HR = 0.69, 95% CI, 0.44 to 1.07, p = 0.09) in the palbociclib plus ET arm. Premenopausal patients with palbociclib plus ET maintained QoL without compromising treatment efficacy.
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