@article{8b767b6edda545e991c033a8b72e16af,
title = "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)",
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.",
keywords = "Breast neoplasm, Capecitabine, Palbociclib, Patient-reported outcome measures, Premenopause",
author = "Soohyeon Lee and Im, {Seock Ah} and Kim, {Gun Min} and Jung, {Kyung Hae} and Kang, {Seok Yun} and Park, {In Hae} and Kim, {Jee Hyun} and Lee, {Kyoung Eun} and Ahn, {Hee Kyung} and Lee, {Moon Hee} and Kim, {Hee Jun} and Kim, {Han Jo} and Lee, {Jong In} and Koh, {Su Jin} and Park, {Yeon Hee}",
note = "Funding Information: This work was supported by a grant from the South Korean Ministry of Health and Welfare (HA17C0055) and by the South Korean National R&D Program for Cancer Control, Ministry of Health and Welfare (1720150). This study was supported by three companies that provided the study drugs: Pfizer (exemestane and palbociclib), Shinpoong (capecitabine), and Daewoong Korea and Takeda (leuprolide). The authors thank the academic contract research organisation in Samsung Medical Center (SMC), the Statistics and Data Center for data management in SMC, and study coordinators from each institute. The authors also thank the team members who supported this trial; Seonwoo Kim and Min-JI Kim who did the statistical analysis in SMC; Korean Cancer Study Group Breast Cancer committee members; and study staff at each site Funding Information: Funding: This work was supported by a grant from the South Korean Ministry of Health and Welfare (HA17C0055) and by the South Korean National R&D Program for Cancer Control, Ministry of Health and Welfare (1720150). Funding Information: Acknowledgments: This study was supported by three companies that provided the study drugs: Pfizer (exemestane and palbociclib), Shinpoong (capecitabine), and Daewoong Korea and Takeda (leuprolide). The authors thank the academic contract research organisation in Samsung Medical Center (SMC), the Statistics and Data Center for data management in SMC, and study coordinators from each institute. The authors also thank the team members who supported this trial; Seonwoo Kim and Min-JI Kim who did the statistical analysis in SMC; Korean Cancer Study Group Breast Cancer committee members; and study staff at each site. Publisher Copyright: {\textcopyright} 2020 by the authors. Licensee MDPI, Basel, Switzerland.",
year = "2020",
month = nov,
doi = "10.3390/cancers12113265",
language = "English",
volume = "12",
pages = "1--12",
journal = "Cancers",
issn = "2072-6694",
publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",
number = "11",
}