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)
- 주제(키워드) palbociclib , capecitabine , breast neoplasm , premenopause , patient-reported outcome measures
- 주제(기타) Oncology
- 설명문(일반) [Lee, Soohyeon] Korea Univ, Coll Med, Dept Internal Med, Div Oncol Hematol,Anam Hosp, Seoul 02841, South Korea; [Im, Seock-Ah] Seoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Dept Internal Med,Canc Res Inst, Seoul 03080, South Korea; [Kim, Gun Min] Yonsei Univ, Coll Med, Dept Internal Med, Div Med Oncol, Seoul 03722, South Korea; [Jung, Kyung Hae] Univ Ulsan, Coll Med, Asan Med Ctr, Dept Oncol, Seoul 05505, South Korea; [Kang, Seok Yun] Ajou Univ, Sch Med, Dept Hematol Oncol, Suwon 16499, South Korea; [Park, In Hae] Natl Canc Ctr, Ctr Breast Canc, Goyang 10408, South Korea; [Kim, Jee Hyun] Seoul Natl Univ, Coll Med, Dept Internal Med, Bundang Hosp, Seongnam 13620, South Korea; [Lee, Kyoung Eun] Ewha Womans Univ Hosp, Dept Hematol & Oncol, Seoul 07985, South Korea; [Ahn, Hee Kyung] Gachon Univ, Dept Internal Med, Div Med Oncol, Gil Med Ctr, Incheon 21563, South Korea; [Lee, Moon Hee] Inha Univ, Dept Internal Med, Sch Med, Incheon 22332, South Korea; [Kim, Hee-Jun] Chung Ang Univ, Dept Internal Med, Coll Med, Seoul 06974, South Korea; [Kim, Han Jo] Soonchunhyang Univ Hosp, Dept Internal Med, Div Hematol & Oncol, Cheonan 31151, South Korea; [Lee, Jong In] Yonsei Univ, Wonju Severance Christian Hosp, Dept Internal Med, Div Hematol Oncol,Wonju Coll Med, Wonju 26426, South Korea; [Koh, Su-Jin] Ulsan Univ, Ulsan Univ Hosp, Dept Hematol & Oncol, Coll Med, Ulsan 44033, South Korea; [Park, Yeon Hee] Sungkyunkwan Univ, Samsung Med Ctr, Dept Med, Div Hematol Oncol,Sch Med, Seoul 06351, South Korea; [Park, In Hae] Korea Univ, Guro Hosp, Dept Med Oncol, Seoul 08308, South Korea
- 등재 SCIE, SCOPUS
- OA유형 gold, Green Published
- 발행기관 MDPI
- 발행년도 2020
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000174685
- 본문언어 영어
- Published As http://dx.doi.org/10.3390/cancers12113265
- PubMed https://pubmed.ncbi.nlm.nih.gov/33167305
초록/요약
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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