帕博西利布
医学
安慰剂
乳腺癌
生活质量(医疗保健)
内科学
肿瘤科
心情
癌症
物理疗法
妇科
转移性乳腺癌
临床心理学
替代医学
护理部
病理
作者
José Ángel García-Sáenz,Frederik Marmé,Michael Untch,Hervé Bonnefoi,Sung‐Bae Kim,Harry D. Bear,Nicole Mc Carthy,Karen A. Gelmon,Miguel Martín,Catherine M. Kelly,Toralf Reimer,Masakazu Toi,Ernest Law,Helen Bhattacharyya,Michael Gnant,Andreas Makris,Sabine Seiler,Nicole Burchardi,Valentina Nekljudova,Sibylle Loibl,Hope S. Rugo
标识
DOI:10.1016/j.ejca.2023.113420
摘要
Background The PENELOPEB trial investigating efficacy and safety of additional 1-year post-neoadjuvant palbociclib to standard endocrine therapy (ET) high-risk hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) early breast cancer patients failed to improve invasive disease-free survival (iDFS). This analysis compared patient-reported outcomes (PROs) between treatment groups. Patients and Methods Patients received 13 cycles of palbociclib 125 mg/day (n=631) or placebo (n=619) orally for 3 out of 4 weeks + ET. European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30), its breast cancer (BR23) and fatigue (FA13) modules, mood questionnaire GAD7 and European Quality of Life 5 Dimensions (EQ-5D) instruments were used for the assessment of quality of life (QoL). Repeated-measures mixed-effects models were used to evaluate differences in PRO, changes of PRO over time, and treatment-by-time interactions. Results 924 of 1,250 patients (73.9%) completed baseline and at least one post-baseline questionnaire of all PRO instruments. General health status (GHS)/QoL based on EORTC QLQ-C30 was high in both arms (mean [SD]: palbociclib 70.1 [19.3], placebo 71.4 [18.8]) and was slightly higher in the placebo arm (LeastSquare mean difference: 0.82, p<0.001). Higher fatigue was reported in the palbociclib arm (mean [SD]: 30.3 [23.8] vs. placebo 28.3 [22.7]; p<0.001). No statistically significant differences were observed among FA13 physical, cognitive, and emotional fatigue subscales. Conclusion Patient-reported global QoL and fatigue did not substantially change in both treatment arms. Slight differences in GHS, physical functioning, and fatigue favored the placebo arm statistically without achieving clinically meaningful thresholds.
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