Endocrine therapy (ET)-based regimens are the mainstay of treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer. With the introduction of new treatment classes, it is important to examine patient symptoms and health-related quality of life (HRQoL) at the start of this changing therapeutic landscape. This real-world study describes the patient-reported outcomes (PROs) of women with HR+/HER2− advanced breast cancer receiving ET-based regimens who were naïve to systemic treatment in the advanced setting across five European countries (EU5). Data were collected between March and July 2017 from surveyed oncologists and their patients at a single time point using the multinational Adelphi Advanced Breast Cancer Disease Specific Programme™. Patients completed PRO questionnaires on HRQoL (EORTC QLQ-C30), pain severity and interference, and work and activity impairment. A multiple linear regression model explored factors associated with HRQoL. Across EU5, 226 physicians provided data on 781 women with HR+/HER2− advanced breast cancer taking their first ET-based regimen for advanced disease, of whom 252 provided PRO data. This subset had a mean age of 67.1 years, 94% were postmenopausal, 89% were diagnosed with advanced breast cancer at initial presentation, 79% had stage IV disease (66% of these patients had bone metastases and 38% had visceral metastases, including 18% with liver metastases) and 77% were on endocrine-only therapy as their initial treatment for advanced disease. The mean EORTC QLQ-C30 global health score (50.9) was worse than the reference value for patients with advanced breast cancer (60.2). Fatigue, pain, and insomnia were the most severe symptoms, and mean functioning scores were also worse than reference values. “Worst pain” and “pain interference” were moderate/severe for 42 and 80% of patients. Mean activity impairment was 44%, and greater activity impairment was associated with poorer HRQoL. Despite receiving first-line ET-based regimens for advanced disease, these women had a poor HRQoL and high levels of symptoms, pain, pain interference and activity impairment. New treatments that maintain a stable disease state and reduce activity impairment may have a positive effect on the HRQoL of those living with advanced breast cancer.

中文翻译：

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在五个欧洲国家中，接受HR + / HER2晚期乳腺癌接受基于内分泌的初始治疗的妇女的真实患者报告的结局。

基于内分泌治疗（ET）的方案是激素受体阳性/人表皮生长因子受体2阴性（HR + / HER2-）晚期乳腺癌患者的主要治疗手段。随着新的治疗方法的引入，在这种变化的治疗环境开始时，检查患者症状和与健康相关的生活质量（HRQoL）非常重要。这项现实世界的研究描述了HR + / HER2晚期乳腺癌的女性患者接受基于ET方案的患者报告的结局（PROs），这些方案在五个欧洲国家（EU5）的晚期均未进行过系统性治疗。2017年3月至2017年7月之间，使用跨国公司Adelphi Advanced Breast Cancer Disease Specific Programme™在单个时间点从接受调查的肿瘤学家及其患者收集了数据。患者完成了关于HRQoL（EORTC QLQ-C30），疼痛严重程度和干扰以及工作和活动障碍的PRO问卷调查。多元线性回归模型探索了与HRQoL相关的因素。在整个EU5中，有226位医生提供了781名患有HR + / HER2−晚期乳腺癌的妇女的数据，这是他们第一个基于ET的晚期疾病治疗方案，其中252名医生提供了PRO数据。该亚组的平均年龄为67.1岁，绝经后为94％，初诊时诊断为晚期乳腺癌，有89％为IV期疾病（其中66％的患者有骨转移，38％的内脏转移，包括18％的患者有肝转移）和77％的患者仅接受内分泌治疗作为晚期疾病的初始治疗。EORTC QLQ-C30平均全球健康评分（50。9）较晚期乳腺癌患者的参考值差（60.2）。疲劳，疼痛和失眠是最严重的症状，平均功能评分也比参考值差。42％和80％的患者的“最严重疼痛”和“疼痛干扰”为中度/重度。平均活动能力减退为44％，更大的活动能力减退与较差的HRQoL相关。尽管这些妇女接受了一线治疗以ET为基础的晚期疾病，但这些妇女的HRQoL差，症状，疼痛，疼痛干扰和活动障碍的水平很高。维持疾病稳定状态并减少活动障碍的新疗法可能对晚期乳腺癌患者的HRQoL产生积极影响。平均功能评分也比参考值差。42％和80％的患者的“最严重疼痛”和“疼痛干扰”为中度/重度。平均活动能力减退为44％，更大的活动能力减退与较差的HRQoL相关。尽管这些妇女接受了一线治疗以ET为基础的晚期疾病，但这些妇女的HRQoL差，症状，疼痛，疼痛干扰和活动障碍的水平很高。维持疾病稳定状态并减少活动障碍的新疗法可能对晚期乳腺癌患者的HRQoL产生积极影响。平均功能评分也比参考值差。42％和80％的患者的“最严重疼痛”和“疼痛干扰”为中度/重度。平均活动能力减退为44％，更大的活动能力减退与较差的HRQoL相关。尽管这些妇女接受了一线治疗以ET为基础的晚期疾病，但她们的HRQoL差，症状，疼痛，疼痛干扰和活动障碍的水平很高。维持疾病稳定状态并减少活动障碍的新疗法可能对晚期乳腺癌患者的HRQoL产生积极影响。尽管这些妇女接受了一线治疗以ET为基础的晚期疾病，但她们的HRQoL差，症状，疼痛，疼痛干扰和活动障碍的水平很高。维持疾病稳定状态并减少活动障碍的新疗法可能对晚期乳腺癌患者的HRQoL产生积极影响。尽管这些妇女接受了一线治疗以ET为基础的晚期疾病，但这些妇女的HRQoL差，症状，疼痛，疼痛干扰和活动障碍的水平很高。维持疾病稳定状态并减少活动障碍的新疗法可能对晚期乳腺癌患者的HRQoL产生积极影响。