Supplementary materials: A systematic review of health-related quality of life outcomes in patients with advanced breast cancer treated with palbociclib

These are peer-reviewed supplementary materials for the article 'One-year budget impact of InTandem™: a novel neurorehabilitation system for individuals with chronic stroke walking impairment' published in the Journal of Comparative Effectiveness Research.Appendix ATable A1: PRISMA 2020 ChecklistTable A2: Search StrategyTable A3: List of Congresses Manually SearchedTable A4: PICOS CriteriaTable A5: List of Included StudiesTable A6: Quality Assessment of Randomized Controlled Trial Full Text Publications using the National Institute for Health and Care Excellence Single Technology Appraisal Quality Assessment ChecklistTable A7: Quality Assessment of Single-Arm Trial and Cohort Text Publications using the Newcastle-Ottawa Scale AppraisalAppendix Table A8: Detailed HRQoL outcomes in randomized clinical trials of patients with advanced breast cancer patients treated with palbociclibAppendix Table A9: Detailed HRQoL outcomes in clinical single-arm trials of patients with advanced breast cancer treated with palbociclibAppendix Table A10: Detailed HRQoL outcomes in real-world evidence studies of patients with advanced breast cancer treated with palbociclibTable A11: Definition of minimal important difference used in included studiesAim: To evaluate the impact of palbociclib treatment on health-related quality of life (HRQoL) in patients with hormone receptor-positive, human epidermal growth factor 2-negative advanced breast cancer (HR+/HER2- aBC) or metastatic breast cancer (mBC) in both the clinical and real-world setting. Materials & methods: A systematic literature review was conducted to identify clinical trials and real-world evidence studies up to June 2023 that reported HRQoL outcomes in patients with HR+/HER2- aBC or mBC treated with Palbociclib. Results: 15 unique studies reported across 35 records were identified. Of these, seven were randomized controlled trials (RCTs), three were single-arm clinical trials and five were real-world evidence (RWE) studies. HRQoL was generally found to be maintained in patients with HR+/HER2-aBC or mBC across RCTs, single-arm clinical trials and RWE studies. HRQoL measures across instruments, study types and line of therapy, were largely reported to be at least maintained if not improved from baseline among patients treated with palbociclib and were observed to be comparable or better in the palbociclib group versus monotherapy control arm in RCTs. Similar results were seen for treatment related outcomes (e.g., sexual functioning, upset by hair loss, systemic therapy side effects etc.), and important individual patient outcomes, including pain, fatigue and physical functioning. Findings were also consistent across key clinical characteristics (visceral metastases, neutropenia), as well as patient populations often underrepresented in clinical trials (Asian patients, older adults). Conclusion: Overall, current evidence suggests that HRQoL is largely preserved with the addition of palbociclib to endocrine therapy in patients with HR+/HER2- aBC or mBC across study types and populations.

本数据集为发表于《比较疗效研究杂志》的论文《InTandem™神经康复系统对慢性中风步态障碍个体一年预算影响》的同行评审补充材料。附录A表A1：PRISMA 2020检查清单表A2：搜索策略表A3：手动搜索的会议列表表A4：PICOS标准表A5：纳入研究列表表A6：使用英国国家健康与护理卓越研究所单一技术评估质量评估清单对随机对照试验全文出版物进行质量评估表A7：使用纽卡斯尔-渥太华量表评估单臂试验和队列文本出版物质量表A8：接受派博西尼布治疗的晚期乳腺癌患者随机临床试验中详细的HRQoL结果表A9：接受派博西尼布治疗的晚期乳腺癌单臂临床试验中详细的HRQoL结果表A10：接受派博西尼布治疗的晚期乳腺癌真实世界证据研究中详细的HRQoL结果表A11：纳入研究中使用的最小重要差异定义目标：评估派博西尼布治疗对激素受体阳性、人表皮生长因子2阴性晚期乳腺癌（HR+/HER2- aBC）或转移性乳腺癌（mBC）患者在临床和真实世界环境中的健康相关生活质量（HRQoL）的影响。材料与方法：进行了一项系统文献综述，以识别截至2023年6月报告了HR+/HER2- aBC或mBC患者使用派博西尼布治疗的HRQoL结果的临床试验和真实世界证据研究。结果：在35份记录中识别出15项独特的研究，其中7项为随机对照试验（RCTs），3项为单臂临床试验，5项为真实世界证据（RWE）研究。在RCTs、单臂临床试验和RWE研究中，HR+/HER2-aBC或mBC患者的HRQoL普遍得到维持。在派博西尼布治疗组中，各种评估工具、研究类型和治疗方案下的HRQoL指标普遍报告至少维持基线水平，甚至有所改善，且在RCTs中，与单药对照组相比，派博西尼布组的HRQoL观察到相似或更好的结果。治疗相关结果（如性功能、因脱发而感到不安、系统性治疗副作用等）以及重要的个体患者结果（包括疼痛、疲劳和身体功能）也显示出类似的结果。在关键临床特征（内脏转移、中性粒细胞减少）以及临床试验中往往代表性不足的患者群体（亚洲患者、老年人）中，发现结果也保持一致。结论：总体而言，现有证据表明，在HR+/HER2- aBC或mBC患者中，将派博西尼布加入内分泌治疗可以很大程度上维持HRQoL，且在研究类型和人群方面均如此。