DOI: 10.6084/m9.figshare.26978143.v1
title: Supplementary materials: A systematic review of health-related quality of life outcomes in patients with advanced breast cancer treated with palbociclib

description: <b>These are peer-reviewed supplementary materials for the article '</b><b>One-year budget impact of InTandem™: a</b><b> </b><b>novel neurorehabilitation system for</b><b> </b><b>individuals with chronic stroke walking</b><b> </b><b>impairment</b><b>' published in the</b><b> </b><b><i>Journal of Comparative Effectiveness Research</i></b><b>.</b><b>Appendix A</b><b>Table A1: </b>PRISMA 2020 Checklist<b>Table A2: </b>Search Strategy<b>Table A3: </b>List of Congresses Manually Searched<b>Table A4: </b>PICOS Criteria<b>Table A5: </b>List of Included Studies<b>Table A6: </b>Quality Assessment of Randomized Controlled Trial Full Text Publications using the National Institute for Health and Care Excellence Single Technology Appraisal Quality Assessment Checklist<b>Table A7:</b> Quality Assessment of Single-Arm Trial and Cohort Text Publications using the Newcastle-Ottawa Scale Appraisal<b>Appendix Table A8: </b>Detailed HRQoL outcomes in randomized clinical trials of patients with advanced breast cancer patients treated with palbociclib<b>Appendix Table A9: </b>Detailed HRQoL outcomes in clinical single-arm trials of patients with advanced breast cancer treated with palbociclib<b>Appendix Table A10: </b>Detailed HRQoL outcomes in real-world evidence studies of patients with advanced breast cancer treated with palbociclib<b>Table A11: </b>Definition of minimal important difference used in included studies<b>Aim: </b>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. <b>Materials </b><b>& methods:</b> 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. <b>Results:</b> 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). <b>Conclusion:</b> 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.