Health-related quality of life outcomes in randomized controlled trials in metastatic hormone-sensitive prostate cancer: a systematic review

Susanne Osanto*, Anne-Laurien van de Vliert-Bout, Cristina Alvarez Gomez de Segura, Fabio Efficace, Francesco Sparano, Peter-Paul Willemse, Jan Schoones, Adam Cohen, Sahar Barjesteh van Waalwijk van Doorn-Khosrovani

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

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Abstract

BACKGROUND: Since 2015 multiple combination treatments became available for metastatic hormone-sensitive prostate cancer (mHSPC) without effectiveness cross-comparison. Health-related quality of life (HRQoL) could aid in decision-making.

METHODS: We systematically reviewed HRQoL publications (January 2015-September 2024) of phase III randomized controlled trials (RCTs) in mHSPC using PRISMA guidelines, cross-compared HRQoL results and assessed usefulness to support decision-making (PROSPERO: CRD42023470698). International Society for Quality-of-Life Research (ISOQOL) recommended standards were used to assess quality of Patient-reported Outcomes reporting.

FINDINGS: We identified nine HRQoL publications from eight RCTs investigating an estradiol patch, or either radiotherapy, docetaxel, androgen-receptor-pathway-inhibitor (ARPI) abiraterone, apalutamide or enzalutamide added to androgen deprivation therapy (ADT) versus ADT ± placebo in ≥8000 patients. Only three studies were considered to have low overall risk of bias (RoB2). Eight HRQoL measures (1-4 per study) were used; 3/5 RCTs investigating an ARPI measured HRQoL using Brief Pain Inventory (BPI-SF), and Functional Assessment of Cancer Therapy-Prostate (FACT-P). Overall, the quality of PRO reporting was high, but PRO-hypothesis was provided by only 25% and reasons for missing data explained in only 50% of RCTs.

INTERPRETATION: Conceptual and methodological HRQoL heterogeneity, along with risk of biases, hampers cross-comparison and failed to robustly support decision-making underscoring the importance of harmonizing methodological approaches.

FUNDING: None.

Original languageEnglish
Article number102914
Number of pages18
JournalEClinicalMedicine
Volume78
DOIs
Publication statusPublished - Dec 2024

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