EClinicalMedicine · 2024
Health-related quality of life outcomes in randomized controlled trials in metastatic hormone-sensitive prostate cancer: a systematic review.
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Osanto Susanne, Vliert-Bout Anne-Laurien van de, Gomez de Segura Cristina Alvarez, Efficace Fabio, Sparano Francesco, Willemse Peter-Paul, Schoones Jan, Cohen Adam, Barjesteh van Waalwijk van Doorn-Khosrovani Sahar
Аннотация
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.
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.