TY - JOUR
T1 - Health-related quality of life outcomes in randomized controlled trials in metastatic hormone-sensitive prostate cancer
T2 - a systematic review
AU - Osanto, Susanne
AU - Vliert-Bout, Anne-Laurien van de
AU - Gomez de Segura, Cristina Alvarez
AU - Efficace, Fabio
AU - Sparano, Francesco
AU - Willemse, Peter-Paul
AU - Schoones, Jan
AU - Cohen, Adam
AU - Barjesteh van Waalwijk van Doorn-Khosrovani, Sahar
N1 - Publisher Copyright:
© 2024 The Author(s)
PY - 2024/12
Y1 - 2024/12
N2 - 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.
AB - 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.
U2 - 10.1016/j.eclinm.2024.102914
DO - 10.1016/j.eclinm.2024.102914
M3 - Review article
C2 - 39619239
SN - 2589-5370
VL - 78
JO - EClinicalMedicine
JF - EClinicalMedicine
M1 - 102914
ER -