Quality of life of prostate cancer (PCa) patients aged 60 years and older: Changes in QLQ-ELD14 dimensions after a six-month gonadotropin-releasing hormone agonist (GnRHa) therapy, according to age groups–Primary analysis of PRISME study.

Abstract

55 Background: PCa mostly affects elderly men and impacts their health-related quality of life (HRQOL). Our purpose was to compare the evolution, between age groups, of HRQOL measured through EORTC QLQ-ELD14 instrument, specific to the elderly cancer patients, after a 6-month GnRHa therapy. Methods: Between March 2018 and February 2020, a prospective, multicenter, non-interventional study was conducted in France (PRISME, NCT03516110). Urologists, radiation oncologists and medical oncologists recruited patients aged 60 years and older, with PCa, initiating a GnRHa therapy. 1000 patients were planned to be included 1:2:1 in prespecified age groups ([60-70[, [70-75[, ≥ 75 years). They reported HRQOL using ELD14 (7 dimensions, each scored 0-100): “Maintaining purpose”, “Family support” (higher scores represent better functioning), “Mobility”, “Worries about others”, “Future worries”, “Burden of illness” and “Joint stiffness” (higher scores represent worse functioning). Analyses of covariance (ANCOVA) were performed to compare evolution of each of the 7 dimensions of ELD14 between subgroups of ages, adjusted on baseline scores. Level of significance was set to 0.002 because of the multiplicity testing on the 7 dimensions (Bonferroni). Results: After enrollment of 814 patients by 138 investigators, enrollment was stopped because of a slow recruitment in the [70-75[ group. The final analysis included 652 patients (full analysis set population). Mean (±SD) age was 72.5±6.2 years. There were 193, 269 and 190 patients, in the [60-70[, [70-75[ and ≥75y age groups, respectively. 71.6% had at least one comorbidity at baseline and 65.0% were receiving at least one concomitant systemic treatment. Main reasons for GnRHa initiation were high risk PCa in 65.3%, metastatic stage in 18.4%, biochemical recurrence in 13.3%. For each dimension, ANCOVA analyses showed that changes from baseline, adjusted on baseline values, were not significantly different between age groups. For example, least square (LS) means (SE) changes in “Mobility” scores from baseline were 3.01 (1.13), 3.14 (0.95) and 6.13 (1.15) in the [60-70[, [70-75[ and ≥75y age groups, indicating a worsening in all groups, but without significant differences between groups (Table). Conclusions: In this large observational cohort of PCa men with prespecified age groups, HRQOL changes after a 6-month GnRHa therapy didn’t depend on age group. Clinical trial information: NCT03516110. [Table: see text]