Visual analogue scales (VAS) as exploratory evaluation of eight dimensions in prostate cancer (PCa) patients aged 60 years and older initiating a gonadotropin-releasing hormone agonist (GnRHa) therapy: Secondary analysis of PRISME study.

Abstract

221 Background: Age, PCa and GnRHa treatment may modify patients health-related quality of life (HRQOL) and clinical parameters routinely evaluated: health status, urinary function, sexual function, memory, mood, motricity, autonomy. Our purpose was to investigate the use of VAS in these 8 domains before and after a 6-month GnRHa therapy, in order to simplify questions and minimize administration burden in future routine practice. 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 histologically confirmed 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 their levels of satisfaction in the 8 domains at baseline and after a 6-month GnRHa treatment. Each item included a title and a 10 cm-linear analogue scale with descriptive phrases anchored at the ends (0: not satisfied at all; 10: totally satisfied). Significant changes were concluded in case of means 95% CIs not including 0. Correlations between VAS and validated questionnaires on the same dimensions changes were evaluated through Pearson correlation. Results: The final analysis included 652 patients (full analysis set population), enrolled by 138 investigators. Mean (±SD) age was 72.5±6.2 years. 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 in 65.3%, metastatic stage in 18.4%, biochemical recurrence in 13.3%. 36% had received at least one prior treatment for PCa (prostatectomy 57%, radiotherapy 34.5%). Respectively, 47.1%, 58.0% and 17.6% presented at least one urinary symptom, one sexual symptom, or one other clinical symptom at baseline. Baseline mean [CI 95%] scores were: 7.5 [7.3-7.6] in general QOL, 6.8 [6.6-7.0] in general health status, 6.2 [6.0-6.4] in urinary function, 3.4 [3.2-3.6] in sexual function, 7.0 [6.8-7.2] in mood, 7.0 [6.9-7.2] in memory, 7.6 [7.4-7.8] in motricity and 8.0 [7.9-8.2] in autonomy VAS. At follow-up, significant and clinically relevant overall change was observed in sexual (-1.2 [-1.4;-0.9]) VAS. No correlations were found between the changes in VAS and in validated questionnaires. Conclusions: The exploratory use of VAS in the 8 dimensions routinely evaluated in elderly PCa patients treated with GnRHa therapy showed interesting results. No correlations could be shown between evolution in VAS and in validated questionnaire scores. Further explorations on this topic remain to be made. Clinical trial information: NCT03516110.