Skeletal-related events significantly impact health-related quality of life in metastatic castration-resistant prostate cancer: data from PREVAIL and AFFIRM trials

• Published in: Prostate cancer and prostatic diseases Vol. 20; no. 1; pp. 110 - 116
• Main Authors: Saad, F, Ivanescu, C, Phung, D, Loriot, Y, Abhyankar, S, Beer, T M, Tombal, B, Holmstrom, S
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01.03.2017; Nature Publishing Group
• Subjects: 692/308/409; 692/699/67/589/466; Aged; Analysis; Biomedical and Life Sciences; Biomedicine; Bone and Bones - pathology; Cancer metastasis; Cancer Research; Clinical Trials as Topic; Combined Modality Therapy; Comorbidity; Health aspects; Humans; Male; Middle Aged; Original; original-article; Outcome Assessment (Health Care); Prostate cancer; Prostatic Neoplasms, Castration-Resistant - complications; Prostatic Neoplasms, Castration-Resistant - epidemiology; Prostatic Neoplasms, Castration-Resistant - pathology; Prostatic Neoplasms, Castration-Resistant - therapy; Quality of Life; Risk factors; Self Report
• ISSN: 1365-7852; 1476-5608
• DOI: 10.1038/pcan.2016.62

Background: We investigated the impact of skeletal-related events (SREs) on health-related quality of life (HRQoL) in patients with metastatic castration-resistant prostate cancer (mCRPC) in phase III trials of enzalutamide versus placebo. Methods: Patients with mCRPC experiencing at least one SRE during AFFIRM and PREVAIL were assessed for trajectory-adjusted mean change in HRQoL by first SRE using Functional Assessment of Cancer Therapy-Prostate (FACT-P; AFFIRM, three domains, and PREVAIL, nine domains) and EQ-5D (PREVAIL) instruments. Results: First SREs caused HRQoL deterioration in both trials. Spinal cord compression had the largest impact, with clinically meaningful reductions in seven of nine FACT-P domains in PREVAIL and all three in AFFIRM (mean (95% confidence interval (CI)) change in FACT-P total score –16.95 (–26.47, –7.44) and –9.69 (–16.10, –3.27), respectively). In PREVAIL, first SREs caused clinically meaningful declines in EQ-5D utility index, irrespective of category; spinal cord compression had the largest impact (mean (95% CI) change –0.24 (–0.39, –0.08)). In AFFIRM, FACT-P and FACT-General total scores showed clinically meaningful declines after radiation/surgery to bone. Conclusions: SREs were associated with clinically meaningful functional declines in the daily lives of patients with mCRPC. Spinal cord compression had the largest impact on HRQoL.