Health-Related Quality of Life in Metastatic, Hormone-Sensitive Prostate Cancer: ENZAMET (ANZUP 1304), an International, Randomized Phase III Trial Led by ANZUP

Stockler, MR; Martin, AJ; Davis, ID; Dhillon, HM; Begbie, SD; Chi, KN; Chowdhury, S; Coskinas, X; Frydenberg, M; Hague, WE; Horvath, LG; Joshua, AM; Lawrence, NJ; Marx, GM; McCaffrey, J; McDermott, R; McJannett, M; North, SA; Parnis, F; Parulekar, WR; Pook, DW; Reaume, MN; Sandhu, S; Tan, A; Tan, TH; Thomson, A; Vera-Badillo, F; Williams, SG; Winter, DG; Yip, S; Zhang, AY; Zielinski, RR; Sweeney, CJ; Enzamet Trial Investigators; Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)

Author(s): Stockler, MR; Martin, AJ; Davis, ID; Dhillon, HM; Begbie, SD; Chi, KN; Chowdhury, S; Coskinas, X; Frydenberg, M; Hague, WE; Horvath, LG; Joshua, AM; Lawrence, NJ; Marx, GM; McCaffrey, J; McDermott, R; McJannett, M; North, SA; Parnis, F; Parulekar, WR; Pook, DW; Reaume, MN; Sandhu, S; Tan, A; Tan, TH; Thomson, A; Vera-Badillo, F; Williams, SG; Winter, DG; Yip, S; Zhang, AY; Zielinski, RR; Sweeney, CJ; Enzamet Trial Investigators; Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP);
Details: Publication Year 2022-03-10,Volume 40,Issue #8,Page 837-846
Journal Title: Journal of Clinical Oncology
Publication Type: Research article
Abstract: PURPOSE: We previously reported that enzalutamide improved overall survival when added to standard of care in metastatic, hormone-sensitive prostate cancer. Here, we report its effects on aspects of health-related quality of life (HRQL). METHODS: HRQL was assessed with the European Organisation for Research and Treatment of Cancer core quality-of-life questionnaire and QLM-PR25 at weeks 0, 4, 12, and then every 12 weeks until progression. Scores from week 4 to 156 were analyzed with repeated measures modeling to calculate group means and differences. Deterioration-free survival was from random assignment until the earliest of death, clinical progression, discontinuation of study treatment, or a worsening of 10 points or more from baseline in fatigue, physical function, cognitive function, or overall health and quality of life (OHQL). HRQL scores range from 0 (lowest possible) to 100 (highest possible). RESULTS: HRQL was assessed in 1,042 of 1,125 participants (93%). Differences in means favored control over enzalutamide for fatigue (5.2, 95% CI, 3.6 to 6.9; P < .001), cognitive function (4.0, 95% CI, 2.5 to 5.5; P < .001), and physical function (2.6, 95% CI, 1.3 to 3.9; P < .001), but not OHQL (1.2, 95% CI, -0.2 to 2.7; P = .1). Deterioration-free survival rates at 3 years, and log-rank P values comparing the whole distributions, favored enzalutamide over control for OHQL (31% v 17%; P < .0001), cognitive function (31% v 20%; P = .001), and physical function (31% v 22%; P < .001), but not fatigue (24% v 18%; P = .16). The effects of enzalutamide on HRQL were independent of baseline characteristics. CONCLUSION: Enzalutamide was associated with worsening of self-reported fatigue, cognitive function, and physical function, but not OHQL. Enzalutamide was associated with improved deterioration-free survival for OHQL, physical function, and cognitive function because delays in disease progression outweighed early deteriorations in these aspects of HRQL.
Publisher: American Society of Clinical Oncology
Keywords: Antineoplastic Combined Chemotherapy Protocols/therapeutic use; Fatigue/chemically induced/drug therapy; Hormones/therapeutic use; Humans; Male; Nitriles/therapeutic use; *Prostatic Neoplasms, Castration-Resistant/drug therapy; *Quality of Life
Department(s): Radiation Oncology
PubMed ID: 34928708
Publisher's Version: https://doi.org/10.1200/JCO.21.00941
Open Access at Publisher's Site: https://doi.org/10.1200/jco.21.00941
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2025-04-11 03:02:48

Last Modified: 2025-04-11 03:05:16