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

2021; Lippincott Williams & Wilkins; Volume: 40; Issue: 8 Linguagem: Inglês

10.1200/jco.21.00941

1527-7755

Martin R. Stockler, Andrew Martin, Ian D. Davis, Haryana M. Dhillon, Stephen Begbie, Kim N., Simon Chowdhury, Xanthi Coskinas, Mark Frydenberg, Wendy Hague, Lisa G. Horvath, Anthony M. Joshua, Nicola Jane Lawrence, Gavin Marx, John McCaffrey, Ray McDermott, Margaret McJannett, Scott North, Francis Parnis, Wendy R. Parulekar, David Pook, M. Neil Reaume, Shahneen Sandhu, Alvin Tan, Thean Hsiang Tan, Alastair Thomson, Francisco Vera-Badillo, Scott Williams, Diana Winter, Sonia Yip, Alison Y. Zhang, Robert Zielinski, Christopher J. Sweeney,

Bone health and treatments

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).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).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.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.