Health-Related Quality of Life in Metastatic, Hormone-Sensitive Prostate Cancer: ENZAMET (ANZUP 1304), an International, Randomized Phase III Trial Led by ANZUP. Issue 8 (10th March 2022)

• Record Type: Journal Article
• Authors: Stockler, Martin R.; Martin, Andrew J.; Davis, Ian D.; Dhillon, Haryana M.; Begbie, Stephen D.; Chi, Kim N.; Chowdhury, Simon; Coskinas, Xanthi; Frydenberg, Mark; Hague, Wendy E.; Horvath, Lisa G.; Joshua, Anthony M.; Lawrence, Nicola J.; Marx, Gavin M.; McCaffrey, John; McDermott, Ray; McJannett, Margaret; North, Scott A.; Parnis, Francis; Parulekar, Wendy R.; Pook, David W.; Reaume, M. Neil; Sandhu, Shahneen; Tan, Alvin; Tan, Thean Hsiang; Thomson, Alastair; Vera-Badillo, Francisco; Williams, Scott G.; Winter, Diana G.; Yip, Sonia; Zhang, Alison Y.; Zielinski, Robert R.; Sweeney, Christopher J.;
• Is Part Of: Journal of clinical oncology. Volume 40:Issue 8(2022)
• Page Start: 837
• Page End: 846
• Publication Date: 2022-03-10
• Subjects: Oncology -- Periodicals; Cancer -- Periodicals; Oncology; Medical Oncology; Cancérologie -- Périodiques; Cancer -- Périodiques; Cancérologie; Cancer; Oncology; Oncologia; Càncer; Periodicals; 616.994
• DOI: 10.1200/JCO.21.00941
• Languages: English
• ISSNs: 0732-183X

Abstract

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. Abstract :