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

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.

• Authors: Martin R Stockler, Andrew J Martin, Ian D Davis, Haryana M Dhillon, Stephen D Begbie, Kim N Chi, Simon Chowdhury, Xanthi Coskinas, Mark Frydenberg, Wendy E Hague, Lisa G Horvath, Anthony M Joshua, Nicola J Lawrence, Gavin M Marx, John McCaffrey, Ray McDermott, Margaret McJannett, Scott A North, Francis Parnis, Wendy R Parulekar, David W Pook, M Neil Reaume, Shahneen Sandhu, Alvin Tan, Thean Hsiang Tan, Alastair Thomson, Francisco Vera-Badillo, Scott G Williams, Diana G Winter, Sonia Yip, Alison Y Zhang, Robert R Zielinski, Christopher J Sweeney, ENZAMET Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 40 Issue 8 Pg. 837-846 (03 10 2022) ISSN: 1527-7755 [Electronic] United States
• PMID: 34928708 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Hormones
• Nitriles

Topics

• 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