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

Author(s): Martin R. Stockler, MBBS, MSc1; Andrew J. Martin, MBBS, PhD1; Ian D. Davis, PhD2; Haryana M. Dhillon, BSc, MA, PhD3; Stephen D. Begbie, MBBS4; Kim N. Chi, MD5; Simon Chowdhury, MBBS, PhD6; Xanthi Coskinas, BHSc, MMedSc (Clin Epid)1; Mark Frydenberg, MBBS2; Wendy E. Hague, MBBS, MBA, PhD, GAICD1; Lisa G. Horvath, MBBS, PhD7; Anthony M. Joshua, BSc, MBBS, PhD8; Nicola J. Lawrence, MBChB, PhD9; Gavin M. Marx, BSc (Med), MBBS10; John McCaffrey, MBBCh, BAO11; Ray McDermott, MD, PhD12; Margaret McJannett, RN13; Scott A. North, MD14; Francis Parnis, MBBS15; Wendy R. Parulekar, MD16; David W. Pook, MBBS, MD17; M. Neil Reaume, BSc, MD, MSc18; Shahneen Sandhu, MBBS19; Alvin Tan, MBChB20; Thean Hsiang Tan, MBBS21; Alastair Thomson, BM22; Francisco Vera-Badillo, MD, MSc23; Scott G. Williams, MBBS, MD19; Diana G. Winter, BSc1; Sonia Yip, BSc, PhD1; Alison Y. Zhang, MBBS, MMed1; Robert R. Zielinski, MBBS24; and Christopher J. Sweeney, MBBS25 for the ENZAMET Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
Source: DOI: 10.1200/JCO.21.00941 Journal of Clinical Oncology Published online December 20, 2021. PMID: 34928708
Lucio Gordan MD

Dr. Gordan's Thoughts

Interesting and common scenario in clinic. Self-reported symptoms do exist but delaying disease-progression may have salutary benefits in the long haul insofar as using dual androgen-deprivation therapy.

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% v17%; 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.

Author Affiliations

1NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia 2Monash University, Melbourne, Victoria, Australia 3CEMPED: The University of Sydney Centre for Medical Psychology and Evidence-Based Decision-Making, Sydney, NSW, Australia 4Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia 5BC Cancer Agency Vancouver Centre, Vancouver, BC, Canada 6Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom 7Chris O’Brien Lifehouse, Sydney, New South Wales, Australia 8Kinghorn Cancer Centre, St Vincent’s Hospital, Sydney, New South Wales, Australia 9Auckland District Health Board, Auckland, New Zealand 10Sydney Adventist Hospital, Sydney, NSW, Australia 11Cancer Trials Ireland, Dublin, Ireland 12St Vincent’s University Hospital, Dublin, Ireland 13ANZUP Cancer Trials Groups, Sydney, NSW, Australia 14Cross Cancer Institute, Edmonton, Alberta, Canada 15Adelaide Cancer Centre, Adelaide, South Australia, Australia 16Canadian Cancer Trials Group, Kingston, Ontario, Canada 17Monash Health, Melbourne, Victoria, Australia 18University of Ottawa, Ottawa, Ontario, Canada 19Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia 20Waikato District Health Board, Hamilton, New Zealand 21Royal Adelaide Hospital, Adelaide, South Australia, Australia 22Royal Cornwall Hospital, Cornwall, United Kingdom 23Kingston Health Sciences Centre, Kingston, Ontario, Canada 24Orange Health Service, Orange, New South Wales, Australia 25Dana-Farber Cancer Institute, Boston, MA

Leave a Comment

Your email address will not be published.

Related Articles

Low Risk of Cardiovascular Events With ADT for Prostate Cancer; Higher Risk in Older Men

The risk of major adverse cardiovascular events (MACE) following the initiation of androgen deprivation therapy (ADT) in men with prostate cancer is higher for older men compared with their younger counterparts. However, the overall MACE risk at 1 year in all age groups starting ADT is 1% or less, which is much lower than previously published reports. The findings, gleaned from analyses of U.S. electronic medical records, were presented during the virtual National Comprehensive Cancer Network 2022 Annual Meeting.

Read More »