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

Author:

Stockler Martin R.1ORCID,Martin Andrew J.1,Davis Ian D.2ORCID,Dhillon Haryana M.3ORCID,Begbie Stephen D.4ORCID,Chi Kim N.5ORCID,Chowdhury Simon6,Coskinas Xanthi1,Frydenberg Mark2,Hague Wendy E.1,Horvath Lisa G.7,Joshua Anthony M.8ORCID,Lawrence Nicola J.9ORCID,Marx Gavin M.10,McCaffrey John11ORCID,McDermott Ray12,McJannett Margaret13,North Scott A.14,Parnis Francis15,Parulekar Wendy R.16ORCID,Pook David W.17ORCID,Reaume M. Neil18ORCID,Sandhu Shahneen19ORCID,Tan Alvin20,Tan Thean Hsiang21,Thomson Alastair22,Vera-Badillo Francisco23ORCID,Williams Scott G.19ORCID,Winter Diana G.1,Yip Sonia1,Zhang Alison Y.1,Zielinski Robert R.24ORCID,Sweeney Christopher J.25ORCID,

Affiliation:

1. NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia

2. Monash University, Melbourne, Victoria, Australia

3. CEMPED: The University of Sydney Centre for Medical Psychology and Evidence-Based Decision-Making, Sydney, NSW, Australia

4. Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia

5. BC Cancer Agency Vancouver Centre, Vancouver, BC, Canada

6. Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom

7. Chris O'Brien Lifehouse, Sydney, New South Wales, Australia

8. Kinghorn Cancer Centre, St Vincent's Hospital, Sydney, New South Wales, Australia

9. Auckland District Health Board, Auckland, New Zealand

10. Sydney Adventist Hospital, Sydney, NSW, Australia

11. Cancer Trials Ireland, Dublin, Ireland

12. St Vincent's University Hospital, Dublin, Ireland

13. ANZUP Cancer Trials Groups, Sydney, NSW, Australia

14. Cross Cancer Institute, Edmonton, Alberta, Canada

15. Adelaide Cancer Centre, Adelaide, South Australia, Australia

16. Canadian Cancer Trials Group, Kingston, Ontario, Canada

17. Monash Health, Melbourne, Victoria, Australia

18. University of Ottawa, Ottawa, Ontario, Canada

19. Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

20. Waikato District Health Board, Hamilton, New Zealand

21. Royal Adelaide Hospital, Adelaide, South Australia, Australia

22. Royal Cornwall Hospital, Cornwall, United Kingdom

23. Kingston Health Sciences Centre, Kingston, Ontario, Canada

24. Orange Health Service, Orange, New South Wales, Australia

25. Dana-Farber Cancer Institute, Boston, MA

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 (ASCO)

Subject

Cancer Research,Oncology

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