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

被引：33

作者：

Stockler, Martin R. ^{[1
]}

Martin, Andrew J. ^{[1
]}

Davis, Ian D. ^{[2
]}

Dhillon, Haryana M. ^{[3
]}

Begbie, Stephen D. ^{[4
]}

Chi, Kim N. ^{[5
]}

Chowdhury, Simon ^{[6
]}

Coskinas, Xanthi ^{[1
]}

Frydenberg, Mark ^{[2
]}

Hague, Wendy E. ^{[1
]}

Horvath, Lisa G. ^{[7
]}

Joshua, Anthony M. ^{[8
]}

Lawrence, Nicola J. ^{[9
]}

Marx, Gavin M. ^{[10
]}

McCaffrey, John ^{[11
]}

McDermott, Ray ^{[12
]}

McJannett, Margaret ^{[13
]}

North, Scott A. ^{[14
]}

Parnis, Francis ^{[15
]}

Parulekar, Wendy R. ^{[16
]}

Pook, David W. ^{[17
]}

Reaume, M. Neil ^{[18
]}

Sandhu, Shahneen ^{[19
]}

Tan, Alvin ^{[20
]}

Tan, Thean Hsiang ^{[21
]}

Thomson, Alastair ^{[22
]}

Vera-Badillo, Francisco ^{[23
]}

Williams, Scott G. ^{[19
]}

Winter, Diana G. ^{[1
]}

Yip, Sonia ^{[1
]}

Zhang, Alison Y. ^{[1
]}

Zielinski, Robert R. ^{[24
]}

Sweeney, Christopher J. ^{[25
]}

机构：

[1] Univ Sydney, NHMRC Clin Trials Ctr, Sydney, NSW, Australia

[2] Monash Univ, Melbourne, Vic, Australia

[3] Univ Sydney, Ctr Med Psychol & Evidence Based Decis Making, CEMPED, Sydney, NSW, Australia

[4] Port Macquarie Base Hosp, Port Macquarie, NSW, Australia

[5] BC Canc Agcy, Vancouver Ctr, Vancouver, BC, Canada

[6] Guys & St Thomas NHS Fdn Trust, London, England

[7] Chris OBrien Lifehouse, Sydney, NSW, Australia

[8] St Vincents Hosp, Kinghorn Canc Ctr, Sydney, NSW, Australia

[9] Auckland Dist Hlth Board, Auckland, New Zealand

[10] Sydney Adventist Hosp, Sydney, NSW, Australia

[11] Canc Trials Ireland, Dublin, Ireland

[12] St Vincents Univ Hosp, Dublin, Ireland

[13] ANZUP Canc Trials Grp, Sydney, NSW, Australia

[14] Cross Canc Inst, Edmonton, AB, Canada

[15] Adelaide Canc Ctr, Adelaide, SA, Australia

[16] Canadian Canc Trials Grp, Kingston, ON, Canada

[17] Monash Hlth, Melbourne, Vic, Australia

[18] Univ Ottawa, Ottawa, ON, Canada

[19] Peter MacCallum Canc Ctr, Melbourne, Vic, Australia

[20] Waikato Dist Hlth Board, Hamilton, New Zealand

[21] Royal Adelaide Hosp, Adelaide, SA, Australia

[22] Royal Cornwall Hosp, Truro, Cornwall, England

[23] Kingston Hlth Sci Ctr, Kingston, ON, Canada

[24] Orange Hlth Serv, Orange, NSW, Australia

[25] Dana Farber Canc Inst, Boston, MA 02115 USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2022年 / 40卷 / 08期

基金：

澳大利亚国家健康与医学研究理事会; 英国医学研究理事会;

关键词：

ANDROGEN DEPRIVATION THERAPY; EUROPEAN-ORGANIZATION; ENZALUTAMIDE; QUESTIONNAIRE;

D O I：

10.1200/JCO.21.00941

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. (C) 2021 by American Society of Clinical Oncology.

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页码：837 / +

页数：12

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