TY - JOUR
T1 - Health-Related Quality of Life in Metastatic, Hormone-Sensitive Prostate Cancer
T2 - ENZAMET (ANZUP 1304), an International, Randomized Phase III Trial Led by ANZUP
AU - Stockler, Martin R.
AU - Martin, Andrew J.
AU - Davis, Ian D.
AU - Dhillon, Haryana M.
AU - Begbie, Stephen D.
AU - Chi, Kim N.
AU - Chowdhury, Simon
AU - Coskinas, Xanthi
AU - Frydenberg, Mark
AU - Hague, Wendy E.
AU - Horvath, Lisa G.
AU - Joshua, Anthony M.
AU - Lawrence, Nicola J.
AU - Marx, Gavin M.
AU - McCaffrey, John
AU - McDermott, Ray
AU - McJannett, Margaret
AU - North, Scott A.
AU - Parnis, Francis
AU - Parulekar, Wendy R.
AU - Pook, David W.
AU - Reaume, M. Neil
AU - Sandhu, Shahneen
AU - Tan, Alvin
AU - Tan, Thean Hsiang
AU - Thomson, Alastair
AU - Vera-Badillo, Francisco
AU - Williams, Scott G.
AU - Winter, Diana G.
AU - Yip, Sonia
AU - Zhang, Alison Y.
AU - Zielinski, Robert R.
AU - Sweeney, Christopher J.
AU - for the ENZAMET Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
PY - 2022/3/10
Y1 - 2022/3/10
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85125966739&partnerID=8YFLogxK
U2 - 10.1200/JCO.21.00941
DO - 10.1200/JCO.21.00941
M3 - Article
C2 - 34928708
AN - SCOPUS:85125966739
SN - 0732-183X
VL - 40
SP - 837
EP - 846
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 8
ER -
