TY - JOUR
T1 - Health-related quality of life in metastatic, hormone-sensitive prostate cancer : ENZAMET (ANZUP 1304), an international, randomized phase iii trial led by ANZUP
AU - Stockler, M.R.
AU - Martin, Andrew J.
AU - Davis, I.D.
AU - Dhillon, H.M.
AU - Begbie, S.D.
AU - Chi, K.N.
AU - Chowdhury, S.
AU - Coskinas, X.
AU - Frydenberg, M.
AU - Hague, W.E.
AU - Horvath, L.G.
AU - Joshua, A.M.
AU - Lawrence, N.J.
AU - Marx, G.M.
AU - McCaffrey, J.
AU - McDermott, R.
AU - McJannett, M.
AU - North, S.A.
AU - Parnis, F.
AU - Parulekar, W.R.
AU - Pook, D.W.
AU - Reaume, M.N.
AU - Sandhu, S.
AU - Tan, A.
AU - Tan, T.H.
AU - Thomson, A.
AU - Vera-Badillo, F.
AU - Williams, S.G.
AU - Winter, D.G.
AU - Yip, S.
AU - Zhang, A.Y.
AU - Zielinski, Robert R.
AU - Sweeney, C.J.
AU - ENZAMET, Trial
PY - 2022
Y1 - 2022
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, 20.2 to 2.7; P 5 .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 5 .001), and physical function (31% v 22%; P, .001), but not fatigue (24% v 18%; P 5 .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, 20.2 to 2.7; P 5 .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 5 .001), and physical function (31% v 22%; P, .001), but not fatigue (24% v 18%; P 5 .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 - https://hdl.handle.net/1959.7/uws:74208
U2 - 10.1200/JCO.21.00941
DO - 10.1200/JCO.21.00941
M3 - Article
SN - 1527-7755
SN - 0732-183X
VL - 40
SP - 837
EP - 846
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 8
ER -