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Enzalutamide improved health-related quality of life in prostate cancer
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Enzalutamide was associated with significant improvements in disease-related symptoms and all aspects of health-related quality of life among men with metastatic castration-resistant prostate cancer, according to results of the phase 3, double blind AFFIRM trial.
The trial included 1,199 patients who progressed during treatment with docetaxel.
Karim Fizazi, MD, PhD, medical oncologist in the department of cancer medicine at Institut Gustave Roussy at the University of Paris, and colleagues randomly assigned 800 patients to 160 mg daily enzalutamide (Xtandi; Astellas, Medivation). The other 399 patients received placebo.
Karim Fizazi
Previously published results showed patients assigned enzalutamide experienced significantly longer median OS (18.4 months vs. 13.6 months; HR=0.63; 95% CI, 0.53-0.75).
In the current analysis, Fizazi and colleagues reported on secondary endpoints, including occurrence of skeletal-related events, measures of pain control and patient-reported health-related quality of life.
Results showed enzalutamide extended median time to first skeletal-related event (16.7 months vs. 13.3 months; HR=0.69; 95% CI, 0.57-0.84) and median time to pain progression (not reached vs. 13.8 months; HR=0.56; 95% CI, 0.41-0.78).
By week 13, 39% of evaluable patients assigned placebo and 28% of evaluable patients assigned enzalutamide reported pain progression.
Researchers also reported significantly better mean treatment effects for pain severity (change from baseline, -0.15 for enzalutamide vs. 0.5 for placebo; difference, -0.65; 95% CI, -0.89 to -0.41) and interference (change from baseline, -0.01 for enzalutamide vs. 0.74 for placebo; difference, -0.74; 95% CI, -1.06 to -0.43) in the enzalutamide arm.
A higher percentage of patients assigned enzalutamide reported palliation of pain by 13 weeks (45% vs. 7%) and improvement in overall health-related quality of life (42% vs. 15%; P<.0001).
In addition, patients assigned enzalutamide experienced longer median time to deterioration of health-related quality of life (9 months vs. 3.7 months; HR=0.45; 95% CI, 0.37-0.55).
“Our results with enzalutamide and those of other therapies in patients with metastatic castration-resistant prostate cancer progressing after docetaxel suggest that, although treatment delayed or prevented skeletal-related events and prevented health-related quality of life deterioration, more improvement is still possible in the relief of baseline symptoms,” Fizazi and colleagues wrote. “This unmet need might be addressed with combinations of new-generation tumor-targeted therapies with bone-targeting agents.”
Disclosure: The study was funded by Astellas and Medivation. The researchers report consultant or advisory roles with, research funding or honoraria from, expert testimony for and other remuneration from Astellas, Amgen, AstraZeneca, Bayer, Dendreon, Ipsen, Janssen, Janssen-Cilag, Johnson & Johnson, Medivation, Millennium, Novartis, Orion, Roche, Sanofi -Aventis, Takeda and Veridex.
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