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Enzalutamide improved outcomes in prostate cancer regardless of age
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Enzalutamide significantly prolonged OS, radiographic PFS and time to PSA progression in both younger and older patients with metastatic castration-resistant prostate cancer, according to a post-hoc analysis of the phase 3 AFFIRM trial.
The original analysis of the randomized, double blind trial indicated that patients with prostate cancer who previously received docetaxel chemotherapy demonstrated improved median OS when treated with enzalutamide (Xtandi, Astellas Pharma) — an oral androgen receptor inhibitor — compared with patients assigned placebo (18.4 months vs. 13.6 months; HR=0.63; 95% CI, 0.53-0.75).
Cora N. Sternberg
Cora N. Sternberg, MD, chief of the department of medical oncology at the San Camillo and Forlanini Hospitals in Rome, and colleagues conducted additional analyses to evaluate the safety and efficacy of enzalutamide among patients younger than 75 years and those aged at least 75 years.
Enzalutamide was associated with improved median OS in both the younger cohort (not yet reached vs. 13.6 months; HR=0.63; 95% CI, 0.52-0.78) and older cohort (18.2 months vs. 13.3 months; HR=0.61; 95% CI, 0.43-0.86).
Researchers observed improved radiographic PFS among younger (HR=0.45; 95% CI, 0.38-0.53) and older (HR=0.27; 95% CI, 0.2-0.37) patients assigned enzalutamide.
Enzalutamide also was associated with increased time to PSA progression and improved PSA response in both age groups.
Among all patients treated with enzalutamide, those older 75 years experienced higher rates of all-grade peripheral edema (22.1% vs. 12.5%), fatigue (39.7% vs. 31.6%) and diarrhea (26.6% vs. 19.6%). The frequency and severity of other adverse events, including grade ≥3 adverse events, were comparable between age groups.
Three patients in the younger cohort and two in the older cohort experienced seizures.
Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.
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