Apalutamide-related adverse events in prostate cancer common but manageable

Dermatological adverse events (dAEs) associated with apalutamide, though common, can be managed with topical steroids with or without oral antihistamines, reports a study.

Three hundred three prostate cancer patients treated with apalutamide were included in the analysis. The researchers calculated DAE frequency and time to onset and described clinicopathological features and management. Using logistic regression models, they examined the associations between dAE occurrence and clinical trial participation, as well as abiraterone/prednisone exposure.

Of the patients, 71 (23.4 percent) had all-grade dAE occurring at a median of 77 days postexposure. Twenty (6.6 percent) dAE-related therapy interruptions were recorded, including eight (2.6 percent) with dose maintained on rechallenge, seven (2.3 percent) with dose reduction, and five (1.7 percent) with discontinuation. Maculopapular rashes (33.8 percent) and xerosis (32.4 percent) were the most common dAEs.

Of the nine histological analyses of skin biopsies, seven (77.8 percent) supported a drug reaction. No significant differences were seen in laboratory haematological, hepatic, and renal function between dAE and no dAE cohorts.

Most grade 1/2 dAEs (n=29, 40.8 percent) were treated with topical steroids (n=14, 19.7 percent), while a few required oral steroids (n=3, 4.2 percent) with or without oral antihistamines. For grade 3 AEs (n=8, 11.3 percent), most required oral/topical steroids (n=5, 7.0 percent), and a few were treated with topical steroids (n=3, 4.2 percent) with or without antihistamines.

Clinical trial patients (n=180, 59.4 percent) had a higher likelihood of reporting dAEs compared to those in the off-trial setting (odds ratio [OR], 5.1, 95 percent confidence interval [CI], 2.55‒10.12; p<0.001). Among patients in clinical trials, recipients of concomitant abiraterone/prednisone (n=109, 60.6 percent) were more likely to report dAEs (OR, 3.1, 95 percent CI, 1.53‒6.17; p=0.002).

“With expanded approval of apalutamide, dAE identification and management are essential,” the researchers said.