Kim N. Chi, MD, a professor at the University of British Columbia and a medical oncologist at BC Cancer Vancouver, discusses the safety findings for the next-generation androgen receptor (AR) inhibitor apalutamide (Erleada) in combination with androgen receptor therapy (ADT) in patients with metastatic castration-sensitive prostate cancer, according to the phase III TITAN study. This combination was compared to placebo and presented at the 2019 ASCO Annual Meeting. Overall, apalutamide plus ADT was well-tolerated in this patient population. The safety profile was not that different from the placebo arm in this trial, says Chi. However, there are some specific adverse events to be noted, including rash and hypothyroidism.
Rash occurred in 27% of the patients in this trial, and it was typically grade 1 or 2. This mild rash can be managed symptomatically or with creams, says Chi. Two percent of patients in the TITAN trial discontinued treatment due to rash.
Hypothyroidism was also noted in laboratory tests and was grade 1. However, no intervention was required, Chi notes. Other toxicities associated with the AR inhibitor included fatigue, falls, fractures, and seizures. However, these additional AEs were no different than those noted in the placebo arm.
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