Dr. Saad on the Safety Profile of Apalutamide in M0CRPC

Fred Saad, MD, FRCS, professor and chief of Urology, director of Genitourinary Oncology, Raymond Garneau Chair in Prostate Cancer, University of Montreal Hospital Center, and director, Prostate Cancer Research, Montreal Cancer Institute, discusses the safety profile of apalutamide (Erleada) in nonmetastatic castration-resistant prostate cancer (M0CRPC).

Final survival results of the SPARTAN trial showed that patients who received apalutamide plus androgen-deprivation therapy (ADT) had a significant overall survival improvement and prolonged risk of second progression or death compared with placebo plus ADT in men with M0CRPC.

Regarding safety, an increased rate of fatigue and rash were observed in patients who received apalutamide versus placebo, says Saad. However, these toxicities are a class effect of antiandrogen agents and were expected and manageable.

Additionally, some patients developed low-grade hypothyroidism that was also manageable, explains Saad. The uptick of hypothyroidism could be explained by the older patient population that was evaluated and the significantly longer follow-up period patients receiving apalutamide had compared with those who received placebo.

Ultimately, patients’ quality of life was not negatively impacted by the addition of apalutamide. In February 2018, apalutamide received regulatory approval for the treatment of men with M0CRPC, concludes Saad.