Dr. Hussain on the Safety Profile of Olaparib in the PROfound Trial in mCRPC

Maha Hussain, MD, FACP, FASCO, Genevieve E. Teuton Professor of Medicine, Division of Hematology and Oncology, Deputy Director, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, discusses the safety profile of olaparib (Lynparza) in the phase 3 PROfound trial in men with metastatic castration-resistant prostate cancer (mCRPC).

The final overall survival (OS) analysis of the PROfound trial, which was presented during the 2020 ESMO Virtual Congress, favored olaparib versus enzalutamide (Xtandi)/abiraterone acetate (Zytiga) in patients with mCRPC who harbor homologous recombination repair gene alterations, despite crossover.

The safety profile of olaparib observed in the study was consistent with previously reported data with the agent in other tumor types, says Hussain.

Common adverse effects (AEs) observed in the overall patient population included anemia, nausea, fatigue or asthenia, decreased appetite, diarrhea, vomiting, and constipation.

Aside from anemia, the majority of AEs were low-grade, Hussain explains. Grade 3 or higher anemia was observed in 23% of the 256 patients treated with olaparib.

Notably, many patients were heavily pretreated. Patients had prior exposure to enzalutamide or abiraterone, in addition to chemotherapy or other anticancer treatment, concludes Hussain.