Real-World PSA Response Data Similar to Clinical Trials in Prostate Cancer
April 07, 2020 01:01am
By Stephen J. Freedland, MD
Karim Fizazi, MD, PhD, discusses the potential role for darolutamide in combination with androgen deprivation therapy in patients with nonmetastatic castration-resistant prostate cancer.
Karim Fizazi, MD, PhD, head of the Department of Cancer Medicine at the Institut Gustave Roussy, Villejuif, France, discusses the potential role for darolutamide (Nubeqa) in combination with androgen deprivation therapy (ADT) in patients with nonmetastatic castration-resistant prostate cancer (CRPC).
According to data from the phase III ARAMIS trial, darolutamide, when combined with ADT, resulted in a median metastasis-free survival of 40.4 months compared with 18.4 months with ADT alone. There was also a trend toward improvement in overall survival (OS), but the median OS data were still not mature. The 3-year OS rate is 83% with the combination versus 73% with ADT alone, Fizazi says.
The addition of darolutamide led to a 59% reduction in the risk of metastasis or death. The drug also had a good safety profile with minimal adverse events compared to placebo. Quality of life, assessed by the FACT-P and EORTC questionnaire, was maintained with the combination versus ADT alone.