Fred Saad, MD
Treatment with apalutamide (Erleada) was not associated with a significant impact on health-related quality of life (HRQoL) in patients with high-risk nonmetastatic castration-resistant prostate cancer, according to patient-reported outcome (PRO) data from the phase III SPARTAN trial.
In the study overall, patients treated with the addition of apalutamide to standard hormone therapy also had an improvement in metastasis-free survival (MFS) and longer time to symptomatic progression compared with those who were treated with placebo.
“These findings completely surpassed the improvement we predicted we would see with the addition of apalutamide,” said lead study author Fred Saad, MD.
HRQOL was assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D-3L questionnaires. Results showed that the FACT-P total and subscale scores were associated with a preservation of HRQOL from baseline to cycle 29 in the apalutamide group. The data were similar for EQ-5D-3L.
At baseline, the mean for FACT-P total score in both the apalutamide and placebo arms were consistent with the FACT-P general population norm for adult men in the United States. Moreover, the group mean PRO scores show that HRQOL was maintained from baseline following the start of apalutamide therapy and was similar over time among patients receiving apalutamide versus placebo.
As a result of the MFS findings, the FDA approved apalutamide for the treatment of this patient population, becoming the first available drug in that setting, in February 2018.
In SPARTAN, which was a randomized, double-blind, placebo-controlled study, 1207 patients were randomized to receive 240 mg/day apalutamide plus androgen deprivation therapy (n = 806) or placebo (n = 401) between October 2013 and December 2016. Each treatment cycle was 28 days. Results also showed that MFS was 40.5 months in the apalutamide arm versus 16.2 months in the placebo arm.
In an interview with OncLive®
, Saad, professor and chief, Urology, director of Genitourinary Oncology, University of Montreal Hospital Centers, discussed the clinical significance of the SPARTAN trial, the HRQoL data, and remaining steps in the treatment of patients with nonmetastatic CRPC.
OncLive: Please provide some background to the SPARTAN trial.
: SPARTAN was one of the first clinical trials done in patients with nonmetastatic CRPC using an extremely effective class of agents that we use in metastatic disease. Apalutamide is a new-generation androgen receptor (AR) inhibitor that was tested in patients with high-risk CRPC. We defined high risk by prostate-specific antigen (PSA) doublet time. This is the best predictor of how quickly patients will become metastatic and likely die from their disease.
Approximately 1200 patients were randomized 2:1 to either apalutamide or placebo. Obviously, we have many treatment options for patients with metastases, but unfortunately, it was an unmet need for what to do in a patient with a rising PSA who we know is destined to become metastatic. Therefore, clearly, there was a need for us to do something here.
SPARTAN, which was published in the New England Journal of Medicine
in February 2018, showed that apalutamide significantly delayed the time to first metastases compared with placebo. It was in the range of about 40 months to the first development of metastases compared with 15 to 17 months for placebo. This, in a nutshell, was the most important finding of the SPARTAN trial.