When metastasis-free survival (MFS) and time to symptomatic progression outcomes were reported for the phase 3 SPARTAN trial earlier this year, calls for the androgen receptor inhibitor apalutamide to become a new standard of care for men with nonmetastatic castration-resistant prostate cancer (CRPC) were tempered by concerns about higher rates of adverse events compared with placebo — particularly hypothyroidism (8% vs 2%, respectively), falls and bone fractures (11.7% vs 6.5%, respectively) and rash (23.8% vs 5.5%, respectively).1,2
But now SPARTAN’s health-related quality of life (HRQoL) findings have been reported, and they suggested that apalutamide’s improved MFS did not come at the cost of impaired quality of life.3,4
At a median follow-up for overall survival (OS) of 20.3 months among 1207 men with asymptomatic, nonmetastatic CRPC, adding apalutamide (in 806 individuals) to androgen deprivation therapy (ADT) was associated with maintenance of baseline HRQoL at rates similar to those associated with treatment with ADT plus placebo (in 401 individuals).3
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“The data are impressive,” commented Mark Christopher Markowski, MD, PhD, of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland, who was not involved in the study. “We’re not hurting anybody with long-term therapy. Patients are benefitting because their cancer is responding and we’re not impacting their quality of life with the medication. That’s very reassuring.”
SPARTAN is the latest study to suggest that ADT can be intensified to improve clinical outcomes without diminishing patients’ quality of life. The phase 3 PROSPER trial showed that enzalutamide was associated with a 71% reduction in the relative risk of metastasis or death among men with nonmetastatic CRPC, and a median MFS time of 36.6 months — similar to SPARTAN’s median MFS time of 40.5 months with apalutamide.3-5 In PROSPER and SPARTAN, baseline HRQoL was similarly maintained for patients receiving enzalutamide or apalutamide — but more patients in the SPARTAN study remained on treatment.3-5
