Results from the TITAN trial that were presented at 2022 ASCO GU showed a link between deep PSA responses with apalutamide and patient-related outcomes.
At the 2022 Genitourinary Cancers Symposium, data presented from the phase 3 TITAN (NCT02489318) and SPARTAN (NCT01946204) trials of apalutamide (Erleada) in prostate cancer showed that deep PSA response was associated with a positive effect on patient-reported outcomes.1
“Not only does a deep PSA response identify patients who will have improved survival and progression-free outcomes, but also it is also associated with maintenance of health-related quality of life, improved patient reported physical wellbeing, and a reduced risk of worsening pain and fatigue intensity,” said Eric Jay Small, MD, coleader of the UCSF Prostate Cancer Program and deputy director of the UCSF Helen Diller Family Comprehensive Cancer Center.
Small said that previous results from TITAN and SPARTAN showed that apalutamide plus androgen depravation therapy (ADT) was associated with improved overall survival (OS), preserved health-related quality of life (HRQoL), and rapid and deep reductions in PSA. In this analysis, he and his colleagues set out to determine the relationship between PSA decline and HRQoL following apalutamide.
Investigators assessed HRQoL in the 2 trials separately because each had “distinct” patient populations with different disease burdens and different prior therapies. Small said that at 3 and 6 months, patients whose PSA was at or below 0.2 ng/mL had prolonged time to deterioration in their Functional Assessment of Cancer Therapy-Prostate total (FACT-P) and FACT-P Physical Wellbeing scores on both studies. In TITAN, patients had better scores on the Brief Pain Inventory-Short Form (BPI-SF) worst pain intensity progression and Brief Fatigue Inventory (BFI) worst fatigue intensity progression.
A total of 1052 patients with metastatic castration-sensitive prostate cancer enrolled in TITAN and were randomly assigned to apalutamide 240 mg daily plus or placebo. Both groups received standard ADT.2
In findings published in 2021, the median OS for patients treated with apalutamide was not reached (NR) compared with 52.2 months for patients assigned to apalutamide (HR, 0.65; 95% CI, 0.53-0.79; P < .0001). At 48 months, the OS rate was 65.1% vs 51.8% in favor of apalutamide.
Patients with nonmetastatic castration-resistant prostate cancer in SPARTAN were assigned to apalutamide (n = 806) or placebo (n = 401). At a median follow-up of 52 months, the median OS was 73.9 months (95% CI, 61.2-NR) in the apalutamide group compared with 59.9 months (95% CI, 52.8-NR) with placebo (HR, 0.78; 95% CI, 0.64-0.96; P = .016).3
The FDA approved apalutamide for this indication in February 2018 based on results from SPARTAN.4
Investigators presented real-world evidence from the SPARTAN trial at the 2021 American Urological Association Annual Meeting. The overall PSA response was 83.5% at 6 months after initiating apalutamide treatment and 86% at 12 months.5