Patient-Reported Outcomes in SPARTAN

Exploratory Analysis

Patients reported that there was no negative impact to their health-related quality of life (HRQoL) after initiation of treatment with ERLEADA®*†1

Total scores for FACT-P were maintained with ERLEADA® + ADT from baseline until treatment cycle 291

Mean FACT-P Total Score During the Treatment Phase (Before the Development of Distant Metastasis)‡1

Fact Mean Score Charts

*The FACT-P patient-reported outcome questionnaire was used to assess prostate cancer symptoms, pain-related symptoms, and overall HRQoL in the SPARTAN study. The FACT-P is a 39-item questionnaire developed and validated specifically in patients with prostate cancer. The scores for 5 FACT-P subscales (physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) can be added together to make a single overall score that ranges from 0-156. Higher values of FACT-P total and all subscales indicate a higher HRQoL. The FACT-P was given and collected during the treatment phase at baseline, on day 1 of cycle 1 (before dose), day 1 of cycles 2-6, day 1 of every 2 cycles starting at cycle 7 to cycle 13, and then day 1 of every 4 cycles, unless otherwise specified. Each treatment cycle was 28 days.1

Study Design: SPARTAN was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of patients with non-metastatic CRPC (N=1207). Patients had a PSA doubling time ≤10 months and serum testosterone levels <50 ng/dL. All patients in the SPARTAN trial received a concomitant GnRH analog or had a bilateral orchiectomy. All patients enrolled were confirmed to be non-metastatic by blinded central imaging review. Patients with a history of seizure, predisposing factors for seizure, or receiving drugs known to decrease the seizure threshold or to induce seizure were excluded. Patients were randomized 2:1 to receive ERLEADA® 240 mg orally once daily + ADT or placebo orally once daily + ADT. The primary endpoint was metastasis-free survival (MFS), defined as the time from randomization to the time of first evidence of blinded independent central review-confirmed distant metastasis, defined as new bone or soft tissue lesions or enlarged lymph nodes above the iliac bifurcation, or death due to any cause, whichever occurred first.2-4

Learn more about the SPARTAN study design

Cycle 29 is approximately 25.8 months from the start of treatment.

Post Hoc Analysis

Patients receiving ERLEADA® + ADT had similar responses to those on placebo + ADT when asked about side effects and energy levels*†1

The distribution of responses and distribution of change from baseline (stable, improved, and worsened) were comparable between treatment groups1

Analysis of answers to the question from the FACT-P physical well-being domain,

"I am bothered by side effects of treatment"§1

Placebo ADT

Analysis of answers to the question from the FACT-P physical well-being domain,

"I have a lack of energy"§1

Placebo ADT cycle

§The results were consistent across all FACT-P subscales.

ADT = androgen deprivation therapy; BL = baseline; CRPC = castration-resistant prostate cancer; FACT-P = Functional Assessment of Cancer Therapy–Prostate; GnRH = gonadotropin-releasing hormone; PBO = placebo; PSA = prostate-specific antigen; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509.

 

References