Patient-Reported Outcomes in nmCRPC

Exploratory Analysis From the SPARTAN Study

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

Mean FACT-P Total Score During the Treatment Phase, Erleada and A D T vs Placebo and A D T

*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 nmCRPC (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.

HRQoL based on patient-reported outcomes is not reported in the ERLEADA® Prescribing Information. HRQoL should be viewed in the context of patient management and the overall physical condition and clinical course of the patient.

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

Chart showing patients who improved or stabilized vs those who worsened over 29 months

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

"I have a lack of energy"§1

Chart showing patients who improved or stabilized vs those who worsened over 29 months

§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; nmCRPC = non-metastatic castration-resistant prostate cancer; PBO = placebo; PSA = prostate-specific antigen; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509.

 

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