CRPC: apalutamide does not affect health-related QoL

  • Saad F& et al.
  • Lancet Oncol
  • 10 Sep 2018

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Mean health-related QoL (HRQoL) scores were maintained after initiation of treatment with apalutamide in patients with nonmetastatic castration-resistant prostate cancer (CRPC).
  • A trend toward HRQoL deterioration from baseline was noted with placebo.

Why this matters

  • Apalutamide extended metastasis-free survival in SPARTAN in these patients.
  • QoL data further support the addition of apalutamide to current standard of care in this setting.

Study design

  • Exploratory analysis from the phase 3 double-blind SPARTAN trial that evaluated 1207 patients with nonmetastatic CRPC and PSA doubling time ≤10 months, randomly assigned 2:1 to receive apalutamide or placebo.
  • Functional Assessment of Cancer Therapy-Prostate and -General (FACT-P and FACT-G) patient-reported outcome questionnaire and EuroQol 5-dimension, 3-level questionnaire (EQ-5D-3L) were used.
  • Funding: Janssen Research & Development.

Key results

  • Patient-reported outcomes were reported for 29 cycles and 25.8 months from treatment initiation.
  • Median follow-up for OS, 20.3 months.
  • Group mean patient-reported outcome scores showed FACT-P total score, FACT-G score, FACT-P subscale score, and EQ-5D-3L were maintained from baseline and did not change over time in patients receiving apalutamide vs placebo.
  • Least-squares mean change from baseline showed that with placebo, there was a greater decrease in FACT-P total score, FACT-G score, FACT-P subscale score, and EQ-5D-3L vs apalutamide.

Limitations

  • Missing data.

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