Final analysis: abiraterone ups survival in high-risk metastatic prostate cancer

  • Fizazi K & et al.
  • Lancet Oncol
  • 12 Apr 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Final analysis of the LATITUDE trial confirmed a survival advantage for adding abiraterone acetate+prednisone to androgen deprivation therapy (ADT) for newly diagnosed, high-risk castration-sensitive metastatic prostate cancer (mCSPC).
  • No new safety concerns were identified.

Why this matters

  • Findings highlight the importance of early introduction of abiraterone acetate plus prednisone in addition to ADT in high-risk patients.

Study design

  • Randomized, double-blind, phase 3 LATITUDE trial.
  • Final OS analysis of 1199 patients with newly diagnosed high-risk metastatic CSPC, randomly assigned to either ADT+abiraterone acetate+prednisone or ADT+placebo.
  • Crossover to abiraterone+prednisone was allowed in the open-label extension phase of the study (up to 18 months).
  • Funding: Janssen Research & Development.

Key results

  • Median follow-up was 51.8 months.
  • Median treatment duration in the crossover group was 11.9 months.
  • The abiraterone acetate group had significantly longer median OS vs placebo (53.3 vs 36.5 months; HR, 0.66; P<.0001>
  • Grade 3-4 adverse event rate was 68% in abiraterone acetate, 50% in placebo, and 19% in crossover group; most common were hypertension (21% vs 10% vs 4%), hypokalemia (12% vs 2% vs 2%).
  • Grade 3-4 serious adverse event rate was 27%, 20%, and 4%, respectively.

Limitations

  • Next-generation imaging was not routinely used.

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