Rapid Readouts: ODENZA trial


Dr Zhang, MD, discusses cognitive assessment data from patients with metastatic castrate-resistant prostate cancer in the ODENZA trial receiving either darolutamide or enzalutamide that was presented at the European Society for Medical Oncology 2021 Annual Meeting.

OncLive® Rapid Readout from European Society of Medical Oncology 2021: Results from ODENZA Trial

Segment Description:

Tian Zhang, MD, discusses data from the following presentation: “Objective Computerized Cognitive Assessment in Men With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) Randomly Receiving Darolutamide or Enzalutamide in the ODENZA Trial.” (Colomba, ESMO 2021, 603P)

Segment Body Content:

  • ODENZA (NCT03314324) is a prospective, cross-over, preference, randomized phase 2 trial of darolutamide and enzalutamide in patients with mCRPC.
  • Methods
    • Patients (n = 249) were randomized 1:1 to receive darolutamide 1200 mg daily for 12 weeks followed by enzalutamide 160 mg daily for 12 weeks or the reverse sequence.
    • Cognitive assessment using computerized cognitive tests (Cogstate) was a key secondary end point of ODENZA.
      • Cognitive tests were prospectively realized by patients with laptop and questionnaire.
      • Changes from baseline were described by assessing each 12 weeks period.
      • Individual tests (detection test: psychomotor function; identification test: visual attention; one-back test: working memory; International Shopping List Test (ISL): verbal learning; International Shopping List Test Delayed Recall (ISRL): verbal memory; Groton Maze Learning: executive function) were used and 3 composite scores (eg ISL/ISRL for episodic memory) were created.
      • Treatment effects were analyzed using Mixed-Effects Model Repeated Measures.
      • Effect sizes were classified as clinically meaningful when greater than or equal to 0.5.
  • Results
    • Cognitive data were available in 193 patients among 250 patients enrolled in ODENZA trial.
    • Performance on verbal learning (ISL) was significantly better with darolutamide at each of the postbaseline assessments, within both periods and when averaged over periods.
      • Effects were clinically meaningful at the second period (0.62, P = .0001) and overall (0.54, P < .0001).
    • Performance on verbal memory (ISRL) was significantly better with darolutamide at the second period and when averaged over periods
      • However, the effect sizes were less meaningful (second period: 0.4, P = .01 and overall: 0.29, P = .0075).
    • No difference in other tests was found. The composite scores reported a moderate benefit in episodic memory after treatment with darolutamide compared with enzalutamide.
  • Conclusions
    • In early mCRPC, darolutamide was associated with a statistically significant benefit in verbal learning and verbal memory compared with enzalutamide.
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