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Phase 3 Trial Validates Low-Dose Olanzapine for Chemo-Induced Nausea Without Heavy Sedation

Experts project that the regimen’s improved tolerability with reduced costs will prompt international antiemetic guideline revisions.

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Overview

  • A phase 3, double-blind, placebo-controlled trial of 500 Japanese breast cancer patients found 58.1% of those receiving 5 mg olanzapine achieved complete response in the first five days after anthracycline-plus-cyclophosphamide chemotherapy versus 35.5% on placebo.
  • A single 5 mg dose administered at home within five hours post-chemotherapy and before the evening meal delivered effective antiemetic control while minimizing sedation.
  • Severe or very severe concentration impairment occurred in 10% of patients on 5 mg olanzapine compared with 14% on placebo, and no treatment-related deaths were reported.
  • The trial’s patient-centered design was shaped by feedback from breast cancer survivors at a 2015 MASCC meeting to reduce burdensome side effects and support outpatient care.
  • By cutting sedation risks and financial burden compared with the standard 10 mg dose, the low-dose regimen could improve access to supportive care in resource-limited settings.