Olanzapine reduces nausea, vomiting during moderately emetogenic chemotherapy
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Key takeaways:
- Patients assigned olanzapine achieved better nausea control than those assigned observation.
- More patients assigned observation required rescue medications for nausea.
Olanzapine significantly reduced nausea and vomiting compared with observation for patients with solid tumors undergoing moderately emetogenic chemotherapy, according to results of a randomized phase 3 trial.
Olanzapine — an antipsychotic used to treat schizophrenia and bipolar disorder — has demonstrated effectiveness for treating nausea and vomiting associated with highly emetogenic chemotherapy.
Vikas Ostwal, DM, professor at Tata Memorial Centre in India, and colleagues conducted a multicenter trial to assess whether olanzapine benefitted chemotherapy-naïve patients receiving moderately emetogenic chemotherapy.
Eligible patients included adults with solid tumors receiving oxaliplatin-, carboplatin- or irinotecan-based chemotherapy.
Researchers randomly assigned 560 patients (64% men; median age, 51 years) 1:1 to dexamethasone, aprepitant and palonosetron with or without 10 mg oral olanzapine given nightly on days 1 through 3 of chemotherapy. More than half (58%) of trial participants had colorectal cancer. Other cancer types included biliary tract cancer (11%), non-small cell lung cancer (10%), bladder cancer (9%), and gastric or gastroesophageal cancer (8%).
Complete response — defined as no vomiting, no significant nausea and no use of rescue medications for nausea — served as the primary endpoint.
The proportion of patients who experienced nausea and chemotherapy-induced nausea and vomiting, experienced adverse events or received rescue medications served as secondary endpoints.
The analysis included 544 evaluable patients.
The study met its primary endpoint, demonstrating a higher rate of complete response in the olanzapine group (91% vs. 82%) in the 120-hour treatment period.
Researchers also reported higher rates of nausea control (96% vs. 87%) and chemotherapy-induced nausea and vomiting control (96% vs. 91%) in the olanzapine group.
Nearly three times as many patients assigned observation required rescue medications for nausea (11% vs. 4%).
The findings suggest this regimen “could be considered as one of the standards of antiemetic therapy” for patients who receive carboplatin-, oxaliplatin- or irinotecan-based chemotherapy, Ostwal and colleagues wrote.
Twenty-seven patients (10%) assigned olanzapine experienced grade 1 somnolence.
Researchers acknowledged study limitations, including lack of placebo in the control arm and no assessment of efficacy of a 5 mg olanzapine dose.
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Ostwal V, et al. JAMA Netw Open. 2024;doi:10.1001/jamanetworkopen.2024.26076.
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