Olanzapine may reduce nausea unrelated to chemotherapy among patients with advanced cancer
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Olanzapine appeared to improve symptoms of nausea and vomiting unrelated to chemotherapy or radiotherapy among patients with advanced cancer, according to results of a randomized pilot trial published in JAMA Oncology.
“We have performed a number of previous studies with olanzapine in the prevention of chemotherapy-induced nausea and vomiting in which olanzapine was effective as a preventative agent,” Rudolph M. Navari, MD, PhD, FACP, professor of medicine in the division of hematology and oncology at The University of Alabama at Birmingham School of Medicine, told Healio.
“We also used olanzapine in treating breakthrough chemotherapy-induced nausea and vomiting, demonstrating that olanzapine was effective in treating established nausea and vomiting after chemotherapy," he added. "Based upon these studies, we thought it may be effective in treating chronic nausea and vomiting unrelated to chemotherapy in [patients with advanced cancer].”
Navari and colleagues compared olanzapine, an antipsychotic, with placebo among 30 outpatients (median age, 63 years; range, 39-79; n = 16 women) with advanced cancer who had chronic nausea and vomiting. None of the participants had received chemotherapy or radiotherapy within the previous 14 days.
Researchers randomly assigned 15 patients to 5 mg oral olanzapine daily for 7 days. The other 15 patients received placebo.
Patients rated their nausea on a scale of 1 to 10 daily during the weeklong study.
Change in nausea numeric rating scores from baseline to the final day of treatment served as the primary endpoint.
Baseline median nausea scores among all patients were 9 out of 10 (range, 8-10). After 1 day and 1 week, median nausea scores remained 9 out of 10 (range, 8-10) in the placebo group; however, median scores in the olanzapine group declined to 2 out of 10 (range, 2-3) after 1 day and 1 out of 10 (range, 0-3) after 1 week.
The olanzapine group demonstrated an eight-point (95% CI, 7-8) higher reduction in nausea scores than the placebo group at the end of 1 week (primary two-sided endpoint P < .001).
Moreover, patients in the olanzapine group reported less vomiting, less use of other antiemetic agents, increased appetite, less sedation, less fatigue and improved well-being.
A patient in the placebo group withdrew from treatment early due to lack of perceived benefit.
After study completion, researchers broke the 7-day protocol code and allowed patients in the olanzapine group to proceed on olanzapine as a prescription medication. Months later, researchers contacted patients’ clinicians to find out how patients were faring on olanzapine. They learned that all patients in the olanzapine group remained on treatment with continued efficacy and without any adverse events. Of the 14 patients in the placebo group offered olanzapine, 13 initiated treatment and one declined due to disease progression and inability to take oral medications.
All patients continued on olanzapine for 3 to 12 weeks, with reasons for treatment discontinuation including disease progression, inability to take oral medications or death.
“Chronic nausea and vomiting in [patients with cancer] are common problems and there have not been medications that have been shown to consistently treat this problem,” Navari told Healio. “Our study suggests that olanzapine works well without side effects and should be effective in many [patients with cancer] who have chronic nausea and vomiting. In addition, olanzapine is generic, and a 1-month supply is available for between $10 and $15. Based on the results of our study, we will design clinical studies to use olanzapine to improve cancer-associated anorexia and for the treatment of nausea and vomiting caused by abdominal radiation treatment.”
For more information:
Rudolph M. Navari, MD, PhD, FACP, can be reached at The University of Alabama at Birmingham School of Medicine, 1670 University Blvd., Birmingham, AL 35233; email: rnavari@uabmc.edu.
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