Olanzapine (Zyprexa), an FDA-approved antipsychotic, effectively controlled chemotherapy-induced nausea and vomiting (CINV) in patients who failed to respond to guideline-recommended antiemetic therapy in a phase III trial presented at the ASCO Annual Meeting.1
“This is the first randomized trial to demonstrate an effective treatment for breakthrough CINV, which typically occurs within 2 to 4 days despite guideline-directed prophylaxis. Olanzapine was significantly better than metoclopramide in controlling breakthrough CINV, and the study suggests that olanzapine will be very useful in these patients, who can be debilitated from their symptoms,” said lead author Rudolph M. Navari, MD, PhD, Harper Cancer Institute, Indiana University School of Medicine in South Bend, Indiana.
The double-blind, randomized, controlled, phase III trial enrolled 205 chemotherapy-naive patients who were treated with highly emetogenic chemotherapy, including cisplatin, doxorubicin, and cyclophosphamide. All patients were given standard guideline-recommended antiemetic therapy. Of the 205 patients, 80 developed breakthrough CINV despite recommended therapy and were randomly assigned to 72 hours of treatment with either oral olanzapine at 10 mg/d or oral metoclopramide at 10 mg/d (3 times a day for 3 days).
During 72 hours of monitoring, 30 of the 42 patients in the olanzapine arm (71%) had no vomiting vs 12 of the 38 patients assigned to metoclopramide (32%), a difference that was statistically significant (P < .001). Nausea was eliminated in 28 (67%) patients in the olanzapine arm vs 9 (24%) in the metoclopramide arm, again a statistically significant difference (P < .01).
Disclosure: Dr. Navari reported no potential conflicts of interest.
1. Navari RM, Nagy CK, Gray SE: 2012 ASCO Annual Meeting. Abstract 9064. Presented June 2, 2012.