Navari, R.M., Einhorn, L.H., Loehrer, P.J., Sr., Passik, S.D., Vinson, J., McClean, J., … Johnson, C.S. (2007). A phase II trial of olanzapine, dexamethasone, and palonosetron for the prevention of chemotherapy-induced nausea and vomiting: a Hoosier oncology group study. Supportive Care in Cancer, 15, 1285-1291.
To examine the effectiveness of olanzapine in the treatment of chemotherapy-induced nausea and vomiting without the use of dexamethasone after day 1
A 10-mg oral dose of olanzapine was given every day, four times a day for prevention (rather than breakthrough) nausea and vomiting. On day 1 of chemotherapy, patients received 0.25 mg IV palonosetron and dexamethasone (8 mg for moderately emetogenic chemotherapy [MEC], 20 mg for highly emetogenic chemotherapy [HEC]) as well as 10 mg oral olanzapine. On days 2-4, patients received only 10 mg olanzapine daily. The same antiemetic regimen was continued for as many cycles as the patient completed (1-6 cycles). Patients received no other antiemetics on days 2-4. Patients were permitted to take rescue therapy.
The sample consisted of 40 patients who were chemotherapy-naive and receiving HEC or MEC.
This was a prospective, nonrandomized trial with no control or comparison group, consisting of descriptive analysis only (percentage of patients with response described).
Complete response (CR), defined as no emesis and no rescue medications administered and no nausea, was found in 100% of HEC patients and 97% of MEC patients in the acute period (0-24 hours after chemotherapy).
Responses for the delayed period (24-120 hours) decreased. Seventy-five percent of patients reported CR in the delayed and overall periods for emesis and even fewer for control of nausea (50% of HEC patients with CR for nausea and 78% of MEC patients with CR for nausea in the delayed and overall periods). No adverse events to study drugs were noted (no grade 3 or 4 toxicities). Olanzapine was not associated with sedation, weight gain, or hyperglycemia.