Navari, R.M., Nagy, C.K., Le-Rademacher, J., & Loprinzi, C.L. (2016). Olanzapine versus fosaprepitant for the prevention of concurrent chemotherapy radiotherapy-induced nausea and vomiting. The Journal of Community and Supportive Oncology, 14, 141–147. 

To compare the effectiveness of an olanzapine-based triple-drug antiemetic regimen with a fosaprepitant-based triple-drug regimen

Patients were randomized to either olanzapine, palonosetron, and dexamethasone (OPD) or fosaprepitant, palonosetron, and dexamethasone (FPD) before the first course of chemotherapy. The OPD regimen was palonosetron 0.25 mg and dexamethasone 20 mg IV prior to chemotherapy and 10 mg PO olanzapine on days 1–4. The FPD regimen was 12 mg dexamethasone, 0.25 mg palonosetron and 150 mg fosaprepitant IV prior to chemotherapy, followed by oral dexamethasone 4 mg twice daily on days 2–3. Patients were allowed to take rescue medication. All patients received a placebo to ensure that the medication provided looked identical to the patient. Daily episodes of vomiting, symptom intensity, and use of rescue therapy were recorded by the patient in a diary for five days.

• N = 101   
• MEDIAN AGE = 62 years
• AGE RANGE = 52–76 years
• MALES: 78.2%, FEMALES: 21.8%
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Patients with locally advanced head and neck or esophageal cancer receiving HEC and daily radiotherapy

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: United States

PHASE OF CARE: Active antitumor treatment

• Single-blind, placebo-controlled, randomized trial

• MD Anderson Symptom Inventory (MDASI) mean of daily MDASI scores was used in analysis
• Visual analog scale (VAS) for nausea severity
• Complete response defined as no emesis and no use of rescue medication

No difference existed between groups in complete response for the acute period. For the delayed and overall periods, those on the olanzapine regimen showed a CR rate of 76% compared to 74% in the comparison group. Twelve percent of the OPD group required rescue during the acute phase, and 12% required rescue medication during the delayed period. In the FPD group, 10% required rescue during the delayed phase, and 26% required rescue medication in the acute period. The percentage of patients with no nausea was higher in the OPD group in all phases (p < 0.01). Patients on olanzapine had more drowsiness that was resolved by day 3–4.

Findings suggest that both the standard triple-drug antiemetic regimen and the olanzapine-based regimen were effective in controlling vomiting. As a greater proportion of those receiving olanzapine had no nausea, the olanzapine regimen may provide greater nausea control.

This study showed that both antiemetic regimens were similar in terms of control of emesis and need for rescue medications, and that nausea was better controlled with olanzapine. Nausea has been more difficult to control with currently used antiemetic regimens. These results suggest that olanzapine-based regimens may provide better nausea control. Olanzapine is also generally much less expensive than NK1s, providing a good treatment alternative at a lower cost.