Tan, L., Liu, J., Liu, X., Chen, J., Yan, Z., Yang, H., & Zhang, D. (2009). Clinical research of olanzapine for prevention of chemotherapy-induced nausea and vomiting. Journal of Experimental & Clinical Cancer Research, 28, 131.

To evaluate the efficacy and safety of olanzapine compared with 5-hydroxtryptamine3 (5-HT₃) receptor antagonists for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) and to evaluate the impact of olanzapine on quality of life (QOL) of those receiving chemotherapy

Patients were randomized into the test group or the control group. On day 1, the test group received 10 mg oral olanzapine, 10 mg IV azasetron, and 10 mg IV dexamethasone; the control group received 10 mg IV azasetron and 10 mg IV dexamethasone. On days 2–5, the test group received 10 mg oral olanzapine and the control group received 10 mg IV dexamethasone. Patients were permitted to take other antiemetic therapy for nausea or emesis based on clinical circumstances. Assessments occurred on days 1–5 post-treatment, and QOL was measure on day 6.

• The study consisted of 229 participants.
• Men in the test group had a mean age of 54 ± 9.23; women in the test group had a mean age of 48.25 ± 12.7. Men in the control group had a mean age of 54.5 ± 10.33; women in the control group had a mean age of 49.58 ± 12.12.
• The test group was 40.5% female and 59.5% male. The control group was 40% was female and 60% male.
• Cancer diagnoses were breast (24%), lung (23%), colorectal (13%), lymphoma (10%), stomach (9%), esophageal (5%), ovarian (5%), teratoma (2%), thymus (2%), cervical (1%), gingival (1%), glioblastoma (1%), laryngeal (1%), malignant melanoma (1%), and oropharyngeal (1%),
• Chemotherapy agents were cisplatin (44%), oxaliplatin (23%), epirubicin (18%), adriamycin (8%), carboplatin (6%), and dacarbazine (1%).

The setting was not identified.

All patients were in active treatment.

This was a randomized controlled trial.

• The Common Terminology Criteria for Adverse Events, version 3 (CTAE v.3) observation table was used to grade CINV.
• The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was used to evaluate quality of life.

• No significant difference was noted between both groups for complete response (CR) for acute periods with HEC or MEC.
• Respective improvement in CR occurred in the test group for delayed nausea and vomiting with HEC (39%) and MEC (25%). The whole period of nausea improved 41% with HEC and 27% with MEC (p < 0.05).
• The olanzapine regimen protected more than two-thirds of patients from emesis after receiving HEC and MEC, thus avoiding the use of rescue therapy 2–4 days after chemotherapy.

Olanzapine can improve the CR of delayed nausea and vomiting and QOL in patients receiving HEC and MEC.

• The study was not blinded. The test group received oral medication, which the control group did not receive.
• Other antiemetic therapies were used as needed and not monitored or factored into the analysis.
• Validity and reliability of the measurement tools was not included.
• Drug safety and toxicity were not defined or monitored.
• Reporting of statistical results was unclear; the authors reported two values with each measurement (e.g., \"complete response for delayed nausea and vomiting in patients with HEC improved 39%, 22%\") without explanation of what these two measurements correspond to.
• Discrepeancies were reported with the QOL measurements.

Olanzapine may be effective in preventing delayed CINV in patients receiving HEC or MEC, but results should be used cautiously because of poor statistical evaluation and reporting.