Sato, J., Kashiwaba, M., Komatsu, H., Ishida, K., Nihei, S., & Kudo, K. (2016). Effect of olanzapine for breast cancer patients resistant to triplet antiemetic therapy with nausea due to anthracycline-containing adjuvant chemotherapy. Japanese Journal of Clinical Oncology, 46, 415–420. 

To determine the effectiveness and safety of adding olanzapine to triple antiemetic therapy with aprepitant, palonosetron, and dexamethasone as highly emetic anthracycline-containing adjuvant chemotherapy for patients with primary breast cancer

Forty-five patients with breast cancer who experienced greater than grade 1 nausea or any vomiting after the first cycle of chemotherapy using both epirubicin and cyclophosphamide were included. Low-dose olanzapine (2.5 mg per day) was administered orally from the first day of chemotherapy for four days, and the number of episodes of vomiting, scale of nausea, dietary intake, and somnolence were compared with the symptoms after the first cycle.

• N = 45   
• MEAN AGE = 49.7 (SD = 13 years)
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer receiving 5-flourouracil, epirubicin, and cyclophosfamide (FEC) or epirubicin and cyclophosphamide (EC) therapy in an adjuvant or neoadjuvant setting

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Iwate Medical University Hospital

• PHASE OF CARE: Active antitumor treatment

• Nonrandomized, prospective, phase-II trial without placebo control

• Common Terminology Criteria for Adverse Events
• Clopper-Pearson method
• Excel statistics
• Cochran-Armitage test
• Paired t-test or Dunnett t-test

The nausea was significantly improved by adding olanzapine (p < 0.05). The mean nausea scale and dietary intake were improved by adding olanzapine.

Adding low-dose olanzapine for patients with insufficient nausea relief with triplet antiemetic therapy consisting of palonosetron, a steroid, and aprepitant can be effective and is tolerable.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results

Patients with breast cancer with highly emetogenic regimens containing both cyclophosphamide and anthracycline treated with triple therapy for resistant nausea could benefit from the addition of low-dose olanzapine.