Babu, G., Saldanha, S.C., Kuntegowdanahalli Chinnagiriyappa, L., Jacob, L.A., Mallekavu, S.B., Dasappa, L., . . . Arroju, V. (2016). The efficacy, safety, and cost benefit of olanzapine versus aprepitant in highly emetogenic chemotherapy: A pilot study from South India. Chemotherapy Research and Practice, 2016, 3439707. 

DOI Link

Study Purpose

To compare the efficacy, safety, and cost of olanzapine-based triplet antiemetics compared to the use of aprepitant as part of antiemetics in chemotherapy-naïve patients receiving highly emetogenic chemotherapy

Intervention Characteristics/Basic Study Process

The olanzapine group received 10 mg olanzapine orally (PO), 0.25 mg palonosetron intravenously (IV), and 20 mg dexamethasone IV on day 1; and then 5 mg olanzapine PO and 4 mg dexamethasone PO on days 2–4. The aprepitant group was given 125 mg aprepitant PO, 0.25 mg palonosetron IV, and 12 mg dexamethasone IV on day 1; 80 mg aprepitant PO on days 2 and 3; and 4 mg dexamethasone PO on days 2–4. Patients were asked to record the intensity of nausea, the use of rescue medication, and vomiting daily in a diary. Patients were contacted daily for reminders to record symptoms.

Sample Characteristics

  • N = 100   
  • MEAN AGE = 43.6 years
  • MALES: 30%, FEMALES: 70%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Patients had various tumor types, and the majority were breast cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: The study included patients receiving various types of highly emetogenic chemotherapy, and all received six cycles.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: India

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

  • Prospective, two-group, non-randomized trial

Measurement Instruments/Methods

  • Visual analog scale (VAS) for nausea intensity 
  • CTC
  • Complete response defined as no emesis and no rescue medication
  • Complete response recorded for acute, delayed, and overall periods

Results

No significant differences existed between groups in complete response rates or nausea severity. No grade 3 or 4 toxicities existed. Adverse events associated with olanzapine were sedation and dizziness in less than 10% of patients.

Conclusions

Olanzapine-based triplet antiemetic therapy was as effective as aprepitant-based triplet antiemetics in this study.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • No information provided on timing of measurements analyzed or trends over time
  • No information on rescue medications used

Nursing Implications

Findings suggest that the use of olanzapine in substitution for an NK1 in a triplet antiemetic regimen was effective. The study is limited by its lack of random assignment to study groups, but the groups were well matched on most demographic and other treatment variables. Olanzapine is much less expensive than an NK1 and may be a good alternative for patients who have limited financial resources or insurance coverage for antiemetics.