Mukhopadhyay, S., Kwatra, G., Pamela, A.K., & Badyal, D. (2017). Role of olanzapine in chemotherapy-induced nausea and vomiting on platinum-based chemotherapy patients: A randomized controlled study. Supportive Care in Cancer, 25, 145–154. 

DOI Link

Study Purpose

To evaluate the efficacy of olanzapine in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving platinum-based chemotherapy and prophylactic palonosetron and dexamethasone

Intervention Characteristics/Basic Study Process

The authors defined moderately emetogenic chemotherapy (MEC) as cisplatin less than 50 mg/m2, carboplatin, and oxaliplatin. Highly emetogenic chemotherapy (HEC) was defined as cisplatin 50 mg/m2​ or greater. On day 1 of MEC or HEC, all patients received palonosetron 0.25 mg IV and dexamethasone 30–60 minutes prior to chemotherapy administration. Patients receiving MEC received 8 mg of dexamethasone IV, and patients receiving HEC received 16 mg of dexamethasone IV. Patients receiving MEC received 8 mg dexamethasone PO daily on days 2 and 3, and patients receiving HEC received 8 mg dexamethasone PO BID on days 2–4. Patients in the test group received the above regimen and olanzapine 10 mg PO on day 1 prior to chemothearpy and then on days 2–5. For all patients, metoclopramide 10–20 mg PO or IV was allowed for rescue medication per the treating clinicians.

Sample Characteristics

  • N = 100   
  • MEAN AGE = Control group: 55.04 years (SD = 1.5); test group: 53.66 years (SD = 1.55)
  • MALES: 58%, FEMALES: 42%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Head and neck cancer, cervical cancer, esophageal cancer, ovarian cancer

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified
  • LOCATION: Hospital in northwest India

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care

Study Design

This was a randomized, controlled, assessor-blind study.

Measurement Instruments/Methods

Patients recorded the frequency and time of emetic episodes and the frequency and time of rescue antiemetics for the first five days. Patients also used the Multinational Association for Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) to record the control of nausea and vomiting and intensity of symptoms from days 1–5. Patients also recorded any adverse effects on days 1, 3, and 8–10 and as needed, as well as the duration and severity of the adverse effect. A trained nurse assessed all patients between day 8–10. At this time, the patients' overall quality of life was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30), version 3, questionnaire.

Results

Complete response was defined as no emesis and no rescue medications on days 1–5. Complete control was defined as no emetic episodes, no rescue medications, and no moderate or severe nausea on days 1–5. Nausea in the delayed phase was significantly less in the test group patients (p < 0.0001). Complete response was significantly higher in the test groups for delayed emesis and overall (p < 0.0001 and p < 0.0001). Complete control was significantly higher in the test groups for delayed emesis and overall (p < 0.0001 and p < 0.0001). Failure was defined as at least one antiemetic episode or use of rescue antiemetics on days 1–5. Failure was higher in the control group for delayed emesis and overall (p = 0.007 and p = 0.0038).

Conclusions

For patients receiving platinum-based chemotherapy, olanzapine is an effective addition for the prevention of CINV. The only side effect listed is more sedation.

Limitations

Findings not generalizable

Nursing Implications

Olanazpine is effective for the prevention of CINV in this sample with few adverse effects. It may not be generalizable, but more studies are supporting its use.