Liu, J., Tan, L., Zhang, H., Li, H., Liu, X., Yan, Z., . . . Zhang, D. (2015). QoL evaluation of olanzapine for chemotherapy-induced nausea and vomiting comparing with 5-HT3 receptor antagonist. European Journal of Cancer Care, 24, 436–443. 

DOI Link

Study Purpose

To evaluate the effect of olanzapine on quality of life (QOL) during chemotherapy compared with a 5HT3 receptor antagonist

Intervention Characteristics/Basic Study Process

Patients receiving multiple different chemotherapy regimens were randomized to one of two groups. Group one received olanzapine 10 mg PO, azasetron 10mg IV, and dexamethasone 10 mg IV, followed by olanzapine 10 mg PO on days 2-5. The control group received azasetron 10 mg IV and dexamethasone 10 mg IV, followed by dexamethasone 10 mg IV on days 2-5. Use of breakthrough antiemetics was permitted based on clinical circumstances. It is not reported whether patients received one cycle only. Patients were not all chemotherapy naive, but this was not controlled in the sample description.

Sample Characteristics

  • N = 229  
  • AGE = 18-74 years
  • MALES: 65%-72%, FEMALES: 43%-49%
  • KEY DISEASE CHARACTERISTICS: lung, breast, colorectal, lymphoma, ovarian, stomach, esophageal, teratoma, thymus, oropharyngeal, cervical, gingival, melanoma, and glioblastoma. All patients were receiving moderately or highly emetogenic chemotherapy.
  • OTHER KEY SAMPLE CHARACTERISTICS: normal CBC, LFTs, metabolic profile, normal cardiac function, EKG, performance status of 2 or better, no nausea preceding 24 hours. Multiple exclusion criteria.

Setting

  • SITE: Single site    
  • SETTING TYPE: Not specified    
  • LOCATION: Harbin Medical University, China

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Randomized trial using random digits

Measurement Instruments/Methods

  • EORTC-QLQ C30 was measured on day 0 and 6. CINV was measured with Common Toxicity Criteria.

Results

There was no significant difference in acute CINV, but delayed CINV showed complete response rates of 76.85% in the olanzapine group and 46.2% in the 5HT3 group (p < 0.05). CINV was also better controlled in five days post chemotherapy, with 85.95% in the olanzapine arm and 67.59% in the control arm. Not all patients completed QOL. Global health status, emotional functioning, social functioning, fatigue, CINV, and insomnia were improved in the olanzapine group. Pain and dyspnea improved in both groups.

Conclusions

CINV influences QOL for patients undergoing chemotherapy. Although olanzapine did not change CINV in the acute phase, it showed significance in the delayed CINV group. This demonstrated improvements in global health status, fatigue, and insomnia. 5HT3 antagonists were effective against acute CINV but not effective in delayed CINV.

Limitations

  • Risk of bias (no blinding)
  • Other limitations/explanation: The authors did not identify any limitations. All data comparisons were not identified. Description of prior treatments for patients were not listed. No subgroup analysis was completed between those receiving MEC and HEC regimens. No information was provided regarding use of other antiemetics as allowed in the study protocol

Nursing Implications

Olanazapine offers another option for treatment of CINV. Other symptoms may also be controlled with this medication, such as insomnia, appetite loss, fatigue, and global health status. Nurses can consider this when standard medications are ineffective.