Lee, H.Y., Kim, H.K., Lee, K.H., Kim, B.S., Song, H.S., Yang, S.H., ... Park, H.S. (2014). A randomized double-blind, double-dummy, multicenter trial of azasetron versus ondansetron to evaluate efficacy and safety in the prevention of delayed nausea and vomiting induced by chemotherapy. Cancer Research and Treatment, 46(1), 19–26. 

DOI Link

Study Purpose

To evaluate the efficacy and safety of azasetron compared to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Patients were randomized into two groups. 
 
Group 1
  • Day 1: Azasetron 10 mg IV 30 minutes to 2 hours before chemotherapy and dexamethasone 20 mg IV 30 minute before chemotherapy
  • Days 2–6: Azasetron 10 mg PO, placebo PO BID, dexamethasone 4 mg PO BID on days 2–4
 
Group 2
  • Day 1: Azasetron 10 mg IV 30 minutes to 2 hours before chemo and Dexamethasone 20 mg IV 30 minutes before chemo
  • Days 2–6: Placebo PO, ondansetron 8 mg PO BID, and dexamethasone 4 mg PO BID on days 2–4
 
Patients self-recorded data on days 1–6, in the hospital on day 7, and at 4 weeks. 

Sample Characteristics

  • N = 262  
  • MEAN AGE: 58 years (range = 20–75 years)
  • MALES: 74%, FEMALES: 26%
  • KEY DISEASE CHARACTERISTICS: Multiple sites of cancer were included in the study
  • OTHER KEY SAMPLE CHARACTERISTICS: Moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC)

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Not specified  
  • LOCATION: Korea

Phase of Care and Clinical Applications

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

Study Design

A multi-center, prospective, randomized, double-dummy, double-blind, parallel-group trial.

Measurement Instruments/Methods

Patients completed daily logs for nausea and vomiting frequency with visual analog scales (VAS) on days 1–6 post chemotherapy administration. Tests were administered on day 7 and week 4 +/– one week. The primary endpoint was the effective ratio of complete response for CINV, and the secondary end points were degree of nausea by treatment day (grade 0–3), complete control (CC of vomiting and nausea) by treatment day, physician’s global assessment (PGA) score on day 7, and VAS by treatment day. There was no significant difference between groups on the secondary endpoints.

Results

The authors acknowledge that azasetron has shown safety and efficacy with CINV in previous studies. However, the effectiveness of azasetron (45%) and ondansetron (54.5%) towards a complete response to CINV did not support azasetron’s superiority over ondansetron.

Conclusions

Azasetron showed inferiority for controlling delayed CINV when compared to ondansetron. The authors recommend that further studies about 5-HT3 receptor antagonists are not necessary; the superiority of NK1 receptor antagonists is documented. There was no difference between the groups for degree of nausea or complete control by treatment day.

Limitations

Other limitations/explanation: The authors did not identify limitations for the study. The data were gathered between May 2005 and December 2005 and may be “dated.” Azasetron is only available in Japan at this time. Day 7 visit was missed by 21 patients.

Nursing Implications

Findings will assist nurses with the prevention of CINV for patients receiving moderate to high levels of emetogenic chemotherapy. Azasetron was not found to be superior to ondansetron for the prevention of CINV for patients receiving moderate to high levels of emetogenic chemotherapy.