Koshiyama, M., Matsumura, N., Imai, S., Yamanoi, K., Abiko, K., Yoshioka, Y., . . . Konishi, I. (2017). Combination of aprepitant, azasetron, and dexamethasone as antiemetic prophylaxis in women with gynecologic cancers receiving paclitaxel/carboplatin therapy. Medical Science Monitor, 23, 826–833.

DOI Link

Study Purpose

The purpose of this study was to compare outcomes in patients who received aprepitant, azasetron, and dexamethasone versus patients who received a 5-HT3 receptor antagonist and dexamethasone.

Intervention Characteristics/Basic Study Process

Thirty-seven women received double combination therapy on cycle 1 and then triple combination therapy on cycle 2. Forty-one women received triple combination therapy on cycles 1 and 2. Eighty-five women only received double combination therapy. Double combination therapy consisted of azasetron 10 mg IV and dexamethasone 20 mg IV prior to chemotherapy on day 1. Triple combination therapy consisted of azasetron 10 mg IV, dexamethasone 8 mg IV and aprepitant 125 mg PO prior to chemotherapy on day 1 and then aprepitant 80 mg PO on days 2 and 3.

Sample Characteristics

  • N = 163
  • AGE: Not stated
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Endometrial cancer (n = 62), cervical cancer (n = 27), ovarian cancer (n = 74)

Setting

  • SITE: Single site 
  • SETTING TYPE Not specified 
  • LOCATION: Japan

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Prospective, non-randomized trial

Measurement Instruments/Methods

Nausea, vomiting, and appetite loss were self-reported and measured on a scale of 0 (not present) to 2 (strongly present). Dietary intake was self-reported and measured on a scale of  0-10 for staple foods and 0-10 for side dishes (score of 20 = perfect score). It is unclear how the investigators collected this data, but it was collected for day 1 and day 5.

Results

For the patients who received double combination therapy on cycle 1 and then triple combination therapy on cycle 2, there was a significant improvement in day 5 (delayed) nausea (p < 0.001), appetite loss (p < 0.0001), and dietary intake (p = 0.04) on cycle 2. There was not a significant difference in vomiting.

When comparing all cycles with double combination therapy to all cycles with triple combination therapy, patients who received double combination therapy for that cycle reported higher nausea (p = 0.002), appetite loss (p = 0.002), and vomiting (p = 0.02) on day 1. There were no significant differences between the two groups on day 5.

Conclusions

This study suggests that triple combination therapy (aprepitant plus dexamethasone plus azasetron) may result in less delayed nausea and less acute nausea, appetite loss, and vomiting, when compared to double combination therapy (dexamethasone plus azasetron). However, there are several limitations to this study.

Limitations

  • Baseline sample/group differences of import–unsure if there are baseline differences
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable

Nursing Implications

Aprepitant, when added to dexamethasone and azasetron, for patients with gynecological cancers receiving carboplatin and paclitaxel may decrease acute nausea, appetite loss, and vomiting as well as delayed nausea.