Choi, C.H., Kim, M.K., Park, J.Y., Yoon, A., Kim, H.J., Lee, Y.Y., . . . Bae, D.S. (2014). Safety and efficacy of aprepitant, ramosetron, and dexamethasone for chemotherapy-induced nausea and vomiting in patients with ovarian cancer treated with paclitaxel/carboplatin. Supportive Care in Cancer, 22(5), 1181–1187. 

DOI Link

Study Purpose

To evaluate the efficacy of aprepitant, ramosetron, and dexamethasone 20 mg on chemotherapy-induced nausea and vomiting (CINV) in women with ovarian cancer receiving paclitaxel/carboplatin

Intervention Characteristics/Basic Study Process

On day 1, one hour before chemotherapy, patients received 125 mg oral aprepitant, 0.6 mg IV ramosetron, and 20 mg IV dexamethasone (over 30 minutes). On days 2 and 3, patients received 80 mg aprepitant. Vomiting episodes and use of rescue therapy were recorded for 120 hours after chemotherapy was administered. A daily Visual Analog Scale was completed on the first five mornings after chemotherapy. Rescue medications were permitted throughout the study, and type of medication was at the treating physicians' discretion.

Sample Characteristics

  • N = 85  
  • MEDIAN AGE = 55 years (range = 28–88 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Ovarian cancer

Setting

  • SITE: Single-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: South Korea

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, nonrandomized trial

Measurement Instruments/Methods

  • Visual Analog Scale (VAS, 0–100) of nausea
  • Number of emetic episodes
  • Number of rescue medications
  • Complete response (CR, defined as no vomiting or emesis for five days)

Results

98.8% of patients had CR in the acute phase, 89.4% in the delayed phase, and 89.4% overall. Patients over age 55 had a significantly higher rate of CR (97.8%) than those younger than 55 (80%) (p = 0.011). 95.3% of patients experienced no vomiting in the overall phase, and 91.8% took no rescue medications in the overall phase. Overall CR (89.4%) achieved in cycle 1 was maintained in cycles 2–6. Four hundred and sixty cycles were analyzed for adverse events. Results are as follows: ≥ 1 adverse event occurred in 179 (38.9%) cycles, drug-related adverse events occurred in 35 (7.6%) cycles, and serious adverse events occurred in 10 (2.2%) cycles. No patients discontinued therapy due to adverse events.

Conclusions

The combination of aprepitant, ramosetron, and dexamethasone for CINV is highly effective in the acute and delayed phases after chemotherapy administration. CR is achieved by a high number of patients for the six days following chemotherapy.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Findings not generalizable
  • Other limitations/explanation: All subjects were women with ovarian cancer.

Nursing Implications

Nurses can educate patients on the available pharmacologic options to control CINV, including the combination of aprepitant, ramosetron, and dexamethasone.