Hayashi, T., Ikesue, H., Esaki, T., Fukazawa, M., Abe, M., Ohno, S., … Oishi, R. (2012). Implementation of institutional antiemetic guidelines for low emetic risk chemotherapy with docetaxel: A clinical and cost evaluation. Supportive Care in Cancer, 20, 1805–1810.

DOI Link

Study Purpose

To evaluate the effect of implementation of institutional guidelines (12 mg dexamethasone alone) for low-emetic risk chemotherapy with docetaxel and to estimate the cost savings for all low-emetic risk chemotherapies in a year

Intervention Characteristics/Basic Study Process

All patients with breast cancer received either four courses of FEC therapy  (500 mg/m5-fluorouracil, 100 mg/mepirubicin, and 500 mg/mcyclophosphamide) or EC therapy (100 mg/mepirubicin and 600 mg/mcyclophosphamide, every 21 days) followed by adjuvant docetaxel therapy (70–75 mg/m2) every 21 days for four cycles.

Before implementation of the institutional antiemetic guidelines, group one (41 patients, 151 courses) received 4 mg ondansetron plus 8 mg IV dexamethasone 30 minutes before treatment with docetaxel.

After implementation of the guidelines, group two (56 patients, 205 courses) received 12 mg dexamethasone only. In both groups, 4 mg oral dexamethasone was given twice a day on days 2 and 3 of docetaxel therapy for prevention of docetaxel-related fluid retention.

Effectiveness and adverse effects were compared between groups. With patients who received dexamethasone and ondansetron, investigators evaluated incidence of nausea, vomiting, and adverse reactions with docetaxel retrospectively in the medical records. 

Additionally, a cost minimization analysis was performed to assess the economic impact of implementing institutional antiemetic guidelines. The cost comparison looked at 4 mg ondansetron + 8 mg dexamethasone + 100 ml normal saline versus 12 mg dexamethasone + 100 ml normal saline plus the time to prepare the antiemetic guidelines, attending committee, and change order sets.

Sample Characteristics

  • The study reported on 97 patients (41 in group one and 56 in group two).
  • The mean age in group one was 50.2 years (SD = 11.6 groups). The mean age in group two was 50.8 years (SD = 8.9 years).
  • The percentage of males and females was not indicated.
  • All patients were diagnosed with breast cancer.
  • No significant characteristic differences were observed between the groups before or after implementation of the institutional guidelines.

Setting

This study was conducted at a single site, the National Hospital Organization Kyushu Cancer Center (NKCC) in Fukuoka, Japan.

Phase of Care and Clinical Applications

All patients were in active treatment. This study has applications for late effects and treatment.

Study Design

This was a retrospective cohort study.

Measurement Instruments/Methods

The Common Terminology Criteria for Adverse Events, version 3.0, was used to grade adverse drug reactions.

Results

  • Overall, 97 patients were observed during 356 treatments either before or after implementation of the institutional guidelines (ondansetron + 8 mg dexamethasone versus 12 mg dexamethasone alone).
  • Nausea (19.5% in group one versus 16.1% in group two) and vomiting (2.4% in group one versus 0% in group two) occurred in both groups; however, no significant differences in the incidence of emesis were found between the two groups.
  • Although anticipated to be higher in the dexamethasone group, no differences were found between the groups in incidence of constipation (34.1% in group one versus 30.4% in group two) or insomnia (17.1% in group one versus 17.9% in group two).
  • The cost of ondansetron + 8 mg dexamethasone ($68) decreased to $7.50 with 12 mg dexamethasone.
  • Considerable savings occurred between the two groups when ondansetron was eliminated from the low risk antiemetic guidelines.

Conclusions

Dexamethasone alone (12 mg) appeared to be as effective in preventing nausea and vomiting as ondansetron and dexamethasone (8 mg) in low-risk emetic chemotherapy with docetaxel, and it was more cost effective.

Limitations

  • This was not a prospective, randomized, or blinded study
  • Outcomes were only evaluated with adjuvant docetaxel therapy for patients with breast cancer and not with other low-emetic risk drugs.
  • Adverse reactions caused from the antiemetics were evaluated from medical records.
  • Whether 12 mg of dexamethasone is optimal could not be determined from the study.

Nursing Implications

The use of 12 mg dexamethasone alone for low-risk ematogenic antineoplastic therapies such as docetaxel is recommended in the literature, has shown reasonable effectiveness for preventing nausea and vomiting, and is economically advantageous.