Pacetti, U., Veltri, E., Fattoruso, S.I., Cardillo, F.D., Evangelista, S., Cognetti, F., & Fabi, A. (2013). Single-dose palonosetron and dose-reduced regimen of dexamethasone in preventing nausea and vomiting by anthracycline-including chemotherapy in patients with early breast cancer. Anticancer Research, 33(4), 1721–1724.

Study Purpose

To evaluate the effectiveness of low-dose dexamethasone (4 mg) given with palonosetron on acute and delayed nausea and vomiting in patients receiving highly emetogenic chemotherapy (HEC)

Intervention Characteristics/Basic Study Process

Day 1 (30 minutes before chemotherapy): Administration of palonosetron 0.25 mg and dexamethasone 4 mg intravenously

Days 2 and 3: Dexamethasone 4 mg intramuscularly daily

Sample Characteristics

  • N = 26
  • MEDIAN AGE = 58 years (range = 42–76 years)
  • MALES: 1 (4%), FEMALES: 25 (96%)
  • KEY DISEASE CHARACTERISTICS: 100% patients with breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: 54% received epirubicin and cyclophosphamide; 35% received fluorouracil, epirubicin, and cyclophosphamide; and 11% received epirubicin, cyclophosphamide, and trastuzumab. Of the 25 females, 8% were premenopausal and 92% were postmenopausal. 

Setting

  • SITE: Not stated/unknown  
  • SETTING TYPE: Not specified
  • LOCATION: Not stated but assumed in Italy since all authors are from Italy

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Observational

Measurement Instruments/Methods

Patients were given a diary to record their emesis episodes, nausea and its severity, and use of rescue medication within the first 24 hours and on days 2–5 after chemotherapy. Patients participated in minimum of one chemotherapy course up to a maximum of four chemotherapy courses.

Results

Course 1: 72% of patients had completed response (no emesis, no rescue medication) in the acute phase and complete control (no emesis, no rescue medication, no more than mild nausea) in the delayed phase; 12% had partial response (one emesis, no more than two days of rescue medication) in the acute phase and complete control in the delayed phase; 12% had partial response in the acute phase and partial control (severe nausea no more than two days and needing rescue medication) in the delayed phase; and one patient (4%) did not respond to prophylaxis. Among all chemotherapy courses combined: 72% of the courses showed complete response in the acute phase and complete control in the delayed phase; 8% had partial response in the acute phase and complete control in the delayed phase; 4% had partial response in the acute phase and partial control in the delayed phase; 15% had complete response in the acute phase and partial control in the delayed phase; no control of emesis occurred in one of the courses (1%). No adverse side effects (e.g., constipation, abdominal pain, insomnia, elevated blood glucose levels) were reported.

Conclusions

Low-dose dexamethasone given in conjunction with one dose of palonosetron appears to be effective for the treatment of acute and delayed nausea and vomiting in patients with breast cancer receiving HEC. However, additional research is needed to allow for further comparison of response to variable dexamethasone dosing in conjunction with 5-HT3 for prophylaxis of HEC.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described

Nursing Implications

Low-dose dexamethasone is an effective treatment for acute and delayed nausea and vomiting with no significant side effects. However, additional research studies are needed to allow for further comparison of response to variable dexamethasone dosing in conjunction with 5-HT3 for prophylaxis of HEC. The authors suggest that patients may experience similar efficacy with an antiemetic regimen that includes lower doses of steroids. Reducing the total dose of steroids has the potential to simultaneously reduce the untoward effects that are known to result from administration of steroids (e.g., altered glucose levels, bone loss, sleep disturbances, mood changes).