Kosaka, Y., Tanino, H., Sengoku, N., Minatani, N., Kikuchi, M., Nishimiya, H., . . . Watanabe, M. (2015). Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy. Supportive Care in Cancer, 24, 1405–1411.

To investigate if the use of a second-generation 5-HT3 receptor antagonist (palonosetron) and a NK1 receptor agonist (aprepitant) could allow a decreased dose of dexamethasone based on nausea and vomiting in patients with breast cancer receiving highly emetogenic chemotherapy

Randomization was to Group A: palonosetron IV plus dexamethasone IV with oral aprepitant on day 1 followed by 8 mg dexamethasone IV and 80 mg aprepitant PO on days 2 and 3. Group B received a placebo instead of dexamethasone on days 2 and 3. Patients were treated in the hospital.

• N = 80   
• MEAN AGE = Group A: 53.5 years, Group B: 52.6 years
• AGE RANGE = 35–76 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Chemotherapy naïve patients with breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Six patients who were included had metastatic disease. Patients were chemotherapy naïve with confirmed breast cancer and older than 19 years. Patients received chemotherapy that included an anthracycline-cyclophosphamide combination.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Japan

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

Phase-II, single-center, single-blind, placebo-controlled, parallel, randomized trial. Randomization was done on a one to one ratio using a minimization method.

• Self-report diary of nausea and vomiting
• Chart extractions measuring emetic episodes and use of rescue medications
• Adverse events were classified according to the Common Terminology Criteria of Adverse Events (CTCAE), version 4.0.
• Patients were classified as having complete control if they used no rescue medications and had no emetic episodes and only mild nausea.
• Complete response (CR) was defined as no emetic episodes and no rescue medication.  
• Nausea was measured as none, mild, moderate, or severe, based on subjective patient reports.

This study showed that complete control and CR revealed equivalent findings in acute and delayed chemotherapy-induced nausea and vomiting (CINV) with 1 day or 3 days of dexamethasone. No statistical differences were noted between both groups. Subgroup analysis looked at patients younger than 50 years. This also did not show any differences.

Using one dose of dexamethasone is feasible in treating CINV.

• Small sample (< 100)
• Measurement validity/reliability questionable
• Findings not generalizable
• Uncertainty as to how patients were hospitalized for the duration of the study, but this certainly added to purer date 
• The researchers relied on self-reports of nausea and vomiting and medical records of emesis, which can lead to underestimation if the nausea and/or vomiting was not documented.

Reducing the use of dexamethasone may be possible in treating CINV prospectively. This may be critical in uncontrolled diabetics.