Komatsu, Y., Okita, K., Yuki, S., Furuhata, T., Fukushima, H., Masuko, H., . . . Takahashi, Y. (2015). Open-label, randomized, comparative, phase III study on effects of reducing steroid use in combination with palonosetron. Cancer Science, 106, 891–895. 

To evaluate chemotherapy-induced nausea and vomiting and adverse events when dexamethasone is eliminated on days 2 and 3 of moderately emetogenic chemotherapy (not including anthracyclines or cyclophosphamide) in combination with palonosetron or another 5HT3 receptor antagonist

The control group received 9.9 mg of dexamethasone IV then 0.75 mg of palonosetron IV before moderately emetogenic chemotherapy then either 8 mg of oral dexamethasone or 6.6 mg of IV dexamethasone on days 2 and 3 of chemotherapy. The treatment group received only 9.9 mg of dexamethasone IV then 0.75 mg of palonosetron IV before moderately emetogenic chemotherapy and no additional prophylactic antiemetics. Rescue antiemetic drugs (excluding dexamethasone, NK1 receptor antagonists, serotonin reuptake inhibitors, and serotonin–norepinephrine reuptake inhibitors) were allowed for both the treatment and control groups. 

• N = 305 (151 in treatment group and 154 in control group)  
• MEAN AGE = 64 years (range = 23–88 years)
• MALES: 173 (57%), FEMALES: 132 (43%)
• KEY DISEASE CHARACTERISTICS: Not specified (inclusion criteria was just malignant tumor)
• OTHER KEY SAMPLE CHARACTERISTICS: Received primarily oxaliplatin-based chemotherapy then irinotecan- and carboplatin-based chemotherapy in a one-day administration; 45% (n = 138) consumed alcohol within 180 days of chemotherapy

• SITE: Multi-site    
• SETTING TYPE: Not specified    
• LOCATION: Hokkaido, Japan

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

Open-label, noninferiority, randomized, comparative, phase 3 study

• Gastrointestinal symptom diary of number of vomiting events and nausea rated on a four-point Likert scale that was completed by patient every 24 hours for five days after chemotherapy administration.
• Adverse events were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE), but no indication of how the data were gathered was given.
• The exacerbation of symptoms by one grade level or higher compared to baseline was considered an adverse event.
• Complete control and complete response rates in acute and delayed phases 

The noninferiority of the experimental group in regard to complete response rate (acute and delayed phases) and complete control rate (overall, acute, and delayed phases) was demonstrated. There was no difference between the treatment and control groups. A subgroup analysis according to age, sex, and chemotherapy showed no statistical differences in complete response rates. No significant difference in adverse events was found between the treatment and control group with primary events in both groups being constipation, hiccups, anorexia, and elevated alanine transaminase.

There was no difference in chemotherapy-induced nausea and vomiting (acute and delayed) or adverse events between one-day dexamethasone plus palonosetron versus three-day dexamethasone plus palonosetron among patients receiving moderately emetogenic chemotherapy (not including anthracyclines or cyclophosphamide).

• Measurement/methods not well described
• Measurement validity/reliability questionable

The one-day administration of dexamethasone (with palonosetron) was adequate in controlling acute and delayed nausea and vomiting in patients receiving moderately emetogenic chemotherapy when the chemotherapy did not include anthracyclines or cyclophosphamide.