Hajdenberg, J., Grote, T., Yee, L., Arevalo-Araujo, R., & Latimer, L.A. (2006). Infusion of palonosetron plus dexamethasone for the prevention of chemotherapy-induced nausea and vomiting. Journal of Supportive Oncology 4(9), 467-471.

To evaluate the efficacy and safety of palonosetron and dexamethasone as an antiemetic regimen

• Eligible patients received palonosetron plus dexamethasone infusion as an antiemetic treatment: 0.25 mg palonosetron admixed with 8 mg dexamethasone in 50 ml infusion solution prior to chemotherapy.
• Patients self-recorded efficacy data in diaries and were contacted on day three at home to review diary completion and inquire about other possible antiemetic treatments.
• Patients then returned to the clinic between days 6 and 8 after chemotherapy for final study procedures.

The study consisted of 33 patients.

The study was conducted at three sites.

This was a nonblinded, open-label, phase II study.

• Patients used a four-point Likert-type scale to rate nausea intensity.
• The number of emetic episodes and use of rescue medication also were documented in patient diaries.

• Twenty-nine (91%) patients had no emetic episodes during the acute interval, 26 (81%) had no emesis during the delayed interval, and 23 (72%) had no emesis during the overall interval.
• Emesis-free rates for the acute, delayed, and overall intervals for the historic population were 79%, 72%, and 66%, respectively.

No significant differences were found in any of the outcomes of interest between groups. The report stated that the addition of dexamethasone increased in benefit in the acute interval by 12%, but this was not significant.

The study refers to a historic population as the control rather than having a control group. The historic control is not described other than that patients received palonosetron without concomitant dexamethasone.