Musso, M., Scalone, R., Bonanno, V., Crescimanno, A., Polizzi, V., Porretto, F., … Perrone, T. (2009). Palonosetron (Aloxi) and dexamethasone for the prevention of acute and delayed nausea and vomiting in patients receiving multiple-day chemotherapy. Supportive Care in Cancer, 17, 205–209. 

To determine the efficacy of palonosetron combined with dexamethasone in prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving multiple-day chemotherapy and the efficacy of a second dose of palonosetron in treating breakthrough emesis

An historic control group was used. Group O received ondansetron (8 mg IV) as a single dose on day one, along with dexamethasone each day of the regimen. Breakthrough emesis was treated with metoclopramide in the control group (but only after 72 hours following the first dose).

• The study consisted of 91 participants, which included 45 historic cases.
• The median age in the study group (P) was 51 years with a range of 15–80. The median age in the control group (O) was 50 years with a range of 20–77.
• The study sample was 37% female and 63% male; the control sample was 40% female and 60% male.
• Diagnoses were non-Hodgkin lymphoma, Hodgkin lymphoma, and acute myeloid leukemia.
• Patients in both the control and study groups received similar chemotherapy regimens with a total of 180 total cycles of chemotherapy administered in the study group and 173 cycles administered in the control group.

This study was conducted at a single inpatient setting in Palermo, Italy.

All patients were in active treatment.

This was a prospective trial with historic control comparison.

The number of vomiting episodes, grade of nausea (grading scale included), and need for rescue therapy were recorded in patient diaries.

• Nausea and vomiting were absent in 80% of patients of the study (P) group and 60% in the control (O) group (p < 0.05).
• In the study (P) group, 67% of patients who experienced CINV were successfully rescued by a second dose of palonosetron, whereas in the ondansetron group, 22% were successfully rescued after treatment with metoclopramide (p = 0.04).

Palonosetron was effective for prophylaxis of CINV and for treatment of breakthrough emesis in the setting of multiple-day chemotherapy.

• No concurrent control or random patient assignment was used.
• Use of retrospective comparison to ondansetron is based on the premise that repeat dosing of ondansetron in multiple-day regimens is not effective and uses a different type of medication for breakthrough emesis, thus decreasing the utility of this as an effective control group.

Palonosetron demonstrates effective prevention of acute CINV in the setting of multiple-day chemotherapy regimens and treatment of breakthrough emesis when repeated 72 hours after the initial dose.