DiRenzo, N., Montanini, A., Mannina, D., Dondi, A., Muci, S., Mancuso, S., … Federico, M. (2011). Single-dose palonosetron for prevention of chemotherapy-induced nausea and vomiting in patients with aggressive non-Hodgkin's lymphoma receiving moderately emetogenic chemotherapy containing steroids: results of a phase II study from the Gruppo Italiano per lo Studio dei Linfomi (GISL). Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer, 19(10), 1505-1510.

To evaluate the efficacy and safety of a single dose of palonosetron, a second-generation serotonin type 3 (5-HT₃) receptor antagonist, in patients with aggressive non-Hodgkin lymphoma receiving moderately emetogenic chemotherapy (MEC)-containing steroids

Patients received a single IV bolus of palonosetron (0.25 mg) over 30 minutes before administration of chemotherapy (day 1), and patients were assessed from day 1 through day 5. The antiemetic response was evaluated during the acute, delayed, and overall phases, as well on each day.

• The study reported on 86 participants.
• Median age was 65 years, with a range of 20–87.
• The sample was 55% male and 45% female.
• Patients had aggressive, stage I–IV, non-Hodgkin lymphoma (diffuse large B cell lymphoma = 78%).
• Patients had European Cooperative Oncology Group (ECOG) status of 0–2, were receiving R-CHOP, CHOP, R-COMP, and other chemotherapy regimens. Dexamethasone or metoclopramide as rescue medication were available upon patient request.

This multisite was conducted in Italy.

• All patients were in active treatment.
• This study has application for late effects and survivorship.

This was a prospective, open label, nonrandomized, phase II study.

• Complete response (CR) was defined as no vomiting and no rescue therapy during overall phase (0–120 hours).    
• Complete control was defined as CR and only mild nausea.
• The percentage of patients experiencing emesis and nausea was recorded.
• Patients completed diaries on days 1–5, recording the nausea occurrence; nausea severity on a 3-point, Likert-type scale; and use of rescue medication.
• Patient global satisfaction with antiemetic therapy was measured using a visual analog scale (VAS).

• CR was observed in 86% of patients during the overall phase. CR during the acute phase was 90.7%, and CR during the delayed phase was 88.4%.
• CC was 82.6% overall, 89.5% during the acute phase, and 82.6% in the delayed phase. During the overall study period, the emesis-free rate was 74.4%, the nausea-free rate was 74.4%, and no patients experienced severe nausea. The median global satisfaction with antiemetic therapy was 8.0 out of 10.
• The treatment was well tolerated, and no patients experienced severe adverse events.
• The most common, grade 1–2 adverse events were constipation (7.0%), headache (5.8%), asthenia (7.0%), and dizziness (1.2%). No grade 3–4 adverse events or significant changes in lab tests or vital signs were recorded during the study period.

A single dose of palonosetron is effective, tolerable, and safe in control of CINV in patients receiving MEC-regimen-containing steroids.

• No appropriate control group was included.
• No control for risk factors for CINV other than gender and age. Although antiemetic regimen did not include dexamethasone, the chemotherapy regimen included prednisone.

A single dose palonosetron infusion is a tolerable and safe option for patients receiving MEC-containing steroids. A single-dose palonosetron infusion could be less expensive in comparison to multiple administration of IV infusions of the first generation 5-HT₃ RAs, which also could save time and required workforce.