Longo, F., Mansueto, G., Lapadula, V., DeSanctis, R., Quadrini, S., Grande, R., … DiSeri, M. (2011). Palonosetron plus 3-day aprepitant and dexamethasone to prevent nausea and vomiting in patients receiving highly emetogenic chemotherapy. Supportive Care in Cancer, 19, 1159-1164.

To evaluate the efficacy of a regimen of three-day aprepitant, a single dose of palonosetron, and three-day dexamethasone in patients receiving cisplatin-based, highly emetogenic chemotherapy (HEC)

Patients were given the following regimen. On day 1, patients were given 0.25 mg IV palonosetron, 20 mg IV dexamethasone, and 125 mg oral aprepitant before chemotherapy; on day 2, they received 80 mg oral aprepitant and 4 mg oral or intramuscular dexamethasone; and on day 3, they were given 80 mg oral aprepitant and 4 mg oral or intramuscular dexamethasone.

Rescue therapy was 10 mg metoclopramide and 4 mg dexamethasone. Patient diaries were used to record emesis, use of rescue medication, and severity of nausea for 5 days after chemotherapy.

• The study consisted of 222 participants.
• Median age was 62 years, with a range of 22–82 years.
• The sample was 23.4% female and 76.6% male.
• The most frequent diagnoses were lung, head and neck, stomach, and bladder cancers.
• Patients with stage IV disease represented 77.5% of the sample.
• All patients were chemotherapy naïve and receiving HEC.

The study was conducted in multiple outpatient settings in Italy.

All patients were in active treatment.

This was a prospective trial.

• Patients rated nausea severity on a 4-point Likert-type scale.
• The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ30) was used.
• Complete response was defined as no emetic episodes and no use of rescue medication.

• The majority of patients (70.3%) had complete response, and 92.8% did not have vomiting but did use rescue medication.
• More than half of patients (59.9%) did not experience any nausea, and 31.1% experienced mild nausea.
• Nausea was the main reason for use of rescue medication.
• No major adverse events with antiemetics were seen.
• Patients reporting constipation represented 39% of participants, and headache was reported by 5%.

Palonosetron in combination with aprepitant and dexamethasone was found to be effective in preventing acute and delayed nausea and vomiting with HEC.

• The study did not have an appropriate control group.
• Data for complete response were analyzed only for the overall phase with no subgroup analysis for acute and delayed symptoms.

The findings confirmed the efficacy of palonosetron as part of an antiemetic drug regimen for patients receiving HEC.