Randomized trial of two schedules of palonosetron for the prevention of nausea and vomiting in patients with metastatic melanoma receiving interleukin-2–based concurrent biochemotherapy

e20008 Background: Interleukin-2–based biochemotherapy (BCT) is a common therapy for patients (pts) with metastatic melanoma (MM). BCT induced nausea and vomiting (N/V) remains a significant problem (26% grade 3 and 4). Palonosetron (PALO) is a 5-HT3 receptor antagonist indicated for the prevention of N/V associated with chemotherapy. The recommended dosing schedule of PALO for patients on BCT is unknown. Methods: Chemo-naive MM pts undergoing their first BCT cycle were randomized to receive PALO 0.25 mg as premedication intravenously on days 1 and 4, or the same dose on days 1, 3, and 5. The BCT regimen included: cisplatin (20 mg/m2) and vinblastine (1.6 mg/m2) on days 1–4, dacarbazine (800 mg/m2) on day 1, interleukin-2 (9 MIU/m2/day) by continuous infusion on days 1–4 and interferon alpha (5 MU/m2/day) on days 1–5. A nausea episode was defined as nausea of any severity reported by the patient or documented by the nursing staff at anytime. Pts with N/V due to known central nervous system or gastrointest...