Daily Palonosetron Is Superior to Ondansetron in the Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting in Patients With Acute Myelogenous Leukemia

BACKGROUND Nausea and vomiting in patients with acute myelogenous leukemia (AML) can be from various causes including the use of high-dose cytarabine METHODS The authors compared 2 schedules of palonosetron versus ondansetron in the treatment of chemotherapy-induced nausea and vomiting (CINV) in patients with AML receiving high-dose cytarabine Patients were randomized to 1) ondansetron 8 mg intravenously (IV) followed by 24 mg continuous infusion 30 minutes before high-dose cytarabine and until 12 hours after the high-dose cytarabine infusion ended 2) palonosetron 0 25 mg IV 30 minutes before chemotherapy daily from Day 1 of high dose cytarabine up to Day 5 or 3) palonosetron 0 25 mg IV 30 minutes before high-dose cytarabine on Days 1 3 and 5 RESULTS Forty-seven patients on ondansetron and 48 patients on each of the palonosetron arms were evaluable for efficacy Patients in the palonosetron arms achieved higher complete response rates (no emetic episodes plus no rescue medication) but the difference was not statistically significant (ondansetron 21% palonosetron on Days 1-5 31% palonosetron on Days 1 3 and 5 35% P = 32) Greater than 77% of patients in each arm were free of nausea on Day 1 however on Days 2 through 5 the proportion of patients without nausea declined similarly in all 3 groups On Days 6 and 7 significantly more patients receiving palonosetron on Days 1 to 5 were free of nausea (P = 001 and P = 0247 respectively) CONCLUSIONS The daily assessments of emesis did not show significant differences between the study arms Patients receiving palonosetron on Days 1 to 5 had significantly less severe nausea and experienced significantly less impact of CINV on daily activities on Days 6 and 7 Cancer 2010,116 5659-66 (C) 2010 American Cancer Society