• Support Care Cancer · Oct 2011

    Multicenter Study

    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).

    • Nicola Di Renzo, Antonella Montanini, Donato Mannina, Alessandra Dondi, Stefania Muci, Salvatrice Mancuso, M Rosaria De Paolis, Caterina Plati, Caterina Stelitano, Catia Patti, Attilio Olivieri, Eliana Liardo, Gabriele Buda, Renato Cantaffa, and Massimo Federico.
    • UO di Ematologia e Trapianto di Cellule Staminali, Ospedale Vito Fazzi, Piazza Filippo Muratore, 73100 Lecce, Italy. direnzo.ematolecce@libero.it
    • Support Care Cancer. 2011 Oct 1; 19 (10): 1505-10.

    PurposeThe control of nausea and vomiting induced by chemotherapy is paramount for overall treatment success in cancer patients. Antiemetic therapy during chemotherapy in lymphoma patients generally consists of anti-serotoninergic drugs and dexamethasone. The aim of this trial was to evaluate the efficacy of a single dose of palonosetron, a second-generation serotonin type 3 (5-HT(3)) receptor antagonist, in patients with aggressive non-Hodgkin's lymphoma receiving moderately emetogenic chemotherapy (MEC) containing steroids.MethodsPatients received a single intravenous bolus of palonosetron (0.25 mg) before administration of chemotherapy. Complete response (CR) defined as no vomiting and no rescue therapy during overall phase (0-120 h) was the primary endpoint. Complete control (CC) defined as CR and only mild nausea was a secondary endpoint.ResultsEighty-six evaluable patients entered in the study. A CR was observed in 74 patients (86.0%) during the overall phase; the CR during the acute (0-24 h) and delayed (24-120 h) phases was 90.7% and 88.4%, respectively. CC was 89.5% during the acute and 84.9% during the delayed phase; the overall CC was 82.6%.ConclusionsThis was the first trial, which demonstrated the efficacy of a single dose of palonosetron in control CINV in patients with aggressive non-Hodgkin's lymphoma receiving MEC regimen containing steroids.

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