Aim of this phase I study was to identify the maximum tolerated dose and dose limiting toxicity of continuous infusion of Irinotecan through a port-a-cath placed in the hepatic artery in patients with hepatocellular carcinoma and cirrhosis to explore new strategies in advanced hepatocellular carcinoma. Response rate and time-to-progression were analysed. METHODS: Irinotecan was delivered as a five-day continuous infusion every 21 days, with increases of 2.5mg/m(2)/day every three patients, starting from 7.5mg/m(2)/day. Dose limiting toxicity corresponded to one patient in each triplet developing G4 haematological or G3 non-haematological toxicity, confirmed in two triplets. Twenty-eight patients (17 Child-Pugh A, 11 B) received treatment and tumour response was assessed after three courses completed by 22 patients. RESULTS: Dose limiting toxicity was G3 diarrhoea in two patients, reached at 27.5mg/m(2)/day and the recommended dose was set at 25mg/m(2)/day. Nineteen of 30 patients experienced adverse events related to porth-a-cath placement and one died from liver ischemia and sepsis. Median time-to-progression was 11.3 months. CONCLUSION: Intrarterial infusion of Irinotecan is feasible in patients with hepatocellular carcinoma on cirrhosis at a recommended dose of 25mg/m(2)/day, with no major adverse drug-related events, but with some concerns about the insertion and management of the intra-arterial device.

A phase I study of continuous hepatic arterial infusion of Irinotecan in patients with locally advanced hepatocellular carcinoma

DI PAOLO, ANTONELLO;DANESI, ROMANO;
2011

Abstract

Aim of this phase I study was to identify the maximum tolerated dose and dose limiting toxicity of continuous infusion of Irinotecan through a port-a-cath placed in the hepatic artery in patients with hepatocellular carcinoma and cirrhosis to explore new strategies in advanced hepatocellular carcinoma. Response rate and time-to-progression were analysed. METHODS: Irinotecan was delivered as a five-day continuous infusion every 21 days, with increases of 2.5mg/m(2)/day every three patients, starting from 7.5mg/m(2)/day. Dose limiting toxicity corresponded to one patient in each triplet developing G4 haematological or G3 non-haematological toxicity, confirmed in two triplets. Twenty-eight patients (17 Child-Pugh A, 11 B) received treatment and tumour response was assessed after three courses completed by 22 patients. RESULTS: Dose limiting toxicity was G3 diarrhoea in two patients, reached at 27.5mg/m(2)/day and the recommended dose was set at 25mg/m(2)/day. Nineteen of 30 patients experienced adverse events related to porth-a-cath placement and one died from liver ischemia and sepsis. Median time-to-progression was 11.3 months. CONCLUSION: Intrarterial infusion of Irinotecan is feasible in patients with hepatocellular carcinoma on cirrhosis at a recommended dose of 25mg/m(2)/day, with no major adverse drug-related events, but with some concerns about the insertion and management of the intra-arterial device.
Brandi, G; Biasco, G; Mirarchi, Mg; Golfieri, R; DI PAOLO, Antonello; Borghi, A; Fanello, S; Derenzini, E; Agostini, V; Giampalma, E; Cappelli, A; Pini, P; Costantini, S; Danesi, Romano; Bolondi, L; Piscaglia, F.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11568/190394
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