Biomaterial Database

A phase I study of continuous hepatic arterial infusion of Irinotecan in patients with locally advanced hepatocellular carcinoma. 2011

Giovanni Brandi, and Guido Biasco, and Maria Grazia Mirarchi, and Rita Golfieri, and Antonello Di Paolo, and Alberto Borghi, and Silvia Fanello, and Enrico Derenzini, and Valentina Agostini, and Emanuela Giampalma, and Alberta Cappelli, and Patrizia Pini, and Sarah Costantini, and Romano Danesi, and Luigi Bolondi, and Fabio Piscaglia

Seràgnoli Department of Haematology and Oncological Sciences, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy. giovanni.brandi@unibo.it

OBJECTIVE 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. CONCLUSIONS 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.

UI	MeSH Term	Description	Entries
D007261	Infusions, Intra-Arterial	Regional infusion of drugs via an arterial catheter. Often a pump is used to impel the drug through the catheter. Used in therapy of cancer, upper gastrointestinal hemorrhage, infection, and peripheral vascular disease.	Infusions, Regional Arterial,Infusions, Intra Arterial,Infusions, Intraarterial,Arterial Infusion, Intra,Arterial Infusion, Regional,Arterial Infusions, Intra,Arterial Infusions, Regional,Infusion, Intra Arterial,Infusion, Intra-Arterial,Infusion, Intraarterial,Infusion, Regional Arterial,Intra Arterial Infusion,Intra Arterial Infusions,Intra-Arterial Infusion,Intra-Arterial Infusions,Intraarterial Infusion,Intraarterial Infusions,Regional Arterial Infusion,Regional Arterial Infusions
D007262	Infusions, Intravenous	The long-term (minutes to hours) administration of a fluid into the vein through venipuncture, either by letting the fluid flow by gravity or by pumping it.	Drip Infusions,Intravenous Drip,Intravenous Infusions,Drip Infusion,Drip, Intravenous,Infusion, Drip,Infusion, Intravenous,Infusions, Drip,Intravenous Infusion
D008113	Liver Neoplasms	Tumors or cancer of the LIVER.	Cancer of Liver,Hepatic Cancer,Liver Cancer,Cancer of the Liver,Cancer, Hepatocellular,Hepatic Neoplasms,Hepatocellular Cancer,Neoplasms, Hepatic,Neoplasms, Liver,Cancer, Hepatic,Cancer, Liver,Cancers, Hepatic,Cancers, Hepatocellular,Cancers, Liver,Hepatic Cancers,Hepatic Neoplasm,Hepatocellular Cancers,Liver Cancers,Liver Neoplasm,Neoplasm, Hepatic,Neoplasm, Liver
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D002166	Camptothecin	An alkaloid isolated from the stem wood of the Chinese tree, Camptotheca acuminata. This compound selectively inhibits the nuclear enzyme DNA TOPOISOMERASES, TYPE I. Several semisynthetic analogs of camptothecin have demonstrated antitumor activity.	Camptothecine
D002404	Catheterization	Use or insertion of a tubular device into a duct, blood vessel, hollow organ, or body cavity for injecting or withdrawing fluids for diagnostic or therapeutic purposes. It differs from INTUBATION in that the tube here is used to restore or maintain patency in obstructions.	Cannulation,Cannulations,Catheterizations
D003967	Diarrhea	An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.	Diarrheas
D005260	Female		Females
D006499	Hepatic Artery	A branch of the celiac artery that distributes to the stomach, pancreas, duodenum, liver, gallbladder, and greater omentum.	Arteries, Hepatic,Artery, Hepatic,Hepatic Arteries