Hepatic Arterial Chemotherapy in Combination with Systemic Chemotherapy Compared with Hepatic Arterial Chemotherapy Alone for Liver Metastases from Colorectal Cancer: Results of a Multi-centric Randomized Study

Hepatic arterial infusion (HAI) chemotherapy is accepted to be an option in patients with non-resectable metastases from colorectal cancer confined to the liver. In a multi-istitutional trial, 76 patients were randomly assigned to receive HAI versus HAI plus systemic bolus 5-fluorouracil and leucovo...

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Veröffentlicht in:In vivo (Athens) 2006-11, Vol.20 (6A), p.707
Hauptverfasser: Fiorentini, Giammaria, Cantore, Maurizio, Rossi, Susanna, Vaira, Marco, Tumolo, Salvatore, Dentico, Patrizia, Mambrini, Andrea, Bernardeschi, Paolo, Turrisi, Gina, Giovanis, Petros, Guadagni, Stefano, Valori, Vanna, De Simone, Michele
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container_issue 6A
container_start_page 707
container_title In vivo (Athens)
container_volume 20
creator Fiorentini, Giammaria
Cantore, Maurizio
Rossi, Susanna
Vaira, Marco
Tumolo, Salvatore
Dentico, Patrizia
Mambrini, Andrea
Bernardeschi, Paolo
Turrisi, Gina
Giovanis, Petros
Guadagni, Stefano
Valori, Vanna
De Simone, Michele
description Hepatic arterial infusion (HAI) chemotherapy is accepted to be an option in patients with non-resectable metastases from colorectal cancer confined to the liver. In a multi-istitutional trial, 76 patients were randomly assigned to receive HAI versus HAI plus systemic bolus 5-fluorouracil and leucovorin. The primary end-point was survival, followed by response, recurrence and toxicity. Survival was longer for HAI plus systemic chemotherapy (HAI+SYC) than HAI (median, 20 vs. 14 months; p=0.0033), as were responses (47.5% and 41.7%; p=0.09) and time to hepatic progression (12 vs. 8 months; p=0.039). Side effects included haematological toxicity that was mostly mild and reversible in 432 cases. Neutropenia grade 3 occurred in four patients in the HAI+SYC arm and one in the HAI arm. Diarrhoea occurred in 20% and 7% of patients and stomatitis occurred in 18% and 2%, respectively. On the contrary biliary toxicity was significant; twelve patients had evidence of bilirubin elevations of more than 3 mg/dl (six in each arm), and two had asymptomatic arterial biliary-tree fistulae: one in the HAI+SYC arm and one in the HAI arm. Grade 3 elevation in alkaline phosphatase and aminotransferase levels occurred in 26% and 24%, respectively. In conclusion, the combination of HAI+SYC is active and safe showing a clinical advantage with respect to simple HAI, increasing overall survival, response rate and time to progression.
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In a multi-istitutional trial, 76 patients were randomly assigned to receive HAI versus HAI plus systemic bolus 5-fluorouracil and leucovorin. The primary end-point was survival, followed by response, recurrence and toxicity. Survival was longer for HAI plus systemic chemotherapy (HAI+SYC) than HAI (median, 20 vs. 14 months; p=0.0033), as were responses (47.5% and 41.7%; p=0.09) and time to hepatic progression (12 vs. 8 months; p=0.039). Side effects included haematological toxicity that was mostly mild and reversible in 432 cases. Neutropenia grade 3 occurred in four patients in the HAI+SYC arm and one in the HAI arm. Diarrhoea occurred in 20% and 7% of patients and stomatitis occurred in 18% and 2%, respectively. On the contrary biliary toxicity was significant; twelve patients had evidence of bilirubin elevations of more than 3 mg/dl (six in each arm), and two had asymptomatic arterial biliary-tree fistulae: one in the HAI+SYC arm and one in the HAI arm. Grade 3 elevation in alkaline phosphatase and aminotransferase levels occurred in 26% and 24%, respectively. 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Grade 3 elevation in alkaline phosphatase and aminotransferase levels occurred in 26% and 24%, respectively. In conclusion, the combination of HAI+SYC is active and safe showing a clinical advantage with respect to simple HAI, increasing overall survival, response rate and time to progression.</abstract><cop>Greece</cop><pub>International Institute of Anticancer Research</pub><pmid>17203750</pmid></addata></record>
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source MEDLINE; EZB-FREE-00999 freely available EZB journals
subjects Antimetabolites, Antineoplastic - administration & dosage
Colorectal Neoplasms - drug therapy
Colorectal Neoplasms - mortality
Colorectal Neoplasms - pathology
Drug Combinations
Floxuridine - administration & dosage
Fluorouracil - administration & dosage
Hepatic Artery
Humans
Injections, Intra-Arterial
Injections, Intravenous
Leucovorin - administration & dosage
Liver Neoplasms - drug therapy
Liver Neoplasms - mortality
Liver Neoplasms - secondary
Survival Rate
Treatment Outcome
title Hepatic Arterial Chemotherapy in Combination with Systemic Chemotherapy Compared with Hepatic Arterial Chemotherapy Alone for Liver Metastases from Colorectal Cancer: Results of a Multi-centric Randomized Study
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