Transhepatic Arterial Chemoembolization with Oxaliplatin-eluting Microspheres (OEM-TACE) for Unresectable Hepatic Tumors

Background: While conventional transhepatic arterial chemoembolization (TACE) is accepted worldwide as an effective treatment for patients with unresectable hepatocellular carcinoma (HCC), its use in other hepatic tumors is not supported by randomized studies. Preliminary results have shown that new...

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Veröffentlicht in:Anticancer research 2008-11, Vol.28 (6B), p.3835-3842
Hauptverfasser: POGGI, Guido, QUARETTI, Pietro, MONTAGNA, Michela, AMATU, Alessio, TERAGNI, Cristina, PALUMBO, Ilaria, TRAVERSO, Elena, TONINI, Stefano, VILLANI, Laura, SCELSI, Mario, BAIARDI, Paola, GRAZIA FELISI, Maria, MINOIA, Claudio, SOTTOTETTI, Federico, TAGLIAFERRI, Barbara, RICCARDI, Alberto, BERNARDO, Giovanni, REGAZZI BONORA, Mario, GAGGERI, Raffaella, RONCHI, Anna, MASSA SALUZZO, Cesare, AZZARETTI, Andrea, RODOLICO, Giuseppe
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container_end_page 3842
container_issue 6B
container_start_page 3835
container_title Anticancer research
container_volume 28
creator POGGI, Guido
QUARETTI, Pietro
MONTAGNA, Michela
AMATU, Alessio
TERAGNI, Cristina
PALUMBO, Ilaria
TRAVERSO, Elena
TONINI, Stefano
VILLANI, Laura
SCELSI, Mario
BAIARDI, Paola
GRAZIA FELISI, Maria
MINOIA, Claudio
SOTTOTETTI, Federico
TAGLIAFERRI, Barbara
RICCARDI, Alberto
BERNARDO, Giovanni
REGAZZI BONORA, Mario
GAGGERI, Raffaella
RONCHI, Anna
MASSA SALUZZO, Cesare
AZZARETTI, Andrea
RODOLICO, Giuseppe
description Background: While conventional transhepatic arterial chemoembolization (TACE) is accepted worldwide as an effective treatment for patients with unresectable hepatocellular carcinoma (HCC), its use in other hepatic tumors is not supported by randomized studies. Preliminary results have shown that new drug-eluting microspheres (DEM) seem to optimize TACE procedures. The aim of this study was to evaluate the capability of HepaSphere™ to load oxaliplatin and their pharmacokinetic outcome. The feasibility and safety of treatment with oxaliplatin-eluting microspheres (OEM-TACE) was also evaluated in patients with unresectable liver metastasis of colorectal cancer and unresectable intrahepatic cholangiocarcinoma. Patients and Methods: An inductively coupled plasma mass spectrometer (ICP-MS) was used to quantify the oxaliplatin bound to microspheres and the oxaliplatin in liver biopsies. Fifteen patients (8 with colorectal carcinoma liver metastases, 7 with intrahepatic cholangiocarcinoma) were treated with 27 sessions of OEM-TACE. Results: The data suggested that the microspheres can bind oxaliplatin entirely. The pharmacokinetic parameters were significantly different between the OEM-TACE patients and a control group of patients treated with oxaliplatin chemotherapy. The mean oxaliplatin concentration within the tumor was twenty-times higher than the extratumoral liver concentration in the OEM-TACE patients. According to response evaluating criteria in solid tumors (RECIST), stable disease was observed in 8 out of the 15 patients (53.3%), a partial response in 2 (13.3%) and intrahepatic or extrahepatic tumor progression in 5 out of the 15 patients (33.3%). No major adverse event (AE G3/4) occurred. Conclusion: TACE with oxaliplatin-loaded microspheres is a safe and feasible treatment without major adverse events and with a favorable pharmacokinetic profile.
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Preliminary results have shown that new drug-eluting microspheres (DEM) seem to optimize TACE procedures. The aim of this study was to evaluate the capability of HepaSphere™ to load oxaliplatin and their pharmacokinetic outcome. The feasibility and safety of treatment with oxaliplatin-eluting microspheres (OEM-TACE) was also evaluated in patients with unresectable liver metastasis of colorectal cancer and unresectable intrahepatic cholangiocarcinoma. Patients and Methods: An inductively coupled plasma mass spectrometer (ICP-MS) was used to quantify the oxaliplatin bound to microspheres and the oxaliplatin in liver biopsies. Fifteen patients (8 with colorectal carcinoma liver metastases, 7 with intrahepatic cholangiocarcinoma) were treated with 27 sessions of OEM-TACE. Results: The data suggested that the microspheres can bind oxaliplatin entirely. The pharmacokinetic parameters were significantly different between the OEM-TACE patients and a control group of patients treated with oxaliplatin chemotherapy. The mean oxaliplatin concentration within the tumor was twenty-times higher than the extratumoral liver concentration in the OEM-TACE patients. According to response evaluating criteria in solid tumors (RECIST), stable disease was observed in 8 out of the 15 patients (53.3%), a partial response in 2 (13.3%) and intrahepatic or extrahepatic tumor progression in 5 out of the 15 patients (33.3%). No major adverse event (AE G3/4) occurred. 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Preliminary results have shown that new drug-eluting microspheres (DEM) seem to optimize TACE procedures. The aim of this study was to evaluate the capability of HepaSphere™ to load oxaliplatin and their pharmacokinetic outcome. The feasibility and safety of treatment with oxaliplatin-eluting microspheres (OEM-TACE) was also evaluated in patients with unresectable liver metastasis of colorectal cancer and unresectable intrahepatic cholangiocarcinoma. Patients and Methods: An inductively coupled plasma mass spectrometer (ICP-MS) was used to quantify the oxaliplatin bound to microspheres and the oxaliplatin in liver biopsies. Fifteen patients (8 with colorectal carcinoma liver metastases, 7 with intrahepatic cholangiocarcinoma) were treated with 27 sessions of OEM-TACE. Results: The data suggested that the microspheres can bind oxaliplatin entirely. The pharmacokinetic parameters were significantly different between the OEM-TACE patients and a control group of patients treated with oxaliplatin chemotherapy. The mean oxaliplatin concentration within the tumor was twenty-times higher than the extratumoral liver concentration in the OEM-TACE patients. According to response evaluating criteria in solid tumors (RECIST), stable disease was observed in 8 out of the 15 patients (53.3%), a partial response in 2 (13.3%) and intrahepatic or extrahepatic tumor progression in 5 out of the 15 patients (33.3%). No major adverse event (AE G3/4) occurred. Conclusion: TACE with oxaliplatin-loaded microspheres is a safe and feasible treatment without major adverse events and with a favorable pharmacokinetic profile.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Agents - administration &amp; dosage</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - chemistry</subject><subject>Antineoplastic Agents - pharmacokinetics</subject><subject>Biological and medical sciences</subject><subject>Chemoembolization, Therapeutic - adverse effects</subject><subject>Chemoembolization, Therapeutic - methods</subject><subject>Cholangiocarcinoma - metabolism</subject><subject>Cholangiocarcinoma - therapy</subject><subject>Drug Delivery Systems</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Hepatic Artery</subject><subject>Humans</subject><subject>Liver Neoplasms - metabolism</subject><subject>Liver Neoplasms - therapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Microspheres</subject><subject>Middle Aged</subject><subject>Organoplatinum Compounds - administration &amp; 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QUARETTI, Pietro ; MONTAGNA, Michela ; AMATU, Alessio ; TERAGNI, Cristina ; PALUMBO, Ilaria ; TRAVERSO, Elena ; TONINI, Stefano ; VILLANI, Laura ; SCELSI, Mario ; BAIARDI, Paola ; GRAZIA FELISI, Maria ; MINOIA, Claudio ; SOTTOTETTI, Federico ; TAGLIAFERRI, Barbara ; RICCARDI, Alberto ; BERNARDO, Giovanni ; REGAZZI BONORA, Mario ; GAGGERI, Raffaella ; RONCHI, Anna ; MASSA SALUZZO, Cesare ; AZZARETTI, Andrea ; RODOLICO, Giuseppe</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-h270t-5bcfa73c04803d40716ff3ac96ddae40217d3141c8470a4be6fede79aa7370f73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Agents - administration &amp; dosage</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Antineoplastic Agents - chemistry</topic><topic>Antineoplastic Agents - pharmacokinetics</topic><topic>Biological and medical sciences</topic><topic>Chemoembolization, Therapeutic - adverse effects</topic><topic>Chemoembolization, Therapeutic - methods</topic><topic>Cholangiocarcinoma - metabolism</topic><topic>Cholangiocarcinoma - therapy</topic><topic>Drug Delivery Systems</topic><topic>Feasibility Studies</topic><topic>Female</topic><topic>Hepatic Artery</topic><topic>Humans</topic><topic>Liver Neoplasms - metabolism</topic><topic>Liver Neoplasms - therapy</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Microspheres</topic><topic>Middle Aged</topic><topic>Organoplatinum Compounds - administration &amp; 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Preliminary results have shown that new drug-eluting microspheres (DEM) seem to optimize TACE procedures. The aim of this study was to evaluate the capability of HepaSphere™ to load oxaliplatin and their pharmacokinetic outcome. The feasibility and safety of treatment with oxaliplatin-eluting microspheres (OEM-TACE) was also evaluated in patients with unresectable liver metastasis of colorectal cancer and unresectable intrahepatic cholangiocarcinoma. Patients and Methods: An inductively coupled plasma mass spectrometer (ICP-MS) was used to quantify the oxaliplatin bound to microspheres and the oxaliplatin in liver biopsies. Fifteen patients (8 with colorectal carcinoma liver metastases, 7 with intrahepatic cholangiocarcinoma) were treated with 27 sessions of OEM-TACE. Results: The data suggested that the microspheres can bind oxaliplatin entirely. The pharmacokinetic parameters were significantly different between the OEM-TACE patients and a control group of patients treated with oxaliplatin chemotherapy. The mean oxaliplatin concentration within the tumor was twenty-times higher than the extratumoral liver concentration in the OEM-TACE patients. According to response evaluating criteria in solid tumors (RECIST), stable disease was observed in 8 out of the 15 patients (53.3%), a partial response in 2 (13.3%) and intrahepatic or extrahepatic tumor progression in 5 out of the 15 patients (33.3%). No major adverse event (AE G3/4) occurred. Conclusion: TACE with oxaliplatin-loaded microspheres is a safe and feasible treatment without major adverse events and with a favorable pharmacokinetic profile.</abstract><cop>Attiki</cop><pub>International Institute of Anticancer Research</pub><pmid>19192637</pmid><tpages>8</tpages></addata></record>
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source MEDLINE; EZB-FREE-00999 freely available EZB journals
subjects Aged
Aged, 80 and over
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Antineoplastic Agents - chemistry
Antineoplastic Agents - pharmacokinetics
Biological and medical sciences
Chemoembolization, Therapeutic - adverse effects
Chemoembolization, Therapeutic - methods
Cholangiocarcinoma - metabolism
Cholangiocarcinoma - therapy
Drug Delivery Systems
Feasibility Studies
Female
Hepatic Artery
Humans
Liver Neoplasms - metabolism
Liver Neoplasms - therapy
Male
Medical sciences
Microspheres
Middle Aged
Organoplatinum Compounds - administration & dosage
Organoplatinum Compounds - adverse effects
Organoplatinum Compounds - chemistry
Organoplatinum Compounds - pharmacokinetics
Survival Rate
Tumors
title Transhepatic Arterial Chemoembolization with Oxaliplatin-eluting Microspheres (OEM-TACE) for Unresectable Hepatic Tumors
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