Interventionally implanted port catheter systems for hepatic arterial infusion of chemotherapy in patients with primary liver cancer: a phase II-study (NCT00356161)

TY - JOUR

T1 - Interventionally implanted port catheter systems for hepatic arterial infusion of chemotherapy in patients with primary liver cancer: a phase II-study (NCT00356161)

AU - Sinn, Marianne

AU - Nicolaou, Annett

AU - Ricke, Jens

AU - Podrabsky, Pjotr

AU - Seehofer, Daniel

AU - Gebauer, Bernhard

AU - Pech, Maciej

AU - Neuhaus, Peter

AU - Dörken, Bernd

AU - Riess, Hanno

AU - Hildebrandt, Bert

PY - 2013/8/9

Y1 - 2013/8/9

N2 - BACKGROUND: Hepatic arterial infusion (HAI) of chemotherapy requires the implantation of a transcatheter application system which is traditionally performed by surgery. This procedure, but particularly the adjacent drug application via pump or port is often hampered by specific complications and device failure. Interventionally implanted port catheter systems (IIPCS) facilitate the commencement of HAI without need for laparatomy, and are associated with favorable complication rates. We here present an evaluation of the most important technical endpoints associated with the use of IIPCS for HAI in patients with primary liver cancers.METHODS: 70 patients (pts) with hepatocellular (HCC, n=33) and biliary tract cancer (BTC, n=37) were enrolled into a phase II -study. Of those, n=43 had recurrent disease and n=31 suffered from liver-predominant UICC-stage IVb. All pts were provided with IIPCSs before being treated with biweekly, intraarterial chemotherapy (oxaliplatin, 5-Flourouracil, folinic acid). The primary objective of the trial was defined as evaluation of device-related complications and port duration.RESULTS: Implantation of port catheters was successful in all patients. Mean treatment duration was 5.8 months, and median duration of port patency was not reached. Disease-progression was the most common reason for treatment discontinuation (44 pts., 63%), followed by chemotherapy-related toxicity (12 pts., 17%), and irreversible device failure (5 pts., 7%). A total of 28 port complications occurred in 21 pts (30%). No unexpected complications were observed.CONCLUSIONS: HAI via interventionally implanted port catheters can be safely applied to patients with primary liver tumors far advanced or/and pretreated.

AB - BACKGROUND: Hepatic arterial infusion (HAI) of chemotherapy requires the implantation of a transcatheter application system which is traditionally performed by surgery. This procedure, but particularly the adjacent drug application via pump or port is often hampered by specific complications and device failure. Interventionally implanted port catheter systems (IIPCS) facilitate the commencement of HAI without need for laparatomy, and are associated with favorable complication rates. We here present an evaluation of the most important technical endpoints associated with the use of IIPCS for HAI in patients with primary liver cancers.METHODS: 70 patients (pts) with hepatocellular (HCC, n=33) and biliary tract cancer (BTC, n=37) were enrolled into a phase II -study. Of those, n=43 had recurrent disease and n=31 suffered from liver-predominant UICC-stage IVb. All pts were provided with IIPCSs before being treated with biweekly, intraarterial chemotherapy (oxaliplatin, 5-Flourouracil, folinic acid). The primary objective of the trial was defined as evaluation of device-related complications and port duration.RESULTS: Implantation of port catheters was successful in all patients. Mean treatment duration was 5.8 months, and median duration of port patency was not reached. Disease-progression was the most common reason for treatment discontinuation (44 pts., 63%), followed by chemotherapy-related toxicity (12 pts., 17%), and irreversible device failure (5 pts., 7%). A total of 28 port complications occurred in 21 pts (30%). No unexpected complications were observed.CONCLUSIONS: HAI via interventionally implanted port catheters can be safely applied to patients with primary liver tumors far advanced or/and pretreated.

KW - Adult

KW - Aged

KW - Antineoplastic Combined Chemotherapy Protocols/administration & dosage

KW - Bile Duct Neoplasms/drug therapy

KW - Bile Ducts, Intrahepatic

KW - Carcinoma, Hepatocellular/drug therapy

KW - Catheterization/adverse effects

KW - Catheters/adverse effects

KW - Cholangiocarcinoma/drug therapy

KW - Disease Progression

KW - Equipment Failure

KW - Female

KW - Fluorouracil/administration & dosage

KW - Hepatic Artery

KW - Humans

KW - Leucovorin/administration & dosage

KW - Liver Neoplasms/drug therapy

KW - Male

KW - Middle Aged

KW - Organoplatinum Compounds/administration & dosage

KW - Oxaliplatin

KW - Withholding Treatment

U2 - 10.1186/1471-230X-13-125

DO - 10.1186/1471-230X-13-125

M3 - SCORING: Journal article

C2 - 23927554

VL - 13

SP - 125

JO - BMC GASTROENTEROL

JF - BMC GASTROENTEROL

SN - 1471-230X

ER -