Interventionally implanted port catheter systems for hepatic arterial infusion of chemotherapy in patients with primary liver cancer: a phase II-study (NCT00356161)
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Interventionally implanted port catheter systems for hepatic arterial infusion of chemotherapy in patients with primary liver cancer: a phase II-study (NCT00356161). / Sinn, Marianne; Nicolaou, Annett; Ricke, Jens; Podrabsky, Pjotr; Seehofer, Daniel; Gebauer, Bernhard; Pech, Maciej; Neuhaus, Peter; Dörken, Bernd; Riess, Hanno; Hildebrandt, Bert.
in: BMC GASTROENTEROL, Jahrgang 13, 09.08.2013, S. 125.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 -