Interventionally implanted port catheter systems for hepatic arterial infusion of chemotherapy in patients with primary liver cancer: a phase II-study (NCT00356161).
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.
CharitéCentrum für Tumormedizin, Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie, Campus Virchow Klinikum, Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, D-13344 Berlin, Germany.
Marianne
M
Sinn
Annett
A
Nicolaou
Jens
J
Ricke
Pjotr
P
Podrabsky
Daniel
D
Seehofer
Bernhard
B
Gebauer
Maciej
M
Pech
Peter
P
Neuhaus
Bernd
B
Dörken
Hanno
H
Riess
Bert
B
Hildebrandt
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D001650:Bile Duct Neoplasms / Q000188:drug therapy*; D001653:Bile Ducts, Intrahepatic; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D002404:Catheterization / Q000009:adverse effects* / Q000295:instrumentation; D057785:Catheters / Q000009:adverse effects; D018281:Cholangiocarcinoma / Q000188:drug therapy*; D018450:Disease Progression; D004868:Equipment Failure; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006499:Hepatic Artery; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D028761:Withholding Treatment
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil