Abstract
BackgroundThe high complication rates of surgically implanted port catheter systems (SIPCS) represents a major drawback in the treatment of isolated liver neoplasms by hepatic arterial infusion (HAI) of chemotherapy. Interventionally implanted port catheter systems (IIPCS) have evolved into a promising alternative that enable initiation of HAI without laparatomy, but prospective data on this approach are still sparse. Aim of this study was to evaluate the most important technical endpoints associated with the use of IIPCS for the delivery of 5-fluorouracil-based HAI in patients with colorectal liver metastases in a phase 2-study, and to perform a non-randomised comparison with a historical group of patients in which HAI was administered via SIPCS.Methods41 patients with isolated liver metastases of colorectal cancer were enrolled into a phase II-study and provided with IIPCS between 2001 and 2004 (group A). The primary objective of the trial was defined as evaluation of device-related complications and port duration. Results were compared with those observed in a pre-defined historical collective of 40 patients treated with HAI via SIPCS at our institution between 1996 and 2000 (group B).ResultsBaseline characteristics were balanced between both groups, except for higher proportions of previous palliative pre-treatment and elevated serum alkaline phosphatase in patients of group A. Implantation of port catheters was successful in all patients of group A, whereas two primary failures were observed in group B. The frequency of device-related complications was similar between both groups, but the secondary failure rate was significantly higher with the use of surgical approach (17% vs. 50%, p < 0.01). Mean port duration was significantly longer in the interventional group (19 vs. 14 months, p = 0.01), with 77 vs. 50% of devices functioning at 12 months (p < 0.01). No unexpected complications were observed in both groups.ConclusionHAI via interventionally implanted port catheters can be safely provided to a collective of patients with colorectal liver metastases, including a relevant proportion of preatreated individuals. It appears to offer technical advantages over the surgical approach.
Highlights
The high complication rates of surgically implanted port catheter systems (SIPCS) represents a major drawback in the treatment of isolated liver neoplasms by hepatic arterial infusion (HAI) of chemotherapy
Patients' collectives and eligibility criteria Patients with isolated liver metastases of colorectal cancer were prospectively enrolled into a phase II-trial evaluating technical complications associated with the use of interventionally implanted port catheters in patients with cancers confined to the liver (ClinicalTrials.gov Identifier: NCT00356161)
Complication rates and duration of interventionally implanted port catheter systems, as well as, reasons for primary and secondary device failure of the first 41 colorectal cancer patients enrolled were assessed, and compared with those observed in a pre-defined [21] historical collective of 40 patients with colorectal liver metastases provided with a surgically implanted port system
Summary
The high complication rates of surgically implanted port catheter systems (SIPCS) represents a major drawback in the treatment of isolated liver neoplasms by hepatic arterial infusion (HAI) of chemotherapy. The role of hepatic arterial infusion in patients with colorectal liver metastases has been frequently studied throughout the past decades. More than a dozen of randomized trials have been completed in which HAI with one of the fluoropyrimidines floxuridine (FUDR) or 5-flourouracil (5-FU) was compared to intravenous drug application in patients with unresectable metastases or after resection (reviewed in [1,2]). Adjacent trials completed in North America demonstrated that systemic control rates of intraarterial FUDR can be improved by combination with intravenous 5-FU [7,8]. European and Asian investigators aimed to optimise results by taking the advantage of achieving systemic drug concentrations and limiting hepatic toxicity as it is provided by the intraarterial application of 5-FU [9,10]
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