U.S. Food and Drug Administration FDA ; Programmable, implantable infusion pumps are regulated by the FDA as Class III devices. Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to ensure safety and effectiveness solely through general or special controls. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Premarket approval is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Implantable infusion pumps that have been granted FDA approval include, but are not limited to, Synchromed Infusion System Medtronic, Neurological, Minneapolis, MN ; and InfusAid pump, Arrow International, Walpole, MA ; . Hepatic Artery Chemotherapy Optimal treatment for patients with primary or metastatic cancer confined to the liver is surgical resection. Primary cancer of the liver is commonly associated with cirrhosis from either alcohol abuse, or the hepatitis B virus or C virus. Isolated liver metastasis can result from colorectal cancer and neuroendocrine tumors, and occasionally from gastrointestinal cancers, sarcomas, ocular melanoma and breast cancer de Wilt, et al., 2004 ; . Many patients with liver tumors are not candidates for resection due to tumor size, location, the number of tumors, and involvement of vascular structure or significantly compromised liver function. For these situations, other treatment options are available. Few patients are candidates for liver transplant. Systemic chemotherapy is widely used, although survival outcomes are usually poor, and this is considered a palliative measure. Dislocation and catheter occlusion have been reported with percutaneous implantation of catheter systems into the hepatic artery. The hepatic artery is the main pathway in which a liver tumor receives its blood supply. Normal hepatocytes derive most of their blood supply from the portal vein and little from the hepatic artery. As a result of the unique anatomy, a number of regional therapies have been designed to improve the efficacy of treatment while minimizing systemic toxicity, including: hepatic arterial embolization, intratumoral injections of ethanol, radiotherapy, cryotherapy and radiofrequency ablation. In addition, hepatic artery infusion has been widely studied by several authors. Hepatic arterial infusion by way of an implanted infusion pump provides delivery of chemotherapeutic agents directly to the liver through a catheter placed into the hepatic artery. This method of administration improves efficacy by increasing drug delivery directly to the site of the tumor. In addition, the primary function of the liver is metabolism and excretion. The ability of the liver to metabolize the infused agents increases the opportunity to increase dosages while limiting systemic effects Fraker, Soulen, 2002 ; . It has been suggested that intra-arterial infusion may increase survival time, delay tumor progression, and reduce side effects, thereby improving quality of life. In review of the published scientific literature, currently there is no single chemotherapy drug or combination that clearly demonstrates improved survival or improved quality of life. Combination chemotherapy generally produces better response rates than single drug therapies. The standard systemic therapy for metastatic colorectal cancer consists of various combinations of 5-flourouracil 5-Fu ; based regimens e.g., Saltz regimen, De Gramont regimen ; . Floxuridine FUDR ; is a 5-Fu analog. Pharmacologic studies demonstrate that 9799% of FUDR is cleared or metabolized during the first pass of infusion to the liver, while the clearance of 5-FU is lower. Infusing FUDR directly into the hepatic artery allows for administration of high drug concentrations with minimal systemic exposure. The most common side effect of FUDR administration is biliary toxicity Elias, et al., 2004 ; . FUDR is commonly used for intrahepatic arterial infusion, and is often used in combination with other chemotherapeutic agents e.g., cisplatin, doxorubicin ; . Literature Review: The scientific evidence and reported patient outcomes associated with intrahepatic chemotherapy should be better in terms of response rates or reduced toxicity when compared to standard systemic chemotherapy Fraker, Soulen, 2002 ; . For patients with unresectable colorectal cancer confined to the liver, hepatic artery infusion using FUDR-based regimens have high response rates Alexander, et al., 2005 ; . Early randomized studies have been conducted comparing hepatic arterial infusion with FUDR to either intravenous 5-FU, intravenous FUDR or to supportive care Kemeny, et al., 1987; Allen-Mersh, et al., 1994 ; . Response rates for these early trials are generally improved compared to intravenous routes.
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