Cancer & HAI Summary
Colorectal cancer (CRC) is one of the three most common cancers. Tumors first form in the inner lining of the colon or the rectum, parts of the digestive system. As with many cancers, if the tumors have spread beyond the colon where they originated, patient treatment can become more complex and challenging. The main route of spread of CRC tumor cells is to the liver.
Cholangiocarcinoma, also known as bile duct cancer, is rarer than colorectal cancer. Bile is a digestive fluid that is created by the liver, stored in the gall bladder, then delivered to the upper small intestine via the bile ducts to help digest fats to be absorbed by the intestines. Cancer of the bile ducts, like colorectal cancer, can also spread to the liver.
Hepatic Artery Infusion (HAI) is a treatment option for patients whose gastrointestinal cancer has spread to the liver. The Hepatic Arterial Infusion pump, placed just below the skin, slowly dispenses concentrated chemotherapy. A hollow catheter integrated with the pump carries the chemotherapy into the blood supply that feeds directly to the liver metastases.
Intera Oncology was founded with the mission to ensure an FDA Approved Hepatic Artery Infusion implantable pump is available to hospitals and their patients.
Hepatic Artery Infusion (HAI)
Drugs for cancer in the liver are frequently given through a patient’s vein and advance throughout the entire body with only a small fraction/portion reaching the liver tumors. This results in toxicity that impacts the patient’s entire body. In contrast, Hepatic Artery Infusion therapy (HAI) delivers floxuridine directly to the liver tumors minimizing side effects elsewhere. Such local delivery results in high drug concentrations in the liver tumors that could reach up to 400 times higher concentration if compared to delivery of the same drugs through a vein. The healthy parts of the liver continue to receive the blood supply from a separate blood vessel, the portal vein, which is not impacted by HAI therapy. Additionally, it has been shown that the liver rapidly clears floxuridine reducing toxicity.
For patients with unresectable colorectal liver metastases (CLM), treatment with HAI therapy has been demonstrated to shrink tumors and in some cases to the point that they can be surgically resected. For those undergoing resection, treatment with HAI Therapy as an adjuvant (an addition) to systemic chemotherapy has been shown to reduce tumor recurrence.
For over 25 years, the Intera 3000 Hepatic Artery Infusion Pump* has been used to deliver the chemotherapy directly to the liver tumors while minimizing side effects elsewhere.
*Note: The Intera 3000 Hepatic Artery Infusion Pump was previously marketed as the Model 3000 Series Pump and Codman® 3000 Series Pump.
Disclaimer: Codman is a registered trademark of Integra LifeSciences Corporation. Intera Oncology is not endorsed by, affiliated with, or sponsored by Integra LifeSciences Corporation.
HAI Therapy FAQs
A: A patient whose cancer is confined to the liver (absence of extrahepatic disease) and who typically possess the following:
- Less than 70% replacement of the hepatic parenchyma with tumor burden;
- Preserved hepatic function, including total bilirubin less than 1.5 mg/dL;
- No evidence of portal hypertension or portal vein thrombosis; and
- Good performance status (Eastern Cooperative Oncology Group 0 or 1) and able to tolerate laparotomy.
Patients with chronic hepatitis and/or cirrhosis may be eligible, as long as they are Child-Pugh class A.
(Lewis HL, Bloomston M. Hepatic Artery Infusional Chemotherapy. Surg Clin N am 96 (2016) 341-355.)
Your physician can discuss the indications for HAI therapy as they may or may not apply to your individual treatment. With the exception of other medical reasons preventing you from undergoing an operation, the major disqualification from HAI therapy is the presence of cancer in your body somewhere other than only the liver.
HAI pump therapy is an adjuvant (supplemental) treatment that provides chemotherapy only to the liver. If there is evidence of cancer outside of the liver (i.e. the lungs) then you may not be a candidate for HAI pump therapy.
The clear presence of metastases to portal nodes preoperatively is considered a relative contraindication to pump placement given the high likelihood of extrahepatic recurrence.
Liver tumors greater than 3 mm obtain their blood supply from the hepatic artery (as opposed to the portal vein). Systemic chemotherapy is infused into a vein (through a port) and rapidly extracted from the circulation before reaching the liver.
Hepatic Arterial Infusion chemotherapy delivers the drug directly into the hepatic artery, making the level of chemotherapy that reaches the liver tumors significantly higher. Additionally, floxuridine, the chemotherapy agent used in HAI, is quickly metabolized by the liver and has minimal systemic effects.
When receiving therapy, your Intera 3000 Pump will be refilled every 2 weeks alternating between your chemotherapy treatment (floxuridine) and heparinized saline. This heparinized saline keeps the pump flowing between floxuridine treatments. For time periods when patients are not on active floxuridine delivery, your doctor might choose to fill the HAI pump with glycerin, a viscous material that slows the flow rate of the pump and extends the refill cycle to every 6 to up to 8 weeks.