Chemoembolization for the Treatment of Surgically Unresectable Hepatocellular Carcinoma
DESCRIPTION
Transcatheter arterial chemoembolization (TACE) was developed as an alternative to conventional systemic or intra-arterial chemotherapy. TACE has been investigated as a treatment of isolated liver metastases and for hepatocellular carcinoma.
The rationale for TACE is that infusions of viscous material will occlude arterial blood, causing an infarct and subsequent necrosis of tumors in the infarcted region. The cytotoxic effect of arterial occlusion can be potentiated by labeling the infusion with radioactive isotopes or by adding cytotoxic drugs. The liver is especially amenable to such an approach given the distinct lobular anatomy of the liver, the existence of two independent blood supplies, and the ability of healthy hepatic tissue to compensate for tissue mass lost during chemoembolization. Another rationale is that TACE provides for effective local dose intensity while avoiding systemic toxicities associated with intravenous chemotherapy. However, TACE of the liver is associated with its own constellation of potentially life-threatening toxicities and complications, such as severe postembolization syndrome, hepatic insufficiency, abscess, or infarction.
The chemoembolization procedure requires hospitalization. Prior to the procedure, the patency of the portal vein must be demonstrated in order to ensure an adequate post-treatment hepatic blood supply. Under local anesthesia and mild sedation, a superselective catheter is inserted via the femoral artery and threaded into the hepatic artery. Angiography is then performed to delineate the hepatic vasculature, followed by injection of the embolic chemotherapy mixture. Embolic material varies, but may include a viscous collagen agent, polyvinyl alcohol particles, or ethiodized oil. Typically, only one lobe of the liver is treated during a single session, with subsequent embolization procedures scheduled from 5 days to 6 weeks later. In addition, since the embolized vessel recanalizes, chemoembolization can be repeated as many times as necessary.
Note: This policy does not address the use of transcatheter hepatic arterial chemoembolization as a bridge to liver transplantation.
POLICY
Transcatheter hepatic arterial chemoembolization for the treatment of surgically unresectable hepatocellular carcinoma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Transcatheter hepatic arterial chemoembolization, for all other indications, is considered investigational.
MEDICAL APPROPRIATENESS
Transcatheter hepatic arterial chemoembolization is considered medically appropriate if ALL of the following criteria are met:
Performance status must be good per a standardized performance assessment tool (e.g., Karnofsky Performance Scale); and
Individual must have normal, Child's A, or Child's B liver function
Individual must have a negative metastatic evaluation (should included negative chest x-ray, CT or MRI of the abdomen)
Individual should have multiple or extensive hepatocellular carcinoma tumors of the liver
Patency of the portal vein must be demonstrated prior to the procedure
ADDITIONAL INFORMATION
Childs-Turcotte-Pugh (CTP) score is a scoring system for liver function based on the presence of encephalopathy and/or ascites, and laboratory measures of bilirubin, albumin, and prothrombin time.
There is lack of randomized controlled trials that provide evidence of the efficacy of transcatheter hepatic arterial chemoembolization for other indications.
SOURCES
American Association for the Study of Liver Diseases. (2005). Management of hepatocellular carcinoma. Retrieved March 10, 2009 from http://www.aasld.org/practiceguidelines/Documents/Practice%20Guidelines/Hepatocellularcarcinomapg.pdf.
Battula, N., Madanur, M., Priest, O., Srinivasan, P., O’Grady, J., Heneghan, M. A., et al. (2009). Spontaneous rupture of hepatocellular carcinoma: A Western experience. The American Journal of Surgery, 197 (2), 164–167. (Level 1 Evidence)
Battula, N., Srinivasan, P., Madanur, M., Chava, S. P., Priest, O., Rela, M et al. (2007). Ruptured hepatocellular carcinoma following chemoembolization: A western experience. Hepatobiliary and Pancreatic Diseases International, 6 (1), 49-51. Retrieved April 25, 2007 from PubMed database.
Befeler, A. S. (2005). Chemoembolization and bland embolization: A critical appraisal. Clinics in Liver Disease, 9, 287-300.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2008). Transcatheter arterial chemoembolization to treat primary or metastatic liver malignancies (8.01.11). Retrieved March 10, 2009 from BlueWeb.
BlueCross BlueShield of Tennessee network providers. July-August 2005.
BlueCross BlueShield of Tennessee network providers. June-August 2000.
Choh, M. S., & Madura, J. A. (2009). The role of minimally invasive treatments in surgical oncology. The Surgical clinics of North America, 89 (1), 53-77.
Decaens, T., Roudot-Thoraval, F., Bresson-Hadni, S., Meyer, C., Gugenheim, J., Durand, F., et al. (2005). Impact of pretransplantation transarterial chemoembolization on survival and recurrence after liver transplantation for hepatocellular carcinoma. Liver Transplantation, 11 (7), 767-775. (Level 3 Evidence)
Marrero, J. A., & Pelletier, S. (2006). Hepatocellular carcinoma. Clinics in Liver Disease, 10 (2), 339-351.
National Comprehensive Cancer Network. (2009, February). NCCN clinical practice guidelines in oncology™. Hepatobiliary cancers. (V.2.2009). Retrieved March 10, 2009 from http://www.nccn.org/professionals/physician_gls/PDF/hepatobiliary.pdf.
National Guideline Clearinghouse. (2005, November). Management of hepatocellular carcinoma. Retrieved March 10, 2009 from http://www.guidelines.gov.
Ozcınar, B., Guven, K., Poyanlı, A., & Ozden, I. (2009). Necrotizing pancreatitis after transcatheter arterial chemoembolization for hepatocellular carcinoma. Diagnostic and Interventional Radiology, 15 (1), 36-38.
Reso, A., Ball, C. G., Sutherland, F. R., Bathe, O, & Dixon, E. (2009). Rupture and intra-peritoneal bleeding of a hepatocellular carcinoma after a transarterial chemoembolization procedure: A case report. Cases Journal, 2 (1), 68. (Level 4 Evidence)
Sasaki, A., Iwashita, Y., Shibata, K., Ohta, M., Kiano, S. & Mori, M. (2006). Preoperative transcatheter arterial chemoembolization reduces long-term survival rate after hepatic resection for resectable hepatocellular carcinoma. European Journal of Surgical Oncology, 32 (7), 773-779. Retrieved April 25, 2007 from PubMed database.
Sherman, M., Takayama, Y. (2004). Screening and treatment for hepatocellular carcinoma. Gastroenterology Clinics of North America, 33, 671-691.
Sotiropoulos, G. C., Malago, M., Molmenti, E., Paul, A., Nadalin, S., Brokalaki, E. I., et al. (2005). Efficacy of transarterial chemoembolization prior to liver transplantation for hepatocellular carcinoma as found in pathology. Hepatogastroenterology, 52 (62), 329-32. Abstract retrieved June 14, 2005 from PubMed database.
U. S. Department of Veterans Affairs. National HIV/AIDS Program. (2008, August). Karnofsky performance scale. Retrieved March 10, 2009 from http://www.hiv.va.gov/vahiv?page=cm-1003_karnofsky.
Varela, M., Sanchez, W., Bruix, J., & Gores, G. J. (2006). Hepatocellular carcinoma in the setting of liver transplantation. Liver Transplantation, 12, 1028-1036.
ORIGINAL EFFECTIVE DATE: 6/1/2000
MOST RECENT REVIEW DATE: 4/9/2009
ID_BT
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