Gemcitabine hepatic arterial chemoembolization (TACE) in the treatment of unresectable HCC

Abstract

4141 Background: Hepatocellular carcinoma (HCC) generally arises in the presence of cirrhosis and is typically multifocal and bilobar and thus not often resectable. A major limitation of chemotherapy is due to the damaged underlying liver as a result of cirrhosis. A non-hepatotoxic drug such as Gemcitabine is thus potentially useful in patient management. Methods: 57 patients with biopsy-proven HCC were evaluated for response, survival and toxicity after treatment with gemcitabine via hepatic arterial chemoembolization. Patients were treated with 1250 mg/m2, given in 150 ml of normal saline over 30 min to either the right or left hepatic artery at any one treatment session. Treatments were repeated every 8 to 10 weeks. Embospheres (Embogold, Biosphere Medical) 100–300 micron size were also injected to vascular slowing but not to occlusion of the same hepatic artery during the chemotherapy infusion. A CT scan was performed at baseline and just prior to each repeat treatment, which was continued until tumor progression. CBC, liver function tests and AFP were performed at baseline and monthly. Results: There were 19 partial responses (PR) (33%), 2 minor responses (4%), 24 patients with stable tumors (42%), 9 with tumor progression (16%) and 3 unevaluable (diffuse) (5%). Survival was: median 12 mo (range 1–36 mo). 23 patients survived 24 mo. There were no hepatotoxicities greater than grade 1 and no myelotoxicities greater than grade 2 (NCI common toxicity criteria). Conclusions: Gemcitabine chemoembolization (TACE) in unresectable HCC patients with normal bilirubin and without ascites appears to be entirely safe with a minimal clinical or laboratory toxicity and is associated with encouraging responses and survival. No significant financial relationships to disclose.