Cediranib (AZD2171) in patients with advanced hepatocellular carcinoma: A phase II north central cancer treatment group clinical trial
American Journal of Clinical Oncology: Cancer Clinical Trials
AZD2171; cediranib; hepatocellular carcinoma; phase II; VEGF
Objectives: Vascular endothelial growth factor has been shown to be overexpressed in several studies of hepatocellular carcinoma (HCC). Cediranib is a potent inhibitor of vascular endothelial growth factor signaling. We assessed the efficacy and toxicity of cediranib in patients with HCC. Methods: Twenty-eight patients with unresectable or metastatic HCC were enrolled in this study. Patients received 45 mg of cediranib orally, once daily, for 28-day cycles. The primary objective of this phase II study was to assess 6-month survival. Secondary objectives were to assess tumor response, time to progression, and toxicity. Results: All 28 patients were evaluable for efficacy outcomes. Twelve patients (42.9%) survived 6 months, 15 (53.6%) died within 6 months, and 1 (3.6%) was lost to follow-up before 6 months. The median overall survival was 5.8 months (95% confidence interval, 3.4-7.3 mo). No patients experienced confirmed response. The median time to progression was 2.8 months (95% confidence interval, 2.3-4.4 mo). Twenty-six patients (93%) experienced a grade 3+ adverse event with the most common adverse event s being fatigue (46%), anorexia (25%), hypertension (21%), and elevated alanine aminotransferase (18%). Conclusions: Owing to the toxicity, cediranib at this dose and schedule is not an effective treatment in patients with unresectable or metastatic HCC. Copyright © 2012 by Lippincott Williams & Wilkins.
Alberts, S., Fitch, T., Kim, G., Morlan, B., Dakhil, S., Gross, H., & Nair, S. (2012). Cediranib (AZD2171) in patients with advanced hepatocellular carcinoma: A phase II north central cancer treatment group clinical trial. American Journal of Clinical Oncology: Cancer Clinical Trials, 35 (4). http://dx.doi.org/10.1097/COC.0b013e3182118cdf