Cediranib (AZD2171) in Patients With Advanced Hepatocellular Carcinoma: A Phase II North Central Cancer Treatment Group Clinical Trial

Publication/Presentation Date

8-2012

Abstract

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.

Volume

35

Issue

4

First Page

329

Last Page

333

ISSN

1537-453X

Disciplines

Analytical, Diagnostic and Therapeutic Techniques and Equipment | Chemicals and Drugs | Medical Sciences | Medical Specialties | Medicine and Health Sciences | Oncology | Therapeutics

PubMedID

21422991

Department(s)

Department of Medicine, Hematology-Medical Oncology Division, Department of Medicine Faculty

Document Type

Article

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