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Eur J Cancer. 2012 Jan;48(2):196-201. doi: 10.1016/j.ejca.2011.11.017. Epub 2011 Dec 14.

A phase II study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: a multicentre, multinational study.

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1
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.

Abstract

BACKGROUND:

Biliary tract carcinoma (BTC) is rare in the West, but not uncommon in Asia and is a highly fatal malignancy. VEGF expression is related with poor outcome in patients with BTC. Therefore, we conducted a phase II study to evaluate the efficacy and safety of sunitinib as second-line treatment.

METHODS:

This was a prospective, single-arm, multicentre, multinational study. Patients with unresectable, metastatic BTC who progressed after first-line chemotherapy were eligible. Sunitinib was administered at 37.5mg once daily continuously with 4-week cycle. The primary end point was the time to progression (TTP).

RESULTS:

Between May 2009 and October 2010, a total of 56 patients were enrolled from three countries. The median age was 55 years (range 38-75) and male to female ratio was 37:19. Median TTP was 1.7 months (95% confidence interval (CI) 1.0-2.4). The objective response rate was 8.9% (5 partial response) and disease control rate was 50.0%. (23 stable disease) Grade 3-4 toxicities were observed in 46.4% of the patients with neutropenia and thrombocytopenia being the most frequent (21.4%).

CONCLUSIONS:

This phase II study suggests that sunitinib monotherapy demonstrated marginal efficacy in metastatic BTC patients although toxicity should be concerned in Asian population.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01082809.

PMID:
22176869
DOI:
10.1016/j.ejca.2011.11.017
[Indexed for MEDLINE]
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