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Br J Cancer. 2010 Jan 5;102(1):68-72. doi: 10.1038/sj.bjc.6605458. Epub 2009 Nov 24.

Sorafenib in patients with advanced biliary tract carcinoma: a phase II trial.

Author information

1
Division of Medical Oncology, University Hospital, University of Modena and Reggio Emilia, 41100 Modena, Italy. carmelo.bengala@unimore.it

Abstract

BACKGROUND:

Advanced biliary tract carcinoma has a very poor prognosis, with chemotherapy being the mainstay of treatment. Sorafenib, a multikinase inhibitor of VEGFR-2/-3, PDGFR-beta, B-Raf, and C-Raf, has shown to be active in preclinical models of cholangiocarcinoma.

METHODS:

We conducted a phase II trial of single-agent sorafenib in patients with advanced biliary tract carcinoma. Sorafenib was administered at a dose of 400 mg twice a day. The primary end point was the disease control rate at 12 weeks.

RESULTS:

A total of 46 patients were treated. In all, 26 (56%) had received chemotherapy earlier, and 36 patients completed at least 45 days of treatment. In intention-to-treat analysis, the objective response was 2% and the disease control rate at 12 weeks was 32.6%. Progression-free survival (PFS) was 2.3 months (range: 0-12 months), and the median overall survival was 4.4 months (range: 0-22 months). Performance status was significantly related to PFS: median PFS values for ECOG 0 and 1 were 5.7 and 2.1 months, respectively (P=0.0002). The most common toxicities were skin rash (35%) and fatigue (33%), requiring a dose reduction in 22% of patients.

CONCLUSIONS:

Sorafenib as a single agent has a low activity in cholangiocarcinoma. Patients having a good performance status have a better PFS. The toxicity profile is manageable.

PMID:
19935794
PMCID:
PMC2813746
DOI:
10.1038/sj.bjc.6605458
[Indexed for MEDLINE]
Free PMC Article
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