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Clinical Trial
. 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

C Bengala  1 , F Bertolini, N Malavasi, C Boni, E Aitini, C Dealis, S Zironi, R Depenni, A Fontana, C Del Giovane, G Luppi, P Conte
Affiliations
Clinical Trial

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

C Bengala et al. Br J Cancer. .

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.

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Figures

Figure 1
Figure 1
Progression-free survival (N=46).
Figure 2
Figure 2
Overall survival (N=46).
Figure 3
Figure 3
Progression-free survival and overall survival stratified by ECOG performance status.
See this image and copyright information in PMC

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