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

C Bengala1, F Bertolini, N Malavasi

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

British Journal of Cancer
|November 26, 2009
PubMed
Abstract

Insights

Single-agent sorafenib showed limited efficacy in advanced biliary tract carcinoma. Good performance status correlated with better progression-free survival, and toxicities were manageable.

Area of Science:

  • Oncology
  • Medical Research

Background:

  • Advanced biliary tract carcinoma (BTC) has a poor prognosis, with chemotherapy as the primary treatment.
  • Sorafenib, a multikinase inhibitor, demonstrated preclinical activity in cholangiocarcinoma models.

Purpose of the Study:

  • To evaluate the efficacy and safety of single-agent sorafenib in patients with advanced biliary tract carcinoma.

Main Methods:

  • A phase II trial administered sorafenib (400 mg twice daily) to 46 patients with advanced BTC.
  • The primary endpoint was the disease control rate at 12 weeks.

Main Results:

  • The objective response rate was 2%, and the 12-week disease control rate was 32.6%.
  • Median progression-free survival (PFS) was 2.3 months, and median overall survival was 4.4 months.
  • Good performance status (ECOG 0) was linked to significantly longer PFS (5.7 months vs. 2.1 months for ECOG 1).

Conclusions:

  • Single-agent sorafenib exhibits low activity in advanced cholangiocarcinoma.
  • Patient performance status is a key factor for predicting PFS.
  • The observed toxicities, including skin rash and fatigue, were manageable and often required dose reduction.

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