According to a new study published in the European Journal of Cancer, researchers have found that the addition of sorafenib to gemcitabine for the treatment of patients with advanced biliary tract cancer is not more effective than gemcitabine alone. For the phase 2 study, researchers enrolled 102 patients with unresectable or metastatic biliary tract cancer.
Patients were randomly assigned to receive gemcitabine 1,000mg/m2 once weekly for the first 7 weeks with 1 week of rest followed by once weekly for 3 weeks and 1 week of rest, plus sorafenib 400mg twice daily or placebo. Patients were treated until disease progression or unacceptable toxicity.
Results showed that patients tolerated the combination well. Four patients achieved partial responses in the sorafenib group and three patients achieved partial responses in the placebo group. The researchers found no difference in median progression-free survival between the two group (3.0 months for sorafenib vs 4.9 months placebo, P = 0.859).
In addition, there was no difference in overall survival between sorafenib and placebo (8.4 months vs 11.2 months, P = 0.775). Patients with liver metastases after surgery to remove primary biliary tract cancer survived longer with sorafenib compared with placebo (P = 0.019).
The authors evaluated first–line gemcitabine plus sorafenib in a double–blind phase II study. The addition of sorafenib to gemcitabine did not demonstrate improved efficacy in advanced BTC patients.