Panitumumab in combination with gemcitabine and oxaliplatin does not prolong survival in wild-type KRAS advanced biliary tract cancer, a new study published online ahead of print in the journal Cancer has shown.1
Although biliary tract cancer is rare, it is a lethal disease with limited therapeutic options. Preclinical research suggested that the epidermal growth factor receptor (EGFR) pathway could be involved in the progression of this fatal disease.
Therefore, researchers sought to evaluate whether adding panitumumab, an anti-EGFR monoclonal antibody, to chemotherapy would improve survival in patients with advanced disease.
For the open-label, phase 2 study, researchers enrolled 89 chemotherapy-naïve patients with advanced biliary tract cancer who have a wild-type KRAS mutation status. Participants were randomly assigned to receive gemcitabine 1000 mg/m2 plus oxaliplatin 100 mg/m2 intravenously with or without panitumumab 6 mg/kg intravenously for up to 12 cycles.
Results showed that after a median follow-up of 10.1 months, median progression-free survival was 5.3 months (95% CI, 3.3–7.2) among those who received panitumumab compared with 4.4 months for those who did not receive immunotherapy. There was also no significant difference in overall survival between the 2 treatment arms.
In regard to safety, 80% of patients who received panitumumab experienced dermatologic toxicity, and that group also had a higher incidence of diarrhea, mucositis, and constipation compared with those who did not receive the drug.
“These results confirm the marginal role of anti-EGFR therapy even for WT KRAS–selected [biliary tract cancer],” the authors conclude.
1. Leone F, Marino D, Cereda S, et al. Panitumumab in combination with gemcitabine and oxaliplatin does not prolong survival in wild-type KRAS advanced biliary tract cancer: A randomized phase 2 trial (Vecti-BIL study) [published online ahead of print November 5, 2015]. Cancer. doi:10.1002/cncr.29778.