e15653 Background: To determine the overall survival for patients with metastatic pancreatic cancer treated with lapatinib and gemcitabine. Methods: Patients with metastatic pancreatic cancer received lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression. This multicenter phase II study was planned to enter 125 patients to evaluate if the treatment regimen could achieve a 1-year survival of 30% and a median survival of 7 months. An additional subset of 20 patients were to receive 2 months of single agent lapatinib followed by lapatinib and gemcitabine. Results: At a planned 6 month analysis, the Brown University Oncology Group Data Safety Monitoring Board terminated accrual after 29 patients due to futility analysis. The median survival was 4 months (95% CI, 2.0–5.5 months). The four patients who received single agent lapatinib all progressed at 1 month. Conclusions: Lapatinib is not effective in pancreatic cancer. Evaluation of HER2 inhibitors in pancreatic cancer is not warranted. [Table: see text]
A randomized phase II study of weekly nab-paclitaxel plus gemcitabine or simplified LV5FU2 as first-line therapy in patients with metastatic pancreatic cancer: the AFUGEM GERCOR trial