Lapatinib and gemcitabine for metastatic pancreatic cancer: A phase II study

Howard Safran, Thomas Miner, Nathan Bahary, Sam Whiting, Charles D. Lopez, Weijing Sun, Kevin Charpentier, Joshua Shipley, Elliot Anderson, Brendan McNulty, Andrew Schumacher, Alessandra Clark, Jamsheed Vakharia, Teresa Kennedy, Terence Sio

Research output: Contribution to journalArticlepeer-review

35 Scopus citations


Purpose: To determine the overall survival for patients with metastatic pancreatic cancer treated with lapatinib and gemcitabine. Materials and Methods: Patients with metastatic pancreatic cancer received lapatinib, 1,500 mg/d, and Gemcitabine, 1 g/m2/wk for 3 weeks followed by 1 week off, until disease progression. This multicenter phase II study was planned to enter 125 patients to evaluate whether 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 because of futility analysis. The median survival was 4 months (95% confidence interval, 3.0-5.0 months). Three of the 29 (10%) patients had a partial response. The 4 patients who received single agent lapatinib all progressed at 1 month. Conclusion: Lapatinib is not effective in pancreatic cancer. Evaluation of HER2 inhibitors in pancreatic cancer is not warranted.

Original languageEnglish (US)
Pages (from-to)50-52
Number of pages3
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number1
StatePublished - Feb 2011


  • gemcitabine
  • lapatinib
  • pancreatic cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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