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

Howard Safran, Thomas Miner, Nathan Bahary, Sam Whiting, Charles 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 journalArticle

    30 Citations (Scopus)

    Abstract

    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
    Volume34
    Issue number1
    DOIs
    StatePublished - Feb 2011

    Fingerprint

    gemcitabine
    Pancreatic Neoplasms
    Survival
    Clinical Trials Data Monitoring Committees
    Medical Futility
    lapatinib
    Disease Progression

    Keywords

    • gemcitabine
    • lapatinib
    • pancreatic cancer

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research

    Cite this

    Lapatinib and gemcitabine for metastatic pancreatic cancer : A phase II study. / Safran, Howard; Miner, Thomas; Bahary, Nathan; Whiting, Sam; Lopez, Charles; Sun, Weijing; Charpentier, Kevin; Shipley, Joshua; Anderson, Elliot; McNulty, Brendan; Schumacher, Andrew; Clark, Alessandra; Vakharia, Jamsheed; Kennedy, Teresa; Sio, Terence.

    In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 34, No. 1, 02.2011, p. 50-52.

    Research output: Contribution to journalArticle

    Safran, H, Miner, T, Bahary, N, Whiting, S, Lopez, C, Sun, W, Charpentier, K, Shipley, J, Anderson, E, McNulty, B, Schumacher, A, Clark, A, Vakharia, J, Kennedy, T & Sio, T 2011, 'Lapatinib and gemcitabine for metastatic pancreatic cancer: A phase II study', American Journal of Clinical Oncology: Cancer Clinical Trials, vol. 34, no. 1, pp. 50-52. https://doi.org/10.1097/COC.0b013e3181d26b01
    Safran, Howard ; Miner, Thomas ; Bahary, Nathan ; Whiting, Sam ; Lopez, Charles ; Sun, Weijing ; Charpentier, Kevin ; Shipley, Joshua ; Anderson, Elliot ; McNulty, Brendan ; Schumacher, Andrew ; Clark, Alessandra ; Vakharia, Jamsheed ; Kennedy, Teresa ; Sio, Terence. / Lapatinib and gemcitabine for metastatic pancreatic cancer : A phase II study. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 2011 ; Vol. 34, No. 1. pp. 50-52.
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    AU - Charpentier, Kevin

    AU - Shipley, Joshua

    AU - Anderson, Elliot

    AU - McNulty, Brendan

    AU - Schumacher, Andrew

    AU - Clark, Alessandra

    AU - Vakharia, Jamsheed

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    N2 - 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.

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