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Efficacy and Safety Results of the Afatinib Expanded Access Program

Efficacy and Safety Results of the Afatinib Expanded Access Program Oncol Ther (2017) 5:103–110 DOI 10.1007/s40487-017-0043-5 BRIEF REPORT Efficacy and Safety Results of the Afatinib Expanded Access Program . . . . Edward S. Kim Balazs Halmos Ingrid F. Kohut Taral Patel . . . Regan D. Rostorfer Alexander I. Spira Agnieszka Cseh . . John McKay Gudrun Wallenstein Kathryn F. Mileham Received: February 9, 2017 / Published online: April 10, 2017 The Author(s) 2017. This article is an open access publication Methods: The afatinib EAP was an open-label, ABSTRACT multicenter, single-arm program in the United States that treated and followed patients with Introduction: Afatinib is an oral, irreversible locally advanced or metastatic NSCLC harbor- ErbB family blocker approved for first-line ing EGFR mutations. Afatinib 40 mg was treatment of metastatic epidermal growth factor administered orally once daily until discontin- receptor (EGFR) mutation–positive non–small uation due to disease progression, adverse cell lung cancer (NSCLC). The expanded access events (AEs), or transition to commercially program (EAP) allowed early access to afatinib available drug. and provided additional data on its safety, tol- Results: Three hundred twenty-two patients erability, and efficacy. received C1 dose of afatinib. Most patients had received prior therapies. Drug-related AEs occurred in 89.4% of patients, including 7.8% with http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Oncology and Therapy Springer Journals

Efficacy and Safety Results of the Afatinib Expanded Access Program

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Publisher
Springer Journals
Copyright
Copyright © 2017 by The Author(s)
Subject
Medicine & Public Health; Internal Medicine
ISSN
2366-1070
eISSN
2366-1089
DOI
10.1007/s40487-017-0043-5
Publisher site
See Article on Publisher Site

Abstract

Oncol Ther (2017) 5:103–110 DOI 10.1007/s40487-017-0043-5 BRIEF REPORT Efficacy and Safety Results of the Afatinib Expanded Access Program . . . . Edward S. Kim Balazs Halmos Ingrid F. Kohut Taral Patel . . . Regan D. Rostorfer Alexander I. Spira Agnieszka Cseh . . John McKay Gudrun Wallenstein Kathryn F. Mileham Received: February 9, 2017 / Published online: April 10, 2017 The Author(s) 2017. This article is an open access publication Methods: The afatinib EAP was an open-label, ABSTRACT multicenter, single-arm program in the United States that treated and followed patients with Introduction: Afatinib is an oral, irreversible locally advanced or metastatic NSCLC harbor- ErbB family blocker approved for first-line ing EGFR mutations. Afatinib 40 mg was treatment of metastatic epidermal growth factor administered orally once daily until discontin- receptor (EGFR) mutation–positive non–small uation due to disease progression, adverse cell lung cancer (NSCLC). The expanded access events (AEs), or transition to commercially program (EAP) allowed early access to afatinib available drug. and provided additional data on its safety, tol- Results: Three hundred twenty-two patients erability, and efficacy. received C1 dose of afatinib. Most patients had received prior therapies. Drug-related AEs occurred in 89.4% of patients, including 7.8% with

Journal

Oncology and Therapy – Springer Journals

Published: Apr 10, 2017

References

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    Miller, VA; Hirsh, V; Cadranel, J
  • Efficacy of the irreversible ErbB family blocker afatinib in epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-pretreated non-small cell lung cancer patients with brain metastases or leptomeningeal disease
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