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Efficacy and Safety Results of the Afatinib Expanded Access Program

  • Kim, Edward S.1
  • Halmos, Balazs2
  • Kohut, Ingrid F.3
  • Patel, Taral4
  • Rostorfer, Regan D.5
  • Spira, Alexander I.6
  • Cseh, Agnieszka7
  • McKay, John8
  • Wallenstein, Gudrun9
  • Mileham, Kathryn F.1
  • 1 Levine Cancer Institute, Carolinas HealthCare System, Department of Solid Tumor Oncology and Investigational Therapeutics, Charlotte, NC, USA , Charlotte (United States)
  • 2 Columbia University, Division of Hematology/Oncology, New York, NY, USA , New York (United States)
  • 3 University of Pennsylvania, Division of Hematology/Oncology, Department of Medicine, Abramson Cancer Center, Philadelphia, PA, USA , Philadelphia (United States)
  • 4 Zangmeister Center, Medical Oncology/Hematology, Columbus, OH, USA , Columbus (United States)
  • 5 Orlando Health, University of Florida Health Cancer Center, Orlando, FL, USA , Orlando (United States)
  • 6 Virginia Cancer Specialists Research Institute, Fairfax, VA, USA , Fairfax (United States)
  • 7 Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria , Vienna (Austria)
  • 8 Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA , Ridgefield (United States)
  • 9 Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany , Ingelheim am Rhein (Germany)
Published Article
Oncology and Therapy
Springer Healthcare
Publication Date
Apr 10, 2017
DOI: 10.1007/s40487-017-0043-5
Springer Nature


IntroductionAfatinib is an oral, irreversible ErbB family blocker approved for first-line treatment of metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung cancer (NSCLC). The expanded access program (EAP) allowed early access to afatinib and provided additional data on its safety, tolerability, and efficacy.MethodsThe afatinib EAP was an open-label, multicenter, single-arm program in the United States that treated and followed patients with locally advanced or metastatic NSCLC harboring EGFR mutations. Afatinib 40 mg was administered orally once daily until discontinuation due to disease progression, adverse events (AEs), or transition to commercially available drug.ResultsThree hundred twenty-two patients received ≥1 dose of afatinib. Most patients had received prior therapies. Drug-related AEs occurred in 89.4% of patients, including 7.8% with serious AEs. The most common afatinib-related AEs (all grades) were diarrhea (77.0%) and rash (36.0%). Dose reductions occurred in 31.1% of patients. Discontinuation rates due to diarrhea (1.6%) or rash/acne (0.3%) were low. Efficacy data were collected and analyzed when available, with 17.1% and 69.9% of patients achieving objective response and disease control, respectively, in this highly pretreated population.ConclusionsNo additional or unexpected safety concerns were revealed, and afatinib demonstrated antitumor activity in a heavily pretreated NSCLC patient population in a routine clinical setting.Trial Identifier: NCT01649284.FundingBoehringer Ingelheim Pharmaceuticals, Inc.

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