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Efficacy and Safety Results of the Afatinib Expanded Access Program
INTRODUCTION: Afatinib 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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5488108/ https://www.ncbi.nlm.nih.gov/pubmed/28680960 http://dx.doi.org/10.1007/s40487-017-0043-5 |
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author | Kim, Edward S. Halmos, Balazs Kohut, Ingrid F. Patel, Taral Rostorfer, Regan D. Spira, Alexander I. Cseh, Agnieszka McKay, John Wallenstein, Gudrun Mileham, Kathryn F. |
author_facet | Kim, Edward S. Halmos, Balazs Kohut, Ingrid F. Patel, Taral Rostorfer, Regan D. Spira, Alexander I. Cseh, Agnieszka McKay, John Wallenstein, Gudrun Mileham, Kathryn F. |
author_sort | Kim, Edward S. |
collection | PubMed |
description | INTRODUCTION: Afatinib 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. METHODS: The 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. RESULTS: Three 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. CONCLUSIONS: No 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 REGISTRATION: ClinicalTrials.gov Identifier: NCT01649284. FUNDING: Boehringer Ingelheim Pharmaceuticals, Inc. |
format | Online Article Text |
id | pubmed-5488108 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-54881082017-07-03 Efficacy and Safety Results of the Afatinib Expanded Access Program Kim, Edward S. Halmos, Balazs Kohut, Ingrid F. Patel, Taral Rostorfer, Regan D. Spira, Alexander I. Cseh, Agnieszka McKay, John Wallenstein, Gudrun Mileham, Kathryn F. Oncol Ther Brief Report INTRODUCTION: Afatinib 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. METHODS: The 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. RESULTS: Three 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. CONCLUSIONS: No 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 REGISTRATION: ClinicalTrials.gov Identifier: NCT01649284. FUNDING: Boehringer Ingelheim Pharmaceuticals, Inc. Springer Healthcare 2017-04-10 /pmc/articles/PMC5488108/ /pubmed/28680960 http://dx.doi.org/10.1007/s40487-017-0043-5 Text en © The Author(s) 2017 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Brief Report Kim, Edward S. Halmos, Balazs Kohut, Ingrid F. Patel, Taral Rostorfer, Regan D. Spira, Alexander I. Cseh, Agnieszka McKay, John Wallenstein, Gudrun Mileham, Kathryn F. Efficacy and Safety Results of the Afatinib Expanded Access Program |
title | Efficacy and Safety Results of the Afatinib Expanded Access Program |
title_full | Efficacy and Safety Results of the Afatinib Expanded Access Program |
title_fullStr | Efficacy and Safety Results of the Afatinib Expanded Access Program |
title_full_unstemmed | Efficacy and Safety Results of the Afatinib Expanded Access Program |
title_short | Efficacy and Safety Results of the Afatinib Expanded Access Program |
title_sort | efficacy and safety results of the afatinib expanded access program |
topic | Brief Report |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5488108/ https://www.ncbi.nlm.nih.gov/pubmed/28680960 http://dx.doi.org/10.1007/s40487-017-0043-5 |
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