PMID- 28680960
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2366-1070 (Print)
IS  - 2366-1089 (Electronic)
IS  - 2366-1089 (Linking)
VI  - 5
IP  - 1
DP  - 2017
TI  - Efficacy and Safety Results of the Afatinib Expanded Access Program.
PG  - 103-110
LID - 10.1007/s40487-017-0043-5 [doi]
AB  - 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.
FAU - Kim, Edward S
AU  - Kim ES
AD  - Department of Solid Tumor Oncology and Investigational Therapeutics, Levine 
      Cancer Institute, Carolinas HealthCare System, Charlotte, NC USA. GRID: 
      grid.468189.a
FAU - Halmos, Balazs
AU  - Halmos B
AD  - Division of Hematology/Oncology, Columbia University, New York, NY USA. ISNI: 
      0000000419368729. GRID: grid.21729.3f
FAU - Kohut, Ingrid F
AU  - Kohut IF
AD  - Division of Hematology/Oncology, Department of Medicine, Abramson Cancer Center, 
      University of Pennsylvania, Philadelphia, PA USA. ISNI: 0000 0004 1936 8972. 
      GRID: grid.25879.31
FAU - Patel, Taral
AU  - Patel T
AD  - Medical Oncology/Hematology, Zangmeister Center, Columbus, OH USA.
FAU - Rostorfer, Regan D
AU  - Rostorfer RD
AD  - University of Florida Health Cancer Center, Orlando Health, Orlando, FL USA. 
      ISNI: 0000 0004 0447 7316. GRID: grid.416912.9
FAU - Spira, Alexander I
AU  - Spira AI
AD  - Virginia Cancer Specialists Research Institute, Fairfax, VA USA.
FAU - Cseh, Agnieszka
AU  - Cseh A
AD  - Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria.
FAU - McKay, John
AU  - McKay J
AD  - Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT USA. ISNI: 0000 0001 
      1312 9717. GRID: grid.418412.a
FAU - Wallenstein, Gudrun
AU  - Wallenstein G
AD  - Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany. ISNI: 0000 
      0001 2171 7500. GRID: grid.420061.1
FAU - Mileham, Kathryn F
AU  - Mileham KF
AD  - Department of Solid Tumor Oncology and Investigational Therapeutics, Levine 
      Cancer Institute, Carolinas HealthCare System, Charlotte, NC USA. GRID: 
      grid.468189.a
LA  - eng
SI  - ClinicalTrials.gov/NCT01649284
PT  - Journal Article
DEP - 20170410
PL  - New Zealand
TA  - Oncol Ther
JT  - Oncology and therapy
JID - 101677510
PMC - PMC5488108
OTO - NOTNLM
OT  - Afatinib
OT  - EGFR
OT  - Expanded access program
OT  - Non-small cell lung cancer
OT  - Safety
EDAT- 2017/07/07 06:00
MHDA- 2017/07/07 06:01
PMCR- 2017/04/10
CRDT- 2017/07/07 06:00
PHST- 2017/02/09 00:00 [received]
PHST- 2017/07/07 06:00 [entrez]
PHST- 2017/07/07 06:00 [pubmed]
PHST- 2017/07/07 06:01 [medline]
PHST- 2017/04/10 00:00 [pmc-release]
AID - 43 [pii]
AID - 10.1007/s40487-017-0043-5 [doi]
PST - ppublish
SO  - Oncol Ther. 2017;5(1):103-110. doi: 10.1007/s40487-017-0043-5. Epub 2017 Apr 10.