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Phase 2 study of intermittent pulse dacomitinib in patients with advanced non-small cell lung cancers

Authors
 Helena A. Yu  ;  Myung-Ju Ahn  ;  Byoung Chul Cho  ;  David E. Gerber  ;  Ronald B Natale  ;  Mark A. Socinski  ;  Nagdeep Giri  ;  Susan Quinn  ;  Eric Sbar  ;  Hui Zhang  ;  Giuseppe Giaccone 
Citation
 Lung Cancer, Vol.112 : 195-199, 2017 
Journal Title
 Lung Cancer 
ISSN
 0169-5002 
Issue Date
2017
Keywords
Dacomitinib ; Egfr ; Non-small-cell lung cancer ; Pulsatile dosing ; T790M ; Tyrosine kinase inhibitors
Abstract
BACKGROUND: Dacomitinib is a second-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). Pre-clinical data suggest that intermittent pulsatile dosing of dacomitinib may result in inhibition of EGFR T790M. METHODS: We evaluated safety, pharmacokinetics and efficacy of intermittent pulsatile dacomitinib in both molecularly unselected patients and patients with lung cancers harboring EGFR T790M (Clinical Trial Registration Number NCT01858389). RESULTS: Thirty-eight patients were treated on study with pulse dacomitinib; sixteen with EGFR T790M in Cohort A and 22 who were not molecularly selected in Cohort B. One patient out of 16 patients in Cohort A had a partial response to study therapy (ORR 6.3%, 95% CI 0.2-30.2%). The median progression-free survival (PFS) in Cohort A was 2.3 months and median PFS in Cohort B was 1.6 months. The adverse event profile was similar to standard daily dose dacomitinib with the most frequent treatment-related toxicities occurring in >20% of patients being diarrhea, rash, stomatitis, nausea, dry skin, paronychia, fatigue, and decreased appetite. CONCLUSION: Intermittent pulsatile dacomitinib is safe and relatively well tolerated but is not effective in patients that harbor EGFR T790M or in unselected patients with non-small cell lung cancer.
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/161572
Full Text
https://www.sciencedirect.com/science/article/pii/S0169500217304907
DOI
10.1016/j.lungcan.2017.08.017
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실)
Yonsei Authors
조병철(Cho, Byoung Chul)
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