TY - JOUR
T1 - Phase II Study of the EGFR-TKI Rechallenge With Afatinib in Patients With Advanced NSCLC Harboring Sensitive EGFR Mutation Without T790M
T2 - Okayama Lung Cancer Study Group Trial OLCSG 1403
AU - Oda, Naohiro
AU - Ichihara, Eiki
AU - Hotta, Katsuyuki
AU - Ninomiya, Kiichiro
AU - Ninomiya, Takashi
AU - Kubo, Toshio
AU - Minami, Daisuke
AU - Murakami, Toshi
AU - Yokoyama, Toshihide
AU - Harada, Daijiro
AU - Kuyama, Shoichi
AU - Ichikawa, Hirohisa
AU - Inoue, Koji
AU - Kishino, Daizo
AU - Inoue, Masaaki
AU - Takigawa, Nagio
AU - Shibayama, Takuo
AU - Harita, Shingo
AU - Tanimoto, Mitsune
AU - Kiura, Katsuyuki
N1 - Funding Information:
K.H. has received honoraria from AstraZeneca, Eli Lilly Japan, Daiichi-Sankyo Pharmaceutical, Boehringer-Ingelheim, Nihon Kayaku, Taiho Pharmaceutical, Chugai Pharmaceutical, and Sanofi-Aventis and has also received research funding from Eli Lilly Japan, MSD, and Chugai Pharmaceutical. N.T. has received honoraria from Eli Lilly Japan, AstraZeneca, Daiichi-Sankyo Pharmaceutical, Chugai Pharmaceutical, Taiho Pharmaceutical, Pfizer Inc. Japan, and Boehringer-Ingelheim. M.T. has received honoraria from Daiichi-Sankyo Pharmaceutical, Chugai Pharmaceutical, Taiho Pharmaceutical, Pfizer Inc. Japan, MSD and Boehringer Ingelheim. K.K. has received honoraria from Eli Lilly Japan, Nihon Kayaku, AstraZeneca, Daiichi-Sankyo Pharmaceutical, Chugai Pharmaceutical, Taiho Pharmaceutical, and Sanofi-Aventis. The remaining authors declare that they have no competing interests.
Funding Information:
The authors thank all investigators in the participating institutions. All authors contributed toward the coordination of the study in each hospital. The study received support from the Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan. The study received no specific grant from any funding agency in the public, commercial, or not-for-profit sector.
Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2017/3/1
Y1 - 2017/3/1
N2 - Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) as first-line therapy for patients with EGFR-mutated non–small-cell lung cancer (NSCLC) have shown a significantly better objective response rate and progression-free survival than platinum doublet therapy. However, acquired resistance often occurs within 12 months. One of the potential strategies for treating acquired resistance in NSCLC is the readministration of EGFR-TKIs, a strategy that has mainly been evaluated using gefitinib or erlotinib. The aim of the present study is to investigate the efficacy and safety of EGFR-TKI readministration with afatinib in patients with advanced NSCLC harboring activating EGFR mutations without T790M. The primary endpoint is progression-free survival. The secondary endpoints include the objective response rate, disease control rate, overall survival, toxicity, and quality of life. A total of 12 patients will be enrolled in this trial.
AB - Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) as first-line therapy for patients with EGFR-mutated non–small-cell lung cancer (NSCLC) have shown a significantly better objective response rate and progression-free survival than platinum doublet therapy. However, acquired resistance often occurs within 12 months. One of the potential strategies for treating acquired resistance in NSCLC is the readministration of EGFR-TKIs, a strategy that has mainly been evaluated using gefitinib or erlotinib. The aim of the present study is to investigate the efficacy and safety of EGFR-TKI readministration with afatinib in patients with advanced NSCLC harboring activating EGFR mutations without T790M. The primary endpoint is progression-free survival. The secondary endpoints include the objective response rate, disease control rate, overall survival, toxicity, and quality of life. A total of 12 patients will be enrolled in this trial.
KW - Epidermal growth factor receptor
KW - Non–small-cell lung cancer
KW - Readministration
KW - Tyrosine kinase inhibitor
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UR - http://www.scopus.com/inward/citedby.url?scp=84995563222&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2016.07.003
DO - 10.1016/j.cllc.2016.07.003
M3 - Article
C2 - 27506489
AN - SCOPUS:84995563222
SN - 1525-7304
VL - 18
SP - 241
EP - 244
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
IS - 2
ER -
