start-ver=1.4
cd-journal=joma
no-vol=6
cd-vols=
no-issue=4
article-no=
start-page=100191
end-page=
dt-received=
dt-revised=
dt-accepted=
dt-pub-year=2021
dt-pub=202108
dt-online=
en-article=
kn-article=
en-subject=
kn-subject=
en-title=
kn-title=Gefitinib induction followed by chemoradiotherapy in EGFR-mutant, locally advanced non-small-cell lung cancer: LOGIK0902/OLCSG0905 phase II study
en-subtitle=
kn-subtitle=
en-abstract=
kn-abstract=Background: The role of epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) induction coupled with standard concurrent chemoradiotherapy (CRT) is unclear in unresectable, stage III, EGFR-mutant non-small-cell lung cancer (NSCLC). Therefore, a phase II trial was conducted to evaluate the efficacy and safety of gefitinib induction followed by CRT in this disease setting.
Patients and methods: Patients with unresectable, EGFR-mutant, stage III NSCLC were administered gefitinib monotherapy (250 mg/day) for 8 weeks. Subsequently, patients without disease progression during induction therapy were administered cisplatin and docetaxel (40 mg/m(2) each) on days 1, 8, 29, and 36 with concurrent radiotherapy at a total dose of 60 Gy. The primary endpoint was the 2-year overall survival (OS) rate, which was hypothesized to reach 85%, with a threshold of the lower limit of 60%.
Results: Twenty patients (median age: 66 years; male/female: 9/11; histology: 20 adenocarcinoma; stage IIIA/IIIB: 9/11; and exon 19/21: 10/10) were enrolled. The 2-year OS rate was 90% (90% confidence interval: 71.4% to 96.8%), indicating that this trial met the primary objective. The overall response rate and 1- and 2-year progression-free survival rates were 85.0%, 58.1%, and 36.9%, respectively. Grade >= 3 adverse events (>10%) included hepatic toxicity during the induction phase and neutropenia and febrile neutropenia in the CRT phase. Radiation pneumonitis grade >= 3 or treatment-related death did not occur.
Conclusions: This is the first prospective study to demonstrate the favorable efficacy and safety of EGFR-TKI induction followed by standard CRT in EGFR-mutant, stage III NSCLC. Further confirmatory studies are needed.
en-copyright=
kn-copyright=
en-aut-name=HottaK.
en-aut-sei=Hotta
en-aut-mei=K.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=1
ORCID=
en-aut-name=SaekiS.
en-aut-sei=Saeki
en-aut-mei=S.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=2
ORCID=
en-aut-name=YamaguchiM.
en-aut-sei=Yamaguchi
en-aut-mei=M.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=3
ORCID=
en-aut-name=HaradaD.
en-aut-sei=Harada
en-aut-mei=D.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=4
ORCID=
en-aut-name=BesshoA.
en-aut-sei=Bessho
en-aut-mei=A.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=5
ORCID=
en-aut-name=TanakaK.
en-aut-sei=Tanaka
en-aut-mei=K.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=6
ORCID=
en-aut-name=InoueK.
en-aut-sei=Inoue
en-aut-mei=K.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=7
ORCID=
en-aut-name=GembaK.
en-aut-sei=Gemba
en-aut-mei=K.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=8
ORCID=
en-aut-name=ShiojiriM.
en-aut-sei=Shiojiri
en-aut-mei=M.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=9
ORCID=
en-aut-name=KatoY.
en-aut-sei=Kato
en-aut-mei=Y.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=10
ORCID=
en-aut-name=NinomiyaT.
en-aut-sei=Ninomiya
en-aut-mei=T.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=11
ORCID=
en-aut-name=KuboT.
en-aut-sei=Kubo
en-aut-mei=T.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=12
ORCID=
en-aut-name=KishimotoJ.
en-aut-sei=Kishimoto
en-aut-mei=J.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=13
ORCID=
en-aut-name=ShioyamaY.
en-aut-sei=Shioyama
en-aut-mei=Y.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=14
ORCID=
en-aut-name=KatsuiK.
en-aut-sei=Katsui
en-aut-mei=K.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=15
ORCID=
en-aut-name=SasakiJ.
en-aut-sei=Sasaki
en-aut-mei=J.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=16
ORCID=
en-aut-name=KiuraK.
en-aut-sei=Kiura
en-aut-mei=K.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=17
ORCID=
en-aut-name=SugioK.
en-aut-sei=Sugio
en-aut-mei=K.
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=18
ORCID=
affil-num=1
en-affil=Center for Innovative Clinical Medicine, Okayama University Hospital
kn-affil=
affil-num=2
en-affil=Department of Respiratory Medicine, Kumamoto University Hospital
kn-affil=
affil-num=3
en-affil=Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center
kn-affil=
affil-num=4
en-affil=Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center
kn-affil=
affil-num=5
en-affil=Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital
kn-affil=
affil-num=6
en-affil=Department of Respiratory Medicine, Kyushu University Hospital
kn-affil=
affil-num=7
en-affil=Department of Respiratory Medicine, Kitakyushu Municipal Medical Center
kn-affil=
affil-num=8
en-affil=Department of Respiratory Medicine, Chugoku Central Hospital
kn-affil=
affil-num=9
en-affil=Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital
kn-affil=
affil-num=10
en-affil=Center for Innovative Clinical Medicine, Okayama University Hospital
kn-affil=
affil-num=11
en-affil=Department of Respiratory Medicine, Okayama University Hospital
kn-affil=
affil-num=12
en-affil=Department of Respiratory Medicine, Okayama University Hospital
kn-affil=
affil-num=13
en-affil=Center for Clinical and Translational Research, Kyushu University Hospital
kn-affil=
affil-num=14
en-affil=Clinical Radiology, Radiology Informatics and Network, Graduate School of Medical Sciences, Kyushu University
kn-affil=
affil-num=15
en-affil=Department of Proton Beam Therapy, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
kn-affil=
affil-num=16
en-affil=Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine
kn-affil=
affil-num=17
en-affil=Department of Respiratory Medicine, Okayama University Hospital
kn-affil=
affil-num=18
en-affil=Department of Thoracic and Breast Surgery, Oita University
kn-affil=
en-keyword=non-small-cell lung cancer
kn-keyword=non-small-cell lung cancer
en-keyword=locally advanced setting
kn-keyword=locally advanced setting
en-keyword=chemoradiation
kn-keyword=chemoradiation
en-keyword=epidermal growth factor receptor
kn-keyword=epidermal growth factor receptor
END