title: Phase II Study of the EGFR-TKI Rechallenge With Afatinib in Patients With Advanced NSCLC Harboring Sensitive EGFR Mutation Without T790M: Okayama Lung Cancer Study Group Trial OLCSG 1403.
abstract: 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.
authors: Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
authors: Naohiro
authors: N
authors: Oda
authors: Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan. Electronic address: ichiha-e@md.okayama-u.ac.jp.
authors: Eiki
authors: E
authors: Ichihara
authors: Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan; Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.
authors: Katsuyuki
authors: K
authors: Hotta
authors: Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
authors: Kiichiro
authors: K
authors: Ninomiya
authors: Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
authors: Takashi
authors: T
authors: Ninomiya
authors: Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
authors: Toshio
authors: T
authors: Kubo
authors: Department of Respiratory Medicine, National Hospital Organization Okayama Medical Center, Okayama, Japan.
authors: Daisuke
authors: D
authors: Minami
authors: Department of Respiratory Medicine, Himeji Red Cross Hospital, Himeji, Japan.
authors: Toshi
authors: T
authors: Murakami
authors: Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
authors: Toshihide
authors: T
authors: Yokoyama
authors: Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
authors: Daijiro
authors: D
authors: Harada
authors: Department of Respiratory Medicine, National Hospital Organization Iwakuni Medical Center, Yamaguchi, Japan.
authors: Shoichi
authors: S
authors: Kuyama
authors: Department of Respiratory Medicine, KKR Takamatsu Hospital, Takamatsu, Japan.
authors: Hirohisa
authors: H
authors: Ichikawa
authors: Department of Respiratory Medicine, Ehime Prefectural Central Hospital, Matsuyama, Japan.
authors: Koji
authors: K
authors: Inoue
authors: Department of Respiratory Medicine, Himeji Red Cross Hospital, Himeji, Japan.
authors: Daizo
authors: D
authors: Kishino
authors: Department of Thoracic Surgery, Shimonoseki City Hospital, Shimonoseki, Japan.
authors: Masaaki
authors: M
authors: Inoue
authors: Department of General Internal Medicine 4, Kawasaki Hospital, Kawasaki Medical School, Okayama, Japan.
authors: Nagio
authors: N
authors: Takigawa
authors: Department of Respiratory Medicine, National Hospital Organization Okayama Medical Center, Okayama, Japan.
authors: Takuo
authors: T
authors: Shibayama
authors: Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan.
authors: Shingo
authors: S
authors: Harita
authors: Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
authors: Mitsune
authors: M
authors: Tanimoto
authors: Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
authors: Katsuyuki
authors: K
authors: Kiura
mesh_terms: D000328:Adult; D000077716:Afatinib; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D066246:ErbB Receptors / Q000235:genetics*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009154:Mutation / Q000235:genetics*; D009367:Neoplasm Staging; D011379:Prognosis; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011799:Quinazolines / Q000627:therapeutic use*; D011838:Radiation-Sensitizing Agents / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D011838:Radiation-Sensitizing Agents; D000077716:Afatinib; C512478:EGFR protein, human; D066246:ErbB Receptors
keywords: Epidermal growth factor receptor; Non–small-cell lung cancer; Readministration; Tyrosine kinase inhibitor