TY - JOUR
T1 - Trastuzumab Emtansine in HER2+ Recurrent Metastatic Non–Small-Cell Lung Cancer
T2 - Study Protocol
AU - Ohashi, Kadoaki
AU - Hotta, Katsuyuki
AU - Hirata, Taizo
AU - Aoe, Keisuke
AU - Kozuki, Toshiyuki
AU - Ninomiya, Kiichiro
AU - Kayatani, Hiroe
AU - Yanai, Hiroyuki
AU - Toyooka, Shinichi
AU - Hinotsu, shiro
AU - Takata, Minoru
AU - Kiura, Katsuyuki
N1 - Funding Information:
The authors wish to acknowledge and thank the investigators, coordinators, and all of the other investigators who have contributed to this study. We especially appreciate Dr Terufumi Kato (Kanagawa Cardiovascular and Respiratory Center), Dr Jiichiro Sasaki (Kitazato University), Dr Noriyuki Ebi (Iizuka Hospital) for their effort as a safety committee, Ritsuko Okamoto (National Hospital Organization Yamaguchi-Ube Medical Center), Akiko Nishioka (National Hospital Organization Shikoku Cancer Center), Hiroto Okuda, Kaoru Miyake, Kumiko Ueda, and Hiromi Nakashima for expert technical support. This study has been conducted with dedicated support from the Center for Innovative Clinical Medicine, Okayama University Hospital. The CS-Lung Network, which supports this trial, includes the following institutes (alphabetical order): Chugoku Central Hospital, Fukuyama; Ehime Prefectural Central Hospital, Matsuyama; Ehime University Hospital, T?on; Fukuyama City Hospital, Fukuyama; Hiroshima Prefectural Hospital, Hiroshima; Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima; Hiroshima University Hospital, Hiroshima; Japanese Red Cross Kobe Hospital, Kobe; Japanese Red Cross Okayama Hospital, Okayama; Japanese Red Cross Society Himeji Hospital, Himeji; Kagawa Prefectural Central Hospital, Takamatsu; Kagawa University Hospital, Kida; Kawasaki Hospital, Okayama; Kawasaki Medical School Hospital, Kurashiki; Kochi Medical School Hospital, Kochi; Kurashiki Central Hospital, Kurashiki; Kure Kyosai Hospital, Kure; Matsuyama Red Cross Hospital, Matsuyama; Miyoshi Central Hospital, Miyoshi; National Hospital Organization Higashi-Hiroshima Medical Center, Higashi-Hiroshima; National Hospital Organization Iwakuni Medical Center, Iwakuni; National Hospital Organization Okayama Medical Center, Okayama; National Hospital Organization Shikoku Cancer Center, Matsuyama; Okayama Health Foundation Hospital, Okayama; Okayama Rosai Hospital, Okayama; Okayama Saiseikai General Hospital, Okayama; Okayama University Hospital, Okayama; Onomichi General Hospital, Onomichi; Onomichi Municipal Hospital, Onomichi; Shimane University School of Medicine, Izumo; Shimonoseki City Hospital, Shimonoseki; Sumitomo Besshi Hospital, Niihama; Takamatsu Hospital, Takamatsu; Tokushima University Hospital, Tokushima; Tottori Prefectural Central Hospital, Tottori; Tottori University Hospital, Yonago; Yamaguchi-ken Saiseikai Shimonoseki General Hospital, Shimonoseki; Yamaguchi-Ube Medical Center, Ube; Yamaguchi University Hospital, Yamaguchi. This research received a specific grant from the Japan Agency for Medical Research and Development (AMED16lk0103014h0004), which is funded by the Japanese governmental. No additional external funding was received for this study. The investigational agent was kindly provided by Chugai Pharmaceuticals.
Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2017/1/1
Y1 - 2017/1/1
N2 - The treatment outcome has been unsatisfactory for patients with non–small-cell lung cancer (NSCLC) refractory to standard first-line chemotherapy. Trastuzumab emtansine (T-DM1), an anti-HER2 antibody conjugated with a vinca alkaloid, has been approved for clinical use in HER2+ breast cancer in many countries. Approximately 5% of NSCLC tumors possess HER2 alterations, and T-DM1 has shown excellent antitumor effects against HER2+ lung cancer cell lines in preclinical models. Therefore, we hypothesized that T-DM1 could significantly inhibit the growth of HER2+ lung cancers. We have launched a nonrandomized phase II trial of T-DM1 monotherapy for patients with HER2+ lung cancers. The major eligibility criteria are as follows: age ≥ 20 years, pathologically diagnosed NSCLC with documented HER2 positivity (immunohistochemistry 3+, both immunohistochemistry 2+ and fluorescence in situ hybridization positive, or exon 20 insertion mutation), and previous chemotherapy. Thirty patients will receive T-DM1 3.6 mg/kg every 3 weeks. The primary endpoint is the overall response rate. This trial will provide information on whether T-DM1 monotherapy is effective against HER2+ lung cancer.
AB - The treatment outcome has been unsatisfactory for patients with non–small-cell lung cancer (NSCLC) refractory to standard first-line chemotherapy. Trastuzumab emtansine (T-DM1), an anti-HER2 antibody conjugated with a vinca alkaloid, has been approved for clinical use in HER2+ breast cancer in many countries. Approximately 5% of NSCLC tumors possess HER2 alterations, and T-DM1 has shown excellent antitumor effects against HER2+ lung cancer cell lines in preclinical models. Therefore, we hypothesized that T-DM1 could significantly inhibit the growth of HER2+ lung cancers. We have launched a nonrandomized phase II trial of T-DM1 monotherapy for patients with HER2+ lung cancers. The major eligibility criteria are as follows: age ≥ 20 years, pathologically diagnosed NSCLC with documented HER2 positivity (immunohistochemistry 3+, both immunohistochemistry 2+ and fluorescence in situ hybridization positive, or exon 20 insertion mutation), and previous chemotherapy. Thirty patients will receive T-DM1 3.6 mg/kg every 3 weeks. The primary endpoint is the overall response rate. This trial will provide information on whether T-DM1 monotherapy is effective against HER2+ lung cancer.
KW - HER2 amplification
KW - HER2 mutations
KW - HER2 over-expression
KW - NSCLC
KW - Trastuzumab emtansine
UR - http://www.scopus.com/inward/record.url?scp=84998537702&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84998537702&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2016.06.014
DO - 10.1016/j.cllc.2016.06.014
M3 - Article
C2 - 27497829
AN - SCOPUS:84998537702
VL - 18
SP - 92
EP - 95
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
SN - 1525-7304
IS - 1
ER -