Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 92-95 |
| Number of pages | 4 |
| Journal | Clinical Lung Cancer |
| Volume | 18 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Jan 1 2017 |
Fingerprint
Keywords
- HER2 amplification
- HER2 mutations
- HER2 over-expression
- NSCLC
- Trastuzumab emtansine
ASJC Scopus subject areas
- Oncology
- Pulmonary and Respiratory Medicine
- Cancer Research
Cite this
Trastuzumab Emtansine in HER2+ Recurrent Metastatic Non–Small-Cell Lung Cancer : Study Protocol. / Oohashi, Kadoaki; Hotta, Katsuyuki; Hirata, Taizo; Aoe, Keisuke; Kozuki, Toshiyuki; Ninomiya, Kiichiro; Kayatani, Hiroe; Yanai, Hiroyuki; Toyooka, Shinichi; Hinotsu, Shiro; Takata, Minoru; Kiura, Katsuyuki.
In: Clinical Lung Cancer, Vol. 18, No. 1, 01.01.2017, p. 92-95.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Trastuzumab Emtansine in HER2+ Recurrent Metastatic Non–Small-Cell Lung Cancer
T2 - Study Protocol
AU - Oohashi, 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
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 -