作者
Justin F Gainor, Giuseppe Curigliano, Dong-Wan Kim, Dae Ho Lee, Benjamin Besse, Christina S Baik, Robert C Doebele, Philippe A Cassier, Gilberto Lopes, Daniel SW Tan, Elena Garralda, Luis G Paz-Ares, Byoung Chul Cho, Shirish M Gadgeel, Michael Thomas, Stephen V Liu, Matthew H Taylor, Aaron S Mansfield, Viola W Zhu, Corinne Clifford, Hui Zhang, Michael Palmer, Jennifer Green, Christopher D Turner, Vivek Subbiah
发表日期
2021/7/1
期刊
The lancet oncology
卷号
22
期号
7
页码范围
959-969
出版商
Elsevier
简介
Background
Oncogenic alterations in RET have been identified in multiple tumour types, including 1–2% of non-small-cell lung cancers (NSCLCs). We aimed to assess the safety, tolerability, and antitumour activity of pralsetinib, a highly potent, oral, selective RET inhibitor, in patients with RET fusion-positive NSCLC.
Methods
ARROW is a multi-cohort, open-label, phase 1/2 study done at 71 sites (community and academic cancer centres) in 13 countries (Belgium, China, France, Germany, Hong Kong, Italy, Netherlands, Singapore, South Korea, Spain, Taiwan, the UK, and the USA). Patients aged 18 years or older with locally advanced or metastatic solid tumours, including RET fusion-positive NSCLC, and an Eastern Cooperative Oncology Group performance status of 0–2 (later limited to 0–1 in a protocol amendment) were enrolled. In phase 2, patients received 400 mg once-daily oral pralsetinib, and could …
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