作者
Vivek Subbiah, Mimi I Hu, Lori J Wirth, Martin Schuler, Aaron S Mansfield, Giuseppe Curigliano, Marcia S Brose, Viola W Zhu, Sophie Leboulleux, Daniel W Bowles, Christina S Baik, Douglas Adkins, Bhumsuk Keam, Ignacio Matos, Elena Garralda, Justin F Gainor, Gilberto Lopes, Chia-Chi Lin, Yann Godbert, Debashis Sarker, Stephen G Miller, Corinne Clifford, Hui Zhang, Christopher D Turner, Matthew H Taylor
发表日期
2021/8/1
期刊
The lancet Diabetes & endocrinology
卷号
9
期号
8
页码范围
491-501
出版商
Elsevier
简介
Background
Oncogenic alterations in RET represent important therapeutic targets in thyroid cancer. We aimed to assess the safety and antitumour activity of pralsetinib, a highly potent, selective RET inhibitor, in patients with RET-altered thyroid cancers.
Methods
ARROW, a phase 1/2, open-label study done in 13 countries across 71 sites in community and hospital settings, enrolled patients 18 years or older with RET-altered locally advanced or metastatic solid tumours, including RET-mutant medullary thyroid and RET fusion-positive thyroid cancers, and an Eastern Co-operative Oncology Group performance status of 0–2 (later limited to 0–1 in a protocol amendment). Phase 2 primary endpoints assessed for patients who received 400 mg once-daily oral pralsetinib until disease progression, intolerance, withdrawal of consent, or investigator decision, were overall response rate (Response Evaluation Criteria in Solid …
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V Subbiah, MI Hu, LJ Wirth, M Schuler, AS Mansfield… - The lancet Diabetes & endocrinology, 2021