阿来替尼用于RET融合基因肺癌的I/II期研究：研究方案
Phase I/II study of alectinib in lung cancer with RET fusion gene: study protocol.
作者信息
Takeuchi Shinji, Murayama Toshinori, Yoshimura Kenichi, Kawakami Takahiro, Takahara Shizuko, Imai Yasuhito, Kuribayashi Yoshikazu, Nagase Katsuhiko, Goto Koichi, Nishio Makoto, Hasegawa Yoshinori, Satouchi Miyako, Kiura Katsuyuki, Seto Takashi, Yano Seiji
机构信息
Division of Medical Oncology, Cancer Research Institute, Kanazawa University.
Innovative Clinical Research Center (iCREK), Kanazawa University Hospital.
出版信息
J Med Invest. 2017;64(3.4):317-320. doi: 10.2152/jmi.64.317.
BACKGROUND
The rearranged during transfection (RET) fusion gene was discovered as a driver oncogene in 1-2% of non-small cell lung cancers (NSCLCs). Alectinib is an approved anaplastic lymphoma kinase (ALK) inhibitor that may also be effective for RET fusion-positive NSCLC.
METHODS/DESIGN: RET fusion-positive NSCLC patients treated with at least one regimen of chemotherapy are being recruited. In step 1, alectinib (600 or 450 mg, twice daily) will be administered following a 3+3 design. The primary endpoint is safety. In step 2, alectinib will be administered at the recommended dose (RD) defined by step 1. The primary endpoint is the response rate of RET inhibitor treatment-naïve patients.
CONCLUSION
This is the first study to investigate the safety and preliminary efficacy of alectinib in RET fusion-positive NSCLC patients. If successful, alectinib treatment may lead to substantial and important changes in the management of NSCLC with RET fusion genes. J. Med. Invest. 64: 317-320, August, 2017.
背景
转染期间重排（RET）融合基因在1%-2%的非小细胞肺癌（NSCLC）中被发现是一种驱动癌基因。阿来替尼是一种已获批的间变性淋巴瘤激酶（ALK）抑制剂，对RET融合阳性NSCLC可能也有效。
方法/设计：正在招募接受过至少一种化疗方案治疗的RET融合阳性NSCLC患者。在第1阶段，将按照3+3设计给予阿来替尼（600或450毫克，每日两次）。主要终点是安全性。在第2阶段，将按照第1阶段确定的推荐剂量（RD）给予阿来替尼。主要终点是初治RET抑制剂患者的缓解率。
结论
这是第一项研究阿来替尼在RET融合阳性NSCLC患者中的安全性和初步疗效的研究。如果成功，阿来替尼治疗可能会给RET融合基因NSCLC的治疗带来重大且重要的改变。《医学调查杂志》64: 317-320，2017年8月。
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