“代码破解”还是“蓝色代码”？评估索托拉西布在转移性结直肠癌中的生命体征
CodeBreaK or code blue? Assessing sotorasib's vital signs in metastatic colorectal cancer.
作者信息
Stevens Samuel X, Gyawali Bishal
机构信息
Department of Oncology, Queen's University, Kingston, Ontario, Canada.
Division of Cancer Care and Epidemiology, Queen's University, Kingston, Ontario, Canada.
出版信息
Cancer. 2025 Sep 1;131(17):e70056. doi: 10.1002/cncr.70056.
Abstract
Although no survival benefit over standard therapies has been established, the combination of sotorasib plus panitumumab recently received full US Food and Drug Administration approval for use in advanced colorectal cancer. The authors highlight key concerns with the CodeBreaK 300 trial design, conduct, and reporting, arguing that excitement for precision medicines must be matched by methodological rigor and transparent reporting.
摘要
尽管与标准疗法相比，索托拉西布联合帕尼单抗尚未显示出生存获益，但该联合疗法最近已获得美国食品药品监督管理局的全面批准，用于治疗晚期结直肠癌。作者强调了CodeBreaK 300试验设计、实施和报告中的关键问题，认为对精准药物的热情必须与方法的严谨性和透明的报告相匹配。
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本文引用的文献
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J Clin Oncol. 2025 Apr 11:JCO2402026. doi: 10.1200/JCO-24-02026.
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Common Sense Oncology principles for the design, analysis, and reporting of phase 3 randomised clinical trials.3期随机临床试验设计、分析和报告的常识性肿瘤学原则。
Lancet Oncol. 2025 Feb;26(2):e80-e89. doi: 10.1016/S1470-2045(24)00451-0.
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Dose optimization of sotorasib: Has the burden of proof for the labeled dose been met?索托拉西布的剂量优化：标签剂量的证据负担是否已得到满足？
Eur J Cancer. 2024 Nov;212:115044. doi: 10.1016/j.ejca.2024.115044. Epub 2024 Sep 27.
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Sotorasib (960 mg or 240 mg) once daily in patients with previously treated KRAS G12C-mutated advanced NSCLC.索托拉西布（960 毫克或 240 毫克）每日一次，用于治疗既往治疗过的 KRAS G12C 突变型晚期 NSCLC 患者。
Eur J Cancer. 2024 Sep;208:114204. doi: 10.1016/j.ejca.2024.114204. Epub 2024 Jul 5.
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