Stevens Samuel X, Gyawali Bishal
Department of Oncology, Queen's University, Kingston, Ontario, Canada.
Division of Cancer Care and Epidemiology, Queen's University, Kingston, Ontario, Canada.
Cancer. 2025 Sep 1;131(17):e70056. doi: 10.1002/cncr.70056.
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.
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。
