在临床试验中解释生存指标的挑战:限制平均生存分析的效用。

IF 6.5 1区 医学 Q1 ONCOLOGY International Journal of Radiation Oncology Biology Physics Pub Date : 2025-06-01 Epub Date: 2025-02-18 DOI:10.1016/j.ijrobp.2025.02.006
Itamar Averbuch MD , Avital Bareket-Samish PhD , Daniel A. Goldstein MD , Sapir Eizenstein MD , Gal Markel MD, PhD , Eli Rosenbaum MD , Dror Limon MD , David Bomze MD, MPH , Ethan B. Ludmir MD , Tomer Meirson MD, PhD
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引用次数: 0

摘要

一名75岁男子因新诊断为高风险局部前列腺癌而进入你的诊所。你向他建议一个最先进的治疗方案:前列腺和淋巴结放射治疗,以及激素治疗。这名男子表达了对尿漏的担忧,并怀疑淋巴结照射是否值得。为了解决他的担忧,您描述了最近的POP-RT试验,该试验将整个骨盆放疗与仅前列腺放疗进行了比较。的确,全盆腔放疗增加了泌尿生殖系统毒性的风险,但无病生存率的提高令人印象深刻,风险比(HR)为0.4。病人看起来很困惑,所以你试着用更简单的术语来交流:“不要害怕,与前列腺放射治疗相比,整个盆腔放射治疗,你的疾病进展率或死亡率会降低60%”(更有统计学头脑的人会咬牙切齿地说,因为HR 0.4并不意味着终点风险降低60%;稍后会详细介绍)。尽管你做出了努力,但病人的目光仍然很困惑,你意识到,用一种更直接的方式来解释治疗的好处,即延缓疾病进展,将会有所帮助。因此,您试图在POP-RT研究中找到两组的中位无病生存期,但在整个POP-RT出版物中找不到中位生存期。在放弃的边缘,你想起了和你的中心统计学家的午餐聊天,他滔滔不绝地谈论这个“改变游戏规则”的指标,限制平均生存时间(RMST),坚持认为它更直观,对病人更友好。当然,他甚至还发了一封电子邮件,详细介绍了RMST的不同临床试验结果,包括POP-RT。在你的收件箱里快速搜索了一下之后,你自信地告诉病人,“平均而言,增加盆腔RT可以将病情进展推迟11个月以上。”沉默片刻后,病人点点头说:“我们开始吧。”
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Challenges in Interpreting Survival Metrics in Clinical Trials: The Utility of Restricted Mean Survival Analyses
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来源期刊
CiteScore
11.00
自引率
7.10%
发文量
2538
审稿时长
6.6 weeks
期刊介绍: International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field. This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.
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