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Exclusion of patients with brain metastases from cancer clinical trials.
Neuro-Oncology ( IF 15.9 ) Pub Date : 2020-04-15 , DOI: 10.1093/neuonc/noz246
Roshal R Patel 1, 2 , Vivek Verma 1 , Austin B Miller 1, 3 , Timothy A Lin 4 , Amit Jethanandani 5 , Andres F Espinoza 6 , Walker Mainwaring 6 , Alexander Augustyn 1 , C David Fuller 1 , Erik P Sulman 7 , Debra N Yeboa 1 , Caroline C Chung 1 , Mary Frances McAleer 1 , Jing Li 1 , Daniel Yoshor 6 , John F de Groot 1 , Jacob J Mandel 6 , Ethan B Ludmir 1
Affiliation  

Historically, cancer clinical trials have excluded patients with brain metastases out of concern for poor life expectancy and intervention tolerability. Given the high incidence of secondary brain metastases across cancer types, excluding these patients in clinical trials may limit generalizability of study results.1–3 Recent efforts have sought to broaden eligibility criteria in oncologic trials, with more nuanced guidelines for patients with intracranial metastases.3–5 We therefore sought to characterize the incidence, correlates, and temporal trends of brain metastasis exclusion criteria (BMEC) among phase III cancer clinical trials.

中文翻译:

从癌症临床试验中排除脑转移患者。

从历史上看,癌症临床试验出于对预期寿命和干预耐受性差的担忧而将脑转移患者排除在外。鉴于跨癌症类型的继发性脑转移发生率很高,因此在临床试验中将这些患者排除在外可能会限制研究结果的推广性。1-3最近的努力试图扩大肿瘤试验的入选标准,并为颅内转移瘤患者制定了更加细致入微的指南。3-5因此,我们试图描述III期癌症临床试验中脑转移排斥标准(BMEC)的发生率,相关性和时间趋势。
更新日期:2020-04-17
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