Background: The sex-neutral language used in preclinical and clinical research intends to be inclusive of both the female and the male population, but the practice of data pooling prevents the detection of the impact of sex on cancer biology and response to medications and treatment. This study aimed to examine the consideration of sex as biological variable in the evaluation of radiation therapy in preclinical and clinical studies.

Methods: Preclinical and clinical studies published over a 12-month period were reviewed for the reporting of cells, animal or patient sex and the inclusion of sex as a biological variable in both study design and data analysis.

Results: A total of 321 articles met the inclusion criteria: 41 (13%) preclinical and 280 (87%) clinical studies. Two articles reported separate outcome data for males and females. Where the sex of participants was stated (230/280 (82%), 81% reported a larger number of male participants, compared to females. Less than half (45%) of studies used sex as a variable in data analysis. Sex disparity was not dependent on study location but may be more prominent in certain cancer sites. In preclinical studies, sex was at best stated in those reporting on animals (48% of studies).

Conclusion: Referring to a radiotherapy cancer patient, the literature is female inclusive, but a gap does exist when it comes to consideration of sex in data analysis. The pooled analysis of female and male data could introduce statistical biases and prevent the identification of key sex-specific biological subtilities that do affect radiation responses.

背景：临床前和临床研究中使用的中性语言旨在囊括女性和男性人群，但是数据汇总的做法阻止了性行为对癌症生物学的影响以及对药物和治疗反应的检测。这项研究的目的是在临床前和临床研究中评估放射治疗评估中性别作为生物学变量的考虑。

方法：对在过去12个月内发表的临床前和临床研究进行了回顾，以报告细胞，动物或患者的性别，并在研究设计和数据分析中纳入性别作为生物学变量。

结果：共有321篇文章符合纳入标准：41篇（13％）临床前研究和280篇（87％）临床研究。有两篇文章分别报告了男性和女性的结局数据。在注明参与者性别的地方（230/280（82％），有81％的受访者表示男性参与者比女性多。只有不到一半（45％）的研究使用性别作为数据分析的变量。在临床前研究中，关于动物的研究报告中最多只提到性别（占研究的48％）。

结论：关于放射治疗癌症患者，文献包括女性，但在数据分析中考虑性别时确实存在差距。对女性和男性数据的汇总分析可能会引入统计偏差，并阻止识别确实影响辐射响应的关键性别特异性生物实体。