Zhong Xingyu, Sun Jianxuan, Zeng Na, Xiong Yifan, An Ye, Wang Shaogang, Xia Qidong
Department and Institute of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No.1095 Jiefang Avenue, Wuhan 430030, China.
Cancers (Basel). 2024 Jan 16;16(2):382. doi: 10.3390/cancers16020382.
Sex is an important factor influencing the immune system, and the distribution of tumors, including their types and subtypes, is characterized by sexual dichotomy. The aim of this study was to investigate whether there is an association between sex and the treatment effect of immune checkpoint inhibitors (ICI).
Four bibliographic databases were searched. Studies of randomized controlled trials (RCTs) assessing the efficacy of ICI were identified and used, and the primary endpoint was the difference in efficacy of ICI between males and females, presented as overall survival (OS), progression-free survival (PFS) and recurrence-free survival (RFS). The study calculated the pooled HRs and 95% CIs for OS, PFS and RFS for males and females using a random effects model or a fixed effects model, and thereby assessed the effect of sex on the efficacy of ICI treatment. This study is registered with PROSPERO (CRD42022370939).
A total of 103 articles, including a total of 63,755 patients with cancer, were retrieved from the bibliographic database, of which approximately 70% were males. In studies with OS as the outcome, the combined hazard ratio (HR) was 0.77 (95% CI 0.74-0.79) for male patients treated with ICI and 0.81 (95% CI 0.78-0.85) for female patients compared to controls, respectively. The difference in efficacy between males and females was significant.
ICI therapy, under suitable conditions for its use, has a positive impact on survival in various types of tumors, and male patients benefit more than females. It may be necessary to develop different tumor immunotherapy strategies for patients of different sexes.
性别是影响免疫系统的重要因素，肿瘤的分布，包括其类型和亚型，具有性别差异特征。本研究的目的是调查性别与免疫检查点抑制剂（ICI）治疗效果之间是否存在关联。
检索了四个文献数据库。确定并使用了评估ICI疗效的随机对照试验（RCT）研究，主要终点是男性和女性之间ICI疗效的差异，以总生存期（OS）、无进展生存期（PFS）和无复发生存期（RFS）表示。该研究使用随机效应模型或固定效应模型计算了男性和女性OS、PFS和RFS的合并风险比（HR）及95%置信区间（CI），从而评估性别对ICI治疗疗效的影响。本研究已在国际前瞻性系统评价注册库（PROSPERO）注册（注册号：CRD42022370939）。
从文献数据库中检索到103篇文章，共纳入63755例癌症患者，其中约70%为男性。在以OS为观察指标的研究中，与对照组相比，接受ICI治疗的男性患者合并风险比（HR）为0.77（95%CI 0.74 - 0.79），女性患者为0.81（95%CI 0.78 - 0.85）。男性和女性之间的疗效差异显著。
在合适的使用条件下，ICI治疗对各种类型肿瘤的生存有积极影响，男性患者比女性患者受益更多。可能有必要为不同性别的患者制定不同的肿瘤免疫治疗策略。
