Non-small cell lung cancer (NSCLC) is one of the world’s leading causes of morbidity and mortality. ICIs alone or combined with chemotherapy have become the standard first-line treatment of metastatic NSCLC. The impressive results obtained have stimulated our interest in applying these therapies in early disease stage treatments, as neoadjuvant immunotherapy has shown promising results. Among many of the factors that may influence responses, the role played by sex is attracting increased interest and needs to be addressed. Here, we aim to first review the state of the art regarding neoadjuvant ICIs, whether they are administered in monotherapy or in combination with chemotherapy at stages IB-IIIA, particularly at stage IIIA, before analyzing whether sex may influence responses. To this end, a meta-analysis of publicly available data comparing male and female major pathological responses (MPR) and pathological complete responses (pCR) was performed. In our meta-analysis, MPR was found to be significantly higher in females than in males, with an odds ratio (OR) of 1.82 (95% CI 1.13–2.93;p= 0.01), while pCR showed a trend to be more favorable in females than in males, but the OR of 1.62 was not statistically significant (95% CI 0.97–2.75;p= 0.08). Overall, our results showed that sex should be systematically considered in future clinical trials settings in order to establish the optimal treatment sequence.
非小细胞肺癌是全球范围内主要的发病和死亡原因之一。免疫检查点抑制剂单药或联合化疗已成为转移性非小细胞肺癌的标准一线治疗方案。其显著疗效激发了我们将这些疗法应用于早期疾病阶段治疗的兴趣，新辅助免疫治疗已展现出令人期待的结果。在众多可能影响治疗反应的因素中，性别所起的作用正受到日益增长的关注并亟待深入探讨。本文旨在首先综述IB-IIIA期（特别是IIIA期）新辅助免疫检查点抑制剂治疗（无论是单药还是联合化疗）的最新进展，进而分析性别因素是否会影响治疗反应。为此，我们通过对公开数据进行荟萃分析，比较了男性和女性患者的主要病理缓解率及病理完全缓解率。分析结果显示，女性患者的主要病理缓解率显著高于男性（比值比1.82，95%置信区间1.13-2.93，p=0.01），而病理完全缓解率虽在女性中呈现更优趋势（比值比1.62），但未达到统计学显著性（95%置信区间0.97-2.75，p=0.08）。总体而言，我们的研究结果表明，在未来临床试验设计中应系统性地考量性别因素，以确立最优的治疗策略序列。
肿瘤(癌症)患者之家