Caliman Enrico, Petrella Maria Cristina, Rossi Virginia, Mazzoni Francesca, Grosso Anna Maria, Fancelli Sara, Paglialunga Luca, Comin Camilla Eva, Roviello Giandomenico, Pillozzi Serena, Antonuzzo Lorenzo
Medical Oncology Unit, Careggi University Hospital, Florence, Italy.
Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Curr Cancer Drug Targets. 2025;25(1):64-71. doi: 10.2174/1568009622666220831142452.
Emerging evidence identified sex as a variable regulating immune system functions and modulating response to immunotherapy in cancer patients.
This retrospective study analysed sex-related differences in immunotherapy outcomes in a real-world population of non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors (ICIs).
We retrospectively investigated clinical data of 99 patients with advanced NSCLC and treated with single-agent nivolumab and pembrolizumab at Medical Oncology Unit, Careggi University Hospital, Florence (Italy), between April 2014 to August 2019. Main clinical characteristics and clinical outcomes were analysed.
Our study showed that the efficacy of ICI treatment differed according to gender. A trend for better median progression-free survival (mPFS) was reported in males (mPFS 5.0 months, 95% Confidence Interval [CI] 4.0-11.0) than females (mPFS 4.5 months, 95% CI 2.0-9.0) (p=0.133), while no significant difference for overall survival (OS) between the two sex groups was observed (p=0.622). In the nivolumab cohort, we showed a statistically significant difference for a longer PFS in men compared to women (log-rank p=0.054), HR for PFS in females versus males was 1.81 (95% CI 0.97- 3.37, p=0.062). Disease control rate (DCR) was achieved in 55.7% and 45.7% of men and women, respectively, while disease progression was registered in 44.3% of males and 54.3% of females (p=0.386).
Gender is a variable that should be taken into account in the choice of immunotherapy. Future prospective randomized trials testing tailored sex-based immunotherapy strategies are required to validate our findings before integrating into clinical practice.
新出现的证据表明，性别是调节免疫系统功能和影响癌症患者免疫治疗反应的一个变量。
这项回顾性研究分析了在接受免疫检查点抑制剂（ICI）治疗的非小细胞肺癌（NSCLC）患者的真实世界人群中，免疫治疗结果的性别差异。
我们回顾性调查了2014年4月至2019年8月期间在意大利佛罗伦萨卡雷吉大学医院医学肿瘤科室接受单药纳武单抗和派姆单抗治疗的99例晚期NSCLC患者的临床数据。分析了主要临床特征和临床结果。
我们的研究表明，ICI治疗的疗效因性别而异。男性的中位无进展生存期（mPFS）（mPFS 5.0个月，95%置信区间[CI] 4.0 - 11.0）有优于女性（mPFS 4.5个月，95% CI 2.0 - 9.0）的趋势（p = 0.133），而两组之间的总生存期（OS）没有显著差异（p = 0.622）。在纳武单抗队列中，我们发现男性的PFS比女性更长，差异有统计学意义（对数秩检验p = 0.054），女性与男性PFS的风险比（HR）为1.81（95% CI 0.97 - 3.37，p = 0.062）。男性和女性的疾病控制率（DCR）分别为55.7%和45.7%，而疾病进展率在男性中为44.3%，女性中为54.3%（p = 0.386）。
性别是免疫治疗选择中应考虑的一个变量。在将我们的研究结果纳入临床实践之前，需要未来进行前瞻性随机试验，以验证基于性别的定制免疫治疗策略。
