Department of Precision Medicine in Medical, Surgical and Critical Care (Me.Pre.C.C.), Section of Medical Oncology, University of Palermo, 90127, Palermo, Italy.
Latin American Cooperative Oncology Group - LACOG, Porto Alegre, RS, Brazil.
Cancer Immunol Immunother. 2024 Jun 4;73(8):142. doi: 10.1007/s00262-024-03719-0.
There is an ongoing debate as to whether sex could be associated with immune checkpoint inhibitor (ICI) benefit. Existing literature data reveal contradictory results, and data on first-line immune combinations are lacking.
This was a real-world, multicenter, international, observational study to determine the sex effects on the clinical outcomes in metastatic renal cell carcinoma (mRCC) patients treated with immuno-oncology combinations as first-line therapy.
A total of 1827 mRCC patients from 71 cancer centers in 21 countries were included. The median OS was 38.7 months (95% CI 32.7-44.2) in the overall study population: 40.0 months (95% CI 32.7-51.6) in males and 38.7 months (95% CI 26.4-41.0) in females (p = 0.202). The median OS was higher in males vs. females in patients aged 18-49y (36.9 months, 95% CI 29.0-51.6, vs. 24.8 months, 95% CI 16.8-40.4, p = 0.426, with + 19% of 2y-OS rate, 72% vs. 53%, p = 0.006), in the clear cell histology subgroup (44.2 months, 95% CI 35.8-55.7, vs. 38.7 months, 95% CI 26.0-41.0, p = 0.047), and in patients with sarcomatoid differentiation (34.4 months, 95% CI 26.4-59.0, vs. 15.3 months, 95% CI 8.9-41.0, p < 0.001). Sex female was an independent negative prognostic factor in the sarcomatoid population (HR 1.72, 95% CI 1.15 - 2.57, p = 0.008).
Although the female's innate and adaptive immunity has been observed to be more active than the male's, women in the subgroup of clear cell histology, sarcomatoid differentiation, and those under 50 years of age showed shorter OS than males.
目前仍存在关于性别的争议，即性别是否与免疫检查点抑制剂（ICI）的疗效相关。现有文献数据显示结果相互矛盾，并且缺乏关于一线免疫联合治疗的数据。
这是一项真实世界、多中心、国际性、观察性研究，旨在确定在转移性肾细胞癌（mRCC）患者中，以免疫肿瘤学联合治疗作为一线治疗时，性别的影响对临床结局的影响。
本研究共纳入了来自 21 个国家 71 家癌症中心的 1827 名 mRCC 患者。在整个研究人群中，中位 OS 为 38.7 个月（95%CI 32.7-44.2）：男性为 40.0 个月（95%CI 32.7-51.6），女性为 38.7 个月（95%CI 26.4-41.0）（p=0.202）。在年龄为 18-49 岁的患者中，男性的中位 OS 高于女性（36.9 个月，95%CI 29.0-51.6，vs. 24.8 个月，95%CI 16.8-40.4，p=0.426，2 年 OS 率增加 19%，72% vs. 53%，p=0.006），在透明细胞组织学亚组中（44.2 个月，95%CI 35.8-55.7，vs. 38.7 个月，95%CI 26.0-41.0，p=0.047），在肉瘤样分化患者中（34.4 个月，95%CI 26.4-59.0，vs. 15.3 个月，95%CI 8.9-41.0，p<0.001）。在肉瘤样分化患者中，女性为独立的负预后因素（HR 1.72，95%CI 1.15-2.57，p=0.008）。
尽管已经观察到女性的先天和适应性免疫比男性更活跃，但在透明细胞组织学亚组、肉瘤样分化和年龄小于 50 岁的女性中，OS 短于男性。
