性别对癌症患者免疫检查点抑制剂疗效的影响：MOUSEION-01 研究。
The impact of gender on The efficacy of immune checkpoint inhibitors in cancer patients: The MOUSEION-01 study.
机构信息
Oncology Unit, Macerata Hospital, Macerata, Italy.
Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Albertoni - 15, Bologna, Italy.
出版信息
Crit Rev Oncol Hematol. 2022 Feb;170:103596. doi: 10.1016/j.critrevonc.2022.103596. Epub 2022 Jan 12.
The primary endpoint of MOUSEION-01 was to assess overall survival (OS) in male and female patients receiving immune checkpoint inhibitors versus control treatments, calculating the pooled OS Hazard Ratio (HR) and 95 % Confidence Interval (CI) in both groups. 37 randomized phase III studies and 22646 patients (16382 men and 6264 women) were included. In patients treated with immunotherapy (as monotherapy or in combination with other agents), the pooled OS HR was 0.78 (0.75-0.82) and 0.77 (95 % CI, 0.72-0.83) in male and female subjects, respectively. The pooled HR for OS in male patients treated with single-agent immunotherapy versus control was 0.77 (95 % CI, 0.70-0.85), while this benefit was smaller in female patients (HR, 0.81; 95 % CI, 0.73-0.9). Our findings highlight that high-quality trials accounting for potential confounders are needed before being able to suggest a real effect of the patient's gender on immune checkpoint inhibitors efficacy in different settings.
MOUSEION-01 的主要终点是评估接受免疫检查点抑制剂与对照治疗的男性和女性患者的总生存期 (OS)，计算两组的汇总 OS 风险比 (HR) 和 95%置信区间 (CI)。纳入了 37 项随机 III 期研究和 22646 名患者（16382 名男性和 6264 名女性）。在接受免疫治疗（单药或联合其他药物）的患者中，男性和女性患者的汇总 OS HR 分别为 0.78（0.75-0.82）和 0.77（95%CI，0.72-0.83）。与对照组相比，男性患者接受单药免疫治疗的 OS 汇总 HR 为 0.77（95%CI，0.70-0.85），而女性患者的获益较小（HR，0.81；95%CI，0.73-0.9）。我们的研究结果强调，在能够提出患者性别对不同环境中免疫检查点抑制剂疗效的真正影响之前，需要进行高质量的试验，以考虑潜在的混杂因素。
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