METHODS: This single-centre retrospective study included patients who underwent lenvatinib/pembrolizumab therapy at Iwate Medical University Hospital between January 2022 and March 2023. Formalin-fixed paraffin-embedded specimens obtained from patients before treatment were collected and classified into the mismatch repair-deficient, p53 abnormal and no specific molecular profile subtypes using immunohistochemistry. The response rate, progression-free survival and adverse events were evaluated using electronic medical records. The study was approved by the hospital\'s ethics committee (approval number: MH2022-093).
RESULTS: This study enrolled 20 patients, who underwent a median follow-up of 17.8 months (95% confidence interval: 16.6-18.9). The best overall response rate was 60.0% (36.1-80.9), and the median progression-free survival was 11.6 months (2.9-20.3). The median progression-free survival in the p53 abnormal group (n = 9) was 3.4 months (3.0-3.8); however, progression-free survival did not reach the median (P < 0.001) in the mismatch repair-deficient/no specific molecular profile group (n = 11). Symptomatic immune-related adverse events (except hypothyroidism) occurred in 4/20 (25.0%) patients, and partial responses were observed in all cases. No treatment-related deaths occurred.
CONCLUSIONS: The p53abn group in the Proactive Molecular Risk Classifier for Endometrial Cancer classification has a poor prognosis even after treatment with lenvatinib/pembrolizumab.
方法:这项单中心回顾性研究包括2022年1月至2023年3月在岩手医科大学医院接受lenvatinib/pembrolizumab治疗的患者。收集治疗前从患者获得的福尔马林固定石蜡包埋标本,并将其分类为错配修复缺陷,使用免疫组织化学的p53异常和没有特定的分子谱亚型。响应率,使用电子病历评估无进展生存期和不良事件.该研究获得了医院伦理委员会的批准(批准号:MH2022-093)。
结果:这项研究招募了20名患者,中位随访时间为17.8个月(95%置信区间:16.6-18.9).最佳总有效率为60.0%(36.1-80.9),中位无进展生存期为11.6个月(2.9-20.3).p53异常组(n=9)的中位无进展生存期为3.4个月(3.0-3.8);然而,在错配修复缺陷/无特定分子谱组(n=11)中,无进展生存期未达到中位数(P<0.001).4/20(25.0%)患者发生症状性免疫相关不良事件(甲状腺功能减退除外),在所有病例中均观察到部分反应。无治疗相关死亡发生。
结论:子宫内膜癌前兆分子风险分类法中的p53abn组即使在接受乐伐替尼/派姆单抗治疗后预后也较差。