Results of recent clinical trials using the immune check point inhibitors (ICI) pembrolizumab or dostarlimab with/without lenvatinib has led to their approval for specific molecular subgroups of advanced recurrent endometrial cancer (EC). Herein, we summarise the clinical data leading to this first tissue-agnostic approval. As this novel therapy is not yet available in the United Kingdom standard care setting, we explore the strengths, weaknesses, opportunities, and threats (SWOT) of ICI treatment in EC. Major databases were searched focusing on clinical trials using programmed cell death protein 1 (PD-1) and its ligand (PD-L1) ICI which ultimately contributed to anti-PD-1 approval in EC. We performed a data quality assessment, reviewing survival and safety analysis. We included 15 studies involving 1609 EC patients: 458 with mismatch repair deficiency (MMRd)/microsatellite instability-high (MSI-H) status and 1084 with mismatch repair proficiency/microsatellite stable (MMRp/MSS) status. Pembrolizumab/dostarlimab have been approved for MMRd ECs, with the addition of lenvatinib for MMRp cases in the recurrent setting. Future efforts will focus on the pathological assessment of biomarkers to determine molecular phenotypes that correlate with response or resistance to ICI in order to identify patients most likely to benefit from this treatment.
近期临床试验结果显示,免疫检查点抑制剂(ICI)帕博利珠单抗或多塔利单抗联合/不联合仑伐替尼的治疗方案,已获批准用于特定分子亚型的晚期复发性子宫内膜癌(EC)。本文系统总结了促成这一首次组织学非依赖性批准的关键临床证据。鉴于该创新疗法尚未纳入英国标准诊疗体系,我们深入探讨了ICI在子宫内膜癌治疗中的优势、劣势、机遇与挑战(SWOT分析)。通过检索主要数据库,聚焦于程序性细胞死亡蛋白1(PD-1)及其配体(PD-L1)抑制剂的临床试验数据,这些研究最终推动了抗PD-1疗法在子宫内膜癌领域的获批。我们进行了数据质量评估,系统回顾了生存期与安全性分析结果。共纳入15项研究,涉及1609例子宫内膜癌患者:其中458例为错配修复缺陷(MMRd)/微卫星高度不稳定(MSI-H)状态,1084例为错配修复功能完整/微卫星稳定(MMRp/MSS)状态。目前帕博利珠单抗/多塔利单抗已获批用于MMRd型子宫内膜癌,而仑伐替尼联合方案则适用于复发性MMRp病例。未来研究重点将聚焦于生物标志物的病理学评估,以确定与ICI治疗应答或耐药相关的分子表型,从而精准筛选最可能从该疗法中获益的患者群体。