In the article by Ott et al,¹ the aim of the study, KEYNOTE-028 (NCT02054806), was to evaluate the activity and safety profile of pembrolizumab in patients with heavily pretreated advanced endometrial cancer (EC), a subgroup with a poor prognosis. This article deserves some consideration to give the study proper meaning. Unfortunately, it is a small study, as are others that explore the activity of different agents in advanced and metastatic EC. Of the 75 patients evaluated for programmed death ligand 1 expression, 36 (48%) had positive tumors. According to eligibility criteria, up to 12 patients were excluded; moreover, another woman was excluded for lack of post-baseline assessment, and three received no assessment at the time of the data cutoff. The study design stated that sarcomas should be excluded; in our opinion, even a patient with a carcinosarcoma should have been excluded to have a more homogeneous group for this investigation. For the same reason, the two patients who received adjuvant radiotherapy should have been excluded. Therefore, only 17 patients were eligible by clinical assessment—certainly too few to answer to the question about clinical activity of pembrolizumab in patients with programmed death ligand 1–positive EC.

中文翻译：

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Pembrolizumab在程序性死亡配体1-子宫内膜癌中的作用

在Ott等人的文章中，¹这项研究的目的是KEYNOTE-028（NCT02054806），目的是评估pembrolizumab在高度预治疗的晚期子宫内膜癌（EC）患者（预后不良）中的活性和安全性。本文值得考虑以赋予研究适当的意义。不幸的是，这是一个很小的研究，其他的研究也探讨了晚期和转移性EC中不同药物的活性。在评估程序性死亡配体1表达的75例患者中，有36例（48％）肿瘤阳性。根据资格标准，最多可排除12例患者。此外，另一名妇女因缺乏基线后评估而被排除在外，三名妇女在数据截止时未接受评估。研究设计表明肉瘤应排除在外；在我们看来，即使是癌肉瘤患者，也应排除在本研究之外，以一个更为均一的人群进行研究。出于同样的原因，应该排除接受辅助放疗的两名患者。因此，只有17例患者通过临床评估合格-肯定很少回答关于程序性死亡配体1阳性EC患者中派姆单抗的临床活性的问题。