Objective To assess the role of histopathological and molecular features in predicting the risk of nodal metastases in apparent early-stage endometrial cancer patients undergoing sentinel node mapping. Methods This is a prospective trial. Consecutive patients with apparent early-stage endometrial cancer, undergoing laparoscopic hysterectomy, bilateral salpingo-oophorectomy, and sentinel node mapping, were enrolled. Histological and molecular features were used to predict the node positivity. Results Charts of 223 apparent early-stage endometrial cancer patients were included in this study. Four (1.8%) patients were excluded from this study due to the lack of data about molecular features. Additionally, nine (4%) patients did not meet the inclusion criteria (due to the presence of peritoneal carcinomatosis or bulky nodes (the presence of p53 abnormality correlated with the presence of advanced stage disease (p<0.001)). The study population included 178 (84.8%) and 32 (15.2%) patients with endometrioid and non-endometrioid endometrial cancer, respectively. According to pathological uterine risk factors, 93 (44.3%), 45 (21.4%), 40 (19.1%), and 32 (15.2%) were classified as low, intermediate, intermediate-high, and high-risk, respectively. Using the surrogate molecular classification, 10 (4.8%), 42 (20%), 57 (27.1%), and 101 (48.1%) were included in the POLE mutated, p53 abnormal, MMRd/MSI-H, and NSMP, respectively. Overall, 41 (19.5%) patients were detected with positive nodes. Molecular features were not associated with the risk of having nodal metastases (OR 1.03, 95% CI 0.21 to 5.05, p=0.969 for POLE mutated; OR 0.788, 95% CI 0.32 to 1.98, p=0.602 for p53 abnormal; OR 1.14, 95% CI 0.53 to 2.42, p=0.733 for MMRd/MSI-H). At multivariable analysis, only deep myometrial invasion (OR 3.318, 95% CI 1.357 to 8.150, p=0.009) and lymphovascular space invasion (OR 6.584, 95% CI 2.663 to 16.279, p<0.001) correlated with the increased risk of positive nodes. Conclusion Our data suggest that molecular classification does not seem useful to tailor the need of nodal dissection in apparent early-stage endometrial cancer. p53 abnormality predicts the risk of having advanced disease at presentation. Further external validation is needed. Clinical trial registration [NCT05793333][1]. Data are available upon reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05793333&atom=%2Fijgc%2Fearly%2F2024%2F04%2F23%2Fijgc-2024-005416.atom

中文翻译：

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通过子宫内膜癌的组织学和分子特征预测 nOdal 疾病的风险：前瞻性 PROME 试验

目的 评估组织病理学和分子特征在预测接受前哨淋巴结定位的明显早期子宫内膜癌患者淋巴结转移风险中的作用。方法 这是一项前瞻性试验。连续入组患有明显早期子宫内膜癌、接受腹腔镜子宫切除术、双侧输卵管卵巢切除术和前哨淋巴结定位的患者。组织学和分子特征用于预测淋巴结阳性。结果 本研究纳入了 223 名明显早期子宫内膜癌患者的图表。由于缺乏分子特征数据，四名患者 (1.8%) 被排除在本研究之外。此外，九名 (4%) 患者不符合纳入标准（由于存在腹膜癌病或大淋巴结（p53 异常的存在与晚期疾病的存在相关 (p<0.001)）。研究人群包括子宫内膜样癌和非子宫内膜样子宫内膜癌患者分别为 178 例（84.8%）和 32 例（15.2%），根据病理子宫危险因素，分别为 93 例（44.3%）、45 例（21.4%）、40 例（19.1%）和 32 例。使用替代分子分类，分别将 10 例 (4.8%)、42 例 (20%)、57 例 (27.1%) 和 101 例 (48.1) 分为低风险、中风险、中高风险和高风险。 %）分别包含在 POLE 突变、p53 异常、MMRd/MSI-H 和 NSMP 中。总体而言，检测到阳性淋巴结的患者有 41 名（19.5%），分子特征与淋巴结转移风险无关。对于 POLE 突变，OR 1.03，95% CI 0.21 至 5.05，p=0.969；对于 p53 异常，OR 0.788，95% CI 0.32 至 1.98，p=0.602；对于 MMRd/，OR 1.14，95% CI 0.53 至 2.42，p=0.733 MSI-H）。在多变量分析中，只有深肌层浸润（OR 3.318，95% CI 1.357至8.150，p=0.009）和淋巴管间隙浸润（OR 6.584，95% CI 2.663至16.279，p<0.001）与阳性淋巴结风险增加相关。结论 我们的数据表明，分子分类似乎无法满足明显早期子宫内膜癌淋巴结清扫的需要。 p53 异常可预测就诊时患有晚期疾病的风险。需要进一步的外部验证。临床试验注册[NCT05793333][1]。数据可根据合理要求提供。 [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05793333&atom=%2Fijgc%2Fearly%2F2024%2F04%2F23%2Fijgc-2024-005416.atom