Department of Gynecologic Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy
Unit of Clinical Epidemiology and Trial Organization, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Int J Gynecol Cancer. 2024 Sep 2;34(9):1366-1372. doi: 10.1136/ijgc-2024-005416.
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.
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.
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 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.
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.
NCT05793333.
评估组织病理学和分子特征在预测接受前哨淋巴结绘图的明显早期子宫内膜癌患者发生淋巴结转移风险中的作用。
这是一项前瞻性试验。连续纳入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绘图的明显早期子宫内膜癌患者。使用组织学和分子特征来预测阳性淋巴结。
本研究纳入了 223 名明显早期子宫内膜癌患者的图表。由于缺乏有关分子特征的数据，4 名（1.8%）患者被排除在本研究之外。此外，9 名（4%）患者不符合纳入标准（由于存在腹膜癌病或大体积淋巴结（p53 异常与晚期疾病的存在相关（p<0.001）。研究人群包括 178 名（84.8%）和 32 名（15.2%）子宫内膜样和非子宫内膜样子宫内膜癌患者。根据病理子宫危险因素，93 名（44.3%）、45 名（21.4%）、40 名（19.1%）和 32 名（15.2%）分别被归类为低、中、中高和高风险。使用替代分子分类，10 名（4.8%）、42 名（20%）、57 名（27.1%）和 101 名（48.1%）被归入 POLE 突变、p53 异常、MMRd/MSI-H 和 NSMP。总体而言，41 名（19.5%）患者检测到阳性淋巴结。分子特征与发生淋巴结转移的风险无关（OR 1.03，95%CI 0.21 至 5.05，p=0.969 用于突变；OR 0.788，95%CI 0.32 至 1.98，p=0.602 用于 p53 异常；OR 1.14，95%CI 0.53 至 2.42，p=0.733 用于 MMRd/MSI-H）。多变量分析显示，仅深肌层浸润（OR 3.318，95%CI 1.357 至 8.150，p=0.009）和淋巴血管间隙浸润（OR 6.584，95%CI 2.663 至 16.279，p<0.001）与阳性淋巴结的风险增加相关。
我们的数据表明，分子分类似乎并不能帮助确定明显早期子宫内膜癌患者是否需要淋巴结清扫。p53 异常预测了晚期疾病的发病风险。需要进一步的外部验证。
NCT05793333。
