Gynecologic Oncology Research Branch, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
Cancer. 2017 Jan 1;123(2):263-272. doi: 10.1002/cncr.30349. Epub 2016 Nov 7.
Previously proposed criteria for preoperatively identifying endometrial cancer patients at low risk for lymph node metastasis remain to be verified. For this purpose, a prospective, multicenter observational study was performed.
Eligible patients with histologically confirmed endometrial cancer underwent magnetic resonance imaging (MRI) and serum cancer antigen 125 (CA 125) testing before surgery. The following criteria were used to identify low-risk patients: 1) endometrioid-type cancer, 2) no evidence of deep myometrial invasion on MRI, 3) no enlarged lymph nodes on MRI, 4) no suspicious metastasis out of the uterine corpus, and 5) serum CA 125 levels less than 35 U/mL. Systematic pelvic and/or para-aortic lymphadenectomy was performed for all patients. The primary endpoint was estimation of the negative predictive value (NPV).
From January 2012 to December 2014, 529 patients from 20 hospitals in 3 Asian countries were consecutively enrolled. According to our criteria, 272 patients (51.4%) were categorized into the low-risk group. Fifty-three of the 529 patients (10.0%) had lymph node metastases; these patients included 8 (2.9%) falsely categorized as low-risk. The sensitivity and specificity of the criteria were 84.9% and 55.5%, respectively. The NPV of 97.1% was higher than the predefined target endpoint of 96%.
The low-risk criteria based on preoperative tests were confirmed to be reliable and accurate for identifying patients at low risk for lymph node metastasis. These criteria may facilitate patient counseling and surgical decision making. Cancer 2017;123:263-272. © 2016 American Cancer Society.
先前提出的术前识别子宫内膜癌患者淋巴结转移低风险的标准仍有待验证。为此，进行了一项前瞻性、多中心观察性研究。
经组织学证实患有子宫内膜癌的合格患者在术前接受磁共振成像（MRI）和血清肿瘤标志物 125（CA 125）检测。使用以下标准来识别低危患者：1）子宫内膜样癌，2）MRI 上无深层肌层浸润证据，3）MRI 上无增大的淋巴结，4）子宫体外无可疑转移，5）血清 CA 125 水平<35U/mL。所有患者均行系统盆腔和/或腹主动脉旁淋巴结切除术。主要终点是估计阴性预测值（NPV）。
2012 年 1 月至 2014 年 12 月，来自亚洲 3 个国家 20 家医院的 529 例患者连续入组。根据我们的标准，272 例（51.4%）患者被归入低危组。529 例患者中有 53 例（10.0%）发生淋巴结转移；其中 8 例（2.9%）被错误地归类为低危。该标准的灵敏度和特异性分别为 84.9%和 55.5%。97.1%的 NPV 高于预设的 96%目标终点。
术前检查的低危标准被证实可可靠且准确地识别淋巴结转移低风险患者。这些标准可能有助于患者咨询和手术决策。癌症 2017；123:263-272。©2016 美国癌症协会。
