METHODS: A total of 151 CIN2-3 women treated with conization between August 2020 and September 2021 were included. To investigate the precision of HPV integration, we further analyzed HPV integration-positive patients. Sensitivity, specificity, positive and negative predictive values (PPV and NPV, respectively), and the Youden index for predicting recurrence/residual disease were calculated.
RESULTS: Among the 151 enrolled CIN2-3 women, 56 were HPV integration-positive and 95 had HPV integration-negative results. Six (10.7%) experienced recurrence among 56 HPV integration-positive patients, which was more than those in HPV integration-negative patients (one patient, 1.1%). In the 56 HPV integration-positive patients, 12 had positive HPV results after treatment, seven had PHISL, and two had positive cone margin. Among the seven patients who tested with PHISL, six (85.7%) had residual/recurrent disease. PHISL was a prominent predictor of persistent/recurrent disease. The HPV test, the HPV integration test, and PHISL all had a sensitivity of 100% and a NPV of 100% for residual/recurrent disease. PHISL showed better specificity (98.0% vs. 82.0%, p = 0.005) and PPV (85.7% vs. 40.0%, p = 0.001) than the HPV test for predicting recurrence.
CONCLUSIONS: The HPV-integration-positive CIN2-3 women had much higher relapse rates than HPV-integration-negative CIN2-3 women. The findings indicate that PHISL derived from preoperative and postoperative HPV integration tests may be a precise biomarker for the identification of residual/recurrent CIN 2/3.
方法:纳入了2020年8月至2021年9月期间接受锥切术治疗的151CIN2-3女性。为了研究HPV整合的准确性,我们进一步分析了HPV整合阳性患者.灵敏度,特异性,阳性和阴性预测值(PPV和NPV,分别),并计算预测复发/残留疾病的Youden指数。
结果:在151名被注册的CIN2-3女性中,56例HPV整合阳性,95例HPV整合阴性。56例HPV整合阳性患者中有6例(10.7%)复发,这比HPV整合阴性患者(一名患者,1.1%)。在56例HPV整合阳性患者中,12名患者治疗后HPV阳性,七个有PHISL,和两个有阳性的锥形边缘。在用PHISL测试的七名患者中,6人(85.7%)有残留/复发疾病.PHISL是持续性/复发性疾病的重要预测因子。HPV检测,HPV整合测试,和PHISL对残留/复发疾病的敏感性均为100%,NPV为100%。PHISL表现出更好的特异性(98.0%vs.82.0%,p=0.005)和PPV(85.7%vs.40.0%,p=0.001)比HPV检测预测复发。
结论:HPV整合阳性CIN2-3女性的复发率远高于HPV整合阴性CIN2-3女性。研究结果表明,来自术前和术后HPV整合测试的PHISL可能是鉴定残留/复发CIN2/3的精确生物标志物。