From the Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Kentucky Markey Cancer Center, Lexington, Kentucky; Applied Clinical Intelligence, Bala Cynwyd, Pennsylvania; and the Department of Pathology, Center for Biomarker Discovery, Johns Hopkins Medical Institutions, Baltimore, Maryland.
Obstet Gynecol. 2011 Jun;117(6):1289-1297. doi: 10.1097/AOG.0b013e31821b5118.
To compare the effectiveness of physician assessment with a new multivariate index assay in identifying high-risk ovarian tumors.
The multivariate index assay was evaluated in women scheduled for surgery for an ovarian tumor in a prospective, multi-institutional trial involving 27 primary- care and specialty sites throughout the United States. Preoperative serum was collected, and results for the multivariate index assay, physician assessment, and CA 125 were correlated with surgical pathology. Physician assessment was documented by each physician before surgery. CA 125 cutoffs were chosen in accordance with the referral guidelines of the American College of Obstetricians and Gynecologists.
The study enrolled 590 women, with 524 evaluable for the multivariate index assay and CA 125, and 516 for physician assessment. Fifty-three percent were enrolled by nongynecologic oncologists. There were 161 malignancies and 363 benign ovarian tumors. Physician assessment plus the multivariate index assay correctly identified malignancies missed by physician assessment in 70% of nongynecologic oncologists, and 95% of gynecologic oncologists. The multivariate index assay also detected 76% of malignancies missed by CA 125. Physician assessment plus the multivariate index assay identified 86% of malignancies missed by CA 125, including all advanced cancers. The performance of the multivariate index assay was consistent in early- and late-stage cancers.
The multivariate index assay demonstrated higher sensitivity and lower specificity compared with physician assessment and CA 125 in detecting ovarian malignancies.
比较医生评估与新的多变量指数检测在识别高危卵巢肿瘤方面的效果。
多变量指数检测在一项前瞻性、多机构试验中进行评估，该试验涉及美国各地的 27 个初级保健和专业机构，计划接受卵巢肿瘤手术的女性参与了该试验。在术前采集血清，将多变量指数检测、医生评估和 CA125 的结果与手术病理相关联。术前由每位医生记录医生评估。CA125 的截止值是根据美国妇产科医师学会的转诊指南选择的。
该研究共纳入 590 名女性，其中 524 名女性可评估多变量指数检测和 CA125，516 名女性可评估医生评估。53%的患者由非妇科肿瘤学家招募。有 161 例恶性肿瘤和 363 例良性卵巢肿瘤。医生评估加多变量指数检测正确识别了 70%的非妇科肿瘤学家和 95%的妇科肿瘤学家错过的恶性肿瘤。多变量指数检测还检测到了 76%被 CA125 遗漏的恶性肿瘤。医生评估加多变量指数检测可识别 86%被 CA125 遗漏的恶性肿瘤，包括所有晚期癌症。多变量指数检测在早期和晚期癌症中的性能一致。
与医生评估和 CA125 相比，多变量指数检测在检测卵巢恶性肿瘤方面具有更高的敏感性和更低的特异性。
