Prospective study using the risk of ovarian cancer algorithm to screen for ovarian cancer
Prospective study using the risk of ovarian cancer algorithm to screen for ovarian cancer
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DOI：
10.1200/jco.2005.01.6642
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发表时间：
2005-11-01
影响因子：
45.3
通讯作者：
Jacobs, IJ
中科院分区：
文献类型：
--
作者：
Menon, U;Skates, SJ;Jacobs, IJ
目的评估在第一次前瞻性试验的一个新的卵巢癌筛查（OCS）策略（卵巢癌的风险或ROC算法）的基础上年龄和CA 125 profile.Patients和方法绝经后妇女，>= 50岁的患病率筛选随机分配到对照组或筛选组。筛查涉及血清CA 125，使用ROC算法解释。结果正常的参与者返回年度筛查;结果中等的参与者重复CA 125检测;值升高的参与者进行经阴道超声（TVS）。女性异常或持续模棱两可的TVS被称为妇科opinions.Results 13582名妇女被招募。在随机分配到筛查的6，682名妇女中，有6，532名妇女接受了第一次筛查。在最初的CA 125之后，5，213名妇女被归类为正常风险，91名妇女升高，1，228名妇女中间。在对后者进行重复CA 125检测时，又有53名妇女被归类为高风险。所有144名风险升高的妇女都接受了TVS。16名妇女接受了手术。11名妇女有良性病理; 1名妇女有卵巢复发的乳腺癌; 1名妇女有边界; 3名妇女有原发性浸润性上皮性卵巢癌（EOC）。原发性浸润性EOC的特异性和阳性预测值（PPV）分别为99.8%（95%CI，99.7 ~ 99.9）和19%（95%CI，4.1 ~ 45.6）。它被用于联合王国的卵巢癌筛查合作试验，并在美国被用于癌症遗传学网络和妇科肿瘤学小组对高危妇女的试验。
Purpose To evaluate prevalence screening in the first prospective trial of a new ovarian cancer screening (OCS) strategy (risk of ovarian cancer or ROC algorithm) on the basis of age and CA125 profile.Patients and Methods Postmenopausal women, >= 50 years were randomly assigned to a control group or screen group. Screening involved serum CA125, interpreted using the ROC algorithm. Participants with normal results returned to annual screening; those with intermediate results had repeat CA125 testing; and those with elevated values underwent transvaginal ultrasound (TVS). Women with abnormal or persistently equivocal TVS were referred for a gynecologic opinion.Results Thirteen thousand five hundred eighty-two women were recruited. Of 6,682 women randomly assigned to screening, 6,532 women underwent the first screen. After the initial CA125, 5,213 women were classified as normal risk, 91 women elevated, and 1,228 women intermediate. On repeat CA125 testing of the latter, a further 53 women were classified as elevated risk. All 144 women with elevated risk had TVS. Sixteen women underwent surgery. Eleven women had benign pathology; one woman had ovarian recurrence of breast cancer; one woman had borderline; and three women had primary invasive epithelial ovarian cancer (EOC). The specificity and positive predictive value (PPV) for primary invasive EOC were 99.8% (95% CI, 99.7 to 99.9) and 19% (95% CI, 4.1 to 45.6), respectivelyConclusion An OCS strategy using the ROC algorithm is feasible and can achieve high specificity and PPV in postmenopausal women. It is being used in the United Kingdom Collaborative Trial of Ovarian Cancer Screening and in the United States in both the Cancer Genetics Network and the Gynecology Oncology Group trials of high-risk women.