University of California, Irvine-Medical Center, Orange, CA, USA.
Gynecol Oncol. 2013 Feb;128(2):252-9. doi: 10.1016/j.ygyno.2012.11.022. Epub 2012 Nov 21.
To validate the effectiveness of a multivariate index assay in identifying ovarian malignancy compared to clinical assessment and CA125-II, among women undergoing surgery for an adnexal mass after enrollment by non-gynecologic oncology providers.
A prospective, multi-institutional trial enrolled female patients scheduled to undergo surgery for an adnexal mass from 27 non-gynecologic oncology practices. Pre-operative serum samples and physician assessment of ovarian cancer risk were correlated with final surgical pathology.
A total of 494 subjects were evaluable for multivariate index assay, CA125-II, and clinical impression. Overall, 92 patients (18.6%) had a pelvic malignancy. Primary ovarian cancer was diagnosed in 65 patients (13.2%), with 43.1% having FIGO stage I disease. For all ovarian malignancies, the sensitivity of the multivariate index assay was 95.7% (95%CI=89.3-98.3) when combined with clinical impression. The multivariate index assay correctly predicted ovarian malignancy in 91.4% (95%CI=77.6-97.0) of cases of early-stage disease, compared to 65.7% (95%CI=49.2-79.2) for CA125-II. The multivariate index assay correctly identified 83.3% malignancies missed by clinical impression and 70.8% cases missed by CA125-II. Multivariate index assay was superior in predicting the absence of an ovarian malignancy, with a negative predictive value of 98.1% (95%CI=95.2-99.2). Both clinical impression and CA125-II were more accurate at identifying benign disease. The multivariate index assay correctly predicted benign pathology in 204 patients (50.7%, 95%CI=45.9-55.6) when combined with clinical impression.
The multivariate index assay demonstrated higher sensitivity and negative predictive value for ovarian malignancy compared to clinical impression and CA125-II in an intended-use population of non-gynecologic oncology practices.
在非妇科肿瘤学医生为附件肿块患者进行手术前，通过多变量指标检测与临床评估和 CA125-II 比较，评估其在识别卵巢恶性肿瘤方面的有效性。
前瞻性、多中心试验纳入了 27 家非妇科肿瘤学机构中计划因附件肿块接受手术的女性患者。术前血清样本和医生对卵巢癌风险的评估与最终手术病理相关联。
共有 494 名受试者可用于多变量指标检测、CA125-II 和临床印象评估。总体而言，92 名患者（18.6%）患有盆腔恶性肿瘤。原发性卵巢癌诊断为 65 例（13.2%），其中 43.1%为 FIGO Ⅰ期疾病。对于所有卵巢恶性肿瘤，当与临床印象相结合时，多变量指标检测的敏感性为 95.7%（95%CI=89.3-98.3）。在早期疾病的 91.4%（95%CI=77.6-97.0）病例中，多变量指标检测正确预测了卵巢恶性肿瘤，而 CA125-II 的敏感性为 65.7%（95%CI=49.2-79.2）。多变量指标检测正确识别了 83.3%临床印象漏诊和 70.8%CA125-II 漏诊的恶性肿瘤。多变量指标检测在预测无卵巢恶性肿瘤方面表现更优，阴性预测值为 98.1%（95%CI=95.2-99.2）。临床印象和 CA125-II 在识别良性疾病方面更准确。当与临床印象相结合时，多变量指标检测正确预测了 204 名患者（50.7%，95%CI=45.9-55.6）的良性病理。
在非妇科肿瘤学实践的预期用途人群中，与临床印象和 CA125-II 相比，多变量指标检测在识别卵巢恶性肿瘤方面具有更高的敏感性和阴性预测值。
