University of Washington Medical Center, Division of Gynecologic Oncology, Seattle, WA, United States.
Vermillion Inc., Austin, TX, United States.
Gynecol Oncol. 2018 Aug;150(2):318-323. doi: 10.1016/j.ygyno.2018.06.004. Epub 2018 Jun 19.
To assess the performance of a symptom index (SI) and multivariate biomarker panel in the identification of ovarian cancer in women presenting for surgery with an adnexal mass.
Prospective study of patients seen at a tertiary medical center. Following consent, patients completed an SI and preoperative serum was collected for individual markers (CA 125) and a second-generation FDA-cleared biomarker test (MIA2G). Results for the SI and MIA2G were correlated with operative findings and surgical pathology. Logistic regression modeling was performed to assess the interaction of the SI with MIA2G to determine the risk of malignancy (ROM).
Of the 218 patients enrolled, the mean age was 53.6 years (range 18-86). One-hundred and forty-seven patients (67.4%) were postmenopausal. Sixty-four patients (29.4%) had epithelial ovarian cancer or fallopian tube cancer (EOC/FTC) and 17 (7.8%) had borderline ovarian tumors. A positive SI or MIA2G correctly identified 96.1% of patients with EOC/FTC. Using logistic regression, we found that both SI and MIA2G score were significantly associated with ROM (p < 0.001). In a simulation with disease prevalence set at 5%, patients with a negative SI and a MIA2G score of 6 had a ROM of 1.8% whereas patients with the same MIA2G and positive SI had a 10.5% ROM, nearly a 6-fold higher risk.
The combination of a patient-reported symptom index and refined biomarker panel allows for improved accuracy in the assessment for ovarian cancer in patients with an adnexal mass. This strategy could offer a personalized approach to addressing ROM to triage patients with an adnexal mass to appropriate care.
评估症状指数（SI）和多变量生物标志物组合在识别因附件包块就诊行手术的女性卵巢癌中的表现。
在三级医疗中心进行的前瞻性研究。征得患者同意后，患者完成 SI 并采集术前血清以检测个体标志物（CA125）和第二代经 FDA 批准的生物标志物检测（MIA2G）。SI 和 MIA2G 的结果与手术结果和手术病理相关联。进行逻辑回归建模以评估 SI 与 MIA2G 的相互作用，以确定恶性肿瘤风险（ROM）。
在纳入的 218 名患者中，平均年龄为 53.6 岁（范围 18-86 岁）。147 名患者（67.4%）绝经后。64 名患者（29.4%）患有上皮性卵巢癌或输卵管癌（EOC/FTC），17 名患者（7.8%）患有交界性卵巢肿瘤。阳性 SI 或 MIA2G 正确识别 96.1%的 EOC/FTC 患者。使用逻辑回归，我们发现 SI 和 MIA2G 评分均与 ROM 显著相关（p<0.001）。在疾病流行率设置为 5%的模拟中，阴性 SI 和 MIA2G 评分 6 的患者 ROM 为 1.8%，而具有相同 MIA2G 和阳性 SI 的患者 ROM 为 10.5%，风险增加近 6 倍。
患者报告的症状指数和改良的生物标志物组合的结合可提高对附件包块患者卵巢癌评估的准确性。这种策略可以提供一种个性化的方法来处理 ROM，以将附件包块患者分诊到适当的护理。
