Program in Women's Oncology, Department of Obstetrics and Gynecology, Women and Infants Hospital, Alpert Medical School, Brown University, Providence, RI, USA.
School of Statistics, University of Minnesota, Minneapolis, MN, USA.
Gynecol Oncol. 2014 Dec;135(3):547-51. doi: 10.1016/j.ygyno.2014.10.017. Epub 2014 Oct 23.
ACOG guidelines for the evaluation of women with a pelvic mass employ a combination of physical exam, imaging, and CA125 to guide physicians in the triage of women to gynecologic oncologists. We studied the use of ROMA with clinical assessment for cancer risk assessment in women with a pelvic mass.
This was a prospective, multicenter trial evaluating women with a pelvic mass who had an initial clinical risk assessment (ICRA) performed by a generalist. ROMA scores were calculated and sensitivity, specificity, PPV and NPV were determined for ICRA and ICRA+ROMA.
A total of 461 women were entered into the study. There were 375 benign tumors, 48 EOC, 18 LMP tumors and 20 non-ovarian malignancies. For detection of ovarian cancer alone, ICRA had a sensitivity of 85.4%, a specificity of 84.3%, and a NPV of 97.8%. Adding ROMA to ICRA produced a significant improvement of 8.4% in sensitivity, achieving a sensitivity of 93.8% with a specificity of 67.2% and a NPV of 98.8%. Examination of all malignancies (ovarian & non-ovarian) provided a sensitivity of 89.7% for ROMA+ICRA in comparison to 77.9% for ICRA alone, a significant increase in sensitivity of 11.8%. The NPV also significantly increased from 95.5% to 97.3%. Overall, ROMA detected 13 additional malignancies missed by ICRA.
Adjunctive use of ROMA with clinical assessment improves the stratification of women with a pelvic mass into low and high risk groups for ovarian cancer. The combination is particularly effective in ruling out malignant disease.
ACOG 对盆腔肿块女性的评估指南采用体格检查、影像学和 CA125 的组合来指导医生对妇科肿瘤医生进行女性分诊。我们研究了 ROMA 与临床评估联合用于评估盆腔肿块女性的癌症风险。
这是一项前瞻性、多中心试验，评估了接受普通科医生进行初始临床风险评估 (ICRA) 的盆腔肿块女性。计算了 ROMA 评分，并确定了 ICRA 和 ICRA+ROMA 的敏感性、特异性、PPV 和 NPV。
共有 461 名女性入组研究。其中 375 例为良性肿瘤，48 例为 EOC，18 例为 LMP 肿瘤，20 例为非卵巢恶性肿瘤。单独检测卵巢癌时，ICRA 的敏感性为 85.4%，特异性为 84.3%，NPV 为 97.8%。将 ROMA 添加到 ICRA 中可使敏感性显著提高 8.4%，达到 93.8%的敏感性，特异性为 67.2%，NPV 为 98.8%。检查所有恶性肿瘤（卵巢和非卵巢）时，ROMA+ICRA 的敏感性为 89.7%，而 ICRA 单独为 77.9%，敏感性显著提高 11.8%。NPV 也从 95.5%显著提高到 97.3%。总体而言，ROMA 检测到 13 例 ICRA 漏诊的额外恶性肿瘤。
ROMA 联合临床评估辅助用于盆腔肿块女性可将其分层为低风险和高风险卵巢癌组。该组合在排除恶性疾病方面特别有效。
