Richard G Moore1, Douglas M Hawkins2, M Craig Miller3, Lisa M Landrum4, Walter Gajewski5, John J Ball6, W Jeffery Allard7, Steven J Skates8. 1. Program in Women's Oncology, Department of Obstetrics and Gynecology, Women and Infants Hospital, Alpert Medical School, Brown University, Providence, RI, USA. Electronic address: rmoore@wihri.org. 2. School of Statistics, University of Minnesota, Minneapolis, MN, USA. 3. Program in Women's Oncology, Department of Obstetrics and Gynecology, Women and Infants Hospital, Alpert Medical School, Brown University, Providence, RI, USA. 4. Section of Gynecology Oncology, Department of Obstetrics and Gynecology, Oklahoma University Health Science Center, Oklahoma City, OK, USA. 5. Zimmer Cancer Center, New Hanover Regional Medical Center, Wilmington, NC, USA. 6. Jackson Clinic, Jackson, TN, USA. 7. Medivice Consulting, New Durham, NH, USA. 8. Cancer Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Abstract
OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Richard G Moore; Alexandra Blackman; M Craig Miller; Katina Robison; Paul A DiSilvestro; Elizabeth E Eklund; Robert Strongin; Geralyn Messerlian Journal: Gynecol Oncol Date: 2019-04-13 Impact factor: 5.482
Authors: Elizabeth Lokich; Marguerite Palisoul; Nicole Romano; M Craig Miller; Katina Robison; Ashley Stuckey; Paul DiSilvestro; Cara Mathews; C O Granai; Geralyn Lambert-Messerlian; Richard G Moore Journal: Gynecol Oncol Date: 2015-09-11 Impact factor: 5.482