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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., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Introduction: Patients diagnosed with epithelial ovarian cancer (EOC) have improved outcomes when cared for at centers experienced in the management of EOC. The objective of this trial was to validate a predictive model to assess the risk for EOC in women with a pelvic mass., Methods: Women diagnosed with a pelvic mass and scheduled to have surgery were enrolled on a multicenter prospective study. Preoperative serum levels of HE4 and CA125 were measured. Separate logistic regression algorithms for premenopausal and postmenopausal women were utilized to categorize patients into low and high risk groups for EOC., Results: Twelve sites enrolled 531 evaluable patients with 352 benign tumors, 129 EOC, 22 LMP tumors, 6 non EOC and 22 non ovarian cancers. The postmenopausal group contained 150 benign cases of which 112 were classified as low risk giving a specificity of 75.0% (95% CI 66.9-81.4), and 111 EOC and 6 LMP tumors of which 108 were classified as high risk giving a sensitivity of 92.3% (95% CI=85.9-96.4). The premenopausal group had 202 benign cases of which 151 were classified as low risk providing a specificity of 74.8% (95% CI=68.2-80.6), and 18 EOC and 16 LMP tumors of which 26 were classified as high risk, providing a sensitivity of 76.5% (95% CI=58.8-89.3)., Conclusion: An algorithm utilizing HE4 and CA125 successfully classified patients into high and low risk groups with 93.8% of EOC correctly classified as high risk. This model can be used to effectively triage patients to centers of excellence.

Objective: The emergence of sentinel lymph node (SLN) technology has provided the ability for an in depth pathologic evaluation for the detection of metastasis to lymph nodes through the use of ultra-staging. The SLN has been shown to be predictive of the metastatic status of its nodal basin. More recently, SLN dissections have been employed in the evaluation of the inguinal lymphatic basins in patients with vulvar malignancies. We hypothesize that the average size of metastasis detected in non-palpable inguinal lymph nodes is smaller when detected through the use of SLN dissection and ultra-staging versus complete inguinal node dissection (CND)., Methods: This was an IRB approved retrospective study. The tumor registry database was searched to identify all patients diagnosed with a vulvar malignancy from 1990 to 2004. The records were reviewed to identify patients with inguinal lymph node metastasis. Only patients with non-palpable inguinal lymph nodes (metastasis 1 cm or less) were included in the analysis. All pathology slides were reviewed. The smallest metastatic foci of cells were measured from lymph nodes obtained through the traditional complete inguinal lymph node dissection (CND) and compared with the largest metastatic foci of cells detected in sentinel lymph node dissections. The mean size and standard deviation for each group was calculated and analyzed with a Mann-Whitney test., Results: There were 336 inguinal node dissections performed in patients identified with a vulvar malignancy. SLN dissections were performed in 52 groins and CND in 284 groins. Fifty-eight patients were found to have metastatic disease to the inguinal lymph nodes. Thirty of these patients had no evidence of lymph node metastasis on clinical exam or at the time of their EUA. There were 7 groins with metastasis detected through an SLN and 23 groins through a CND. The mean size of the metastatic foci detected in the SLN group was 2.52 mm (SD 1.55) and in the CND group was 4.35 mm (SD 2.63). This was not statistically significant (P = 0.109). However, when comparing the detection of micrometastasis in each set, there was a significant difference (P = 0.02) in the detection of the size of metastasis detected with smaller cluster of cells detected in the SLN group., Conclusion: SLN dissection with ultra-staging allows for a more extensive pathologic examination of lymph nodes and may allow for the detection of smaller tumor foci than the traditional pathological examination of lymph nodes obtained from a CND. The clinical implication of the detection of these micrometastasis and smaller metastasis remains to be determined.

Objectives: The purpose of this study was to evaluate the characteristics of metastatic tumors to the ovaries in nongenital tract primaries and to determine the route of dissemination., Methods: An IRB-approved study retrospectively reviewed patient records from January 1992 to January 2003. A tumor registry and pathology database search identified women with metastatic disease to the ovaries that had undergone surgery for the presence of an adnexal mass. The charts were reviewed for age at diagnosis, presenting symptoms, size of ovarian metastasis, laterality of metastasis, and primary tumor site. Pathology reports and specimen slides were reviewed to confirm the diagnosis and evaluate the tumors for various pathological features., Results: A total of 59 cases of metastasis to the ovary were identified. The median age of the study group was 55 years old (range: 27-78). Primary colon cancer was identified in 19 (32.2%) cases; appendix 12 (20.3%); breast 5 (8.4%); small bowel and gastric each contributed 4 (6.8%) cases. Pancreatic cancer added 3 (5.1%), while gallbladder and urinary bladder each contributed 1 (1.7%) case. Tumors of unknown primary contributed 10 (18.5%) of the cases. Stromal invasion was seen in 56 (95%) of the cases and surface involvement in 9 (15%) cases. Bilateral metastasis was found in 39 (66.1%) patients and unilateral metastasis in 20 (33.9%) patients., Conclusions: Metastatic lesions to the ovary are more commonly seen from primary colon cancer, appendiceal, and breast carcinomas. The mechanism of metastasis is through hematogenous pathways as opposed to a transserosal route.

Objectives: To evaluate the value of immunohistochemical (IHC) staining of inguinal sentinel lymph nodes (SLN) found to be negative for metastatic disease by ultrastaging with hematoxylin and eosin (H&E) staining., Methods: An IRB approved study identified 29 patients who had undergone an inguinal sentinel lymph node dissection for squamous cell carcinoma of the vulva. All sentinel lymph nodes found to be negative for metastatic disease based on ultrastaging with H&E staining were reevaluated with pancytokeratin antibody (AE1/AE3) immunohistochemical (IHC) staining to detect micrometastasis., Results: Twenty-nine patients with squamous cell carcinoma of the vulva underwent an inguinal sentinel node dissection. Nineteen patients had inguinal dissections negative for metastatic disease, 2 patients had bilateral inguinal metastasis, and 8 patients had unilateral inguinal metastasis. A total of 42 groin dissections with SLN biopsies were performed; 12 groins were positive for metastatic disease and 30 were negative based on ultrastaging with eosin and hematoxylin staining. A total of 107 sentinel lymph nodes (2.5 SLN per groin) were obtained, of which 18 SLN contained metastatic disease identified by ultrastaging and staining with H&E. Two SLN contained micrometastasis less than 0.3mm in size and 16 SLN contained metastasis greater than 2mm in size. Eighty-nine SLN found to be negative for metastasis by ultrastaging with H&E staining were also negative for micrometastasis on evaluation with pancytokeratin antibody AE1/AE3 IHC staining., Conclusions: The addition of immunohistochemical staining to ultrastaging with H&E staining in the pathologic evaluation of inguinal sentinel lymph nodes does not increase the detection of micrometastasis in patients with primary squamous cell carcinoma of the vulva.

Objectives: The goal of this study was to identify one or more inguinal sentinel nodes in patients with primary squamous cell carcinoma of the vulva and to determine the ability of the sentinel node to predict metastasis to the inguinal lymphatic basin., Methods: Techniques employing technetium-99m (Tc-99m) sulfur colloid and isosulfan blue dye were utilized to identify sentinel nodes in the inguinal lymphatic beds. Technetium-99m sulfur colloid was injected intradermally at the tumor margins 90-180 min preoperatively followed by a similar injection of isosulfan blue dye 5-10 min before the groin dissection. A handheld collimated gamma counter was employed to identify Tc-99m-labeled sentinel nodes. Lymphatic tracts that had taken up blue dye and their corresponding sentinel node were also identified and retrieved. A completion inguinal dissection was then performed. Each sentinel node was labeled as hot and blue, hot and nonblue, or cold and blue. The sentinel nodes were subjected to pathologic examination with step sections and nonsentinel nodes were evaluated in the standard fashion., Results: Twenty-one patients with a median age of 79 were entered onto protocol and a total of 31 inguinal node dissections were performed. A sentinel node was identified in 31/31 (100%) groin dissections with the use of Tc-99m. Isosulfan blue dye identified a sentinel node in 19/31 (61%) groin dissections. Surgical staging revealed 7 patients with stage I disease, 5 with stage II disease, 5 with stage III disease, and 4 with stage IV disease. Lymph nodes in 9 groin dissections were found to have metastatic disease, and in 4 of these dissections, the sentinel node was the only positive node. Lymph nodes in 22 groin dissections had no evidence of metastasis. No false-negative sentinel lymph nodes were obtained (sentinel node negative and a nonsentinel node positive)., Conclusion: Tc-99m sulfur colloid is superior to isosulfan blue dye in the detection of sentinel nodes in inguinal dissections of patients with vulvar cancer. A sentinel node dissection utilizing Tc-99m alone can identify a sentinel node in all inguinal dissections. Pathologic examination with step sections has shown the sentinel node to be an accurate predictor of metastatic disease to the inguinal nodal chain.