Adnexal Masses in Menopausal Women Surgery or Surveillance?

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1 Adnexal Masses in Menopausal Women Surgery or Surveillance? FREDTALK IDEASWORTHSPREADING Disclosure I am a member of Vermillion s Speakers Bureau I am NOT a paid consultant for Vermillion Inc. nor do I have a have financial interest in any related company Frederick R. Ueland, MD Professor and Director Division of Gynecologic Oncology University of Kentucky 2 Ovarian Tumors Ovarian Tumors Past 1980 s palpable ovary syndrome 2000 s observation of unilocular cysts 2010 s observation of septate cysts Present 10% of women undergo surgery for adnexal mass in their lifetime 1 13% 21% of these masses are malignant 2 1. Moore, McMeekin, Brown et al. Gynecol Oncol, Jordan. Current Biomarker Findings, Premenopausal Many tumors, few cancers Low prevalence 15% are malignant Germ cell tumors Borderline tumors Epithelial cancers Benign tumors 70% functional cysts 20% neoplastic 10% endometriomas Other Inflammatory Postmenopausal Few tumors, many cancers High prevalence 50% are malignant Epithelial ovarian cancer Metastatic cancer Granulosa cell tumors Benign tumors Cystadenoma Fibroma Thecoma 1

2 Frequency of Cysts 1 N=39,337 % Premenopausal 15 Incidence 15 Prevalence 35 Postmenopausal 85 Incidence 8 Prevalence 17 Low Risk (70%) 21 Unilocular cysts 54 Cysts with septations 46 High Risk (30%) 9 Cysts with solid areas 80 Solid mass million million 5 million Ultrasound Lessons Learned IOTA s ADNEX Model Kentucky Morphology Index (MI) Comparison 1. Pavlik E, Ueland F, Miller R, et al. Obstet Gynecol, United States Census Bureau, Available from: 5 Lessons Learned Using morphology based ultrasound helps stratify cancer risk. Screening Strategy Surgeries/Cancer UKCTOCS 35.2 PLCO 19.5 Kentucky first decade (1990 S) 12.5 second decade (2000 S) 5.2 third decade (2010 S) 4.0 ADNEX Risk Model International Ovarian Tumor Analysis Belgium, Italy, Czech Republic, Poland, UK, Sweden IOTA - ADNEX model 1. Age of the patient at examination (years) 2. Oncology center (referral center for gyn-oncol)? 3. Maximal diameter of the lesion (mm) 4. Maximal diameter of the largest solid part (mm) 5. More than 10 locules? 6. Number of papillations (papillary projections) 7. Acoustic shadows present? 8. Ascites (fluid outside pelvis) present? 9. Serum CA-125 (U/ml) 7 Clear 8 2

3 Kentucky Morphology Index Kentucky MI? MI Total Malignant ROM (%) 1 2, , , , , % Total 10, Ueland F, DePriest P, Pavlik E, et al. Gynecol Oncol, Elder J, Pavlik E, Long A, et al. Gynecol Oncol, Comparing Models ADNEX Model ROM correlates with increased cancer risk 52% of cancers in lowest ROM groups Limited as decision aid to surgery Misses stage 1 cancers Kentucky MI ROM correlates with increased cancer risk 15% of cancers in lowest ROM groups High risk cutoff effectively identifies CA Identifies stage 1 cancers Biomarkers CA125 OVA1 ROMA Lefringhouse J, Ueland F, Ore R, et al. SGO Annual Meeting abstract,

4 CA125 Performance Management of Adnexal Mass Sensitivity Specificity Cost ($ US) Bimanual exam $ CA $ US morphology $$ US + Doppler $$ CT scan $$$$$$$$$$$ MRI $$$$$$$$$$$$$$$ $=$200 Myers et al. Management of adnexal mass. Rockville (MD): U.S. Department of Health and Human Services, 2006 Myers et al. Management of adnexal mass. Rockville (MD): U.S. Department of Health and Human Services, Ovarian Tumor Biomarker Tests OVA1 FDA cleared September, First preoperative test for ovary Multivariate Index Assay Range 0 10 Premenopausal Postmenopausal Low Risk < 5.0 < 4.4 High Risk ROMA FDA cleared September, 2011 Dual marker test Range 0 10 Premenopausal Postmenopausal Low Risk < 1.31 < 2.77 CA125 + HE4 Comparing Biomarkers Sensitivity OVA1 1,2 ROMA 3 CA125 II 1,4 All malignancies 93% 89% 69% Epithelial ovarian cancers 99% 94% 82% Early stage EOC 98% 75% 66% Premenopausal women 94% 76% 36% Postmenopausal women 100% 92% 80% Specificity All malignancies 54% 75% 87% OVA1 detected 76% of malignancies missed by CA125 1 High Risk Ueland F, DeSimone C, Seamon L et al. Obstet Gynecol, Bristow R, Smith A, Zhang Z, et al. Gynecol Oncol, Moore R, McMeekin S, Brown A et al. Gynecol Oncol, Myers et al. Management of adnexal mass. Rockville (MD): U.S. Department of Health and Human Services,

5 Evaluation Strategy Evaluation Strategy Determine Malignant Risk with Ultrasound 1. Low risk tumors monitor without surgery 2. Indeterminate tumors secondary testing Serial ultrasound Biomarkers 3. High risk tumors refer to Gynecologic Oncologist for surgery Malignant Risk Low Indeterminate High Distribution 65% 25% 10% US morphology Unilocular or septate Partly solid, small wall abnormalities Mostly solid, papillary projections Biomarker testing No YES No Surgery No Maybe YES 18 Low Risk Resolution for Low Risk Unilocular or septate Smooth walled Type of Structure Resolution Time Cyst Cyst & Septation Cyst & Solid Solid Scans, n Structures, n Average Scans, n Mean (mo) Unilocular cyst 1,2 Septate cyst 3 1 Modesitt et al. Gynecol Oncol, Bailey et al. Gynecol Oncol, Saunders B. et al. Gynecol Oncol, Median (mo) th percentile (mo) th percentile (mo) Ore R, Ueland F, Lefringhouse J, et al. SGO Annual Meeting abstract,

6 Malignant Potential for Low Risk Evaluation Strategy Malignant Risk Low Indeterminate High Distribution 65% 25% 10% Summary 33% unilocular 1% malignant 0.54% Premenopausal 2.76% Postmenopausal 7/11 had solid or papillary component on visual surgical inspection US morphology Unilocular or septate Small solid wall, atypical projections Mostly solid, papillary projections Biomarker testing No YES No Surgery No Maybe YES Valentin, Ameye, Franchi et al. Ultrasound Obstet Gynecol, Indeterminate Risk Small, irregular wall abnormalities Partly solid tumors Atypical, non papillary projections Surgery for epithelial ovarian malignancy N MI P value MI per month P value 50 * 1.9 P< P<0.001 Surgery for non malignancy P< P<0.001 Resolved ovarian cysts P< P< * 24 subjects had 1 scan only 6

7 Serial Morphology Index Diagnostic Biomarkers Triage Biomarkers Tumor type Malignant Non malignant Resolving MI score Increase Stable or gradual rise Decrease CEA CA19 9 LDH β hcg AFP HE 4 CA125 OVA1* ROMA *Multivariate Index Assay Elder J, Pavlik E, Long A et al. Gynecol Oncol, Evaluation Strategy High Risk Malignant Risk Low Indeterminate High Distribution 65% 25% 10% US morphology Unilocular or septate Partly solid, small wall abnormalities Mostly solid, papillary projections Biomarker testing No YES No Surgery No Maybe YES Irregular, solid Papillations Ascites ROM >25% Refer to Gynecologic Oncologist

8 Summary 1. Ultrasound is best for menopausal ovarian tumors 2. Determine risk: Low monitor without surgery 6 months, then annually Indeterminate additional testing Serial ultrasound Biomarker testing (consider OVA1 or ROMA) High surgery Refer to a Gynecologic Oncologist 29 8

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