Adnexal Masses in Disclosure Menopausal Women I am a member of - - PDF document

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Adnexal Masses in Disclosure Menopausal Women I am a member of - - PDF document

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9/23/2015 Adnexal Masses in Disclosure Menopausal Women I am a member of Vermillions Speakers Bureau Surgery or Surveillance? I am NOT a paid consultant for Vermillion Inc. nor do I have a have financial interest in any related FRED

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9/23/2015 1

Adnexal Masses in Menopausal Women Surgery or Surveillance?

Frederick R. Ueland, MD Professor and Director Division of Gynecologic Oncology University of Kentucky

FREDTALK

IDEASWORTHSPREADING

Disclosure

2

  • 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 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 lifetime1 – 13%‐21% of these masses are malignant2

  • 1. Moore, McMeekin, Brown et al. Gynecol Oncol, 2009.
  • 2. Jordan. Current Biomarker Findings, 2013.

Ovarian Tumors

  • 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

  • Few tumors, many cancers

–

High prevalence

  • 50% are malignant

–

Epithelial ovarian cancer

–

Metastatic cancer

–

Granulosa cell tumors

  • Benign tumors

–

Cystadenoma

–

Fibroma

–

Thecoma

Ovarian Tumors

Premenopausal Postmenopausal

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Frequency of Cysts1

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 20

23‐Sep‐15 5

30 million2 2.4 million 5 million

  • 1. Pavlik E, Ueland F, Miller R, et al. Obstet Gynecol, 2013.
  • 2. United States Census Bureau, 2010. Available from: www.census.gov.

Ultrasound

Lessons Learned IOTA’s ADNEX Model Kentucky Morphology Index (MI) Comparison

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

23‐Sep‐15 7

Lessons Learned ADNEX Risk Model

International Ovarian Tumor Analysis

Belgium, Italy, Czech Republic, Poland, UK, Sweden

8 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)

C lear

___ __________ _____________ ____________________ ______ _______ ______ _____ _____

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Kentucky Morphology Index

Ueland F, DePriest P, Pavlik E, et al. Gynecol Oncol, 2003.

Kentucky MI

MI Total Malignant ROM (%) 1 2,349 1 0.04 2 2,365 0.00 3 2,635 3 0.11 4 1,579 7 0.44 5 1,061 29 2.73 6 241 9 3.73 7 87 11 12.64 8 30 8 26.67 9 18 5 27.78 10 3 1 33.33 Total 10,368 74 0.71 85%

Elder J, Pavlik E, Long A, et al. Gynecol Oncol, 2014.

?

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

23‐Sep‐15 11 Lefringhouse J, Ueland F, Ore R, et al. SGO Annual Meeting abstract, 2016.

Biomarkers

CA125 OVA1 ROMA

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13

CA125 Performance

Myers et al. Management of adnexal mass. Rockville (MD): U.S. Department of Health and Human Services, 2006

Sensitivity Specificity Cost ($ US) Bimanual exam 0.45 0.90

$

CA‐125 0.78 0.78

$

US morphology 0.90 0.76

$$

US + Doppler 0.86 0.91

$$

CT scan 0.90 0.78

$$$$$$$$$$$

MRI 0.91 0.88

$$$$$$$$$$$$$$$

Management of Adnexal Mass

Myers et al. Management of adnexal mass. Rockville (MD): U.S. Department of Health and Human Services, 2006 14

$=$200

OVA1

  • FDA‐cleared September, 2009. First preoperative test for ovary
  • Multivariate Index Assay

Ovarian Tumor Biomarker Tests

15

ROMA

  • FDA‐cleared September, 2011
  • Dual marker test

CA125 + HE4

Range 0‐10 Premenopausal Postmenopausal Low Risk < 5.0 < 4.4 High Risk ≥ 5.0 ≥ 4.4 Range 0‐10 Premenopausal Postmenopausal Low Risk < 1.31 < 2.77 High Risk ≥ 1.31 ≥ 2.77

Sensitivity OVA11,2 ROMA3 CA125‐II1,4 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 CA1251

Comparing Biomarkers

1. Ueland F, DeSimone C, Seamon L et al. Obstet Gynecol, 2011. 2. Bristow R, Smith A, Zhang Z, et al. Gynecol Oncol, 2013. 3. Moore R, McMeekin S, Brown A et al. Gynecol Oncol, 2009. 4. Myers et al. Management of adnexal mass. Rockville (MD): U.S. Department of Health and Human Services, 2006

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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

Evaluation Strategy

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

1Modesitt et al. Gynecol Oncol, 2003. 2Bailey et al. Gynecol Oncol, 1998. 3Saunders B. et al. Gynecol Oncol, 2010.

Unilocular cyst1,2 Septate cyst3

  • Unilocular or septate
  • Smooth‐walled

Resolution for Low Risk

20

Resolution Time

Type of Structure Cyst Cyst & Septation Cyst & Solid Solid Scans, n 6239 1790 581 154 Structures, n 1288 366 122 24 Average Scans, n 4.8 4.9 4.8 6.4 Mean (mo) 31.0 26.5 23 26.4 Median (mo) 17 14.1 8.3 12.7 75th percentile (mo) 38.4 36.0 33.8 38.7 90th percentile (mo) 70.9 64.5 64.3 93.8

Ore R, Ueland F, Lefringhouse J, et al. SGO Annual Meeting abstract, 2016.

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Malignant Potential for Low Risk

23‐Sep‐15 21 Valentin, Ameye, Franchi et al. Ultrasound Obstet Gynecol, 2013.

Summary 33% unilocular 1% malignant

  • 0.54% Premenopausal
  • 2.76% Postmenopausal

7/11 had solid or papillary component on visual surgical inspection

Evaluation Strategy

Malignant Risk Low Indeterminate High Distribution 65% 25% 10% US morphology Unilocular or septate Small solid wall, atypical projections Mostly solid, papillary projections Biomarker testing No YES No Surgery No Maybe YES

22 23‐Sep‐15 23

Indeterminate Risk

  • Small, irregular wall abnormalities
  • Partly solid tumors
  • Atypical, non‐papillary projections

*24 subjects had 1 scan only

N ∆MI

P‐value

∆MI per month

P‐value

Surgery for epithelial

  • varian malignancy

50* 1.9

P<0.001

0.9

P<0.001

Surgery for non‐malignancy 272 0.7

P<0.001

0.2

P<0.001

Resolved ovarian cysts 5811 ‐2.7

P<0.001

‐1.1

P<0.001

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25

Tumor type MI score

  • Malignant

Increase

  • Non‐malignant

Stable or gradual rise

  • Resolving

Decrease

Elder J, Pavlik E, Long A et al. Gynecol Oncol, 2014.

Serial Morphology Index

‘Diagnostic’ Biomarkers

  • CEA
  • CA19‐9
  • LDH
  • β‐hCG
  • AFP
  • HE‐4
  • CA125
  • OVA1*
  • ROMA

*Multivariate Index Assay

26

Triage Biomarkers

Evaluation Strategy

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

27 23‐Sep‐15 28

High Risk

  • Irregular, solid
  • Papillations
  • Ascites
  • ROM >25%
  • Refer to

Gynecologic Oncologist

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9/23/2015 8

  • 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

Summary

29