1. THE IMPACT OF OVARIAN ULTRASOUND MORPHOLOGY SCORES ON THE DECISION FOR SURGICAL INTERVENTION OVERALL AND BETWEEN UKCTOCS TRIAL CENTRES
Authors
Nazar N, Amso PhD13, Rana Al-Dahlawi MSc,13 Chukwuemeka Iyoke MPH,FWACS 13, Aarti Sharma MRCOG1, Sophia Apostolidou PhD1, Matthew Burnell PhD1, Mariam Habib PhD1, Aleksandra Gentry-Maharaj PhD1, Stuart Campbell DSc2, Nazar Amso PhD13, Mourad W Seif7, Naveena Singh4, Elizabeth Benjamin9, C Brunell9, G Turner8, R Rangar3, Keith Godfrey FRCOG3, David Oram FRCOG4, Jonathan Herod MRCOG5, Karin Williamson FRCOG6, Howard Jenkins FRCOG8, Tim Mould FRCOG9, Robert Woolas MD10, John Murdoch FRCOG11, Stephen Dobbs FRCOG12, Simon Leeson FRCOG14, Derek Cruickshank FRCOG15, Evangelia-Ourania Fourkala PhD1, Andy Ryan PhD1, Mahesh Parmar PhD16, Ian Jacobs FRCOG1, Usha Menon FRCOG1.
Affiliations
1Gynaecological Cancer Research Centre, UCL EGA Institute for Women’s Health, London W1T 7DN; 2Create Health Clinic, Harley Street, London W1G 6AJ; 3Northern Gynaecological Oncology Centre, Queen Elizabeth Hospital, Gateshead NE9 6SX; 4Department of Gynaecological Oncology, St. Bartholomew’s Hospital, London EC1A 7BE; 5Department of Gynaecology, Liverpool Women’s Hospital, Liverpool L8 7SS; 6Department of Gynaecological Oncology, Nottingham City Hospital, Nottingham NG5 1PB ; 7Academic Unit of Obstetrics and Gynaecology, St. Mary’s Hospital, Manchester M13 9WL; 8Department of Gynaecological Oncology, Derby City Hospital, Derby DE22 3NE; 9Department of Gynaecological Oncology, Royal Free Hospital, London NW3 2QG; 10Department of Gynaecological Oncology, St. Mary’s Hospital, Portsmouth PO3 6AD; 11Department of Gynaecological Oncology, St. Michael’s Hospital, Bristol BS2 8EG; 12Department of Gynaecological Oncology, Belfast City Hospital, Belfast BT9 7AB; 13Department of Obstetrics and Gynaecology, Wales College of Medicine, Cardiff University, Cardiff CF14 4XN; 14Department of Gynaecological Oncology, Llandudno Hospital, North Wales LL30 1LB; 15Department of Gynaecological Oncology, James Cook University Hospital, Middlesbrough TS4 3BW; 16Cancer Group, Medical Research Council Clinical Trials Unit, London NW1 2DA .
FOR THE UKCTOCS TEAM

2. INTRODUCTION
Preoperative evaluation of the risk of malignancy in an adnexal mass has serious implications for the patient.
Currently many methods used to aid clinical decision making including ovarian morphological scorings, Risk of Malignancy indices, Logistic regression models, Neural networks.

3. INTRODUCTION
UKCTOCS: Results of the prevalence screen showed very high rates of unnecessary surgeries(45/845).
Could a more sensitive method of ultrasound diagnosis during screening have produced less abnormal screening results( less false-positive clinical assessment)?

4. Objectives
To find the correlation between preoperative ultrasound results and the decision for surgical intervention
To estimate the accuracy of morphological scoring indices (Sassone and Kentucky scores) in predicting malignant tumors in postmenopausal women with ultrasonographically confirmed adnexal masses who underwent surgical intervention
To determine the intervention rates and factors that influenced clinical decisions for surgical intervention

5. Methods A retrospective quantitative observational study
UKCTOCS Protocol (Ultrasound-only arm)
Involved UKCTOCS prevalence screening data
Level II scan of the ultrasound-only arm
Abnormal results had clinical assessment to determine likelihood of cancer; surgery done if cancer suspected; yearly follow up if benign lesion was suspected

6. Methods
Demographics, ultrasound scan results and morphological scores compared between conservatively managed and surgically managed
Sensitivity, specificity, PPV, NPV of morphological scoring (Sassone & Kentucky) estimated on surgically managed
Analysis with SPSS v Categorical variables-X2, Mann-Whitney U. Continuous variables- independent t-test . P ≤ 0.05 significant

7. RESULTS
1900 patients had complex cysts at level II scan (48230 level I; 5779 level II)
845 had surgery; 1055 conservative mgt
96% of conservative group and 97% of surgery group were whites—other ethnic groups ranged between 0.1 and 1.1%
Surgery group did not differ significantly from non-surgery group in any of the general characteristics (Table1)

8. Table 1: Demographic data according to women who had surgery or not

9. Table 2: Comparison of other general characteristics

10. Table3: comparison of Body Mass Index

11. Objective 1
RELATIONSHIP OF ULTRASOUND MORPHOLOGY TO INTERVENTION

12. Tables 4 & 5:Ovarian volume and cyst wall structure

13. Tables6&7: Cyst wall thickness and septal thickness

14. Tables 8&9:Papillation height and solid areas

15. Tables 10&11: Cyst fluid and cyst volume

16. Table 12: Doppler characteristics

17. Objective2:
ACCURACY OF SASSONE AND KENTUCKY SCORES IN PREDICTING MALIGNANCY AMONG POSTMENOPAUSAL WOMEN WITH ADNEXAL MASSES

18. Sassone score
The Sassone morphology index assigns numeric values to four specific morphologic criteria including: inner wall structure, wall thickness, septa and echogenicity: values range 4-15; ≥9 suggests malignancy
Only 859 women out of 1055 in the non-surgery group were found to have the sufficient data to calculate the Sassone score. In 759 out of 845 women in the surgery group the Sassone score was calculated.

19. Table 12: Distribution of groups by Sassone score cut-off values

20. Table 13: Histology results against Sassone cut-off values

21. Table 14: Performance of Sassone score using cut-off value of ≥9 as indicative of malignancy
Sassone Scores
PPV
16.4%
NPV
95.1%
Sensitivity
44.4%
Specificity
82.7%
Accuracy
80%

22. KENTUCKY SCORE
This score was initially created by DePriest et al., It assigns numerical values from 0 to 4 to three morphological parameters, which are: cystic wall structure, tumour volume and septal structure .
A total point score of 0-12 was given per evaluation. If the total point score was equal or more than 5, the mass was considered malignant. Scores were assigned to adnexal masses, not to individual women.

23. contd
Kentucky score was calculated in 830 out of 859 women in the non-surgery group and in 630 out of 759 in the surgery group.

24. Distribution of groups by Kentucky score cut off values

25. Kentucky score applied to cases with histological diagnosis of cancer

26. Performance of Kentucky score using cut-off value ≥ 5 as indicative of malignancy
Kentucky Scores
PPV
6.9%
NPV
95.3%
Sensitivity
62.2%
Specificity
48.1%
Accuracy
48.9%

27. OBJECTIVE 3 INTERVENTION RATES BETWEEN CENTRES AND
FACTORS THAT INFLUENCED DECISION FOR SURGICAL INTERVENTION

28. Intervention rates across centres
The women in the UKCTOCS trial were collected from 13 regional centres. However, to keep comparison anonymous, a centre code was assigned instead of centre name in this study
Women eligible for data analysis were documented in each centre

37. Factors that influenced decision to intervene
13 questionnaires were sent to each centre lead about their decision making for surgery via s. 8 out of the 13 (61.5%) responded electronically.
All of them used the overall ultrasound morphology of the ovary and attention to a specific feature in ultrasound such as, irregular wall, number of cysts, septation, solid area, papillation or echogenicity.

38. Factors that influenced decision to intervene
5 out of 8 used the presence of Doppler signal in the abnormal area as one of the factors.
The presences of abnormal morphology on both sides were used by only half the centres in their decision making for intervention.
Presence of ascites was taken into consideration when opting for surgery in 5 out of 8 centres.

39. contd
All eight centres agreed that the patient’s wishes influenced their decisions to operate.
All centre took into account the results of tumor markers especially CA125.
CT was used in 6 out of 8 centres while the other two centres used MRI with CT in their other investigation.
One centre used hysteroscopy as a mean of investigation.

40. contd
5 centres out of 8 used the risk of malignancy index developed by Jacobs et al (1990) as one of the factors considered in the decision for intervention.
3 of them did not use it in all of their women; the reason being that they did not calculate it for women with raised CA125 and normal ovaries in ultrasound.

41. CONCLUSION
Abnormal ovarian characteristics found significantly more in surgery group than in non-surgery group
Sassone and Kentucky scores had low sensitive and specificity on postmenopausal women.
Wide variation in the surgical intervention rate between UKCTOCS centres: centres relied a lot on ultrasound features to decide intervention
A more sensitive ultrasound morphological scoring could have reduced unnecessary surgeries
In the absence of accurate predictors, a clinical decision prior to intervention was appropriate.

42. FURTHER STUDY
Follow up of volunteers with complex cysts who were managed conservatively could determine the validity of this approach. There is also an urgent need to identify methods with higher sensitivity and specificity to differentiate benign from malignant lesions
This study can be used as a preliminary data to contribute to a much larger study with a longer follow up time for the women who were managed expectantly

43. THANK YOU