1. Audit of Impact of NICE guidelines for Ovarian Cancer Helen Losty Royal United Hospital Bath 17th November 2011

2. Background to Audit Ovarian cancer Ca125 in ovarian cancer Cancer strategy Scope and brief for guidelines Guideline algorithm 17th November 2011

3. Methodology of Audit Requesting of Ca 125 in primary care Analytical method Methodology of audit 17th November 2011

4. Results of audit 17th November 2011

5. Background Image reproduced by kind permission of Dr Sue Barter Ovarian cancer is a challenge to diagnose because of the non- specific nature of symptoms and signs – “silent killer” Most women are diagnosed with advanced disease (stages II– IV)

6. Epidemiology Ovarian cancer is the 5th most common cancer in women in the UK Over 6700 new cases are diagnosed each year, accounting for approximately 1 in 20 cases of cancer in women Around 4300 women die from ovarian cancer each year in the UK, representing 6% of all cancer deaths in women

7. Ca 125 Known as the first and predominant ovarian tumour marker investigated Hybridoma defined tumour marker High molecular weight glycoprotein present in serum of women with primary epithelial ovarian cancer Not present on surface epithelial of normal ovaries

8. Ca 125 lack of specificity Elevated in: Benign gynaecology  Endometriosis  Fibroids  Pelvic Inflammatory Disease Other peritoneal inflammation Benign conditions  Urinary retention  Chronic renal failure  Pancreatitis Cyclical variations in pre-menopausal age group Other malignant disease – gastric and lung

9. Ca125 – lack of sensitiviry Ca 125 not raised in 30% of women with ovarian cancer – early stage disease

10. Ca125 diagnostic efficiency Sensitivity and specificity Ca 125 U/mLSensitivity %Specificity % 65 and greater7982 1506993 1906395

11. Cancer Strategy National awareness and Early Diagnosis Initiative NAEDI 2008 Improving outcomes – save 5,000 lives through earlier diagnosis Cancer and general practice - GP’s in the driving seat Increase access for GP’s to diagnostic tests - imaging

12. Ovarian cancer Ovarian cancer – 29% present through emergency route which is always associated with poorer outcome Increase the number of women accessing the correct treatment pathway earlier.

13. Ovarian cancer Implementing NICE guidance April 2011 NICE clinical guideline 122

14. Detection in primary care Women presents to GP GP assesses symptoms Tests in primary care Urgent referral: assessment in secondary care Suspicion of ovarian cancer Ascites and/or pelvic or abdominal mass Support and information

15. Measure serum CA125 Ultrasound of abdomen and pelvis Advise to return to GP if symptoms become more frequent and/or persistent Investigate Refer urgently Assess carefully: are other clinical causes of symptoms apparent? Suggestive of ovarian cancer 35 IU/ml or greater Normal Less than 35 IU/ml No First tests in primary care Yes

16. Why choice of Ca125 Least expensive option as first test compared with ultrasound – access undeliverable or pelvic examination which is not specific enough Prevalence in primary care in symptomatic woman is only 0.23% ie if all symptomatic patients were referred then only 1:500 would have ovarian cancer. NB GP sees a patient with ovarian cancer every 5-6 years

17. Awareness of symptoms and signs: 1 Refer the woman urgently if physical examination identifies ascites and/or a pelvic or abdominal mass (which is not obviously uterine fibroids)

18. Awareness of symptoms and signs: 2 –Carry out tests in primary care if a woman (especially if 50 or over) reports having any of the following symptoms on a persistent or frequent basis – particularly more than 12 times per month: –persistent abdominal distension (women often refer to this as ‘bloating’) –feeling full (early satiety) and/or loss of appetite –pelvic or abdominal pain –increased urinary urgency and/or frequency

19. Awareness of symptoms and signs: 3 Consider carrying out tests in primary care if a woman reports unexplained weight loss, fatigue or changes in bowel habit Carry out appropriate tests for ovarian cancer in any woman of 50 or over who has experienced symptoms within the last 12 months that suggest irritable bowel syndrome (IBS) Advise any woman who is not suspected of having ovarian cancer to return to her GP if her symptoms become more frequent and/or persistent

20. NICE guidelines Awareness of symptoms Facilitate improved detection in primary care

21. Audit 1- On line requesting

22. Ca 125 methodology Monoclonal antibody – murine lymphocytes immunised with ovarian cancer cell line 433 Sandwich IRMA Most important tumour marker for monitoring therapy and progress of patients with serous carcinoma

23. Audit Computer search of ICE for Ca125 requests from primary care May to July 2011 vs May to July 2010 Itemised for each of 57 practices Sole identifier was laboratory number

24. Results

25. Increase in test requests from primary care 2010 vs 2011

28. Ca 125 10% greater than or equal to 35IU/ml ie 45 requests Clinical details abstracted from information accompanying ICE request