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OVARIAN CANCER New NICE guidelines and the research behind them

OVARIAN CANCER New NICE guidelines and the research behind them. Journal Club 20/5/11 Natalie Brown and Matthew Parkes. Content. Summary of NICE guidelines Critical appraisal of paper

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OVARIAN CANCER New NICE guidelines and the research behind them

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  1. OVARIAN CANCERNew NICE guidelines and the research behind them Journal Club 20/5/11 Natalie Brown and Matthew Parkes

  2. Content • Summary of NICE guidelines • Critical appraisal of paper • Anderson M, Goff B, Lowe K et al. Use of symptom index, CA125 and HE4 to predict ovarian cancer. Gynecol Oncol 2010 March 116(3): 378. • Discussion

  3. NICE guidelines: Ovarian Cancer • The recognition and initial management of ovarian cancer – published April 2011 • Guidelines produced to focus on areas of uncertainty and when wide variation in clinical practice • Statistics • 5th most common cancer in women (1 in 20 cases of cancer) and rising • Leading cause of death from gynaecological cancer (4,300 women die from ovarian cancer each year in the UK) • Overall 5 year survival 35% • Approximately 6,700 new cases of ovarian cancer were diagnosed every year in United Kingdom between 2004 and 2007

  4. Clinical question: What are the symptoms and signs of ovarian cancer?

  5. Recognition in primary care : when to measure CA-125 • Symptoms present particularly >12 times per month (especially if >50yo) • Persistent abdominal distension (‘bloating’) • Early satiety and/or loss of appetite • Pelvic or abdominal pain • Increased urinary urgency and/or frequency • Alternatively, suspect in a woman over 50 who has developed ‘IBS’ symptoms in the last year • Also measure if experiencing weight loss, change in bowel habit or fatigue and ovarian cancer is suspected

  6. When to avoid CA-125 in primary care • If a woman has ascites and/or an abdominal or pelvic mass on clinical examination that is ‘not obviously due to uterine fibroids’ • Refer urgently (2 week referral) to secondary care

  7. Investigation after CA-125 results in primary care • If CA-125 > 35, arrange USS abdomen and pelvis • If USS suggestive of ovarian cancer, refer urgently (2ww) • If normal USS consider other causes • If CA-125<35, consider other causes

  8. Establishing the diagnosis in secondary care • Need to have USS or CA-125 if not already done • If under 40 years old, measure beta-hCG and AFP to identify those who may not have epithelial ovarian cancer • Next calculate RMI score and refer to MDT if score >250

  9. Risk of malignancy index (RMI) • RMI = score based on combination of USS findings, menopausal status and CA-125 level • USS score; 1 point if one of the following present, 3 points if 2-5 of the following present • Multilocular cysts • Solid areas • Metastases • Ascites • Bilateral lesions

  10. RMI continued • Menopausal status • 1 point if pre-menopausal • 3 points if post-menopausal • CA-125 • Use the value itself • Eg a post menopausal lady with ascites and solid areas on USS, and CA-125 of 50 has an RMI of 3 x 3 x 50 = 300 • If RMI is 250 or greater, must be referred to specialist MDT

  11. Further investigation in secondary care • If overall picture suggestive of ovarian cancer, needs CT pelvis, abdomen +/- thorax to assist with staging • MRI not routinely advised • Tissue diagnosis – generally recommend if contemplating chemotherapy • Percutaneous image guided biopsy • Laparoscopic biopsy

  12. Summary of clinical management • Stage I • Oophorectomy • Retroperitoneal lymph node assessment • 1a and 1b – no chemotherapy • 1c and above – adjuvant chemotherapy • Stage II-IV • Surgical objective = complete removal of all macroscopic disease • Intraperitoneal chemotherapy only used in Trials at present

  13. Fertility Sexuality Genetics Physiotherapy Self-help strategies Counselling Support groups Summary of holistic management

  14. Further research recommendations • Further research should be undertaken on the relationship between the duration and frequency of symptoms in women with ovarian cancer before diagnosis, the stage of disease at diagnosis and subsequent survival. • Large multicentre case–control studies should be conducted to compare the accuracy of CT versus MRI for staging in women with ovarian cancer.

  15. Critical Appraisal of journal article • Anderson M, Goff B, Lowe K et al. Use of symptom index, CA125 and HE4 to predict ovarian cancer. Gynecol Oncol 2010 March 116(3): 378. • Using ‘CASP’ framework via BWH Trust library homepage

  16. Did the study address a clearly defined issue? • To evaluate to use of symptom index with serum HE4 or Ca-125 alone and in combination to predict ovarian cancer

  17. Did the authors use an appropriate method to answer their question? • Prospective case-control study • 74 women with ovarian cancer • 137 ‘healthy’ women as controls

  18. Were the cases recruited in an acceptable way? • Cases were recruited from a group that had positive imaging suggesting ovarian cancer and were surveyed prior to surgery and before receiving a definitive diagnosis of ovarian cancer

  19. Were the controls recruited in an acceptable way? • All controls have family histories consistent with inherited susceptibility for ovarian cancer

  20. Was exposure accurately measured to avoid bias?

  21. What confounding factors have the authors accounted for? • Control group selection bias and the ability to record and recall symptoms more specific to ovarian cancer • Recall bias of patients awaiting surgery and ability to remember recent symptoms than a high risk control group • Study does not have detailed information for imaging results • The study did not look at case notes to see if symptoms had been clinically reported – only took results from their own survey

  22. What are the results? • As a single marker CA-125 had the highest overall sensitivity 81.1% and specificity of 95% • HE4 had the highest sensitivity in high risk cases, overall sensitivity 77% and specificity 95% • Symptom index alone showed sensitivity of 63.5% and specificity of 88.3% • Any 2 of 3 above positive sensitivity 83.8% and specificity of 98.5%

  23. How precise are the results? • Wide confidence intervals for results

  24. Do you believe the results? • Unable to comment on quality and appropriateness of ‘survey’ • Measuring of serum markers appropriate

  25. Can the results be applied to the local population? • USA study • Symptom reporting different across Atlantic? • Tumour markers ? Universal across populations

  26. Do the results fit with other available evidence? HE4 • Consistent evidence across studies suggesting HE4 better than Ca-125 • Also suggests that the combination of HE4 and CA125 is more specific, but less sensitive than either marker in isolation.

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