Title: OVARIAN CANCER New NICE guidelines and the research behind them
1OVARIAN CANCERNew NICE guidelines and the
research behind them
- Journal Club 20/5/11
- Natalie Brown and Matthew Parkes
2Content
- 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
3NICE 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
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8Clinical question What are the symptoms and
signs of ovarian cancer?
9Recognition in primary care when to measure
CA-125
- Symptoms present particularly gt12 times per month
(especially if gt50yo) - 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
10When 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
11Investigation after CA-125 results in primary care
- If CA-125 gt 35, arrange USS abdomen and pelvis
- If USS suggestive of ovarian cancer, refer
urgently (2ww) - If normal USS consider other causes
- If CA-125lt35, consider other causes
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13Establishing 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 gt250
14Risk 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
15RMI 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
16Further 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
17Summary 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
18Summary of holistic management
- Fertility
- Sexuality
- Genetics
- Physiotherapy
- Self-help strategies
- Counselling
- Support groups
19Further 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 casecontrol studies should be
conducted to compare the accuracy of CT versus
MRI for staging in women with ovarian cancer.
20Critical 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
21Did 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
22Did the authors use an appropriate method to
answer their question?
- Prospective case-control study
- 74 women with ovarian cancer
- 137 healthy women as controls
23Were 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
24Were the controls recruited in an acceptable way?
- All controls have family histories consistent
with inherited susceptibility for ovarian cancer
25Was exposure accurately measured to avoid bias?
26What 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
27What 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
28How precise are the results?
- Wide confidence intervals for results
29Do you believe the results?
- Unable to comment on quality and appropriateness
of survey - Measuring of serum markers appropriate
30Can the results be applied to the local
population?
- USA study
- Symptom reporting different across Atlantic?
- Tumour markers ? Universal across populations
31Do 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.