Recommendations for detection in primary care are flawed

The recent National Institute for Health and Clinical Excellence
(NICE) guidelines1,2 on the recognition and early detection of ovarian
cancer have generated considerable comment in the primary care and
gynaecological oncology communities, as evidenced by the letters to the
Editor last week3,4. Representing the organisations which practice,
promote and advance gynaecological oncology in the United Kingdom, we
welcome the development of guidelines to heighten awareness of the
challenges in making a diagnosis of ovarian cancer. We acknowledge the
limitation of evidence base on which the NICE guidelines were derived, and
appreciate the rationale for promoting access to CA125 in primary care as
a strategy to reduce the time to diagnosis. However, we believe it is
essential to promote awareness amongst our primary care colleagues of the
role and limitations of CA125 assessment in the detection and diagnosis of
ovarian cancer, and to clarify the context of the NICE recommendations
pertaining to CA125.

In order to improve the survival of women diagnosed with ovarian
cancer, we are keen to promote an understanding amongst women of the
symptoms which appear to be frequently associated with the onset of the
disease, in particular a frequency (more than 12 times per month) and
persistence of the following symptoms: abdominal distension / bloating,
early satiety / loss of appetite, pelvic or abdominal pain and urinary
urgency or frequency. When women with these symptoms present to primary
care, they should be examined and evidence of a pelvic mass (not thought
to be uterine fibroids) or ascites should trigger a "rapid access"
referral.

The CA125 test in isolation, promoted by the NICE guidance, is only
applicable to women with normal examination findings. This test will
identify some additional cases of ovarian malignancy where examination was
unremarkable, but the test is not specific for ovarian cancer and a range
of other diagnoses (benign or malignant) may be made following subsequent
investigations. Where the CA125 is raised (35 IU/ml or higher), an
abdominal and pelvic ultrasound should be performed within two weeks by an
appropriately trained and accredited sonographer.

Most importantly, as specialists in gynaecological cancer practice
we wish to stress that CA125 is normal in approximately one third of cases
of early stage ovarian cancer5. Thus a normal CA125 does not exclude
ovarian cancer in a symptomatic woman. The NICE guidelines indicate that
women should return to their GP if symptoms persist. Whilst neither
wishing to alarm women, or encourage excessive investigation of symptoms
that may not be due to ovarian cancer, we believe that the importance of
an early review by the GP is not sufficiently stressed in the NICE
guidelines. We propose that in symptomatic women a follow-up appointment
is arranged six weeks after a normal CA125 test, in order that symptoms
can be reassessed. Persistent symptoms at that time would indicate the
need for abdominal and pelvic ultrasound, and this should be done within 4
weeks; a negative scan result excludes ovarian cancer with a high degree
of confidence.

1. National Institute for Health and Clinical Excellence.
Recognition and initial management of ovarian cancer. CG122. 2011.
2. Redman C, Duffy S, Bromham N, Francis K; on behalf of the Guideline
Development Group. Recognition and initial management of ovarian cancer:
summary of NICE guidance. BMJ 2011;342:d2073.
3. Olaitan A. NICE on ovarian cancer. Recommendations for detection in
primary care are flawed. BMJ 2011; 342:d3022
4. Cave JA. NICE on ovarian cancer: Please include GPs in developing
guidelines. BMJ2011;342:d3023.
5. Woolas RP, Xu FJ, Jacobs IJ, Yu YH, Daly L, Berchuck A, et al.
Elevation of multiple serum markers in patients with stage I ovarian
cancer. J Natl Cancer Inst 1993;85:1748-51.