New guidance for ovarian cancer tests
The diagnosis and early treatment of ovarian cancer is in the news today, with the publication of new NICE guidance for doctors on recognising ovarian cancer.
NICE calls for more initial investigations (such as a blood test) to take place in GP surgeries. This is so that more women are referred to hospital specialists and begin treatment sooner, greatly increasing their chances of survival.
The guidance focuses on areas where there is current uncertainty or wide variation in clinical practice with regard to the detection of ovarian cancer. Most women will first visit their GP to discuss their symptoms and the guidance gives clear advice to GPs on the best course of action when cancer is suspected.
Dr Fergus Macbeth, Director of the Centre for Clinical Practice at NICE said:
“NICE is advising GPs and other primary care professionals to offer women (particularly those over 50) a blood test to measure the level of a protein called CA125 if they present with the following symptoms on a regular basis - bloating, feeling full quickly, lower abdominal pain and needing to urinate urgently or frequently.
“Based on the results of this test, women should then be offered an ultrasound scan of their abdomen and pelvis. If this suggests ovarian cancer, they should then be referred to see hospital specialists within two weeks; this is the existing national target set by the Department of Health.”
Where does the news come from?
The news stories are based on new guidance from the National Institute for Health and Clinical Excellence (NICE). NICE is the independent body that advises health professionals on the prevention and treatment of ill health.
NICE points out that ovarian cancer is the leading cause of death from gynaecological cancer in the UK and its incidence is rising. The outcome for women with this cancer is generally poor, with an overall five-year survival rate of less than 35%. This is because most women are only diagnosed when the disease is advanced, even though many women have symptoms months before, and also because of delays between when they first go to the doctor with symptoms and when referral is made for specialist investigations and treatment.
To increase the survival rates for ovarian cancer, NICE says there is a need for greater awareness of the disease among GPs and for earlier referral and optimum treatment.
“Delayed presentation coupled with lack of awareness around the possible symptoms, unfortunately mean that far too many women are being referred to hospitals for suspected ovarian cancer once their disease is at an advanced stage,” said Mr Charles Redman, a consultant gynaecological oncologist and contributor to the development of the guidelines. He continues, “This is frustrating as the stage of diagnosis is crucial in determining which treatments can then be offered”.
The guidance focuses on areas where NICE says there is either uncertainty or wide variation in clinical practice, regarding the detection, diagnosis and initial management of the disease. The guidance is applicable to women with suspected or confirmed epithelial ovarian cancer (the most common type), as well as women with fallopian tube cancer, borderline ovarian cancer or primary peritoneal carcinoma (a rare cancer of the thin lining covering the organs of the abdomen and pelvis). It does not cover other types of gynaecological cancer or cancer of other abdominal organs.
What does the NICE guidance advise?
Specifically, the guidelines advise GPs and other healthcare professionals to offer women (particularly those over 50) a blood test to measure the level of a protein called CA125 if they present with certain symptoms on a regular basis. These symptoms are bloating, feeling full quickly, lower abdominal pain and needing to urinate urgently or frequently. CA125 is often called a ‘tumour maker’; however, testing for CA125 is not a way of detecting any one disease. Levels are known to be raised in women with ovarian cancer, but they can also be raised by other cancers (including other cancers of the gynaecological system, bowel and lung) and other non-cancerous conditions such as endometriosis. However, raised levels in the presence of other symptoms should always raise the suspicion of cancer, until it is ruled out.
Based on the results of these tests NICE advises that women should then be offered an ultrasound scan of their abdomen and pelvis. If this suggests ovarian cancer, they should then be referred to hospital within two weeks, in line with existing targets from the Department of Health.
What are the key points from NICE?
Below are the “key priorities” which NICE says need to be implemented:
Awareness of symptoms and signs
GPs, says NICE, should offer tests to any woman (especially if they are aged 50 or over) who reports any of the following symptoms, either persistently or frequently (particularly more than 12 times in a month):
- persistent bloated feeling in the abdomen (abdominal distension)
- loss of appetite or feeling full quickly (early satiety)
- pain in the abdomen or pelvic area
- needing to pass urine urgently or more often than usual
GPs should carry out appropriate tests in any woman aged 50 or over who has had symptoms in the last 12 months that may be suggestive of irritable bowel syndrome (IBS), because the onset of IBS is rare in women of this age. Symptoms include changes of bowel habit (for example, constipation or diarrhoea and abdominal pain).
Asking the right questions – first tests
- If symptoms suggest ovarian cancer, GPs should offer women a blood test to measure the levels of a protein called CA125. Levels of this protein can be raised in women who have ovarian cancer.
- If blood levels of CA125 are 35IU/ml or greater, the GP should arrange for an ultrasound scan of the abdomen and pelvis.
- If the ultrasound suggests that further tests are needed, GPs should urgently refer the patient (within two weeks) to a gynaecologist who specialises in cancer.
- If blood levels of CA125 are normal (below 35IU/ml), or if the ultrasound is normal, doctors should check to see whether any other condition might be causing the symptoms and investigate if appropriate. If no other cause is found, the GP should advise the patient to return if symptoms become more frequent or persistent.
Where the results of the blood tests and ultrasound indicate suspected ovarian cancer (calculated using a risk of malignancy index), the woman should be referred to a specialist multidisciplinary team of healthcare professionals who are experienced in treating women with this type of cancer.
The NICE guidance also covers the diagnosis and treatment of ovarian cancer and the support needs of women who have been diagnosed. These further aspects of management of ovarian cancer are not the focus of this Q&A report.
What are the symptoms of ovarian cancer?
As Dr Craig Dobson, a GP and one of the developers of the guidelines said: “Ovarian cancer is difficult to diagnose from the symptoms alone”. The symptoms of ovarian cancer can often be non-specific and are frequently confused with those of other conditions, including irritable bowel syndrome. However, experiencing changes in bowel habits (for example, bouts of constipation or diarrhoea) can also be associated with ovarian cancer. Dr Dobson continued, “It is important for GPs to remember that irritable bowel syndrome rarely presents for the first time in women over fifty. Conversely, most ovarian cancers present in women over the age of fifty. Recurrent or prolonged symptoms require a diagnosis at any age.”
NICE experts say that the important factor here is the persistence of these symptoms. Age is also a factor to consider, but although most cancers occur in women above the age of 50, the possibility of cancer should not be ruled out in younger women with unexplained symptoms.
Alongside the abdominal and pelvic symptoms listed above (bloating, pain, feeling full quickly or change in bowel or urinary habit), ovarian cancer can also sometimes cause a change in periods (if the woman is pre-menopausal), post-menopausal bleeding or pain during sexual intercourse. Ovarian cancer can also often present with other non-specific symptoms common to many cancers, such as feeling very tired, or losing weight for no obvious reason.
What does the test involve?
The test is a simple blood test, which reportedly costs about £20. It measures blood levels of a key protein called CA125. This can be raised in women with ovarian cancer because CA125 is sometimes produced by ovarian cancer cells. Testing for CA125 has been carried out for many years within the NHS system and is a well-established test used in cases of suspected cancer. The primary purpose of the NICE guidance is to encourage the increased use of the test in primary care and to establish consistency among GPs about when they should be using the test and how they should be responding to the results.
How accurate is the blood test?
The CA125 test alone cannot diagnose ovarian cancer and having a high level of CA125 does not necessarily mean a woman has ovarian cancer. Some healthy women have naturally high levels and levels can also be raised in women who have other conditions such as endometriosis or fibroids. However, if levels of CA125 are high it can indicate the need for further investigations. Diagnosis of ovarian cancer will most likely be made through the use of ultrasound initially, followed by MRI or CT scans.
As CA125 is non-specific for ovarian cancer, the test can also sometimes miss cases of cancer and return lower, less-suspect levels when a woman actually has cancer. This is particularly the case if a woman has early stage disease. Women with advanced cancer almost always have high CA125 levels, but not all women with early stage cancer will have raised levels. For this reason, it is vital to take account of the individual’s medical history and presenting symptoms, without complete reliance on the blood test, and if symptoms are persistent or unexplained, or there is any doubt at all as to the cause, referral for hospital assessment and urgent ultrasound should always be arranged.
Why is NICE advising greater use of the blood test?
Women who have ovarian cancer have a greater chance of surviving the disease if it is caught earlier. Standard use of blood tests when women first complain of symptoms, by GPs and in other primary care settings, will, NICE says, lead to earlier referrals to cancer specialists and more timely treatment.
The NICE recommendations for use of the blood test by GPs are based on evidence of how the test performs, as well as an evaluation of its cost effectiveness. The CA125 test is, they say, currently the most widely used and reliable tumour marker for ovarian cancer.
How do the new guidelines affect you?
The guidelines are important for patients because they set out a recommended standard procedure for investigating possible symptoms of ovarian cancer, which GPs are expected to meet. NICE has also produced information on the new guidelines for patients and carers, in language that is easy to understand.