David Rose
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A new “one-step” test allows breast cancer patients to be treated directly if their disease has spread, meaning that they no longer have to wait weeks for test results to come back or undergo a second operation.
Surgeons say that thousands of women undergoing surgery could benefit from the rapid diagnostic test, known as the breast lymph node assay. It is already being used at hospitals in Surrey and Portsmouth, and is due to be recommended for implementation across the NHS next year.
Quicker and more reliable than existing checks, it involves analysing the glands under the arms, to check if the cancer has already spread, at the same time as a patient has a mastectomy or surgery to remove an initial tumour.
Patients currently have to wait two to three weeks after an operation for the results of laboratory tests on these lymph nodes, and may then face further surgery if their cancer has spread.
But with the new assay, surgeons can obtain results in a matter of minutes, allowing them to treat the patient during the same operation.
Surgeons say that it could improve outcomes for women with breast cancer by eliminating the need for repeat operations and enable them to start chemotherapy earlier. It could also save the NHS money, by potentially avoiding 3,000 secondary surgeries each year.
Breast cancer is the most common type of cancer in Britain, with about 46,000 women receiving a diagnosis every year. Most patients require surgery to remove a tumour or a whole breast, but they will also undergo checks to find if the cancer has spread to the lymph nodes. About one patient in three will have a cancer that has spread in this way — particularly those with larger, “high-grade tumours” — but existing ultrasound or biopsy checks have the potential to miss 10 to 15 per cent of cases.
More than 750 patients in England have so far received lymph node assay: 160 at the Royal Surrey County Hospital in Guildford, using a Japanese technique, One Stop Nucleic Acid Amplification (OSNA), and 500 at Queen Alexandra Hospital in Portsmouth, using the rival Genesearch system distributed by an American company.
Both versions of the test rely on an existing procedure known as a sentinel lymph node biopsy, a selective but accurate method where tissue is surgically removed and sent to a pathology laboratory for tests. While samples are assessed under a microscope, and can take weeks to process, the new assay uses molecular biological techniques to break down and replicate the node tissue in a special solution.
This can then be screened for one or two types of messenger RNA — a key genetic signalling chemical — that can indicate the presence of so-called “micrometastases”, tumours smaller than 0.2mm in size.
Professor Graham Layer, breast surgeon at the Royal Surrey, whose team started using the technique in 2007, said that the speed of the results allowed surgeons to remove any lymph nodes affected by cancer while the patient was under general anaesthetic.
Of the patients so far treated, up to 40 per cent tested positive for some spread of cancer, with results that were obtained in 30 to 45 minutes, he said. “We can see cases where cancer has spread that we could not have spotted with conventional ultrasound or biopsy tests,” he said. “For those women with a positive result, we are able to deal with that much more quickly than if we had waited for the results of routine pathology tests following a traditional breast cancer operation.”
Depending on the extent of the cancer, the upper or lower lymph nodes can then be taken out to prevent the disease recurring or spreading elsewhere, he added.
The NHS has previously been slow to roll out the tests because of the £60,000 cost to individual trusts of installing the screening machines and practical changes needed to run the tests, which cost £200 per patient.
But the NHS Technology Adoption Centre said that it would issue health trusts with guidance next year on how to introduce the checks.
Professor Ian Cree, head of the cancer laboratory that performs the tests in Portsmouth, added: “This is something that should become the gold standard of care, and I think it’s something patients should be asking for. We hope that it will be in widespread use very shortly.”
Hospitals in Sunderland, Morecambe Bay, North Staffordshire and Essex are understood to be in the process of acquiring the technology.
Emma Pennery, clinical director at the charity Breast Cancer Care, said: “We know that women can feel extremely anxious when waiting for biopsy results that could determine whether other treatments or further surgery are needed, so anything that can remove this anxiety would be welcomed.
The Department of Health said it would monitor developments: “We are always interested to know about new and innovative treatments.”
Most common cancer
• Breast cancer is the most common cancer in Britain. In 2006 more than 45,500 women had the disease diagnosed — equivalent to about 125 women a day
• Rates of the disease have increased by more than 50 per cent over the past 25 years, largely because of the extension of the NHS breast screening programme, which identifies about 10,000 cases a year
• The number of women dying from breast cancer has fallen to fewer than 12,000 for the first time in almost 40 years, because of improvements in early detection and treatment
• Treatments typically involve surgery, followed by chemotherapy, radiotherapy or a combination of the two
• Surgery may remove just the lump with a surrounding rim of normal tissue (lumpectomy) or the entire breast may be removed. Typically, surgery also entails some assessment of the underarm glands (axillary lymph nodes), which helps to guide further treatment. The glands may be completely removed (axillary node clearance) or just a few sampled
• Eight out of ten breast cancer cases occur in women aged 50 and over, but genetic forms of the disease can also run in families. Women who have a mother, sister or daughter with breast cancer have an 80 per cent higher risk
• Use of hormone replacement therapy (HRT) has fallen in Britain in recent years, which has been estimated to prevent 1,400 breast cancers annually in women aged 50-59. Other risk factors include excessive drinking, obesity and taking the contraceptive Pill
• It is also possible for men to get breast cancer, and about 300 such cases and 90 deaths occur a year
Source: Cancer Research UK
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