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Research trial sets best practice for melanoma surgery

1 March 2004

A pioneering research trial funded by the Bupa Foundation has found that the amount of apparently healthy skin removed from around the most serious form of skin cancer (melanoma) affects the chances of the disease recurring.

The research, coordinated at The Royal Marsden Hospital and The Institute of Cancer Research on behalf of the UK Melanoma Study Group and The British Association of Plastic Surgeons, shows that the amount of normal-looking skin removed from around a melanoma has a direct influence on patient outcome.

The detailed results of this work have been published in The New England Journal of Medicine. The research study began in 1993 and is known as the UK MSG/BAPS Excision Margin Trial.

The trial was funded by the Bupa Foundation, the North Thames NHS Executive Research and Development and Cancer Research UK.

Malignant melanoma, the most serious form of skin cancer, is becoming more common due to greater exposure to the sun and 6,000 patients are diagnosed with this disease every year in the UK.

Melanomas have a mole-like appearance but usually with distinctive features such as a size, which may be greater than 1cm, an irregular border and especially a change in size, shape or colour. Some melanomas can ulcerate and bleed.

The prognosis of a melanoma is determined by its depth of penetration into the skin. This is known as Breslow tumour thickness. If the tumour thickness is less than 0.76mm, then the risk of recurrence is extremely low. Thereafter there is linear relationship between tumour thickness and risk of recurrence. For example, the risk of recurrence over a five-year period at 2mm is 15 to 20 per cent, and at 5mm is 60 to 70 per cent risk.

Chairman of the Trial Management Group, Mr Meirion Thomas, consultant surgeon at the Royal Marsden, said: "There has been ongoing debate about the amount of normal-looking skin that should be removed when melanomas are excised because it has been thought that small invisible deposits of cancer may have spread to skin close to the melanoma. If these invisible cancer deposits are not removed, they can grow and spread, to appear later as a cancer recurrence."

Judith Bliss, director of the Clinical Trials & Statistics Unit, which conducted the trial at The Institute of Cancer Research, said: "This trial is the largest of its kind ever to be conducted worldwide. It is strategically important in helping to define best surgical practice for patients newly diagnosed with melanoma."

Added Mr Meirion Thomas, Royal Marsden consultant surgeon: "This is the first trial that has ever shown that the amount of normal-looking skin removed from around a melanoma influences the patient's outcome. An overview of this and similar trials suggests that the death rate from melanoma may be increased if the excision margin is too narrow."

This randomised trial which compared removal of a 1cm radius of normal-looking skin around the melanoma with a 3cm radius. It was carried out in patients with melanomas that were 2mm or greater in thickness. A total of 900 patients were entered into the trial, half into the 1cm margin and half into the 3cm margin group. It was found that patients with a 1cm margin were more likely to have a recurrence than those with a 3cm margin. The five-year recurrence rates in the two groups were 42 per cent and 36 per cent respectively. For every five recurrences in patients with a 1cm margin, there were four recurrences in patients with a 3cm margin. The precision with which this difference could be estimated by the trial implied that the true number of recurrences in patients with a 3cm margin lies between five and three recurrences for every five recurrences in patients with a 1cm margin.