Surgery against radiotherapy for basal cell carcinoma of the face

This is the trial that decides the order of the two curative treatments for basal cell carcinoma, and it has never been repeated. Beginning in 1982, the Institut Gustave Roussy randomised 347 patients with a primary facial basal cell carcinoma of less than 4 cm to surgery or radiotherapy. In the surgery arm 71 per cent had local anaesthesia and 91 per cent had frozen section examination of the margin. The radiotherapy arm reflects French practice of the period: 55 per cent interstitial brachytherapy, 33 per cent contact therapy and 12 per cent conventional external beam.

The four-year actuarial failure rate, counting persistent as well as recurrent disease, was 0.7 per cent after surgery (95 per cent confidence interval 0.1 to 3.9) against 7.5 per cent after radiotherapy (4.2 to 13.1), log-rank p=0.003.

The cosmetic comparison was done carefully, with five judges including three people not involved in the trial rating standardised photographs. Four of the five rated surgery significantly better. Eighty-seven per cent of the surgical patients and 69 per cent of the irradiated patients called the cosmetic result good (p<0.01); by the dermatologist's rating it was 79 against 40 per cent. A later analysis of the same cohort showed why the gap widens: appearance improves in the years after surgery and stays the same or deteriorates after radiotherapy, because radiation changes the skin permanently. The exception was the nose, where the difference still favoured surgery but was not significant.

Radiotherapy remains the right treatment for people in whom an operation would be mutilating or is refused, for those too frail for surgery, and after incomplete excision where re-operation is not possible. This trial is why it is second and not first.