A trial looking at treatment for basal cell skin cancer (SINS)

Cancer type:

Basal cell skin cancer

Non melanoma skin cancer

Skin cancer

Status:

Results

Phase:

Phase 3

This trial compared surgery with imiquimod (Aldara) for basal cell skin cancer. This trial was supported by Cancer Research UK.

Basal cell skin cancer (also called basal cell carcinoma or BCC) is the most common form of skin cancer. It usually grows slowly, and rarely spreads. BCCs are often removed with surgery.

Imiquimod (Aldara) is a cream that stimulates the immune system. This means it uses the body’s natural defences to kill the cancer cells in the skin.

The aim of this trial was to compare surgery and imiquimod for the treatment of superficial and nodular BCC. So patients in future might not always have to have an operation to remove their BCC. The doctors didn’t think that imiquimod would be better than surgery, but they wanted to see exactly how good it was against the gold standard treatment Open a glossary item of surgery and to see if the cosmetic outcome was any better.

Summary of results

The trial team found that imiquimod didn’t work as well as surgery for basal cell carcinoma.

This was a phase 3 trial. It recruited 501 people. It was a randomised trial.

254 people were to have imiquimod
247 people were to have surgery

After 3 years they were able to look at the results of 401 people. In the group who had imiquimod, 178 out of 213 were successfully treated (84%). In the group who had surgery, 185 out of 188 were successfully treated (98%).

At 6 months, and 3 years, the researchers asked people to rate the cosmetic appearance of the treatment area. Both groups rated the cosmetic appearance highly (excellent or good).

They also showed pictures of the treatment areas to 2 doctors who specialise in skin conditions (dermatologists) and asked them to rate the cosmetic appearance. The pictures weren’t identified with which treatment the person had. Both dermatologists significantly favoured the cosmetic appearance of those treated with imiquimod.

The most common side effects of imiquimod were

Itchy, red, sore skin at the tumour site
Weeping and scabbing at the tumour site
Flu like symptoms and feeling unwell

The most common complications of surgery were

Itching at the tumour site
Weeping at the tumour site

The trial team concluded that surgery remained the best treatment for basal cell carcinoma. But imiquimod cream might still be a useful treatment for small basal cell carcinomas when factors such as patient preference, the size, number and location of tumours were considered.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.