Surgery vs imiquimod for nodular and superficial basal cell carcinoma (SINS)
The SINS trial compared excisional surgery (standard treatment) with imiquimod 5% cream for nodular and superficial basal cell carcinoma. Although basal cell carcinoma rarely spreads, it can be disfiguring and is one of the commonest skin cancers.
Although imiquimod is known not to be as successful as surgery (we are looking to see if it is “non-inferior”), it may have other benefits in terms of cosmetic appearance outcome, application at home and cost. This study set out to compare various outcomes between the two treatments with long-term follow up of three years in clinic, and five years from patient records.
This randomised, controlled clinical trial was led by Dr Fiona Bath-Hextall and Professor Hywel Williams at the University of Nottingham.
Background
Key facts
1. What interventions did the SINS trial test?
The study compared imiquimod 5% cream to surgical excision using a 4mm margin for superficial and nodular basal cell carcinoma.
2. How many patients took part?
A total of 501 participants took part.
3. What were the main findings?
There was little difference in cost between the two treatments but more patients had their BCC successfully treated by surgery than imiquimod. However, the results showed that imiquimod might still be a useful treatment for smaller, lower risk BCCs and for patients who would prefer not to have surgery.
- Three years after starting treatment 83.6% of patients who had used imiquimod were treated successfully compared to 98.4% who received surgery to remove their BCC
- These results show that the treatments could not be considered to be equivalent to each other
- Most imiquimod treatment failures occurred in the first year
- More patients being treated with imiquimod experienced pain during their actual treatment but more patients being treated by surgery experienced pain during their follow up
- The commonest adverse events for imiquimod were itching (83% patients) and weeping (63% patients)
- There were no serious adverse events related to either of the treatments
- Patients felt their cosmetic appearance after treatment was similar for surgery and imiquimod. When photographs of the patients were reviewed by dermatologists they felt that imiquimod gave a better cosmetic outcome following treatment of the BCC than surgery.
4.Why is the research important?
A topical treatment such as imiquimod that could be applied at home with acceptable success rates and low side effects, might offer an alterative and cost-effective way of dealing with a least some of the people with BCCs that contribute to the heavy work load for current health services.
5. How was the trial funded?
The main funding for the trial was from Cancer Research UK.
A small local R&D grant was provided (£6490, 2002-2007). The imiquimod cream, plus funding for a genetic markers addendum was provided by Meda (previously 3M).
Publications
Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial. J Invest Dermatol. 2017 Mar;137(3):614-619
Surgical excision versus imiquimod 5% cream for nodular and superficial basal-cell carcinoma (SINS): a multicentre, non-inferiority, randomised controlled trial. The Lancet Oncology, Volume 15, Issue 1, pp 96-105, January 2014
What determines patient preferences for treating low risk basal cell carcinoma when comparing surgery vs imiquimod? A discrete choice experiment survey from the SINS trial.
BMC Dermatology. 2012, 12:19.
The SINS trial: A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma. Trials, 2010, 11(1), 42