Imiquimod Fails To Match Surgery For Basal-Cell Carcinoma Treatment

Fewer patients achieve clinical success with imiquimod cream than with surgical excision for low-risk basal-cell carcinoma

medwireNews: Imiquimod cream has failed to meet non-inferiority criteria when tested against surgical excision in a randomised controlled trial of patients with low-risk basal-cell carcinoma.

However, the overall 3-year success rate of imiquimod was, at 84%, “clinically useful”, according to the researchers, and it had slightly better cosmetic outcomes.

Also, surgical excision in the trial was performed by dermatologists. The research team, led by Hywel Williams from the University of Nottingham in the UK, points out that the clinical success rate of dermatologists is not usually matched in primary care, so imiquimod could be equally effective in this setting.

In a commentary accompanying the study in The Lancet Oncology, John Lear, from the University of Manchester, UK, says that imiquimod currently “seems to be the front runner” for topical treatment of superficial basal-cell carcinoma, although he cautions that this is based on the results of just one study.

The current trial involved 188 patients who underwent surgical excision and 213 who received imiquimod 5% cream. Those using imiquimod applied it once daily for a total of 6 weeks in the case of superficial basal-cell carcinoma (51% of all patients) or 12 weeks for nodular basal-cell carcinoma.

John Lear comments that remarkably few trials have compared common basal-cell carcinoma therapies, with most of these being for product registration purposes. “Consequently, clinicians have had little comparative data on which to base their decision making in treatment of low-risk basal-cell carcinoma.”

In this trial, imiquimod failed to meet the prespecified margin for non-inferiority to surgical excision at 1, 2 and 3 years of follow-up. At 3 years, 83.6% of patients in the intention-to-treat analysis who used imiquimod had no signs of initial treatment failure or subsequent local recurrence, compared with 98.4% of those who underwent surgical excision. Results were similar for superficial and nodular basal-cell carcinoma and for patients in the per-protocol analysis.

In terms of cost-effectiveness, the two procedures were broadly similar, with the higher initial costs of surgery being partly offset by factors including the lower efficacy of imiquimod.

The patients were happy with their cosmetic outcomes regardless of the treatment used, but independent dermatologists using digital images rated cosmetic outcomes significantly better for imiquimod than surgical excision.

The researchers conclude: “Excisional surgery remains the best treatment for low-risk basal-cell carcinoma, but other factors, such as patient choice, size and site of the lesion, and whether the patient has more than one lesion, might allow alternative treatments such as imiquimod cream, fluorouracil cream, and photodynamic therapy to be considered.”

References

Bath-Hextall F, Ozolins M, Armstrong SJ, et al. Surgical excision versus imiquimod 5% cream for nodular and superficial basal-cell carcinoma (SINS): a multicentre, non-inferiority, randomised controlled trial. Lancet Oncol; Advance online publication 11 December 2013. doi:10.1016/S1470-2045(13)70530-8.

Lear JT. Evidence-based treatment for low-risk basal cell carcinoma. Lancet Oncol; Advance online publication 11 December 2013. doi:10.1016/S1470-2045(13)70582-5.

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