Imiquimod therapy: Effective off-label for nodular, morpheiform BCCs, SCC

December 1, 2008

Off-label use of imiquimod proves extremely effective for nodular and morpheiform BCCs as well as SCCs, arecent study indicates. According to one expert, long-term immune modulation therapy with imiquimod can significantly benefit patients with chronic actinic dysplasias and skin tumors.

Key Points

Recent results of a study prove that topical imiquimod can be very effective and safe in the treatment of not only nodular BCCs and SCCs, but also morpheiform BCCs.

Bruce L. Warshauer, M.D., of the Center of Pediatric, Adolescent and Adult Dermatology, Point Pleasant, N.J., conducted a chart review, retrospective analysis of 108 patients with a total 122 tumors whom he had treated with topical imiquimod between 1997 and 2007.

"I found that the there was a tremendous cure rate with the use of imiquimod for the treatment of these large and, sometimes, deeply invasive tumors, such as the morpheiform BCCs.

"These tumors are notoriously more difficult to treat, because they have finger-like projections of tumor cell islands that sometimes create a fibrous stroma around them, which makes it difficult to reach a tumor clearance," Dr. Warshauer tells Dermatology Times.

Study results

Study results showed that the overall initial tumor clinical cure rate was 93.4 percent (114/122), with an initial clinical cure rate of 90 percent (72/80) for BCCs combined and 100 percent (42/42) for SCCs combined.

Over the follow-up period, there was only one recurrence in the 114 tumors that were initially cured with imiquimod treatment.

The study was unique because Dr. Warshauer was able treat with imiquimod as long as needed to achieve clinical clearance of the tumors.

Success rate

According to Dr. Warshauer, dermatologists have a 92 percent success rate in achieving a clinical cure.

In some high-risk tumors that were especially challenging and in all of the morpheiform lesions, Dr. Warshauer performed biopsies that confirmed in all cases the clinical assessment of tumor clearance.

However, all of the tumor sites remained intact, allowing Dr. Warshauer to continue to follow the patients, sometimes years after clinical clearance.

Including drug holiday periods (because of the sometimes intense inflammatory reaction), the treatment duration ranged from three to 60 weeks for nodular BCCs, two to 36 weeks for SCCs, and five to 89 weeks for morpheiform BCCs.

Compliance

Dr. Warshauer says compliance was not an issue, because patients who had to apply the cream for an extended period of time had quite large tumors, many of which were on the face and two of which were recurrent tumors previously treated with Mohs surgery.

Therefore, patients took the therapy seriously and follow-up visits were strictly held.

Imiquimod is an important treatment to help patients for whom actinic dysplasias, BCC and SCC are an ongoing process, he says.

Immune system

According to Dr. Warshauer, activating the immune system in a chronic fashion can be a useful long-term treatment in those patients who have chronic dysplasia.

"In my skin type I patients in whom dysplasia is really persistent and chronic, I am using imiquimod on an ongoing basis, like three times a month.

"This novel topical immune therapy activates genes and suppresses others that are related to the induction of skin cancer, and over the long haul, the benefits are very real for my patients," Dr. Warshauer says.

Disclosure: Dr. Warshauer was a member?of the speakers' bureau for 3M and Graceway Pharmaceuticals and has received compensation as a consultant for both companies.