Study Shows New Topical Immunotherapy May Help in Fight Against Early Skin Cancer

The combination of two topical drugs has shown a strong immune response in reducing precancerous skin lesions, according to a study published in the Journal of Clinical Investigation.

Researchers from Washington University School of Medicine in St. Louis and Harvard Medical School studied 132 patients with actinic keratosis, often found on sun-damaged skin and a precursor to squamous cell carcinoma, the second most common form of skin cancer, as reported in a press release.

They used a cream that consisted of a chemotherapy drug called 5-fluorouracil (5-FU) with a synthetic form of vitamin D called calcipotriol. The study notes that topical 5-FU alone is prescribed to treat actinic keratosis, while calcipotriol is approved by the U.S. Food and Drug Administration (FDA) for treatment of psoriasis.

Sixty-five of the patients received the investigational drug combination, and 67 received the standard 5-FU plus Vaseline petroleum jelly, serving as a control group. Each patient was told to use the cream twice daily for four days, a shorter time period than 5-FU alone, which is two to four weeks.

All of the patients had similar numbers of precancerous lesions with sun-damaged skin that were found on the face, scalp and arms. On average, there were 15 lesions on the face, 22 on the scalp, 14 on the right arm and 12 the left arm, the release said.

Overall, following treatment, facial lesions were reduced by almost 88 percent compared with a 26 percent reduction in the control group using standard chemotherapy. There was a 76 percent reduction on the scalp in the investigational group compared with about 6 percent in the control group. On the right arm, precancerous lesions were reduced by 69 percent compared with about 10 percent, and the left arm was 79 percent versus 16 percent.

“Our study shows this combination therapy is more effective and better tolerated than current treatment practices,” Lynn Cornelius, M.D., director of the Division of Dermatology at Washington University and co-author on the study, said in the release.

She also noted that the investigational therapy activates the immune system’s T cells, which then attack the abnormal skin cells.

“The idea behind this study was to induce a heightened immune response in the skin using calcipotriol combined with the 5-fluorouracil that works to destroy the precancerous cells,” she stated in the release. “In so doing, the destroyed precancerous cells release cell proteins, or antigens, and facilitate the heightened immune system to respond.”

Patients who participated in the study experienced some side effects. Both groups experienced skin scaling and itching, while the investigational group reported more redness and increased burning sensations.

The study also noted that patients who had been previously treated with conventional therapies had decreased pain and discomfort after treatment with the investigational drug combination.

The authors on the study plan to further studies by re-contacting the patients examined to determine whether there are differences in precancerous and skin cancer rates between the two treatment groups.