A non-surgical treatment for basal cell skin cancer results in better cosmetic results but might be less effective than surgery at preventing the disease from returning, a study found.
The treatment is called photodynamic therapy and uses skin cream and concentrated light to activate the cream, which kills cancer cells. It is used in Europe, Australia and New Zealand, but a Food and Drug Administration advisory committee last year recommended against U.S. approval.
Basal cell skin cancer, often caused by overexposure to sunlight, is diagnosed in about 2 million people worldwide each year, making it among the most common cancers. It is also among the most curable. Surgical removal is generally the preferred treatment, but since basal cell cancers typically appear on or around the face, some patients worry about scarring.
The new study, published in Monday's Archives of Dermatology, involved 101 patients who received either surgery or two treatment sessions a week apart with Metvix, also known as methyl aminolevulinate cream.
Two years later, cosmetic results from the Metvix treatment got higher marks from patients and doctors, but five cancers treated with Metvix had recurred, compared with one among the surgery patients.
The FDA has approved similar therapy for precancerous skin lesions. But an FDA advisory committee recommended against approval of Metvix after deciding the benefits did not outweigh the risks of recurrence.
PhotoCure of Oslo, Norway, which makes Metvix and funded the study, is challenging the committee's findings. The company has "shown efficacy and safety ... everything that is required" for U.S. approval, said Dr. Vidar Hansson, PhotoCure president.
Hansson said the true cancer-recurrence rates for the two treatments might be closer to each other than the study indicates, because data on several patients in both groups was missing.
Study author Dr. Lesley Rhodes of Hope Hospital in Salford, England, and colleagues said that Metvix might still be preferable for patients who prefer an "excellent cosmetic outcome" over surgery.
Hansson said Metvix treatment can be repeated if cancer recurs.