Photodynamic therapy vs. cryosurgery of basal cell carcinomas: results of a phase III clinical trial

Background A previously reported randomized clinical trial showed treatment of Bowen's disease using photodynamic therapy (PDT) with topically applied delta -aminolaevulinic acid (ALA) to be at least as effective as cryosurge ry and to be associated with fewer adverse effects. Objectives To compare ALA-PDT and cryotherapy in the treatment of histopath ologically verified basal cell carcinomas (BCCs) in a non-blinded, prospect ive phase III clinical trial. Methods One lesion from each of 88 patients was included. The BCCs were div ided into superficial and nodular lesions. The follow-up period was restric ted to 1 year with close follow-up for the first 3 months. Efficacy was ass essed as the recurrence rate 12 months after the first treatment session, v erified by histopathology. Tolerability was evaluated as the time of healin g, pain and discomfort during and after the treatment, and final cosmetic o utcome. Results Histopathologically verified recurrence rates in the two groups wer e statistically comparable and were 25% (11 of 44) for ALA-PDT and 15% (six of 39) for cryosurgery. However, clinical recurrence rates were only 5% (t wo of 44) for PDT and 13% (five of 39) for cryosurgery. Additional treatmen ts, usually one, had to be performed in 30% of the lesions in the PDT group , The healing time was considerably shorter and the cosmetic outcome signif icantly better with PDT. Pain and discomfort during the treatment session a nd in the following week were low, and were equivalent with the two treatme nt modalities. Conclusions In terms of efficacy, ISLA-PDT is comparable with cryosurgery a s a treatment modality for BCCs. Retreatments are more often required with PDT than with cryosurgery, This can easily be performed due to the shorter healing time, less scarring and better cosmetic outcome that follows ALA-PD T.