ABSTRACT
Objective To evaluate the effect of surgery combined with aminolevulinic acid (ALA)-based photodynamic therapy (PDT) on the prognosis of extramammary Paget's disease.Methods A prospective open-labelled controlled trial was conducted.A total of 38 patients with pathologically comfirmed extramammary Paget's disease were enrolled from Shanghai Dermatology Hospital,and divided into 2 groups to be treated with surgery alone (surgery alone group,n =21) or surgery combined with ALA-PDT (combination group,n =17).Patients in the combination group received ALA-PDT after the surgery once every two weeks for 3 sessions.All the patients were followed up once every three months for more than 12 months,and the incidence of relapse was evaluated and compared between the 2 groups after the treatment.Results During the follow-up of 12-58 months (mean,35.45 ± 16.98 months),7 patients in the surgery alone group experienced relapse,and the median time to relapse was 9 months,with an upper quartile of 18 months and a lower quartile of 6 months.However,relapse only occurred in 1 patient in the combination group,and the time to relapse was 18 months after the end of treatment.The recurrence rate was significantly lower in the combination group than in the surgery alone group (P ＜ 0.05),and the time to relapse was also longer in the combination group than in the surgery alone group.Furthermore,ALA-PDT after the surgery was well tolerated in all the patients.Conclusion Surgery combined with ALA-PDT can reduce the recurrence rate of extramammary Paget's disease,and improve its prognosis.