Long-Term Efficacy of Photodynamic Therapy with Fractionated 5-Aminolevulinic Acid 20% versus Conventional Two-Stage Topical Methyl Aminolevulinate for Superficial Basal-Cell Carcinoma

Abstract

<b><i>Background:</i></b> Photodynamic therapy (PDT) is a noninvasive treatment for patients with superficial basal-cell carcinoma (sBCC). The efficacy of PDT may vary with different photosensitizers and treatment schedules. <b><i>Objective:</i></b> Our objective was to evaluate whether fractionated 5-aminolevulinic acid 20% (ALA)-PDT is superior to conventional two-stage methyl aminolevulinate (MAL)-PDT for sBCC. <b><i>Methods:</i></b> We present the 5 years results of a single-blind, randomized, multicenter trial. 162 patients with a histologically confirmed primary sBCC were randomized to fractionated ALA-PDT or MAL-PDT. <b><i>Results:</i></b> The 5-year tumor-free survival rate was 70.7% (95% CI 58.2–80.1%) for ALA-PDT and 76.5% (95% CI 64.4–85.0%) for MAL-PDT. In the first 3 years, there was no significant difference in risk of treatment failure (HR = 1.53, <i>p</i> = 0.283), but in the long-term, the risk of recurrence was significantly lower following MAL-PDT compared to ALA-PDT (HR = 0.125, <i>p</i> = 0.049). As judged by patients, the esthetic result was good-excellent in 96.8% (61/63) and 94.4% (56/59) of patients treated with ALA-PDT and MAL-PDT, respectively (<i>p</i> = 0.631). <b><i>Conclusion:</i></b> The long-term efficacy is significantly higher for conventional two-stage MAL-PDT than for fractionated ALA-PDT, whereas there was no significant difference in esthetic outcome between the treatments at 5 years after treatment. These results indicate that fractionated ALA-PDT offers no benefit over conventional two-stage MAL-PDT.

Photodynamic Therapy for the Treatment of Basal Cell Carcinoma: A Comprehensive Review of Randomized Controlled Trials

“…For inclusion, histological confirmation of the BCC was required in all studies [ 33 – 47 , 49 ] except for one which this was not reported [ 48 ]. As presented in table 1 , for the assessment of response to treatment, clinical evaluation was the main method with histological confirmation to be utilized only in cases of residual or recurrent lesions [ 33 , 34 , 36 – 42 ]. Some trials used clinical evaluation alone [ 43 – 45 , 47 ] or clinical and histological together [ 35 , 46 ] for the confirmation of treatment response.…”

“…Interestingly, data from another study exhibited lower recurrence rates at 5 years of follow-up after conventional two-stage MAL-PDT compared to fractionated ALA-PDT, although no significant risk of treatment failure was observed in the first 3 years. For both interventions the aesthetic results were rated as good-to-excellent for more than 90% of patients [ 33 , 34 ]. Salimvuory et al compared MAL-PDT, ALA-PDT and hexaminolevulinate (HAL)-PDT and showed no differences in the efficacy and safety between the arms but with a short duration of follow-up at 3 months [ 35 ].…”

The impact of photodynamic therapy on immune system in cancer – an update

“…In this study, MAL therapy was proven to be more effective than ALA. It is worth to say that the cosmetic outcome was similar in both therapies (82). However, another study that compares the histological clearance, tolerability and cosmetic outcome of MAL, BF-200 ALA, and lowconcentration Hexyl aminolevulinate (HAL) in the PDT of non aggressive BCC.…”

New, simplified versus standard photodynamic therapy (PDT) regimen for superficial and nodular basal cell carcinoma (BCC): A single-blind, non-inferiority, randomised controlled multicentre study

“…promising short-term complete response rates of up to 80%-95% [15,29]. However, a recent study on the long-term efficacy of fractionated ALA-PDT versus conventional double MAL-PDT showed fractionated PDT to be less effective [30].…”