No abstract

The twofold ALA-PDT scheme resulted in fewer recurrences, although the difference between both treatment groups was not statistically significant. However, ALA-PDT resulted in higher pain scores and more post-treatment side-effects compared with MAL-PDT.

<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.

Summary 光动力疗法(PDT)常用于治疗表浅性基底细胞癌(sBCC)。它通过将卟啉前体膏涂抹于所影响的皮肤部位,并盖上敷料来治疗。几小时后揭开闭合的敷料,使用高强度的可见光照射皮肤部位,使癌细胞死亡。荷兰有两种卟啉前体,分别为5‐氨基酮戊酸20% (ALA)和氨基乙酰丙酸甲酯(MAL)。在传统MAL PDT中,皮肤每隔一周照射一次(光治疗)。对于ALA,皮肤每隔两小时接受两次不同的照射。这被称为分级ALA‐PDT。在这项来自荷兰的研究中,我们调查了这种分级ALA‐PDT是否优于传统MAL‐PDT。162名患者被随机分成两组。82名患者使用分级ALA‐PDT治疗,80名患者使用传统MAL‐PDT。12个月后,ALA‐PDT组有6起治疗失败(sBCC复发),MAL‐PDT组有13起治疗失败。尽管MAL‐PDT组的治疗失败数量高出一倍,但这一差异不具有统计显著性。其次,我们调查了两个治疗组的疼痛分数,因为PDT据悉会引起严重的灼烧感。我们发现与MAL‐PDT相比,ALA‐PDT会导致更剧烈的疼痛和更多副作用,例如红斑(红疹,如晒斑)、伤口/糜烂和囊泡(小水泡)。因此,对于治疗sBCC,相比MAL‐PDT,ALA‐PDT趋向于有更好的疗效,尽管差异并不显著。