Reinhold U, Philipp-Dormston W G, Dirschka T, Ostendorf R, Aschoff R, Berking C, Jäger A, Schmitz B, Foguet M, Szeimies R-M
MVZ Dermatological Center Bonn, Bonn, Germany.
Hautzentrum Köln, Cologne, Germany.
J Eur Acad Dermatol Venereol. 2024 Dec 12. doi: 10.1111/jdv.20452.
In actinic keratosis (AK), field cancerization describes areas of skin where multiple visible AK lesions are surrounded by healthy looking skin containing non-visible (subclinical) lesions. As all AK lesions have a risk of progression to cutaneous squamous cell carcinoma, experts advise field-directed treatment. Photodynamic therapy (PDT) is an effective field-directed treatment option for AK; however, long-term efficacy data are still scarce.
This publication presents follow-up data of a phase III study evaluating the efficacy and safety of field-directed PDT.
The study was conducted in seven centres in Germany. For PDT, participants with AKs on the face and scalp (treatment area of 20 cm) had received up to two field-directed PDTs using BF-200 ALA or placebo, and illumination with narrow-spectrum red light. Only participants or lesions with complete response 12 weeks after the last PDT were assessed for recurrences. The treatment area was evaluated 6 and 12 months after the last PDT for recurrence, cosmetic outcome and new lesions.
Fifty-four participants in the BF-200 ALA and 30 in the placebo group entered the follow-up. The probability of a participant to be initially completely cleared and to remain cleared for 12 months was 57.4% for BF-200 ALA versus 20.0% for placebo. The probability of a lesion to be initially cleared and remain cleared for 12 months was 85.4% for BF-200 ALA versus 31.5% for placebo. 83.3% of participants with cosmetic impairment at baseline rated the cosmetic outcome 12 months after PDT with BF-200 ALA as very good or good. All parameters of skin quality further improved during follow-up.
We showed that effectiveness of field-directed PDT with BF-200 ALA and narrow-spectrum red light was maintained during follow-up. Based on our results, field-directed PDT is a beneficial long-lasting treatment for AK patients.
2013-002510-12 (EudraCT); NCT01966120 (Clinicaltrials.gov).
在光化性角化病（AK）中，场癌化指的是皮肤区域，其中多个可见的AK病变被看似健康的皮肤所包围，而这些健康皮肤中含有不可见的（亚临床）病变。由于所有AK病变都有进展为皮肤鳞状细胞癌的风险，专家建议进行场定向治疗。光动力疗法（PDT）是一种有效的AK场定向治疗选择；然而，长期疗效数据仍然匮乏。
本出版物展示了一项评估场定向PDT疗效和安全性的III期研究的随访数据。
该研究在德国的七个中心进行。对于PDT，面部和头皮患有AK（治疗面积为20平方厘米）的参与者使用BF - 200 ALA或安慰剂接受了多达两次场定向PDT，并使用窄谱红光照射。仅对最后一次PDT后12周出现完全缓解的参与者或病变进行复发评估。在最后一次PDT后6个月和12个月对治疗区域进行复发、美容效果和新病变的评估。
BF - 200 ALA组有54名参与者和安慰剂组有30名参与者进入随访。BF - 200 ALA组参与者最初完全清除并在12个月内保持清除状态的概率为57.4%，而安慰剂组为20.0%。BF - 200 ALA组病变最初清除并在12个月内保持清除状态的概率为85.4%，而安慰剂组为31.5%。基线时有美容损伤的参与者中，83.3%将使用BF - 200 ALA进行PDT后12个月的美容效果评为非常好或好。在随访期间，皮肤质量的所有参数进一步改善。
我们表明，在随访期间，使用BF - 200 ALA和窄谱红光进行场定向PDT的有效性得以维持。基于我们的结果，场定向PDT对AK患者是一种有益的长期治疗方法。
2013 - 002510 - 12（欧盟临床试验数据库）；NCT01966120（Clinicaltrials.gov）。
