Department of Dermatology, College of Medicine, Dong-A University, Busan, Republic of Korea.
JAMA Dermatol. 2017 Mar 1;153(3):289-295. doi: 10.1001/jamadermatol.2016.4463.
Surgical excision is the standard treatment for cutaneous squamous cell carcinoma (SCC). However, microinvasive SCC (Clark level II) is limited to the papillary dermis, and it should be differentiated from invasive SCC. Ablative fractional laser-primed photodynamic therapy (AFL-PDT) may have enhanced efficacy.
To compare 1 session of AFL-PDT with 2 sessions of conventional methyl aminolevulinate-PDT (MAL-PDT) for the treatment of microinvasive SCC.
DESIGN, SETTING, AND PARTICIPANTS: A 2-armed, randomized, single-blind, comparative trial of 45 patients with histologically proven microinvasive SCC. Twenty-one patients were randomized to treatment with a single AFL-PDT session, and 24 patients were randomized to 2 MAL-PDT sessions with a 1-week interval between sessions using a computer-generated program. Standard pretreatment such as curettage was not performed prior to PDT owing to a tendency to bleed. The efficacy, recurrence rate, cosmetic outcomes, and safety were assessed 1 week, 3, 12, and 24 months after the last treatment.
AFL was performed with an ablation depth of 550 µm to 600 µm, coagulation level of 1, treatment density of 22%, and a single pulse. Then, MAL cream was applied under occlusion for 3 hours and illuminated by using a red light-emitting diode light at 37 J/cm2. A second session of MAL-PDT was administered after 7 days.
The primary outcome measures were the lesion response at 3 and 12 months, and the recurrence rate 12 months after the last treatment.
Twenty-one patients (6 men, 15 women) with a mean (SD) age of 76 (6) years were randomized to treatment with a single AFL-PDT session, and 24 patients (11 men, 13 women) with a mean (SD) age of 75 (6) years were randomized to 2 MAL-PDT sessions. The overall complete response rates 3 months after treatment were 84.2% with AFL-PDT and 52.4% with MAL-PDT (P = .03). These differences in efficacy remained significant at the 24-month follow-up. The recurrence rate was significantly lower with AFL-PDT (12.5%) than with MAL-PDT (63.6%) at 24 months (P = .006). AFL-PDT and MAL-PDT did not differ significantly with respect to the cosmetic outcomes, adverse events, or pain intensity.
AFL-PDT can be used as an alternative treatment option for patients with microinvasive SCC who are not suitable for surgical treatment.
clinicaltrials.gov Identifier: NCT02666534.
手术切除是皮肤鳞状细胞癌（SCC）的标准治疗方法。然而，微侵袭性 SCC（Clark Ⅱ级）局限于乳头真皮，需要与侵袭性 SCC 相鉴别。光动力疗法（PDT）联合消融性分数激光可能具有增强疗效。
比较单次消融性分数激光-PDT（AFL-PDT）与 2 次传统的甲氨基酮戊酸-PDT（MAL-PDT）治疗微侵袭性 SCC 的疗效。
设计、地点和参与者：这是一项 2 臂、随机、单盲、对照临床试验，纳入了 45 例组织学证实的微侵袭性 SCC 患者。21 例患者随机接受单次 AFL-PDT 治疗，24 例患者随机接受 2 次 MAL-PDT 治疗，两次治疗间隔 1 周。由于有出血倾向，PDT 治疗前未行常规刮除术等预处理。末次治疗后 1 周、3 个月、12 个月和 24 个月评估疗效、复发率、美容效果和安全性。
AFL 治疗的消融深度为 550-600μm，凝固水平为 1，治疗密度为 22%，单次脉冲。然后，MAL 乳膏避光封包 3 小时，用红色发光二极管光以 37 J/cm2 光照。7 天后进行第二次 MAL-PDT 治疗。
主要结局指标为治疗后 3 个月和 12 个月的皮损反应，末次治疗后 12 个月的复发率。
21 例（6 例男性，15 例女性）患者平均（SD）年龄为 76（6）岁，随机接受单次 AFL-PDT 治疗，24 例（11 例男性，13 例女性）患者平均（SD）年龄为 75（6）岁，随机接受 2 次 MAL-PDT 治疗。治疗后 3 个月的总完全缓解率，AFL-PDT 为 84.2%，MAL-PDT 为 52.4%（P=0.03）。这些疗效差异在 24 个月的随访中仍然显著。AFL-PDT 的复发率为 12.5%，明显低于 MAL-PDT 的 63.6%（P=0.006）。AFL-PDT 和 MAL-PDT 在美容效果、不良反应或疼痛强度方面无显著差异。
AFL-PDT 可作为不适合手术治疗的微侵袭性 SCC 患者的替代治疗选择。
clinicaltrials.gov 标识符：NCT02666534。
