Univ. Lille, INSERM, CHU Lille, U1189 - ONCO-THAI - Image Assisted Laser Therapy for Oncology, F-59000, Lille, France.
Department of Dermatology, CHU Lille, F-59000, Lille, France.
Br J Dermatol. 2019 Apr;180(4):765-773. doi: 10.1111/bjd.17350. Epub 2019 Jan 18.
Photodynamic therapy (PDT) is an effective treatment for actinic keratosis (AK), particularly for patients with large areas of field cancerization. Among the approved protocols in Europe, the most widely used requires irradiation with the Aktilite CL 128 lamp. However, pain during irradiation and the suboptimal adaptability of the lamp relative to the treatment area are two limiting factors of this protocol. To overcome these limits, a new protocol (referred to as the Flexitheralight protocol) involving irradiation with a light-emitting, fabric-based device was developed.
This paper aims to assess the noninferiority, in terms of PDT efficacy for treating AK, of the Flexitheralight protocol compared with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp.
A monocentric, randomized, controlled, phase II clinical study was performed. Twenty-five patients with grade I-II AKs of the forehead and scalp were treated with methyl aminolaevulinate PDT in two symmetrical areas. One area was treated with the conventional protocol (n = 154 AKs), whereas the other area was treated with the Flexitheralight protocol (n = 156 AKs). The primary end-point was the lesion complete response (CR) rate at 3 months (an absolute noninferiority margin of -10% was used). The secondary end-points included patient-reported pain at the end of the irradiation.
At 3 months, the lesion CR rate with the Flexitheralight protocol was noninferior to that obtained with the conventional protocol (66·0% vs. 59·1%, respectively; absolute difference, 6·9%; 95% confidence interval -0·6% to 14·5%). Patient-reported pain was significantly lower with the Flexitheralight protocol than with the conventional protocol (mean ± SD: 0·4 ± 0·6 vs. 5·0 ± 2·6; P < 0·0001).
The Flexitheralight protocol is noninferior in terms of efficacy and superior in terms of tolerability to the conventional protocol for treating AKs of the forehead and scalp.
光动力疗法（PDT）是一种治疗光化性角化病（AK）的有效方法，尤其适用于大面积癌前病变的患者。在欧洲批准的方案中，使用最广泛的方案是用 Aktilite CL 128 灯进行照射。然而，在照射过程中疼痛以及灯相对于治疗区域的适应性不理想是该方案的两个限制因素。为了克服这些限制，开发了一种新的方案（称为 Flexitheralight 方案），涉及使用发光的织物基设备进行照射。
本研究旨在评估 Flexitheralight 方案在治疗 AK 的 PDT 疗效方面与传统方案（用 Aktilite CL 128 灯照射）的非劣效性。
进行了一项单中心、随机、对照、II 期临床研究。25 例额部和头皮 I-II 级 AK 患者，采用 5-氨基酮戊酸 PDT 治疗，在两个对称区域进行。一个区域采用传统方案（n = 154 个 AK）治疗，另一个区域采用 Flexitheralight 方案（n = 156 个 AK）治疗。主要终点是 3 个月时的病变完全缓解（CR）率（使用 -10%的绝对非劣效性边界）。次要终点包括照射结束时患者报告的疼痛。
3 个月时，Flexitheralight 方案的病变 CR 率不劣于传统方案（分别为 66.0%和 59.1%，绝对差值为 6.9%；95%置信区间 -0.6%至 14.5%）。Flexitheralight 方案的患者报告疼痛明显低于传统方案（平均值 ± 标准差：0.4 ± 0.6 与 5.0 ± 2.6；P < 0.0001）。
Flexitheralight 方案在治疗额部和头皮 AK 的疗效方面不劣于传统方案，在耐受性方面优于传统方案。
