Division of Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan.
Division of Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan
Oncologist. 2019 Jul;24(7):885-e413. doi: 10.1634/theoncologist.2019-0156. Epub 2019 Mar 19.
The results of the APPEARANCE trial indicate that adapalene does not prevent acne-like rash over placebo when added to topical moisturizer and oral minocycline but instead may have a detrimental effect. Therefore, adapalene is not recommended as prophylaxis against acne-like rash induced by anti-epidermal growth factor receptor therapies.Given that acne-like rash was completely controlled with placebo in approximately half of patients, predictive measures to identify patients needing intensive prophylaxis are required.
Anti-epidermal growth factor receptor (EGFR) therapies are frequently associated with acne-like rash. To evaluate the prophylactic efficacy of adapalene, a topical retinoid used as first-line therapy for acne vulgaris, we conducted a randomized, placebo-controlled, evaluator-blinded, left-right comparative trial.
Patients with non-small cell lung, colorectal, or head and neck cancer scheduled to receive anti-EGFR therapies were randomly assigned to once-daily adapalene application on one side of the face, with placebo on the other side. All patients had topical moisturizer coapplied to both sides of the face, and received oral minocycline. The primary endpoint was the difference in total facial lesion count of acne-like rash at 4 weeks. Secondary endpoints included complete control rate (CCR) of acne-like rash (≤5 facial lesions) and global skin assessment (Investigator's Global Assessment [IGA] scale, grade 0-4) at 4 weeks. Two blinded dermatologists independently evaluated the endpoints from photographs.
A total of 36 patients were enrolled, of whom 26 were evaluable. Adapalene treatment was associated with a greater lesion count than placebo at 4 weeks, although the difference was not statistically significant (mean, 12.6 vs. 9.8, = .12). All four patients with a difference >10 in lesion count between face sides had a greater count on the adapalene-treated side. No significant differences were observed in CCR of acne-like rash (54% vs. 50%) or IGA scale (mean grade, 1.9 vs. 1.7) between the adapalene and placebo sides.
Adapalene is not recommended as prophylaxis against acne-like rash induced by anti-EGFR therapies.
APPEARANCE 试验的结果表明，当阿达帕林与局部保湿剂和口服米诺环素联合使用时，并不会预防安慰剂样痤疮样皮疹，反而可能有不良影响。因此，不建议将阿达帕林用于预防表皮生长因子受体治疗引起的痤疮样皮疹。
鉴于大约一半的患者使用安慰剂可完全控制痤疮样皮疹，因此需要预测措施来识别需要强化预防的患者。
表皮生长因子受体（EGFR）治疗常伴有痤疮样皮疹。为了评估阿达帕林（一种用于治疗寻常痤疮的一线外用维 A 酸）的预防疗效，我们进行了一项随机、安慰剂对照、评估者盲法、左右侧比较试验。
计划接受抗 EGFR 治疗的非小细胞肺癌、结直肠癌或头颈部癌患者被随机分配至一侧面部每天应用阿达帕林，另一侧面部应用安慰剂。所有患者均在两侧面部同时使用局部保湿剂，并接受口服米诺环素。主要终点为 4 周时痤疮样皮疹的总面部皮损计数的差异。次要终点包括痤疮样皮疹的完全控制率（CCR，≤5 个面部皮损）和 4 周时的整体皮肤评估（研究者全球评估[IGA]量表，0-4 级）。两位盲法皮肤科医生独立根据照片评估终点。
共纳入 36 例患者，其中 26 例可评估。4 周时，阿达帕林治疗组的皮损计数大于安慰剂组，但差异无统计学意义（平均 12.6 对 9.8， = .12）。在面部两侧皮损计数差异>10 的 4 例患者中，阿达帕林治疗侧的皮损计数均更大。痤疮样皮疹的 CCR（54%对 50%）或 IGA 量表评分（平均等级，1.9 对 1.7）在阿达帕林组和安慰剂组之间无显著差异。
不建议将阿达帕林用于预防表皮生长因子受体治疗引起的痤疮样皮疹。
