Lessons learned: 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.
Background: 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.
Methods: 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.
Results: 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, p = .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.
Conclusion: Adapalene is not recommended as prophylaxis against acne-like rash induced by anti-EGFR therapies.
临床试验结果
经验获取
APPEARANCE试验的结果表明，与安慰剂相比，阿达帕林并不能预防痤疮样皮疹，当添加到局部保湿剂和口服米诺环素中时，反而可能会产生有害影响。因此，不推荐使用阿达帕林预防由抗表皮生长因子受体疗法诱发的痤疮样皮疹。
由于大约一半的患者使用安慰剂完全控制了痤疮样皮疹，因此需要采取预测措施来确定需要强化预防的患者。
摘要
背景。抗表皮生长因子受体 (EGFR) 疗法经常与痤疮样皮疹相关。为了评估阿达帕林(一种治疗寻常痤疮的一线局部维甲酸类药物)的预防效果，我们进行了以安慰剂作为对照的评估者盲性左右对比随机试验。
方法。我们对计划接受抗EGFR疗法的非小细胞肺癌、结直肠癌或头颈癌患者进行了随机分配，一侧脸部每天涂抹一次阿达帕林，另一侧每天涂抹一次安慰剂。所有患者均在面部两侧涂抹了局部保湿剂，并口服米诺环素。主要终点是 4 周时面部痤疮样皮疹病变总数的差异。次要终点包括 4 周时痤疮样皮疹(≤5 处面部病变)的完全控制率 (CCR) 和总体皮肤评估 [研究者总体评估 (IGA)评分，0–4 级]。两位不知情的皮肤科医生独立评估了照片中的终点。
结果。共招募了 36 名患者，其中 26 名可评估。4 周时，与安慰剂相比，使用阿达帕林进行治疗产生的病变数更多，但该差异并无统计学意义(平均值，12.6 vs. 9.8，p = 0.12)。所有四名面部病变数差异 >10 的患者中，阿达帕林治疗侧的病变数更大。未观察到阿达帕林与安慰剂侧之间的痤疮样皮疹CCR(54% vs. 50%)或IGA评分(平均等级，1.9 vs. 1.7)存在显著差异。
结论。不推荐使用阿达帕林预防抗EGFR诱发的痤疮样皮疹。
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