Division of Dermatology, Rabin Medical Center, Petah Tikva, Israel,
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel,
Dermatology. 2021;237(6):988-994. doi: 10.1159/000511869. Epub 2020 Dec 30.
The incidence of epidermal growth factor receptor inhibitor (EGFRI)-induced papulopustular rash is 60-85%.
To investigate prophylactic topical treatment for EGFRI-induced rash.
A single-center, randomized, double-blind, placebo-controlled trial. Adult cancer patients initiating treatment with EGFRIs were randomized to receive facial topical treatment with chloramphenicol 3% + prednisolone 0.5% (CHL-PRED) ointment, chloramphenicol 3% (CHL) ointment, or aqua cream (AQUA). The primary end points were the incidence of ≥grade 3 rash using the Common Terminology Criteria for Adverse Events (CTCAE), on days 14 and 30. A subanalysis was conducted for incidence of a protocol-specified significant rash, defined as ≥10 facial papulopustular lesions.
The per-protocol analysis on day 14 included 69 patients, who received CHL-PRED (21), CHL (23), or AQUA (25). The incidence of CTCAE ≥grade 3 rash was not statistically significant between arms; however, the incidence of the protocol-specified significant rash was: CHL-PRED 14%, CHL 39%, and AQUA 48% (p = 0.03, CHL-PRED vs. AQUA). At 30 days, the CTCAE ≥grade 3 incidence was similar, but the incidences of protocol-specified significant rash were 6%, 16%, and 43% (p = 0.03, CHL-PRED vs. AQUA). No significant differences were found between CHL and CHL-PRED and between CHL and AQUA.
Prophylactic topical CHL-PRED was efficacious when compared to AQUA, in the treatment of EGFRI-induced facial papulopustular rash.
表皮生长因子受体抑制剂（EGFRi）诱导的发疹性脓疱病的发病率为 60-85%。
研究 EGFRi 诱导性皮疹的预防性局部治疗。
一项单中心、随机、双盲、安慰剂对照试验。开始接受 EGFRi 治疗的成年癌症患者被随机分配接受面部局部用氯霉素 3%+泼尼松龙 0.5%（CHL-PRED）软膏、氯霉素 3%（CHL）软膏或 Aqua 霜（AQUA）治疗。主要终点是使用不良事件通用术语标准（CTCAE）评估的第 14 天和第 30 天≥3 级皮疹的发生率。进行了一项亚分析，以评估方案规定的显著皮疹的发生率，定义为≥10 个面部丘疹脓疱性病变。
第 14 天的意向治疗分析纳入了 69 例患者，他们分别接受了 CHL-PRED（21 例）、CHL（23 例）或 AQUA（25 例）治疗。各组间 CTCAE ≥3 级皮疹的发生率无统计学意义；然而，方案规定的显著皮疹的发生率为：CHL-PRED 14%、CHL 39%和 AQUA 48%（p=0.03，CHL-PRED 与 AQUA）。30 天时，CTCAE ≥3 级皮疹的发生率相似，但方案规定的显著皮疹的发生率分别为 6%、16%和 43%（p=0.03，CHL-PRED 与 AQUA）。CHL 与 CHL-PRED 之间以及 CHL 与 AQUA 之间无显著差异。
与 AQUA 相比，预防性局部用 CHL-PRED 治疗 EGFRi 诱导的面部丘疹脓疱性皮疹更有效。
