Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Division of Hematology-Oncology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.
Oncologist. 2020 Jan;25(1):e186-e193. doi: 10.1634/theoncologist.2019-0221. Epub 2019 Sep 6.
The efficacy of epidermal growth factor (EGF) receptor (EGFR) inhibitors in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC), or colorectal cancer (CRC) has been demonstrated. However, dermatological reactions to these inhibitors can cause significant physical and psychosocial discomfort. The objective of the present study was to evaluate the efficacy of EGF ointment for EGFR inhibitor-related skin adverse events (ERSEs).
This placebo-controlled, double-blind, multicenter, pilot phase III trial enrolled patients with NSCLC, PC, or CRC treated with EGFR inhibitors. Patients with grade ≥2 ERSEs were included. Patients were randomized to three treatment arms: arm 1, placebo; arm 2, 1 ppm of EGF ointment; and arm 3, 20 ppm of EGF ointment. Patients applied ointment to their skin lesions twice daily.
Efficacy evaluation was available for 80 patients (9 for PC, 28 for NSCLC, and 43 for CRC). Responses were 44.4% in arm 1, 61.5% in arm 2, and 77.8% in arm 3. There was a linear correlation between EGF concentrations and responses (p = .012). Quality of life (QoL) was assessed for 74 patients. Maximum changes in composite scores by Skindex-16 after treatment were significantly different among arms (mean ± SD: -5.2 ± 8.6 for arm 1, -11.7 ± 14.2 for arm 2, and - 18.6 ± 17.7 for arm 3; p = .008). EGF arms showed significant improvement in emotions (p = .005) and functioning (p = .044) scores over the placebo arm.
EGF ointment is effective for managing ERSEs. It can also improve patients' QoL compared with placebo. Clinical trial identification number. NCT02284139 IMPLICATIONS FOR PRACTICE: Patients with non-small cell lung cancer, pancreatic cancer, or colorectal cancer who are treated with epidermal growth factor (EGF) receptor (EGFR) inhibitors may experience dermatologic reactions to their treatment. This study investigated the benefit of an EGF ointment in the treatment of these adverse events and observed the ointment to be effective in managing EGFR inhibitor-related skin adverse events.
表皮生长因子（EGF）受体（EGFR）抑制剂在非小细胞肺癌（NSCLC）、胰腺癌（PC）或结直肠癌（CRC）患者中的疗效已得到证实。然而，这些抑制剂引起的皮肤反应会导致严重的身体和心理不适。本研究旨在评估 EGF 软膏治疗 EGFR 抑制剂相关皮肤不良反应（ERSEs）的疗效。
这是一项安慰剂对照、双盲、多中心、先导性 III 期临床试验，纳入接受 EGFR 抑制剂治疗的 NSCLC、PC 或 CRC 患者。纳入 EGFR 抑制剂相关皮肤不良反应≥2 级的患者。患者随机分为三组：第 1 组，安慰剂；第 2 组，1ppm EGF 软膏；第 3 组，20ppm EGF 软膏。患者每日两次将软膏涂于皮损处。
80 例患者（9 例 PC，28 例 NSCLC，43 例 CRC）可进行疗效评估。第 1 组有效率为 44.4%，第 2 组为 61.5%，第 3 组为 77.8%。EGF 浓度与疗效呈线性相关（p=.012）。对 74 例患者进行了生活质量（QoL）评估。治疗后 Skindex-16 综合评分的最大变化在各组间差异有统计学意义（均值±标准差：第 1 组为-5.2±8.6，第 2 组为-11.7±14.2，第 3 组为-18.6±17.7；p=.008）。EGF 组在情绪（p=.005）和功能（p=.044）评分方面较安慰剂组有显著改善。
EGF 软膏治疗 ERSEs 有效，且与安慰剂相比可改善患者的生活质量。临床试验注册号：NCT02284139。
接受表皮生长因子（EGF）受体（EGFR）抑制剂治疗的非小细胞肺癌、胰腺癌或结直肠癌患者可能会出现皮肤不良反应。本研究调查了 EGF 软膏治疗这些不良反应的益处，并观察到该软膏可有效治疗 EGFR 抑制剂相关皮肤不良反应。
Zotero 插件