Mayo Clinic Foundation, Rochester, Minnesota 55905, USA.
Oncologist. 2010;15(9):1016-22. doi: 10.1634/theoncologist.2010-0082. Epub 2010 Aug 26.
Rash occurs in >50% of patients prescribed epidermal growth factor receptor (EGFR) inhibitors. This study was undertaken to determine whether sunscreen prevents or mitigates these rashes.
This placebo-controlled, double-blinded trial enrolled rash-free patients starting an EGFR inhibitor. Patients were randomly assigned to sunscreen with a sun protection factor of 60 applied twice a day for 28 days versus placebo. They were then monitored for rash and quality of life (Skindex-16) during the 4-week intervention and for an additional 4 weeks.
Fifty-four patients received sunscreen, and 56 received placebo; the arms were balanced at baseline. During the 4-week intervention, physician-reported rash occurred in 38 (78%) and 39 (80%) sunscreen-treated and placebo-exposed patients, respectively (p = 1.00); no significant differences in rash rates emerged over the additional 4 weeks. There were no significant differences in rash severity, and patient-reported outcomes of rash yielded similar conclusions. Adjustment for sun intensity by geographical zone, season, and use of photosensitivity medications did not yield a significant difference in rash across study arms (p = .20). Quality of life scores declined but remained comparable between arms.
Sunscreen, as prescribed in this trial, did not prevent or attenuate EGFR inhibitor-induced rash.
接受表皮生长因子受体 (EGFR) 抑制剂治疗的患者中超过 50% 会出现皮疹。本研究旨在确定防晒霜是否能预防或减轻这些皮疹。
这是一项安慰剂对照、双盲试验,招募了开始使用 EGFR 抑制剂且无皮疹的患者。患者被随机分配至每天两次涂抹防晒系数为 60 的防晒霜组或安慰剂组,持续 28 天。然后在 4 周的干预期间以及额外的 4 周内监测皮疹和生活质量(Skindex-16)。
54 名患者接受了防晒霜治疗,56 名患者接受了安慰剂治疗;两组在基线时平衡。在 4 周的干预期间,分别有 38 名(78%)和 39 名(80%)接受防晒霜治疗和安慰剂暴露的患者出现了医生报告的皮疹(p = 1.00);在接下来的 4 周内,皮疹发生率没有显著差异。皮疹严重程度无显著差异,患者报告的皮疹结果也得出了类似的结论。通过地理区域、季节和光敏性药物使用调整太阳强度后,皮疹在研究组之间没有显著差异(p =.20)。生活质量评分下降,但两组之间仍相当。
按照本试验规定使用防晒霜并不能预防或减轻 EGFR 抑制剂引起的皮疹。