Skin Toxicity Evaluation Protocol With Panitumumab (STEPP), a Phase II, Open-Label, Randomized Trial Evaluating the Impact of a Pre-Emptive Skin Treatment Regimen on Skin Toxicities and Quality of Life in Patients With Metastatic Colorectal Cancer
Skin Toxicity Evaluation Protocol With Panitumumab (STEPP), a Phase II, Open-Label, Randomized Trial Evaluating the Impact of a Pre-Emptive Skin Treatment Regimen on Skin Toxicities and Quality of Life in Patients With Metastatic Colorectal Cancer
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DOI：
10.1200/jco.2008.21.7828
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发表时间：
2010-03-10
影响因子：
45.3
通讯作者：
Yassine, Mohamed
中科院分区：
文献类型：
--
作者：
Lacouture, Mario E.;Mitchell, Edith P.;Yassine, Mohamed
Panitumumab是一种靶向表皮生长因子受体（EGFR）的全人源单克隆抗体，已在美国和欧洲被批准用于治疗难治性转移性结直肠癌（mCRC）。皮肤毒性是EGFR抑制剂最常见的不良事件。这是第一个旨在检查针对任何EGFR抑制剂的mCRC患者特异性皮肤毒性的先发制人和反应性皮肤治疗之间差异的研究。患者和方法接受含帕尼单抗治疗的患者随机分配1:1先发制人或反应性治疗（在皮肤毒性发生后）。先发制人的治疗包括使用皮肤保湿剂、防晒霜、局部类固醇和强力霉素。研究的主要终点是6周皮肤治疗期间方案指定的>= 2级皮肤毒性的发生率。生活质量（QOL）采用皮肤病生活质量指数（DLQI）评估。结果95例患者中，48例接受了先发制人治疗，47例接受了反应性治疗。在6周的皮肤治疗期间，方案规定的>= 2级皮肤毒性的发生率在先发制人组和反应性组分别为29%和62%。从基线到第3周，先发制人组和反应组的DLQI平均评分变化分别为1.3分和4.2分。结论先发制人的皮肤治疗方案耐受性良好。在6周的皮肤治疗期间，与反应组相比，先发制人组的特异性>= 2级皮肤毒性发生率降低了50%以上。先发制人组患者报告的生活质量损害小于反应组患者。
Purpose Panitumumab, a fully human monoclonal antibody targeting the epidermal growth factor receptor (EGFR), is approved in the United States and Europe for the treatment of refractory metastatic colorectal cancer (mCRC). Skin toxicities are the most common adverse events with EGFR inhibitors. This is the first study designed to examine differences between pre-emptive and reactive skin treatment for specific skin toxicities in patients with mCRC for any EGFR inhibitor.Patients and Methods Patients receiving panitumumab-containing therapy were randomly assigned 1: 1 to pre-emptive or reactive treatment (after skin toxicity developed). Pre-emptive treatment included use of skin moisturizers, sunscreen, topical steroid, and doxycycline. The primary end point of the study was the incidence of protocol-specified >= grade 2 skin toxicities during the 6-week skin treatment period. Quality of life (QOL) was assessed with the Dermatology Life Quality Index (DLQI).Results Of 95 enrolled patients, 48 received pre-emptive treatment, and 47 received reactive treatment. The incidence of protocol-specified >= grade 2 skin toxicities during the 6-week skin treatment period was 29% and 62% for the pre-emptive and reactive groups, respectively. Mean DLQI score change from baseline to week 3 was 1.3 points and 4.2 points in the pre-emptive and reactive groups, respectively.Conclusion The pre-emptive skin treatment regimen was well tolerated. The incidence of specific >= grade 2 skin toxicities during the 6-week skin treatment period was reduced by more than 50% in the pre-emptive group compared with the reactive group. Patients in the pre-emptive group reported less QOL impairment than patients in the reactive group.