厄洛替尼联合放射治疗晚期皮肤鳞状细胞癌的Ⅰ期研究。
Phase 1 study of erlotinib plus radiation therapy in patients with advanced cutaneous squamous cell carcinoma.
机构信息
Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama, USA.
出版信息
Int J Radiat Oncol Biol Phys. 2013 Apr 1;85(5):1275-81. doi: 10.1016/j.ijrobp.2012.09.030. Epub 2012 Nov 22.
Abstract
PURPOSE
To assess the toxicity profile of erlotinib therapy combined with postoperative adjuvant radiation therapy in patients with advanced cutaneous squamous cell carcinoma.
METHODS AND MATERIALS
This was a single-arm, prospective, phase 1 open-label study of erlotinib with radiation therapy to treat 15 patients with advanced cutaneous head-and-neck squamous cell carcinoma. Toxicity data were summarized, and survival was analyzed with the Kaplan-Meier method.
RESULTS
The majority of patients were male (87%) and presented with T4 disease (93%). The most common toxicity attributed to erlotinib was a grade 2-3 dermatologic reaction occurring in 100% of the patients, followed by mucositis (87%). Diarrhea occurred in 20% of the patients. The 2-year recurrence rate was 26.7%, and mean time to cancer recurrence was 10.5 months. Two-year overall survival was 65%, and disease-free survival was 60%.
CONCLUSIONS
Erlotinib and radiation therapy had an acceptable toxicity profile in patients with advanced cutaneous squamous cell carcinoma. The disease-free survival in this cohort was comparable to that in historical controls.
摘要
目的
评估厄洛替尼联合术后辅助放疗治疗晚期皮肤鳞状细胞癌患者的毒性谱。
方法和材料
这是一项单臂、前瞻性、1 期开放标签研究，评估厄洛替尼联合放疗治疗 15 例晚期头颈部皮肤鳞状细胞癌患者。总结毒性数据，并采用 Kaplan-Meier 法分析生存情况。
结果
大多数患者为男性（87%），表现为 T4 期疾病（93%）。归因于厄洛替尼的最常见毒性是 100%的患者出现 2-3 级皮肤反应，其次是粘膜炎（87%）。腹泻发生在 20%的患者中。2 年复发率为 26.7%，癌症复发的平均时间为 10.5 个月。2 年总生存率为 65%，无病生存率为 60%。
结论
厄洛替尼联合放疗治疗晚期皮肤鳞状细胞癌的毒性谱可接受。该队列的无病生存率与历史对照相当。
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