厄洛替尼和多西他赛同步调强放疗用于局部晚期头颈部鳞状细胞癌的II期研究
Phase II study of erlotinib and docetaxel with concurrent intensity-modulated radiotherapy in locally advanced head and neck squamous cell carcinoma.
作者信息
Yao Min, Woods Charles, Lavertu Pierre, Fu Pingfu, Gibson Michael, Rezaee Rod, Zender Chad, Wasman Jay, Sharma Neelesh, Machtay Mitchell, Savvides Panayiotis
机构信息
Department of Radiation Oncology, University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.
Department of Otolaryngology - Head and Neck Surgery, University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.
出版信息
Head Neck. 2016 Apr;38 Suppl 1(Suppl 1):E1770-6. doi: 10.1002/hed.24313. Epub 2016 Feb 26.
BACKGROUND
The purpose of this study was to establish the efficacy and toxicities of concurrent erlotinib and docetaxel with intensity-modulated radiotherapy (IMRT) for locally advanced head and neck squamous cell carcinoma (HNSCC).
METHODS
Patients received daily erlotinib for 2 weeks, followed by daily IMRT with concurrent weekly docetaxel and daily erlotinib, followed by daily erlotinib for up to 2 years. The primary objective was disease-free survival (DFS). Secondary objectives included overall survival (OS), patterns of failure, and toxicities. Forty-three patients were recruited for this study.
RESULTS
With a median follow-up of 48.7 months, the 3-year DFS, OS, locoregional failure-free survival, and distant metastasis-free survival was 69.5%, 81%, 82.4%, and 83.7%, respectively. The most common grade III/IV local toxicities were dysphagia, dermatitis, and mucositis. Patients with p16-positive tumors had significantly better outcomes.
CONCLUSION
The regimen is tolerable and effective. It is worthy of further investigation in selected patients and may be useful in patients who cannot tolerate cisplatin. © 2016 Wiley Periodicals, Inc. Head Neck 38: E1770-E1776, 2016.
背景
本研究旨在确定厄洛替尼与多西他赛同步联合调强放疗（IMRT）治疗局部晚期头颈部鳞状细胞癌（HNSCC）的疗效和毒性。
方法
患者先每日服用厄洛替尼2周，随后每日进行IMRT，同时每周服用多西他赛并每日服用厄洛替尼，之后每日服用厄洛替尼长达2年。主要目标是无病生存期（DFS）。次要目标包括总生存期（OS）、失败模式和毒性。本研究招募了43名患者。
结果
中位随访48.7个月，3年DFS、OS、局部区域无失败生存期和远处转移无生存期分别为69.5%、81%、82.4%和83.7%。最常见的III/IV级局部毒性是吞咽困难、皮炎和粘膜炎。p16阳性肿瘤患者的预后明显更好。
结论
该方案耐受性良好且有效。值得在特定患者中进一步研究，可能对无法耐受顺铂的患者有用。©2016威利期刊公司。《头颈》38：E1770 - E1776，2016年。
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