Phase II study of erlotinib and docetaxel with concurrent intensity-modulated radiotherapy in locally advanced head and neck squamous cell carcinoma.

中华整形外科杂志 Pub Date : 2016-04-01 Epub Date: 2016-02-26 DOI:10.1002/hed.24313

Min Yao, Charles Woods, Pierre Lavertu, Pingfu Fu, Michael Gibson, Rod Rezaee, Chad Zender, Jay Wasman, Neelesh Sharma, Mitchell Machtay, Panayiotis Savvides

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引用次数: 0

Abstract

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.

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厄洛替尼和多西他赛联合调强放疗治疗局部晚期头颈部鳞状细胞癌的II期研究。

研究背景本研究旨在确定厄洛替尼和多西他赛同时配合调强放疗（IMRT）治疗局部晚期头颈部鳞状细胞癌（HNSCC）的疗效和毒性：患者每天接受厄洛替尼治疗2周，然后每天接受IMRT治疗，同时每周接受多西他赛和厄洛替尼治疗，之后每天接受厄洛替尼治疗长达2年。首要目标是无病生存期（DFS）。次要目标包括总生存期（OS）、失败模式和毒性反应。这项研究共招募了43名患者：中位随访时间为 48.7 个月，3 年 DFS、OS、无局部失败生存率和无远处转移生存率分别为 69.5%、81%、82.4% 和 83.7%。最常见的III/IV级局部毒性为吞咽困难、皮炎和粘膜炎。p16阳性肿瘤患者的疗效明显更好：结论：该方案可耐受且有效。结论：该方案耐受性好且有效，值得在特定患者中进一步研究，对不能耐受顺铂的患者可能有用。© 2016 Wiley Periodicals, Inc.Head Neck 38: E1770-E1776, 2016.

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中华整形外科杂志

CiteScore

0.20

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0.00%

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5346