Prospective Pilot Study of Second Primary Tumor Prevention With Erlotinib and Celecoxib in Early-Stage Squamous Cell Carcinoma of the Head and Neck: Long-Term Follow-Up.

IF 2.3 3区医学 Q1 OTORHINOLARYNGOLOGY

Head and Neck-Journal for the Sciences and Specialties of the Head and Neck Pub Date : 2025-04-28 DOI:10.1002/hed.28178

Pauline Kim, Nabil F Saba, Ashley McCook-Veal, Yuan Liu, Adam M Klein, Jonathan J Beitler, Amy Chen, Fadlo R Khuri, Dong M Shin

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引用次数: 0

Abstract

Background: Patients with early-stage head and neck squamous cell carcinoma (HNSCC) have an increased risk for secondary primary tumors (SPT) after definitive treatment. The aim of this pilot trial was to investigate the safety and efficacy of erlotinib and celecoxib in preventing SPTs.

Methods: Ten patients with stage I/II HNSCC who completed definitive treatment received erlotinib with celecoxib for 6 months. Primary objectives were safety assessment and SPT-free survival after completion of erlotinib and celecoxib. Secondary objectives included assessing overall survival (OS) and progression-free survival (PFS).

Results: With a median follow-up of 9 (1.7-15.3) years, the median time to SPT-free survival was not reached. The estimated SPT-free survival was 78.8% at 15 years. Two patients had local recurrence, but none of our subjects developed mucosal squamous cell carcinoma at any site.

Conclusion: All three doses of erlotinib and the fixed dose of celecoxib were well tolerated with excellent SPT-free survival with long-term follow-up.

Trial registration: Clinicaltrials.gov identifier: NCT00400374.

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厄洛替尼和塞来昔布预防早期头颈部鳞状细胞癌第二原发肿瘤的前瞻性试点研究：长期随访。

背景：早期头颈部鳞状细胞癌（HNSCC）患者在接受最终治疗后发生继发性原发性肿瘤（SPT）的风险增加。该试验的目的是研究厄洛替尼和塞来昔布预防spt的安全性和有效性。方法：10例完成最终治疗的I/II期HNSCC患者接受厄洛替尼联合塞来昔布治疗6个月。主要目标是厄洛替尼和塞来昔布完成后的安全性评估和无spt生存期。次要目标包括评估总生存期（OS）和无进展生存期（PFS）。结果：中位随访时间为9年（1.7-15.3），未达到无spt生存的中位时间。估计15年无spt生存率为78.8%。两名患者有局部复发，但我们的受试者在任何部位都没有发生粘膜鳞状细胞癌。结论：经长期随访，厄洛替尼和固定剂量塞来昔布均耐受良好，无spt生存期良好。试验注册：Clinicaltrials.gov标识符：NCT00400374。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Head and Neck-Journal for the Sciences and Specialties of the Head and Neck 医学-耳鼻喉科学

CiteScore

7.00

自引率

6.90%

发文量

278

审稿时长

1.6 months

期刊介绍： Head & Neck is an international multidisciplinary publication of original contributions concerning the diagnosis and management of diseases of the head and neck. This area involves the overlapping interests and expertise of several surgical and medical specialties, including general surgery, neurosurgery, otolaryngology, plastic surgery, oral surgery, dermatology, ophthalmology, pathology, radiotherapy, medical oncology, and the corresponding basic sciences.