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Phase II Trial of Chemotherapy, Cetuximab, and Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck.化疗、西妥昔单抗和厄洛替尼治疗转移性或复发性头颈部鳞状细胞癌患者的II期试验
Head Neck. 2025 Apr 1. doi: 10.1002/hed.28152.
2
Chemoprevention of Head and Neck Cancer: A Review of Current Approaches and Future Perspectives.头颈部癌症的化学预防：当前方法和未来展望的综述。
Cancer Prev Res (Phila). 2024 Oct 1;17(10):443-455. doi: 10.1158/1940-6207.CAPR-24-0093.
3
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Cell. 2023 Apr 13;186(8):1541-1563. doi: 10.1016/j.cell.2023.03.013.
4
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Oral Oncol. 2021 Oct;121:105451. doi: 10.1016/j.oraloncology.2021.105451. Epub 2021 Jul 28.
5
Inflammation and tumor progression: signaling pathways and targeted intervention.炎症与肿瘤进展：信号通路与靶向干预。
Signal Transduct Target Ther. 2021 Jul 12;6(1):263. doi: 10.1038/s41392-021-00658-5.
6
Phase Ib Study of Chemoprevention with Green Tea Polyphenon E and Erlotinib in Patients with Advanced Premalignant Lesions (APL) of the Head and Neck.头颈部癌前病变患者中绿茶多酚 E 和厄洛替尼联合化学预防的 Ib 期研究。
Clin Cancer Res. 2020 Nov 15;26(22):5860-5868. doi: 10.1158/1078-0432.CCR-20-2276. Epub 2020 Sep 17.
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The risk of second primary tumors in head and neck cancer: A systematic review.头颈部癌患者发生第二原发性肿瘤的风险：一项系统评价。
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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性肿瘤的前瞻性试点研究：长期随访

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.

作者信息

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

机构信息

Winship Cancer Institute, Emory University, Atlanta, Georgia, USA.

Department of Pharmaceutical Services, Emory University Hospital Midtown, Atlanta, Georgia, USA.

出版信息

Head Neck. 2025 Sep;47(9):2594-2602. doi: 10.1002/hed.28178. Epub 2025 Apr 28.

DOI:10.1002/hed.28178
PMID:40296503
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12339201/
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.

摘要

背景

早期头颈部鳞状细胞癌（HNSCC）患者在接受确定性治疗后发生第二原发性肿瘤（SPT）的风险增加。这项试点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例完成确定性治疗的I/II期HNSCC患者接受厄洛替尼联合塞来昔布治疗6个月。主要目标是完成厄洛替尼和塞来昔布治疗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9（1.7 - 15.3）年，未达到无SPT生存期的中位时间。15年时估计的无SPT生存率为78.8%。2例患者出现局部复发，但我们的受试者均未在任何部位发生黏膜鳞状细胞癌。

结论

所有三种剂量的厄洛替尼和固定剂量的塞来昔布耐受性良好，长期随访显示无SPT生存期良好。

试验注册

Clinicaltrials.gov标识符：NCT00400374。