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尼妥珠单抗联合调强放疗治疗老年局部晚期鼻咽癌的临床观察

Concurrent nimotuzumab and intensity-modulated radiotherapy for elderly patients with locally advanced nasopharyngeal carcinoma.

机构信息

Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, China.

Key Laboratory of Head and Neck Cancer Translational Research of Zhejiang Province, Postgraduate Training Base Alliance of Wenzhou Medical University, Hangzhou, China.

出版信息

Cancer Sci. 2024 Aug;115(8):2729-2737. doi: 10.1111/cas.16213. Epub 2024 May 28.

Abstract

Because of the common physical condition, reduced organ function, and comorbidities, elderly patients with nasopharyngeal carcinoma (NPC) are often underrepresented in clinical trials. The optimal treatment of elderly patients with locally advanced NPC remains unclear. The purpose of this study was to evaluate the efficacy of concurrent nimotuzumab combined with intensity-modulated radiotherapy (IMRT) in elderly patients with locally advanced NPC. We conducted a single-arm, phase II trial for elderly patients with stage III-IVA NPC (according to UICC-American Joint Committee on Cancer TNM classification, 8th edition). All patients received concurrent nimotuzumab (200 mg/week, 1 week prior to IMRT) combined with IMRT. The primary end-point was complete response (CR) rate. The secondary end-points were survival, safety, and geriatric assessment. Between March 13, 2017 and November 12, 2018, 30 patients were enrolled. In total, 20 (66.7%) patients achieved CR, and objective response was observed in 30 (100.0%) patients 1 month after radiotherapy. The median follow-up time was 56.05 months (25th-75th percentile, 53.45-64.56 months). The 5-year locoregional relapse-free survival, distant metastasis-free survival, cancer-specific survival, disease-free survival, and overall survival were 89.4%, 86.4%, 85.9%, 76.5%, and 78.8%, respectively. Grade 3 mucositis occurred in 10 (33%) patients and grade 3 pneumonia in 3 (10%) patients. Concurrent nimotuzumab combined with IMRT is effective and well-tolerated for elderly patients with locally advanced NPC.

摘要

由于常见的身体状况、器官功能下降和合并症,老年鼻咽癌(NPC)患者在临床试验中经常代表性不足。老年局部晚期 NPC 患者的最佳治疗方法仍不清楚。本研究旨在评估尼妥珠单抗联合调强放疗(IMRT)治疗老年局部晚期 NPC 的疗效。我们进行了一项单臂、II 期临床试验,纳入了局部晚期 NPC(根据 UICC-美国癌症联合委员会 TNM 分期,第 8 版)的老年患者。所有患者均接受尼妥珠单抗(200mg/周,在 IMRT 前 1 周)联合 IMRT。主要终点为完全缓解(CR)率。次要终点为生存、安全性和老年评估。2017 年 3 月 13 日至 2018 年 11 月 12 日期间,共纳入 30 例患者。共有 20 例(66.7%)患者达到 CR,放疗后 1 个月观察到 30 例(100.0%)患者的客观缓解。中位随访时间为 56.05 个月(25 分位-75 分位,53.45-64.56 个月)。5 年局部区域无复发生存率、远处转移无复发生存率、癌症特异性生存率、无病生存率和总生存率分别为 89.4%、86.4%、85.9%、76.5%和 78.8%。10 例(33%)患者发生 3 级黏膜炎,3 例(10%)患者发生 3 级肺炎。尼妥珠单抗联合 IMRT 治疗老年局部晚期 NPC 有效且耐受性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2816/11309944/6a05c6276235/CAS-115-2729-g003.jpg

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