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，器官功能降低，和合并症，老年鼻咽癌(NPC)患者在临床试验中的代表性往往不足.老年局部晚期鼻咽癌患者的最佳治疗方法尚不清楚。目的评价尼妥珠单抗联合调强放疗(IMRT)治疗老年局部晚期鼻咽癌的疗效。我们进行了单臂，III-IVA期NPC老年患者的II期试验（根据UICC-美国癌症TNM分类联合委员会，第8版）。所有患者同时接受尼妥珠单抗（200mg/周，IMRT前1周）结合IMRT。主要终点是完全缓解(CR)率。次要终点是生存,安全,和老年评估。在2017年3月13日至2018年11月12日之间，招募了30名患者。总的来说,20例（66.7%）患者达到CR，30例(100.0%)患者放疗后1个月观察到客观反应。中位随访时间为56.05个月(第25-75百分位数，53.45-64.56个月）。5年局部无复发生存率，无远处转移生存率，癌症特异性生存率，无病生存,总生存率为89.4%,86.4%,85.9%,76.5%,78.8%,分别。10例（33%）患者发生3级粘膜炎，3例（10%）患者发生3级肺炎。尼妥珠单抗联合IMRT对老年局部晚期NPC患者有效且耐受性良好。
