Wang Zhongqiu, Sun Yao, Wang Qingxin, Chai Yanlan, Sun Jian, Zhang Ximei, Wang Qi, Wang Wei, Wang Peiguo
Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer, Laboratory of Basic and Translational Medicine on Head & Neck Cancer, Key Laboratory of Cancer Prevention and Therapy, West Huanhu Road, West River District, Tianjin, 300060, China.
BMC Med. 2025 Feb 27;23(1):126. doi: 10.1186/s12916-025-03964-9.
Immunotherapy has been confirmed efficient in recurrent or metastatic nasopharyngeal carcinoma (NPC), but its role in the locoregionally advanced setting is undetermined. Previous evidence in non-endemic areas of NPC is also lacking. This study evaluated the efficacy and safety of induction chemotherapy plus camrelizumab followed by concurrent chemoradiotherapy (CCRT) for patients with locoregionally advanced NPC in non-endemic areas.
In this phase 2 trial, patients born and living in North China with untreated stage III to IVa NPC were enrolled. All patients received two 21-day cycles of camrelizumab (200 mg) plus docetaxel (75 mg/m) and cisplatin (75 mg/m), followed by intensity modulated radiotherapy and concurrent cisplatin (80 mg/m for two 21-day cycles). After CCRT, patients received camrelizumab maintenance for 12 cycles. The primary endpoint was 3-year disease-free survival (DFS) rate.
From February 2021 to September 2023, a total of 57 patients were included for analysis. The objective response rate was 92.8% after induction therapy and 100% after CCRT. With a median follow-up time of 21 months, the 3-year DFS rate was 84%. The 3-year locoregional recurrence-free survival, distant metastasis-free survival, and overall survival rates were 95.8%, 90.9%, and 89.5%, respectively. The most common grade 3 or 4 treatment-related adverse events were leukopenia and neutropenia during induction therapy, and weight loss and lymphopenia during CCRT.
Induction immunochemotherapy combined with CCRT shows promising antitumor activity with a manageable safety profile in patients with locoregionally advanced NPC from non-endemic areas, which deserves further validation.
ClinicalTrials.gov Identifier: NCT04782765.
免疫疗法已被证实对复发或转移性鼻咽癌（NPC）有效，但其在局部晚期鼻咽癌中的作用尚不确定。此前在非鼻咽癌流行地区也缺乏相关证据。本研究评估了诱导化疗联合卡瑞利珠单抗序贯同步放化疗（CCRT）用于非流行地区局部晚期鼻咽癌患者的疗效和安全性。
在这项2期试验中，纳入了出生并居住在中国北方、未经治疗的III至IVa期鼻咽癌患者。所有患者接受两个周期、为期21天的卡瑞利珠单抗（200mg）联合多西他赛（75mg/m²）和顺铂（75mg/m²）治疗，随后进行调强放疗和同步顺铂治疗（80mg/m²，共两个周期、为期21天）。CCRT后，患者接受12个周期的卡瑞利珠单抗维持治疗。主要终点为3年无病生存率（DFS）。
2021年2月至2023年9月，共纳入57例患者进行分析。诱导治疗后的客观缓解率为92.8%，CCRT后的客观缓解率为100%。中位随访时间为21个月，3年DFS率为84%。3年局部区域无复发生存率、远处转移无复发生存率和总生存率分别为95.8%、90.9%和89.5%。最常见的3级或4级治疗相关不良事件为诱导治疗期间的白细胞减少和中性粒细胞减少，以及CCRT期间的体重减轻和淋巴细胞减少。
诱导免疫化疗联合CCRT在非流行地区局部晚期鼻咽癌患者中显示出有前景的抗肿瘤活性，且安全性可控，值得进一步验证。
ClinicalTrials.gov标识符：NCT04782765。
