局部晚期头颈部鳞状细胞癌新辅助免疫化疗后的应答适应性手术（REMATCH）：一项单臂II期试验
Response-Adapted Surgery after Neoadjuvant Immunochemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma (REMATCH): A Single-Arm Phase II Trial.
文献信息
| PMID | 42717678 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Xiaomeng Zhang |
| 作者单位 | Department of Otorhinolaryngology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. |
| 期刊 | Clinical cancer research : an official journal of the American Association for Cancer Research |
| SCI 分区 | Q1 |
| IF | 11.6 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
目的： 我们评估了在局部晚期头颈部鳞状细胞癌（LA-HNSCC）患者中，对新辅助免疫化疗（NAICT）后达到主要肿瘤退缩者采用应答适应性手术策略的可行性和疗效。
患者与方法： 这项II期、单臂、前瞻性试验纳入了可切除、人乳头瘤病毒阴性的III至IVA期LA-HNSCC患者。所有患者均接受三个周期的NAICT（派安普利单抗、白蛋白结合型紫杉醇和顺铂）。第3周期前的影像学检查和喉镜检查指导手术：原发肿瘤退缩≥50%的患者接受减容手术（RVS）；退缩<50%的患者接受标准容量手术（SVS）。所有患者均接受风险适应性辅助放疗。主要终点为2年无病生存（DFS）。
结果： 50例患者完成了NAICT，客观缓解率为94%[95%置信区间（CI），84%-99%]。在中位随访34.0个月（IQR，30.1-39.5）时，符合方案人群的2年DFS为83%（95% CI，69%-91%）。RVS组（n = 42）的2年DFS为90%（95% CI，77%-96%），喉癌/下咽癌患者的喉保留率为100%，而SVS组（n = 5）的2年DFS为20%（95% CI，0.8%-58%）。与NAICT相关的3级不良事件（AE）发生于16%的患者，与手术相关的发生于15%；未发生4级或5级AE。放疗后9个月时，大多数生活质量评分较基线改善或稳定。
结论： REMATCH试验提供了首个前瞻性证据，表明NAICT后的应答适应性手术策略是可行的。达到原发肿瘤退缩≥50%的患者获得了有前景的生存获益和普遍喉保留。这些发现支持启动III期随机试验以验证这一降阶梯策略。
英文摘要
PURPOSE: We assessed the feasibility and efficacy of a response-adapted surgical strategy in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) achieving major tumor regression after neoadjuvant immunochemotherapy (NAICT).
PATIENTS AND METHODS: This phase II, single-arm, prospective trial enrolled patients with resectable, human papillomavirus-negative stage III to IVA LA-HNSCC. All received three cycles of NAICT (penpulimab, nab-paclitaxel, and cisplatin). Pre-cycle 3 imaging and laryngoscopy guided surgery: Patients with ≥50% primary tumor regression underwent reduced-volume surgery (RVS); those with <50% regression received standard-volume surgery (SVS). All received risk-adapted adjuvant radiotherapy. The primary endpoint was 2-year disease-free survival (DFS).
RESULTS: Fifty patients completed NAICT, with an objective response rate of 94% [95% confidence interval (CI), 84%-99%]. At a median follow-up of 34.0 months (IQR, 30.1-39.5), the 2-year DFS for the per-protocol cohort was 83% (95% CI, 69%-91%). The RVS group (n = 42) achieved a 2-year DFS of 90% (95% CI, 77%-96%) with 100% laryngeal preservation in laryngeal/hypopharyngeal cancers, whereas the SVS group (n = 5) had a 2-year DFS of 20% (95% CI, 0.8%-58%). Grade 3 adverse events (AE) occurred in 16% of patients related to NAICT and in 15% related to surgery; there were no grade 4 or 5 AEs. At 9 months after radiotherapy, most quality-of-life scores improved or stabilized compared with baseline.
CONCLUSIONS: The REMATCH trial provides the first prospective evidence that a response-adapted surgical strategy after NAICT is feasible. Patients achieving ≥50% primary tumor regression derived promising survival and universal laryngeal preservation. These findings support the initiation of phase III randomized trials to validate this de-escalation strategy.