Department of Head and Neck Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Front Immunol. 2023 Jul 31;14:1189752. doi: 10.3389/fimmu.2023.1189752. eCollection 2023.
This study aimed to explore the efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant therapy in patients with resectable locally advanced head and neck squamous cell carcinomas (LA-HNSCCs).
In this prospective, single-arm, single-centre clinical trial, patients meeting the inclusion criteria were treated with preoperative neoadjuvant therapy with 200 mg pembrolizumab combined with 75 mg/m2 cisplatin and 175 mg/m2 paclitaxel. This was followed by surgery and postoperative adjuvant therapy. The primary endpoint was the postoperative pathological complete response (pCR) rate. All statistical analyses were performed using SPSS 26.
A total of 22 patients were enrolled. The location of primary lesion showed: hypopharynx were 15 (68.2%), oropharynx were 6 (27.3%) and oral cavity was 1 (4.5%). The postoperative pCR rate, was 36.4% (8/22), and there was no delay to surgery due to adverse drug reactions. The rate of laryngeal function preservation was 90.9% (20/22). Delayed wound healing was the main surgical complication, with an incidence of 22.7% (5/22). The median follow-up time was 9.5 months, and only 1 patient (4.55%) suffered a regional recurrence.
Preoperative treatment with pembrolizumab and chemotherapy in resectable LA-HNSCC has a high pCR rate with no significant impact on surgical safety. This treatment was found to increase the rate of laryngeal function preservation. However, the effects of neoadjuvant immunotherapy on long-term prognosis in LA-HNSCCs require further study.
本研究旨在探索帕博利珠单抗联合化疗作为可切除局部晚期头颈部鳞状细胞癌（LA-HNSCC）新辅助治疗的疗效和安全性。
在这项前瞻性、单臂、单中心临床试验中，符合纳入标准的患者接受术前新辅助治疗，方案为 200mg 帕博利珠单抗联合 75mg/m2 顺铂和 175mg/m2 紫杉醇。随后进行手术和术后辅助治疗。主要终点为术后病理完全缓解（pCR）率。所有统计分析均采用 SPSS 26 进行。
共纳入 22 例患者。原发灶部位：下咽 15 例（68.2%），口咽 6 例（27.3%），口腔 1 例（4.5%）。术后 pCR 率为 36.4%（8/22），无因药物不良反应而延迟手术。喉功能保留率为 90.9%（20/22）。延迟性伤口愈合是主要的手术并发症，发生率为 22.7%（5/22）。中位随访时间为 9.5 个月，仅 1 例（4.55%）发生区域性复发。
在可切除的 LA-HNSCC 中，术前使用帕博利珠单抗和化疗治疗具有较高的 pCR 率，对手术安全性无显著影响。这种治疗方法发现可提高喉功能保留率。然而，新辅助免疫治疗对 LA-HNSCC 长期预后的影响需要进一步研究。
