Wang K, Zhang W, Gui L, He X H, Wang J B, Lu H Z, Li D Z, Liu C, Guo Z Z, Xu M, Liu S Y, Wang X L
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 100021, China.
Department of Nursing, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2024 Apr 7;59(4):343-349. doi: 10.3760/cma.j.cn115330-20231015-00147.
To explore the efficacy and safety of immunoneoadjuvant therapy with pembrolizumab combined with chemotherapy in locally advanced resectable hypopharyngeal squamous cell carcinoma patients. This study was a prospective, single arm, single center clinical study that was opened for enrollment in April 2021. Patients who met the inclusion criteria at the Cancer Hospital of the Chinese Academy of Medical Sciences were treated with neoadjuvant therapy of pembrolizumab combined with cisplatin and paclitaxel, and after treatments, received surgery and postoperative adjuvant therapy. The main endpoint of this study was postoperative pathological complete response (pCR), and other observations included adverse reactions and long-term prognoses of patients after neoadjuvant therapy. By September 2023, a total of 23 patients who underwent neoadjuvant therapy and surgery were enrolled in the study and all patients were males aged 49-74 years. All patients were locally advanced stage, including 3 patients in stage Ⅲ and 20 patients in stage Ⅳ. There were 12 cases of primary lesions with posterior ring involvement accompanied by fixation of one vocal cord and 20 cases of regional lymph node metastases classified as N2. Eighteen cases received a two cycle regimen and 5 cases received a three cycle regimen for neoadjuvant therapy. The postoperative pCR rate was 26.1% (6/23), with no surgical delay caused by adverse drug reactions. The laryngeal preservation rate was 87.0% (20/23). Pharyngeal fistula was the main surgical complication, with an incidence of 21.7% (5/23). The median follow-up time was 15 months, and 3 patients experienced local recurrence. The immunoneoadjuvant therapy of pembrolizumab combined with chemotherapy has a high pCR rate in locally advanced resectable hypopharyngeal squamous cell carcinoma, with increased laryngeal preservation rate and no significant impact on surgical safety.
探讨帕博利珠单抗联合化疗的免疫新辅助治疗在局部晚期可切除下咽鳞状细胞癌患者中的疗效和安全性。本研究是一项前瞻性、单臂、单中心临床研究，于2021年4月开始招募患者。在中国医学科学院肿瘤医院符合纳入标准的患者接受帕博利珠单抗联合顺铂和紫杉醇的新辅助治疗，治疗后接受手术及术后辅助治疗。本研究的主要终点是术后病理完全缓解（pCR），其他观察指标包括新辅助治疗后患者的不良反应和长期预后。截至2023年9月，共有23例接受新辅助治疗和手术的患者纳入本研究，所有患者均为男性，年龄49 - 74岁。所有患者均为局部晚期，其中Ⅲ期3例，Ⅳ期20例。12例原发灶累及后环并伴有一侧声带固定，20例区域淋巴结转移分类为N2。18例患者接受两周期新辅助治疗方案，5例患者接受三周期新辅助治疗方案。术后pCR率为26.1%（6/23），未因药物不良反应导致手术延迟。喉保留率为87.0%（20/23）。咽瘘是主要的手术并发症，发生率为21.7%（5/23）。中位随访时间为15个月，3例患者出现局部复发。帕博利珠单抗联合化疗的免疫新辅助治疗在局部晚期可切除下咽鳞状细胞癌中具有较高的pCR率，提高了喉保留率，且对手术安全性无显著影响。
