Objective: To explore the efficacy and safety of immunoneoadjuvant therapy with pembrolizumab combined with chemotherapy in locally advanced resectable hypopharyngeal squamous cell carcinoma patients. Methods: 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. Results: 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. Conclusions: 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.
目的： 探究帕博利珠单抗联合化疗方案的免疫新辅助治疗对于局部晚期可手术切除下咽鳞状细胞癌患者的疗效及安全性。 方法： 本研究为一项前瞻性、单臂、单中心临床研究，自2021年4月开放入组，对就诊于中国医学科学院肿瘤医院符合入选标准的患者，行帕博利珠单抗联合顺铂及紫杉醇的新辅助治疗，治疗后接受手术及术后辅助治疗。主要观察终点为术后病理完全缓解（pathologic complete response，pCR），并同时关注患者新辅助后药物不良反应及长期预后等情况。 结果： 截至2023年9月研究共入组完成新辅助治疗并接受手术患者23例，均为男性，年龄49~74岁。其中Ⅲ期患者3例，Ⅳ期患者20例。原发病灶中环后区受累伴有一侧声带固定的12例，区域淋巴结转移分类为N2期者20例。新辅助治疗两周期方案18例，三周期方案5例。术后pCR率为26.1%（6/23），无药物不良反应造成的手术延误，总体手术留喉率为87.0%（20/23），手术并发症方面，以咽瘘为主，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。 结论： 帕博利珠单抗联合化疗方案的免疫新辅助治疗在局部晚期可手术切除的下咽鳞状细胞癌中，具有较高的pCR率，且对于手术安全性无显著影响，同时增加了患者喉功能保全率。.