The efficacy and safety of immunotherapy combined with chemotherapy neoadjuvant in locally advanced resectable hypopharyngeal squamous cell carcinoma
10.3760/cma.j.cn115330-20231015-00147
- VernacularTitle:免疫联合化疗新辅助治疗在局部晚期可手术切除下咽鳞癌中的疗效及安全性
- Author:
Kai WANG
1
;
Wei ZHANG
;
Lin GUI
;
Xiaohui HE
;
Jingbo WANG
;
Haizhen LU
;
Dezhi LI
;
Chang LIU
;
Zizhao GUO
;
Meng XU
;
Shaoyan LIU
;
Xiaolei WANG
Author Information
1. 国家癌症中心 国家肿瘤临床医学研究中心 中国医学科学院北京协和医学院肿瘤医院头颈外科，北京100021
- Keywords:
Hypopharyngeal neoplasms;
Carcinoma, squamous cell;
Immune checkpoint inhibitor;
Neoadjuvant therapy;
Locally advanced
- From:
Chinese Journal of Otorhinolaryngology Head and Neck Surgery
2024;59(4):343-349
- CountryChina
- Language:Chinese
-
Abstract:
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.
