新辅助免疫检查点抑制剂联合化疗治疗局部晚期下咽鳞状细胞癌的疗效与安全性：一项回顾性分析
Efficacy and safety of neoadjuvant immune checkpoint inhibitors combined with chemotherapy in locally advanced hypopharyngeal squamous cell carcinoma: a retrospective analysis.
文献信息
| PMID | 42780000 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Xueying Liu |
| 作者单位 | Department of Otolaryngology Head and Neck Surgery, The First Affiliated Hospital of Xiamen University, Xiamen, China. |
| 期刊 | Frontiers in oncology |
| SCI 分区 | Q2 |
| IF | 3.9 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
目的： 评估新辅助PD-1抑制剂联合化疗（白蛋白结合型紫杉醇+顺铂）在局部晚期下咽鳞状细胞癌患者中的疗效与安全性。
方法： 对2021年1月至2023年5月于厦门大学附属第一医院诊断为局部晚期（III-IVA期）下咽癌的75例患者进行回顾性分析。所有患者均接受至少2个周期的新辅助免疫化疗，随后接受根治性手术和辅助放疗。评估客观缓解率（ORR）、主要病理缓解（MPR）、病理完全缓解（pCR）、喉保留手术率、无进展生存期（PFS）和安全性。
结果： 在75例患者中，ORR为77.3%（58/75），MPR率为78.7%（59/75），标准pCR率（原发灶+淋巴结）为17.3%（13/75），原发肿瘤pCR率为26.7%（20/75），喉保留手术率为86.7%（65/75）。中位随访26个月，12个月和24个月总生存率分别为93.3%和76.0%，PFS率分别为92.0%和76.0%。MPR组相比非MPR组显示出显著更优的PFS（HR=0.052，95% CI：0.019-0.140，P<0.001），24个月PFS率分别为89.7%和12.5%。ORR组相比非ORR组也显示出显著更优的PFS（HR=0.29，95% CI：0.13-0.66，P=0.003），24个月PFS率分别为86.2%和41.2%。影像学与病理学评估之间的一致性为中等（κ=0.417，P<0.001）。安全性特征良好，未观察到3-5级治疗相关不良事件。
结论： 新辅助PD-1抑制剂联合化疗在局部晚期下咽癌患者中诱导了显著的影像学和病理学缓解，有效提高了喉保留手术率和无进展生存期，且安全性特征良好。病理学评估（尤其是MPR）可能为影像学评估提供补充性预后信息。该方案显示出有前景的短期疗效和喉保留获益，值得进一步前瞻性验证。
英文摘要
OBJECTIVE: To evaluate the efficacy and safety of neoadjuvant PD-1 inhibitor combined with chemotherapy (nab-paclitaxel + cisplatin) in patients with locally advanced hypopharyngeal squamous cell carcinoma.
METHODS: A retrospective analysis was conducted on 75 patients with locally advanced (stage III-IVA) hypopharyngeal cancer diagnosed at the First Affiliated Hospital of Xiamen University between January 2021 and May 2023. All patients received at least 2 cycles of neoadjuvant immunochemotherapy followed by radical surgery and adjuvant radiotherapy. Objective response rate (ORR), major pathological response (MPR), pathological complete response (pCR), larynx-preserving surgery rate, progression-free survival (PFS), and safety were evaluated.
RESULTS: Among 75 patients, the ORR was 77.3% (58/75), MPR rate was 78.7% (59/75), standard pCR rate (primary + lymph nodes) was 17.3% (13/75), primary tumor pCR rate was 26.7% (20/75), and larynx-preserving surgery rate was 86.7% (65/75). With a median follow-up of 26 months, the 12-month and 24-month overall survival rates were 93.3% and 76.0%, respectively, and the PFS rates were 92.0% and 76.0%, respectively. The MPR group demonstrated significantly superior PFS compared to the non-MPR group (HR = 0.052, 95% CI: 0.019-0.140, P < 0.001), with 24-month PFS rates of 89.7% and 12.5%, respectively. The ORR group also showed significantly superior PFS compared to the non-ORR group (HR = 0.29, 95% CI: 0.13-0.66, P = 0.003), with 24-month PFS rates of 86.2% and 41.2%, respectively. Concordance between radiological and pathological assessments was moderate (κ=0.417, P < 0.001). The safety profile was favorable, with no grade 3-5 treatment-related adverse events observed.
CONCLUSION: Neoadjuvant PD-1 inhibitor combined with chemotherapy induces significant radiological and pathological responses in patients with locally advanced hypopharyngeal cancer, effectively improving larynx-preserving surgery rate and progression-free survival with a favorable safety profile. Pathological assessment (particularly MPR) may provide complementary prognostic information to radiological assessment.This regimen demonstrates promising short-term efficacy and larynx preservation benefits, warranting further prospective validation.