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新辅助化疗免疫治疗局部晚期下咽癌保留喉功能。

Neoadjuvant chemoimmunotherapy for laryngeal preservation in locally advanced hypopharyngeal cancer.

机构信息

Department of Otorhinolaryngology-Head and Neck Surgery, Changhai Hospital, Naval Medical University China.

出版信息

Int Immunopharmacol. 2024 Dec 5;142(Pt B):113197. doi: 10.1016/j.intimp.2024.113197. Epub 2024 Sep 18.

Abstract

OBJECTIVES

To retrospectively investigate the pathological response rate, laryngeal preservation surgery (LPS) rate and progression free survival (PFS) of neoadjuvant chemoimmunotherapy in the treatment of locally advanced hypopharyngeal cancer (LAHPC).

MATERIALS AND METHODS

In this study, LAHPC patients, who were first diagnosed and underwent surgery at the First Affiliated Hospital of Naval Medical University between January 2021 and January 2024, preoperatively administered PD-1 inhibitor and TP induction regimen (albumin-bound paclitaxel 260 mg/m and cisplatin 80 mg/m). The primary endpoint was major pathological response (MPR), with ORR rate, LPS rate and PFS as the secondary endpoints. Then, the correlation between MPR and overall response rate (ORR) was further validated.

RESULTS

A total of 46 patients satisfied the inclusion criteria, with the median follow-up period of 10.5 months. After neoadjuvant chemoimmunotherapy, the ORR was observed to be 71.9 %, and the LPS rate reached 80.4 % (76.5 % in stage IV patients). The pathological response indicated a favorable response, with the MPR ratio at 52.2 % and pathological complete response (pCR) ratio at 32.6 %. The imaging score highly correlated with pathological response (Kappa = 0.058, P<0.001), while the MPR and ORR shared a strong positive linear relationship (r = 0.753, P<0.001). The 1-year and 2-year PFS rates were 97.1 % and 93.8 % for all patients, with stage IV patients having a 1-year PFS of 92.2 %. Patients who achieved MPR demonstrated a significant prognostic advantage (P=0.008), with no recurrence instances or mortality reported. Grade 3 adverse events were observed in 8.7 % of the cohort. The most common Grade 1-2 adverse events were alopecia, reactive telangiosis and loss of appetite, and no delayed surgery occurred.

CONCLUSION

Neoadjuvant therapy of PD-1 inhibitor combined with TP effectively improved the MPR and LPS rates of LAHPC patients, especially in those at clinical stage IV.

摘要

目的

回顾性调查新辅助化疗免疫治疗局部晚期下咽癌(LAHPC)的病理缓解率、喉保留手术(LPS)率和无进展生存期(PFS)。

材料与方法

本研究纳入 2021 年 1 月至 2024 年 1 月在海军军医大学第一附属医院首次诊断并行手术治疗的 LAHPC 患者,术前给予 PD-1 抑制剂和 TP 诱导方案(白蛋白结合紫杉醇 260mg/m²和顺铂 80mg/m²)。主要终点为主要病理缓解(MPR),次要终点为总缓解率(ORR)、LPS 率和 PFS。然后,进一步验证 MPR 与 ORR 的相关性。

结果

共纳入 46 例患者,中位随访时间为 10.5 个月。新辅助化疗免疫治疗后,ORR 为 71.9%,LPS 率达到 80.4%(IV 期患者为 76.5%)。病理反应良好,MPR 比为 52.2%,病理完全缓解(pCR)比为 32.6%。影像学评分与病理反应高度相关(Kappa=0.058,P<0.001),而 MPR 与 ORR 呈强正线性关系(r=0.753,P<0.001)。所有患者的 1 年和 2 年 PFS 率分别为 97.1%和 93.8%,IV 期患者的 1 年 PFS 率为 92.2%。达到 MPR 的患者具有显著的预后优势(P=0.008),无复发或死亡病例。8.7%的患者发生 3 级不良反应。最常见的 1-2 级不良反应为脱发、反应性毛细血管扩张和食欲不振,无延迟手术发生。

结论

PD-1 抑制剂联合 TP 的新辅助治疗可有效提高 LAHPC 患者的 MPR 和 LPS 率,尤其是临床 IV 期患者。

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