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局限期小细胞肺癌新辅助免疫治疗联合化疗的临床疗效与安全性综合研究

A Comprehensive Study on Clinical Outcomes and Safety of Neoadjuvant Immunotherapy Combined With Chemotherapy in Limited-Stage Small Cell Lung Cancer.

作者信息

Ge Fan, Lin Guo, Huo Zhenyu, Wang Zhanyu, Sun Nan, He Jie

机构信息

Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Department of Radiation Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.

出版信息

Thorac Cancer. 2025 Aug;16(15):e70125. doi: 10.1111/1759-7714.70125.

Abstract

BACKGROUND

This study aims to explore clinical outcomes and safety of neoadjuvant immunotherapy combined with chemotherapy in limited-stage small cell lung cancer (SCLC), providing insights for upcoming clinical trials.

METHODS

PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases were searched for relevant original articles and conference proceedings, updated through 10 February 2025. Pathological complete response (pCR) rate and major pathological response (MPR) rate were calculated as the major assessments for the clinical outcomes. The incidences of the rate of R0 resection and treatment-related severe adverse events (tr-SAE) were considered as the primary outcomes for assessing the safety. Subgroup analyses were conducted according to neoadjuvant therapy cycle and study type.

RESULTS

A total of 114 patients from 6 studies were included. The meta-analysis results suggested that the pooled rates of pCR and MPR were 35% [95% confidence interval (CI) 14-56] and 49% (95% CI 18-80) in LS-SCLC patients. In terms of safety, most patients achieved R0 surgical resection [95% (95% CI 85-100)] and the pooled incidence of tr-SAE was 44% (95% CI 13-76). Meanwhile, all studies reported that there were no deaths during the perioperative period. Subgroup analysis suggests that more than two neoadjuvant therapy cycles may be associated with better clinical outcomes.

CONCLUSIONS

In conclusion, the current research findings demonstrate that neoadjuvant immunotherapy has shown promising clinical efficacy and acceptable safety in SCLC. These results provide valuable reference for upcoming clinical trials regarding the optimal neoadjuvant strategy and potential beneficiary populations.

摘要

背景

本研究旨在探讨新辅助免疫治疗联合化疗在局限期小细胞肺癌(SCLC)中的临床疗效和安全性,为即将开展的临床试验提供参考。

方法

检索PubMed、Embase、Cochrane图书馆和ClinicalTrials.gov数据库,查找相关原始文章和会议论文,更新至2025年2月10日。计算病理完全缓解(pCR)率和主要病理缓解(MPR)率作为临床疗效的主要评估指标。将R0切除率和治疗相关严重不良事件(tr-SAE)的发生率作为评估安全性的主要结局指标。根据新辅助治疗周期和研究类型进行亚组分析。

结果

共纳入6项研究中的114例患者。荟萃分析结果显示,局限期小细胞肺癌患者的pCR率和MPR率合并值分别为35%[95%置信区间(CI)14-56]和49%(95%CI 18-80)。在安全性方面,大多数患者实现了R0手术切除[95%(95%CI 85-100)],tr-SAE的合并发生率为44%(95%CI 13-76)。同时,所有研究均报告围手术期无死亡病例。亚组分析表明,新辅助治疗周期超过两个可能与更好的临床疗效相关。

结论

总之,目前的研究结果表明,新辅助免疫治疗在小细胞肺癌中显示出有前景的临床疗效和可接受的安全性。这些结果为即将开展的关于最佳新辅助策略和潜在受益人群的临床试验提供了有价值的参考。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7879/12336672/409ffa3ea1f1/TCA-16-e70125-g005.jpg

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