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术前应用靶向药物治疗ALK阳性NSCLC患者的围手术期安全性分析OA

Perioperative Safety Analysis of Preoperative Targeted Therapy in Patients with ALK-positive Non-small Cell Lung Cancer

中文摘要英文摘要

背景与目的 局部晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的围手术期治疗一直是临床难点.虽然间变性淋巴瘤激酶-酪氨酸激酶抑制剂(anaplastic lymphoma kinase-tyrosine kinase inhibitors,ALK-TKIs)在ALK阳性NSCLC的术后辅助治疗中已确立重要地位,但其在术前新辅助治疗中的应用证据仍较匮乏.ALNEO等探索性研究提示术前ALK-TKIs治疗可带来比较理想的主要病理缓解(major pathological response,MPR)率,但围手术期安全性的临床报道依然有限.本研究旨在通过回顾性分析单中心数据评估术前ALK-TKIs治疗的围手术期安全性与可行性.方法 回顾性分析2021至2024年北京大学肿瘤医院胸外一科前瞻性数据库中记录的接受术前ALK-TKIs靶向治疗并完成手术切除的ALK阳性NSCLC患者资料,评估其近期疗效、手术相关指标、围手术期并发症及远期生存情况.结果 全组共11例患者,以女性并不吸烟患者为主(9/11),病理类型均为腺癌.治疗前临床分期为IIIA期7例、IIIB期3例、IV期寡转移1例.全组患者术前均接受ALK-TKIs治疗,其中4例联合化疗.客观缓解率(objective response rate,ORR)为81.8%.所有患者均顺利完成胸腔镜或机器人辅助手术,平均手术时间为(122.0±62.3)min,中位术中出血量74.0 mL(范围:5.0-300.0 mL).MPR率为45.5%(5/11),病理完全缓解(pathological complete response,pCR)率为27.3%(3/11).所有患者术后均接受了以靶向治疗为主的辅助治疗.中位随访30个月,全组无死亡病例,3例患者出现复发转移,其中1例为肠和肝转移,2例为脑转移.结论 在本小样本队列中ALK阳性的NSCLC患者接受术前ALK-TKIs治疗显示出较好的安全性和可行性.

Background and objective Perioperative management of locally advanced non-small cell lung cancer(NSCLC)remains a significant clinical challenge.Although anaplastic lymphoma kinase-tyrosine kinase inhibitors(ALK-TKIs)have established a definitive role in the adjuvant setting for ALK-positive NSCLC,clinical evidence supporting their preopera-tive application remains scarce.Recent exploratory trials,such as the ALNEO study,indicated that preoperative ALK-TKIs therapy can achieve favorable major pathological response(MPR)rates;however,documented data regarding its perioperative safety remain limited.This study aims to evaluate the perioperative safety and feasibility of preoperative ALK-TKIs therapy through a retrospective,single-center analysis.Methods A retrospective review was conducted using the data of ALK-positive NSCLC patients recorded in the prospective database of Department I of Thoracic Surgery at Peking University Cancer Hospi-tal from 2021 to 2024,who underwent surgical resection following preoperative ALK-TKIs therapy.Short-term efficacy,surgi-cal outcomes,perioperative complications,and long-term survival data were systematically evaluated.Results Eleven patients were included,predominantly consisting of female non-smokers(9/11),and the pathological type for all patients was adeno-carcinoma.Baseline clinical staging included stage IIIA(n=7),stage IIIB(n=3),and stage IV with oligometastasis(n=1).All patients received preoperative ALK-TKIs,with 4 receiving concurrent chemotherapy.The objective response rate(ORR)was 81.8%.All patients successfully underwent surgery via video-or robotic-assisted thoracoscopic surgery.The mean operative time was(122.0±62.3)min and the median intraoperative blood loss was 74.0 mL(range:5.0-300.0 mL).The MPR and patho-logical complete response(pCR)rates were 45.5%(5/11)and 27.3%(3/11),respectively.All patients received postoperative adjuvant therapy,primarily targeted drugs.At a median follow-up of 30 months,no deaths occurred in the entire cohort;how-ever,three patients experienced disease recurrence(one with intestinal and liver metastases,and two with brain metastases).Conclusion Preoperative ALK-TKIs therapy demonstrates favorable safety and feasibility in this small-sample cohort of ALK-positive NSCLC patients.

范梦颖;陈克能;秦存伟;方一凡;付浩;戴亮;杨永波;梁震;熊宏超;闫万璞

100142 北京,北京市癌症与转化研究重点实验室,北京大学肿瘤医院胸外一科100142 北京,北京市癌症与转化研究重点实验室,北京大学肿瘤医院胸外一科||100142 北京,国家分子肿瘤学重点实验室277500 滕州,滕州市中心人民医院胸外科100142 北京,北京市癌症与转化研究重点实验室,北京大学肿瘤医院胸外一科100142 北京,北京市癌症与转化研究重点实验室,北京大学肿瘤医院胸外一科100142 北京,北京市癌症与转化研究重点实验室,北京大学肿瘤医院胸外一科100142 北京,北京市癌症与转化研究重点实验室,北京大学肿瘤医院胸外一科100142 北京,北京市癌症与转化研究重点实验室,北京大学肿瘤医院胸外一科100142 北京,北京市癌症与转化研究重点实验室,北京大学肿瘤医院胸外一科100142 北京,北京市癌症与转化研究重点实验室,北京大学肿瘤医院胸外一科

肺肿瘤新辅助靶向治疗间变性淋巴瘤激酶安全性

Lung neoplasmsNeoadjuvant targeted therapyAnaplastic lymphoma kinaseSafety

《中国肺癌杂志》 2026 (6)

420-427,8

本研究受国家重点研发计划子课题(No.2021YFC2500902、No.2021YFC2500903和No.2021YFC2500905)资助 This study was supported by the grants from Sub-project of National Key R&D Program of China(No.2021YFC2500902,to Wanpu YANNo.2021YFC2500903,to Keneng CHENNo.2021YFC2500905,to Keneng CHEN).

10.3779/j.issn.1009-3419.2026.106.19

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