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免疫杀伤细胞治疗用于既往接受过治疗的 IV 期 NSCLC 患者

英文原题:Immune killer cells treatment for previously treated stage IV NSCLC patients.

查看英文原题

Immune killer cells treatment for previously treated stage IV NSCLC patients.

PubMed 2024/08/21(内容时间) Sci Rep Q1 · IF 4.9(JCR 2025)

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

中文摘要

IV 期非小细胞肺癌(NSCLC)的 5 年生存率较差。近年来,细胞免疫治疗已成为一种新的治疗策略。本研究旨在评估免疫杀伤细胞(IKC)在既往化疗失败的 IV 期 NSCLC 患者中的疗效和安全性。

本研究入组了 26 例至少接受过两线化疗(联合或不联合靶向治疗)后失败的 IV 期 NSCLC 患者。IKC 单独给药,每周一次,持续 24 周。主要终点为无进展生存期(PFS)。次要结局包括总生存期(OS)、疼痛强度、生活质量(QOL)和安全性。意向治疗(ITT)人群(即所有入组患者)的中位 PFS 为 3.8 个月。符合方案(PP)人群(即接受 > 12 次 IKC 输注的患者)的中位 PFS 为 5.6 个月。

此外,ITT 人群的 1 年生存率为 60.0%,而 PP 人群为 85.7%。200 例不良事件中仅有 7 例(3.5%)与 IKC 输注相关,且严重程度均为 1 级。IKC 输注耐受性良好。与历史数据相比,这种新型免疫治疗延长了 PFS 并改善了生存。对于既往化疗失败的 IV 期 NSCLC 患者,这可能是一种潜在的治疗策略。ClinicalTrials.gov 标识符:NCT03499834。

展开英文摘要原文

The 5-year survival is poor for stage IV non-small cell lung cancer (NSCLC). Recently, cell immunotherapy has emerged as a new treatment strategy.

This study aimed to evaluate the efficacy and safety of Immune killer cells (IKC) in patients with stage IV NSCLC after the failure of prior chemotherapy.

This study enrolled 26 patients with stage IV NSCLC who failed at least two lines of chemotherapy with or without targeted therapy. The IKC was given alone weekly for 24 weeks. The primary endpoint was progression-free survival (PFS). Secondary outcomes included overall survival (OS), pain intensity, quality of life (QOL), and safety. The median PFS for the intent-to-treat (ITT) population (i. e. , all enrolled patients) was 3. 8 month. In the per-protocol (PP) population (i. e. , patients receiving > 12 IKC infusions), the median PFS was 5. 6 months.

Moreover, the ITT population showed a 1-year survival rate of 60. 0%, while that for the PP population was 85. 7%. Only 7 out of 200 AEs (3. 5%) were related to the IKC infusion, and they were all rated as grade 1 in severity. The IKC infusion was well tolerated. This novel immunotherapy prolonged the PFS and improved the survival compared with historical data. It might be a potential treatment strategy for stage IV NSCLC patient who failed prior chemotherapy. ClinicalTrials. gov identifier: NCT03499834.

论文信息

作者
Tseng YH、Ho CL、Chian CF、Chiang CL、Chao HS、Tsai CL、Perng WC、Hsiao CF
第一作者单位
Department of Chest Medicine, Taipei Veterans General Hospital, No.201, Sec. 2, Shipai Rd., Beitou District, Taipei, 112, Taiwan.Taiwan
通讯作者单位
Department of Chest Medicine, Taipei Veterans General Hospital, No.201, Sec. 2, Shipai Rd., Beitou District, Taipei, 112, Taiwan. ymchen@vghtpe.gov.tw.Taiwan
文献类型
II 期临床试验
期刊
Scientific reports2024 Aug 21
原文标识
PubMed 39169058 · DOI 10.1038/s41598-024-69587-x