Department of Chest Medicine, Taipei Veterans General Hospital, No.201, Sec. 2, Shipai Rd., Beitou District, Taipei, 112, Taiwan.
School of Medicine, National Yang Ming Chiao Tung University, No.155, Sec.2, Linong Street, Taipei, 112, Taiwan.
Sci Rep. 2024 Aug 21;14(1):19374. doi: 10.1038/s41598-024-69587-x.
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.
对于 IV 期非小细胞肺癌(NSCLC)患者,5 年生存率较差。最近,细胞免疫疗法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)在先前化疗失败的 IV 期 NSCLC 患者中的疗效和安全性。本研究纳入了 26 名至少接受过二线化疗(含或不含靶向治疗)且失败的 IV 期 NSCLC 患者。每周单独给予 IKC 治疗,共 24 周。主要终点为无进展生存期(PFS)。次要终点包括总生存期(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。在符合方案(PP)人群(即接受>12 次 IKC 输注的患者)中,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 例不良反应(AE)中仅有 7 例(3.5%)与 IKC 输注相关,且均为 1 级严重程度。IKC 输注的耐受性良好。与历史数据相比,这种新型免疫疗法延长了 PFS 并提高了生存率。对于先前化疗失败的 IV 期 NSCLC 患者,它可能是一种有潜力的治疗策略。临床试验注册编号:NCT03499834。