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信迪利单抗维持治疗用于广泛期小细胞肺癌一线细胞因子诱导的杀伤细胞联合化疗后

英文原题:Sintilimab maintenance therapy post first-line cytokine-induced killer cells plus chemotherapy for extensive-stage small cell lung cancer.

查看英文原题

Sintilimab maintenance therapy post first-line cytokine-induced killer cells plus chemotherapy for extensive-stage small cell lung cancer.

PubMed 2022/09/09(内容时间) Front Oncol Q2 · IF 3.4(JCR 2025)

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中文摘要

尽管晚期非小细胞肺癌治疗近期有所进展,广泛期小细胞肺癌(ES-SCLC)的临床干预仍停滞不前。本研究评估细胞因子诱导的杀伤(CIK)细胞联合细胞毒性化疗,随后使用抗程序性死亡受体1抗体信迪利单抗维持治疗,对ES-SCLC患者的临床疗效。2019年6月至2021年12月纳入13例患者,均接受一线依托泊苷联合铂类化疗及CIK细胞治疗。达到疾病稳定或对治疗有应答者接受信迪利单抗维持治疗。主要研究目标为中位OS;次要目标包括ORR、PFS1和PFS2(PFS1定义为签署知情同意至肿瘤进展、死亡或末次随访的时间;PFS2定义为首次使用信迪利单抗至肿瘤进展、死亡或末次随访的时间)及不良反应。随访24.1个月时,中位OS为11.8个月(95% CI 10.6–13.0),中位PFS1为5.5个月(95% CI 5.0–6.0),中位PFS2为2.3个月(95% CI 0.5–4.1)。ORR为76.9%(10/13),疾病控制率为100%(13/13),20个月生存率为41.7%。联合治疗后8例参与者发生3或4级不良事件;信迪利单抗维持期间1例患者发生3级不良事件。

总之,在标准化疗方案中加入CIK细胞、随后以信迪利单抗维持,可能成为一种新的安全有效治疗策略。临床试验注册:ClinicalTrials.gov,NCT03983759。

展开英文摘要原文

UNLABELLED: Despite recent progress in treating advanced non-small cell lung cancer, clinical intervention in extensive-stage small-cell lung cancer (ES-SCLC) remains stagnant. The purpose of this study was to evaluate the clinical efficacy of cytokine-induced killer (CIK) cells combined with cytotoxic chemotherapy, followed by anti-programmed death 1 antibody (sintilimab) maintenance, in ES-SCLC patients. To explore a new method for safe treatment of ES-SCLC patients, thirteen ES-SCLC patients were enrolled between June 2019 and December 2021. All patients received first-line chemotherapy (etoposide plus platinum) combined with CIK cell therapy. Patients who reached a stable disease state or responded well to treatment received sintilimab maintenance treatment.

The primary objective of this study was to determine the median overall survival (OS); the secondary objective was to assess the objective response rate (ORR), progression-free survival 1 and 2 (PFS1 was defined as the duration from the signing of informed consent to the date of tumor progression, or death, or the last follow-up. PFS2 was defined as the duration from the first day of sintilimab treatment to the date of tumor progression, death, or the last follow-up.) , and adverse reactions.

At a 24. 1-month follow-up, the median OS was 11. 8 (95% confidence interval [CI]: 10. 6-13. 0) months, median PFS1 was 5. 5 (95% CI: 5. 0-6. 0) months, and the median PFS2 was 2. 3 (95% CI: 0. 5-4. 1) months. The ORR was 76. 9% (10/13), the disease control rate was 100% (13/13), and the 20-month survival rate was 41. 7%. Eight participants exhibited grade 3 or 4 adverse events after combination therapy. During maintenance treatment with sintilimab, level 3 adverse events occurred in 1 patient (1/9).

In conclusion, adding CIK cells to standard chemotherapy regimens, followed by maintenance therapy with sintilimab, may represent a new safe and effective treatment strategy. CLINICAL TRIAL REGISTRATION: ClinicalTrials. gov (NCT03983759).

论文信息

作者
Ma B、Zhou Y、Shang Y、Zhang Y、Xu B、Fu X、Guo J、Yang Y
单位
Department of Immunotherapy, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.China
期刊
Frontiers in oncology2022
原文标识
PubMed 36158690 · DOI 10.3389/fonc.2022.852885