Ma Baozhen, Zhou Yu, Shang Yiman, Zhang Yong, Xu Benling, Fu Xiaomin, Guo Jindong, Yang Yonghao, Zhang Fang, Zhou Mengyuan, Huang Hao, Li Fanghui, Lin Hongwei, Zhao Lingdi, Wang Zibing, Gao Quanli
Department of Immunotherapy, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.
Front Oncol. 2022 Sep 9;12:852885. doi: 10.3389/fonc.2022.852885. eCollection 2022.
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.
ClinicalTrials.gov (NCT03983759).
尽管在治疗晚期非小细胞肺癌方面取得了近期进展，但广泛期小细胞肺癌（ES-SCLC）的临床干预仍停滞不前。本研究的目的是评估细胞因子诱导的杀伤细胞（CIK）联合细胞毒性化疗，随后进行抗程序性死亡1抗体（信迪利单抗）维持治疗，在ES-SCLC患者中的临床疗效。为探索一种安全治疗ES-SCLC患者的新方法，2019年6月至2021年12月期间招募了13例ES-SCLC患者。所有患者均接受一线化疗（依托泊苷加铂类）联合CIK细胞治疗。达到疾病稳定状态或对治疗反应良好的患者接受信迪利单抗维持治疗。本研究的主要目的是确定中位总生存期（OS）；次要目的是评估客观缓解率（ORR）、无进展生存期1和2（PFS1定义为从签署知情同意书到肿瘤进展、死亡或最后一次随访的时间。PFS2定义为从信迪利单抗治疗第一天到肿瘤进展、死亡或最后一次随访的时间）以及不良反应。在24.1个月的随访中，中位OS为11.8（95%置信区间[CI]：10.6-13.0）个月，中位PFS1为5.5（95%CI：5.0-6.0）个月，中位PFS2为2.3（95%CI：0.5-4.1）个月。ORR为76.9%（10/13），疾病控制率为100%（13/13），20个月生存率为41.7%。8名参与者在联合治疗后出现3级或4级不良事件。在信迪利单抗维持治疗期间，1例患者（1/9）出现3级不良事件。总之，在标准化疗方案中加入CIK细胞，随后进行信迪利单抗维持治疗，可能代表一种新的安全有效的治疗策略。
ClinicalTrials.gov（NCT03983759）。
