PMID- 38022664 OWN - NLM STAT- MEDLINE DCOM- 20231201 LR - 20240322 IS - 1664-3224 (Electronic) IS - 1664-3224 (Linking) VI - 14 DP - 2023 TI - Autologous CIK cells combined with chemotherapy as the first-line treatment for locally advanced or metastatic gastric cancer is safe and feasible. PG - 1267369 LID - 10.3389/fimmu.2023.1267369 [doi] LID - 1267369 AB - AIM: To evaluate the safety and initial efficacy of autologous cytokine-induced killer (CIK) cells combined with S-1+oxaliplatin (SOX) as the first-line treatment for locally advanced or metastatic gastric cancer (GC). MATERIALS AND METHODS: In this two-arm, single-center exploratory trial, patients with locally advanced or metastatic GC were randomly assigned (1:1) to receive autologous CIK cells in combination with SOX (CIK-SOX) or SOX alone. The primary endpoint was the incidence of adverse events (AEs). Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR) served as the secondary endpoints. RESULTS: Fifty-nine patients were enrolled in the study between November 20, 2014 and September 6, 2017. A total of 31 patients received CIK-SOX and 28 patients received SOX. The most common AEs in both groups were gastrointestinal reaction, leucopenia, neutropenia, anemia, thrombocytopenia, hyperbilirubinemia, and elevated aspartate transaminase concentration, with a higher incidence of these conditions in the SOX group. The median PFS for the CIK-SOX and SOX groups was 6.9 and 4.9 months, respectively (hazard ratio (HR) 0.80, p=0.45). The respective median OS values were 17.8 and 9.75 months (HR 0.76, p=0.34). Patients who received more than three injections of specific lymphocyte subsets benefited the most from this combination therapy. Cox univariate and multivariate analyses showed that tumor metastasis to more than two organs was the main risk factor for PFS and OS. A total of 29 patients in the CIK-SOX group and 25 in the SOX group had measurable lesions. The ORR for the CIK-SOX and SOX groups was 55.2% and 32.0%, while the DCR was 93.1% and 88.0%, respectively. CONCLUSION: The safety of CIK-SOX as the first-line treatment for patients with locally advanced or metastatic GC was good. Although the PFS and OS in the CIK-SOX group were not statistically significantly different compared to the values in the SOX alone group, this treatment increased the PFS and OS duration, with the absolute improvement in OS of about 8.05 months. Continuous benefit from the CIK-SOX treatment was observed during long-term follow-up. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT02504229?term=NCT02504229&rank=1, identifier ChiCTR-IPR-15005923; NCT02504229. CI - Copyright (c) 2023 Ma, Peng, Wang, Gao, Zhang, Lu, Liu and Yang. FAU - Ma, Xiaoting AU - Ma X AD - Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Peng, Liming AU - Peng L AD - Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Wang, Junqing AU - Wang J AD - Department of Medical Oncology, Beijing Chaoyang Huanxing Cancer Hospital, Beijing, China. FAU - Gao, Lizhen AU - Gao L AD - Department of Medical Oncology, Beijing Chaoyang Huanxing Cancer Hospital, Beijing, China. FAU - Zhang, Wen AU - Zhang W AD - Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Lu, Xu AU - Lu X AD - Department of Oncology, Beijing Biohealthcare Biotechnology Co., Ltd, Beijing, China. FAU - Liu, Jingwei AU - Liu J AD - Department of Oncology, Beijing Biohealthcare Biotechnology Co., Ltd, Beijing, China. FAU - Yang, Lin AU - Yang L AD - Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. LA - eng SI - ClinicalTrials.gov/NCT02504229 PT - Journal Article PT - Randomized Controlled Trial DEP - 20231101 PL - Switzerland TA - Front Immunol JT - Frontiers in immunology JID - 101560960 RN - 04ZR38536J (Oxaliplatin) SB - IM MH - Humans MH - *Stomach Neoplasms MH - *Cytokine-Induced Killer Cells MH - Disease-Free Survival MH - Oxaliplatin/therapeutic use MH - Combined Modality Therapy PMC - PMC10646377 OTO - NOTNLM OT - CIK OT - adverse event OT - gastric cancer OT - overall survival OT - progression-free survival COIS- Authors XL and JL were employed by the company Beijing Biohealthcare Biotechnology Co., Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/11/29 18:43 MHDA- 2023/12/01 06:44 PMCR- 2023/01/01 CRDT- 2023/11/29 15:29 PHST- 2023/07/26 00:00 [received] PHST- 2023/10/23 00:00 [accepted] PHST- 2023/12/01 06:44 [medline] PHST- 2023/11/29 18:43 [pubmed] PHST- 2023/11/29 15:29 [entrez] PHST- 2023/01/01 00:00 [pmc-release] AID - 10.3389/fimmu.2023.1267369 [doi] PST - epublish SO - Front Immunol. 2023 Nov 1;14:1267369. doi: 10.3389/fimmu.2023.1267369. eCollection 2023.