PMID- 35557572 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220518 IS - 2078-6891 (Print) IS - 2219-679X (Electronic) IS - 2078-6891 (Linking) VI - 13 IP - 2 DP - 2022 Apr TI - Efficacy and safety of camrelizumab in combination with trastuzumab and chemotherapy as the first-line treatment for patients with HER2-positive advanced gastric cancer. PG - 548-558 LID - 10.21037/jgo-21-897 [doi] AB - BACKGROUND: Trastuzumab plus chemotherapy is the standard-of-care (SoC) first-line therapy for HER2-positive advanced gastric cancer. Combining PD-1 antibody with SoC first-line therapy showed encouraging results in the KEYNOTE-811 study. The retrospective study aims to evaluate the efficacy and safety of SoC vs. SoC plus camrelizumab (PD-1 antibody) as a first-line treatment for HER2-positive advanced gastric cancer in a real-world setting. METHODS: This study included 41 patients with HER2-positive advanced gastric cancer who received SoC or SoC plus camrelizumab from June 2017 to December 2020. The endpoints were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. RESULTS: Thirteen patients received SoC (SoC group) and 28 patients received SoC plus camrelizumab (camrelizumab group). As of December 2020, the median follow-up time was 10.0 months. In the camrelizumab and SoC groups, the ORRs were 75.0% and 46.2% (P=0.032), respectively. The DCR was 96.4% in the camrelizumab group and 69.2% in the SoC group (P=0.003). The median OS was 18.4 in the camrelizumab group and 13.2 months in the SoC group [hazard ratio (HR) =0.343; 95% confidence interval (CI): 0.151-0.783; P=0.008]. The median PFS was 3.78 in the camrelizumab group and 1.74 months in the SoC group (HR =0.416; 95% CI: 0.186-0.932; P=0.027). In the HER2 subgroups in the camrelizumab group, the median PFS of immunohistochemistry (IHC) 3+ vs. IHC 2+ fluorescence in situ hybridization (FISH) was 11.3 vs. 9.0 months (HR =1.684; 95% CI: 0.710-3.994; P=0.047). The incidence rates of reactive cutaneous capillary endothelial proliferation (RCCEP) (P<0.001), abnormal liver function (P=0.040), and hypothyroidism (P=0.039) between the two groups were significantly different. RCCEP and hypothyroidism were considered to be related to camrelizumab. CONCLUSIONS: First-line treatment with camrelizumab combined with SoC showed significant clinical benefits and good tolerance compared with SoC for HER2-positive advanced gastric cancer. CI - 2022 Journal of Gastrointestinal Oncology. All rights reserved. FAU - Xu, Mengli AU - Xu M AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Meng, Xiangrui AU - Meng X AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Lu, Yao AU - Lu Y AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Wang, Feng AU - Wang F AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. LA - eng PT - Journal Article PL - China TA - J Gastrointest Oncol JT - Journal of gastrointestinal oncology JID - 101557751 PMC - PMC9086057 OTO - NOTNLM OT - HER2-positive advanced gastric cancer OT - Retrospective study OT - camrelizumab OT - efficacy OT - safety COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jgo.amegroups.com/article/view/10.21037/jgo-21-897/coif). The authors have no conflicts of interest to declare. EDAT- 2022/05/14 06:00 MHDA- 2022/05/14 06:01 PMCR- 2022/04/01 CRDT- 2022/05/13 18:05 PHST- 2021/12/03 00:00 [received] PHST- 2022/03/04 00:00 [accepted] PHST- 2022/05/13 18:05 [entrez] PHST- 2022/05/14 06:00 [pubmed] PHST- 2022/05/14 06:01 [medline] PHST- 2022/04/01 00:00 [pmc-release] AID - jgo-13-02-548 [pii] AID - 10.21037/jgo-21-897 [doi] PST - ppublish SO - J Gastrointest Oncol. 2022 Apr;13(2):548-558. doi: 10.21037/jgo-21-897.