Efficacy and safety of camrelizumab plus chemotherapy versus chemotherapy alone in patients with untreated, HER2-negative, unresectable locally advanced, or metastatic gastric cancer or gastroesophageal junction cancer: a retrospective comparative cohort study

Abstract

Background: Nivolumab combined with chemotherapy has been shown to improve prognosis in patients with untreated, human epidermal growth factor receptor 2 (HER2)-negative advanced gastric cancer (GC) and programmed death ligand-1 (PD-L1) combined positive score (CPS) ≥5. However, the available firstline treatment options for advanced GC are limited. Analysis of efficacy and safety of other programmed cell death protein 1 (PD-1) antibodies combined with chemotherapy may provide alternative treatment options.Methods: This retrospective study included patients with untreated, HER2-negative, unresectable locally advanced, or metastatic GC or gastroesophageal junction (GEJ) cancer who received either camrelizumab combined with oxaliplatin plus S-1 (SOX)/capecitabine plus oxaliplatin (CapeOX) or SOX/CapOX alone between November 2020 and April 2022. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety were evaluated.Results: This study included 49 patients in camrelizumab plus chemotherapy group and 54 in chemotherapy group. The baseline clinical characteristics beyond Epstein-Barr virus (EBV) status and PD-L1 CPS had no difference between combination group and chemotherapy group. ORR and DCR were significantly higher in combination therapy group than in chemotherapy group (59.18% vs. 38.89%, P=0.048; 83.67% vs. 62.96%, P=0.018). The median PFS in combination group was significantly longer than chemotherapy group [10.03 vs. 6.24 months, hazard ratio (HR) 0.603, 95% confidence interval (CI): 0.368-0.989, P=0.045]. The OS was not mature at the time of the OS analysis, with 40% patients died. Subgroup analyses showed that PFS was longer in patients with PD-L1 CPS ≥1 compared with CPS <1 and in patients with a neutrophil-lymphocyte ratio (NLR) <2.38 compared with ≥2.38. The most common grade 3-4 treatment-related adverse events (TRAEs) were granulocytopenia (57% in combination group vs. 54% in chemotherapy group), anemia (39% vs. 33%, respectively), and thrombocytopenia (39% vs. 33%, respectively). The proportion of reactive cutaneous capillary endothelial proliferation (RCCEP, 73% vs. 0%) was higher in combination group relative to chemotherapy group; all were grades 1-2.

Neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio as biomarkers to prognosticate survival in advanced gastric cancer patients in the era of immunotherapy: a systematic review and meta-analysis

“…Subsequently, a detailed examination of the full texts of the remaining 30 studies was carried out, leading to the exclusion of 12 studies in accordance with our predefined exclusion criteria. Ultimately, this systematic review included 18 studies ( 12 , 35 - 51 ). Our selection process is summarized in Figure 1 .…”

“…Despite the increasing use of immunotherapy in advanced GC, relevant questions remain concerning the limited efficacy of drugs in a subset of patients, drug-related toxicity, and cost-associated considerations. While the combined predictive score has been widely adopted to define eligibility for ICI therapy, some studies suggest that the treatment efficacy of immunotherapy agents may be irrespective of the patient’s programmed cell death protein ligand 1 (PD-L1) status ( 12 , 13 ). Moreover, some data reported poor survival outcomes in subsets of advanced GC patients who were eligible for ICI treatment ( 14 ).…”

Combination treatment with anti-HER2 therapeutic antibody RC48, PD-1 inhibitor, radiotherapy, and granulocyte macrophage-colony stimulating factor (GM-CSF) in patient with metastatic gastric cancer: a case report

“…These findings further support the superiority of immunotherapy alone or in combination with chemotherapy over chemotherapy alone, with a more pronounced long-term survival benefit observed with immunotherapy. As a PD-1 inhibitor developed in China, camrelizumab exhibits a significantly higher ORR rate when compared to chemotherapy alone (59.18% vs 38.89%), particularly when combined with chemotherapy ( 20 ). Additionally, the median PFS time for camrelizumab is 10.03 months compared to 6.24 months for chemotherapy alone.…”

“…The patient was again assessed as PR ( Figure 3 2022-06-23A-H). However, the patient experienced grade 1 reactive cutaneous capillary endothelial proliferation (RCCEP), a novel immune-related adverse event (irAE) observed in the majority of patients treated with camrelizumab ( 19 , 20 ) ( Figure 4B ). Based on the effectiveness of the regimen and the fact that the patient was in stage IV, we recommended that the patient continue receiving RC48 (120 mg on day 1) and camrelizumab (200 mg on day 1) as maintenance treatment, with each cycle lasting for 2 weeks.…”