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Abstract：
BACKGROUND: Although treatment options for gastric cancer (GC) continue to advance, the overall prognosis for patients with GC remains poor. At present, the predictors of treatment efficacy remain controversial except for high microsatellite instability.
OBJECTIVE: To develop methods to identify groups of patients with GC who would benefit the most from receiving the combination of a programmed cell death protein 1 (PD-1) inhibitor and chemotherapy.
METHODS: We acquired data from 63 patients with human epidermal growth factor receptor 2 (HER2)-negative GC with a histological diagnosis of GC at the Cancer Hospital, Chinese Academy of Medical Sciences between November 2020 and October 2022. All of the patients screened received a PD-1 inhibitor combined with chemotherapy as the first-line treatment.
RESULTS: As of July 1, 2023, the objective response rate was 61.9%, and the disease control rate was 96.8%. The median progression-free survival (mPFS) for all patients was 6.3 months. The median overall survival was not achieved. Survival analysis showed that patients with a combined positive score (CPS) ≥ 1 exhibited an extended trend in progression-free survival (PFS) when compared to patients with a CPS of 0 after receiving a PD-1 inhibitor combined with oxaliplatin and tegafur as the first-line treatment. PFS exhibited a trend for prolongation as the expression level of HER2 increased. Based on PFS, we divided patients into two groups: A treatment group with excellent efficacy and a treatment group with poor efficacy. The mPFS of the excellent efficacy group was 8 months, with a mPFS of 9.1 months after excluding a cohort of patients who received interrupted therapy due to surgery. The mPFS was 4.5 months in patients in the group with poor efficacy who did not receive surgery. Using good/poor efficacy as the endpoint of our study, univariate analysis revealed that both CPS score (P = 0.004) and HER2 expression level (P = 0.015) were both factors that exerted significant influence on the efficacy of treatment the combination of a PD-1 inhibitor and chemotherapy in patients with advanced GC (AGC). Finally, multivariate analysis confirmed that CPS score was a significant influencing factor.
CONCLUSIONS: CPS score and HER2 expression both impacted the efficacy of immunotherapy combined with chemotherapy in AGC patients who were non-positive for HER2.
OBJECTIVE: To develop methods to identify groups of patients with GC who would benefit the most from receiving the combination of a programmed cell death protein 1 (PD-1) inhibitor and chemotherapy.
METHODS: We acquired data from 63 patients with human epidermal growth factor receptor 2 (HER2)-negative GC with a histological diagnosis of GC at the Cancer Hospital, Chinese Academy of Medical Sciences between November 2020 and October 2022. All of the patients screened received a PD-1 inhibitor combined with chemotherapy as the first-line treatment.
RESULTS: As of July 1, 2023, the objective response rate was 61.9%, and the disease control rate was 96.8%. The median progression-free survival (mPFS) for all patients was 6.3 months. The median overall survival was not achieved. Survival analysis showed that patients with a combined positive score (CPS) ≥ 1 exhibited an extended trend in progression-free survival (PFS) when compared to patients with a CPS of 0 after receiving a PD-1 inhibitor combined with oxaliplatin and tegafur as the first-line treatment. PFS exhibited a trend for prolongation as the expression level of HER2 increased. Based on PFS, we divided patients into two groups: A treatment group with excellent efficacy and a treatment group with poor efficacy. The mPFS of the excellent efficacy group was 8 months, with a mPFS of 9.1 months after excluding a cohort of patients who received interrupted therapy due to surgery. The mPFS was 4.5 months in patients in the group with poor efficacy who did not receive surgery. Using good/poor efficacy as the endpoint of our study, univariate analysis revealed that both CPS score (P = 0.004) and HER2 expression level (P = 0.015) were both factors that exerted significant influence on the efficacy of treatment the combination of a PD-1 inhibitor and chemotherapy in patients with advanced GC (AGC). Finally, multivariate analysis confirmed that CPS score was a significant influencing factor.
CONCLUSIONS: CPS score and HER2 expression both impacted the efficacy of immunotherapy combined with chemotherapy in AGC patients who were non-positive for HER2.
摘要：
背景：尽管胃癌（GC）的治疗方案不断发展，GC患者的总体预后仍然较差.目前,除了高度的微卫星不稳定性外,治疗疗效的预测因素仍存在争议.
目的：开发一些方法，以确定接受程序性细胞死亡蛋白1（PD-1）抑制剂和化疗联合治疗的GC患者组获益最大。
方法：我们从肿瘤医院的63例人表皮生长因子受体2（HER2）阴性GC患者中获得了组织学诊断为GC的数据，中国医学科学院，2020年11月至2022年10月。所有筛查的患者均接受PD-1抑制剂联合化疗作为一线治疗。
结果：截至2023年7月1日，客观反应率为61.9％，疾病控制率为96.8%。所有患者的中位无进展生存期（mPFS）为6.3个月。未达到中位总生存期。生存分析显示，在接受PD-1抑制剂联合奥沙利铂和替加氟作为一线治疗后，与CPS为0的患者相比，合并阳性评分（CPS）≥1的患者表现出延长的无进展生存期（PFS）趋势。随着HER2表达水平的增加,PFS表现出延长的趋势。基于PFS,我们将患者分为两组：治疗组疗效好，治疗组疗效差。显效组的mPFS为8个月,排除一组因手术而中断治疗的患者后，mPFS为9.1个月。未接受手术的疗效差的患者的mPFS为4.5个月。使用好/差的疗效作为我们研究的终点，单因素分析显示,CPS评分(P=0.004)和HER2表达水平(P=0.015)均显著影响PD-1抑制剂联合化疗治疗晚期GC(AGC)患者的疗效.最后,多因素分析证实CPS评分是一个显著的影响因素。
结论：CPS评分和HER2表达均影响HER2非阳性AGC患者免疫治疗联合化疗的疗效。
目的：开发一些方法，以确定接受程序性细胞死亡蛋白1（PD-1）抑制剂和化疗联合治疗的GC患者组获益最大。
方法：我们从肿瘤医院的63例人表皮生长因子受体2（HER2）阴性GC患者中获得了组织学诊断为GC的数据，中国医学科学院，2020年11月至2022年10月。所有筛查的患者均接受PD-1抑制剂联合化疗作为一线治疗。
结果：截至2023年7月1日，客观反应率为61.9％，疾病控制率为96.8%。所有患者的中位无进展生存期（mPFS）为6.3个月。未达到中位总生存期。生存分析显示，在接受PD-1抑制剂联合奥沙利铂和替加氟作为一线治疗后，与CPS为0的患者相比，合并阳性评分（CPS）≥1的患者表现出延长的无进展生存期（PFS）趋势。随着HER2表达水平的增加,PFS表现出延长的趋势。基于PFS,我们将患者分为两组：治疗组疗效好，治疗组疗效差。显效组的mPFS为8个月,排除一组因手术而中断治疗的患者后，mPFS为9.1个月。未接受手术的疗效差的患者的mPFS为4.5个月。使用好/差的疗效作为我们研究的终点，单因素分析显示,CPS评分(P=0.004)和HER2表达水平(P=0.015)均显著影响PD-1抑制剂联合化疗治疗晚期GC(AGC)患者的疗效.最后,多因素分析证实CPS评分是一个显著的影响因素。
结论：CPS评分和HER2表达均影响HER2非阳性AGC患者免疫治疗联合化疗的疗效。
