Ma Xiao-Ting, Ou Kai, Yang Wen-Wei, Cao Bi-Yang, Yang Lin
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 100021, China.
World J Clin Oncol. 2024 May 24;15(5):635-643. doi: 10.5306/wjco.v15.i5.635.
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.
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.
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.
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 ( = 0.004) and HER2 expression level ( = 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.
CPS score and HER2 expression both impacted the efficacy of immunotherapy combined with chemotherapy in AGC patients who were non-positive for HER2.
尽管胃癌（GC）的治疗方案不断进步，但GC患者的总体预后仍然较差。目前，除高微卫星不稳定性外，治疗疗效的预测指标仍存在争议。
开发方法以识别最能从程序性细胞死亡蛋白1（PD-1）抑制剂与化疗联合治疗中获益的GC患者群体。
我们收集了2020年11月至2022年10月期间在中国医学科学院肿瘤医院经组织学诊断为GC的63例人表皮生长因子受体2（HER2）阴性GC患者的数据。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。
截至2023年7月1日，客观缓解率为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。中位总生存期未达到。生存分析表明，一线接受PD-1抑制剂联合奥沙利铂和替加氟治疗后，联合阳性评分（CPS）≥1的患者与CPS为0的患者相比，无进展生存期（PFS）呈延长趋势。随着HER2表达水平升高，PFS有延长趋势。基于PFS，我们将患者分为两组：疗效优异治疗组和疗效较差治疗组。疗效优异组的mPFS为8个月，排除因手术接受中断治疗的一组患者后，mPFS为9.1个月。未接受手术的疗效较差组患者的mPFS为4.5个月。以疗效优/差作为研究终点，单因素分析显示CPS评分（P = 0.004）和HER2表达水平（P = 0.015）均是对晚期GC（AGC）患者PD-1抑制剂与化疗联合治疗疗效有显著影响的因素。最后，多因素分析证实CPS评分是一个显著影响因素。
CPS评分和HER2表达均影响HER2非阳性的AGC患者免疫治疗联合化疗的疗效。
