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卡度尼利单抗联合化疗用于HER2中/低/不表达晚期胃腺癌或食管胃结合部腺癌的临床观察
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| 篇名： | 卡度尼利单抗联合化疗用于HER2中/低/不表达晚期胃腺癌或食管胃结合部腺癌的临床观察 |
| TITLE： | Clinical observation of cadonilimab plus chemotherapy in advanced gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction with intermediate，low，or no HER2 expression |
| 摘要： | 目的 考察卡度尼利单抗联合化疗在人表皮生长因子受体2（HER2）中表达、低表达或不表达晚期胃腺癌或食管胃结合部腺癌（AEG）中的效果及安全性。方法回顾性选取2024年10月1日至2025年6月30日于辽宁省肿瘤医院就诊的HER2中表达、低表达或不表达晚期胃腺癌或AEG患者为研究对象，按照治疗方案分为A组[卡度尼利单抗联合奥沙利铂+卡培他滨（XELOX）方案，n＝54]、B组（信迪利单抗联合XELOX方案，n＝68）及C组（替雷利珠单抗联合XELOX方案，n＝49）。比较3组患者治疗4个周期后的近期疗效、生存期及不良反应差异，并进一步采用Cox回归及Logistic回归分析治疗方案和基线资料对生存结局及3～4级治疗相关不良反应（TRAEs）的影响。结果3组患者的客观缓解率和疾病控制率比较，差异均无统计学意义（P＞0.05）。A组患者的中位无进展生存期为7.56（5.62，8.11）个月，B组为7.23（5.33，8.23）个月，C组为7.33（5.42，8.19）个月，3组比较差异无统计学意义（P＞0.05）。A组患者的中位总生存期（mOS）为11.67（8.82，13.88）个月，B组为9.78（6.82，12.73）个月，C组为9.69（6.78，12.66）个月，A组显著长于B组和C组（P<0.05），而B组和C组的差异无统计学意义（P＞0.05）。相关性分析结果显示，治疗方案、美国东部肿瘤协作组体能状态评分、转移器官数目及腹膜转移可能与患者总生存期（OS）相关；治疗方案与3～4级TRAEs发生风险之间未见显著相关性。3组患者的1～2级或3～4级TRAEs发生率比较，差异均无统计学意义（P＞0.05）。结论与信迪利单抗或替雷利珠单抗联合XELOX方案相比，卡度尼利单抗联合XELOX方案治疗HER2中表达、低表达或不表达晚期胃腺癌或AEG可能具有更明显的OS获益，且安全性相近，但仍需更大样本研究进一步验证。 |
| ABSTRACT： | OBJECTIVE To evaluate the efficacy and safety of cadonilimab plus chemotherapy in patients with advanced gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction （AEG） with intermediate， low， or no human epidermal growth factor receptor 2 （HER2） expression. METHODS Patients with advanced gastric adenocarcinoma or AEG with intermediate， low， or no HER2 expression who were treated at Liaoning Cancer Hospital between October 1， 2024 and June 30， 2025 were retrospectively included. According to the treatment regimen received， the patients were divided into group A [cadonilimab plus oxaliplatin and capecitabine （XELOX）， n ＝54 ] ， group B （sintilimab plus XELOX， n ＝68）， and group C （tislelizumab plus XELOX， n ＝49）. Short-term efficacy after 4 cycles of treatment， survival outcomes， and adverse events were compared among the three groups. Cox regression and Logistic regression analyses were further performed to evaluate the effects of the treatment regimen and baseline data on survival outcomes and the risk of grade 3-4 treatment related adverse events （TRAEs）. RESULTS No statistically significant differences in objective response rate or disease control rate were observed among the three groups （ P ＞0.05）. The median progression-free survival was 7.56 （5.62， 8.11） months in group A， 7.23 （5.33， 8.23） months in group B， and 7.33 （5.42， 8.19） months in group C， with no statistically significant difference among the three groups （ P ＞0.05）. The median overall survival （mOS） was 11.67 （8.82， 13.88） months in group A， 9.78 （6.82， 12.73） months in group B， and 9.69 （6.78， 12.66） months in group C. The mOS was significantly longer in group A than in group B and group C （ P ＜0.05）， whereas no statistically significant difference was observed between group B and group C （ P ＞0.05）. The correlation analysis indicated that treatment regimen， Eastern Cooperative Oncology Group performance status （ECOG PS）， number of metastatic organs， and peritoneal metastasis may be associated with overall survival （OS）. No significant association was observed between treatment regimen and the risk of grade 3-4 TRAEs. The incidences of grade 1-2 or grade 3-4 TRAEs did not differ significantly among the three groups （ P ＞0.05）. CONCLUSIONS In patients with advanced gastric adenocarcinoma or AEG with intermediate， low， or no HER2 expression， cadonilimab plus XELOX may provide a more significant OS benefit with a safety profile comparable to that of sintilimab or tislelizumab plus XELOX. Further studies with larger sample sizes are required to validate these findings. |
| 期刊： | 2026年第37卷第14期 |
| 作者： | 祝平；李晓飞；朱佳；田艳飞；徐兴 |
| AUTHORS： | ZHU Ping，LI Xiaofei，ZHU Jia，TIAN Yanfei，XU Xing |
| 关键字： | 卡度尼利单抗; 胃腺癌; 食管胃结合部腺癌; HER2中表达; HER2低表达; HER2不表达 |
| KEYWORDS： | cadonilimab; gastric adenocarcinoma; adenocarcinoma of gastroesophageal junction; intermediate HER2 expression; low HER2 expression; no HER2 expression |
| 阅读数： | 4 次 |
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