张鑫鑫, 李帅, 吴晨, 侯新芳. 晚期胃 食管胃结合部腺癌免疫治疗临床分析[J]. 中国肿瘤临床, 2021, 48(23): 1208-1214. DOI: 10.12354/j.issn.1000-8179.2021.20211122
引用本文: 张鑫鑫, 李帅, 吴晨, 侯新芳. 晚期胃 食管胃结合部腺癌免疫治疗临床分析[J]. 中国肿瘤临床, 2021, 48(23): 1208-1214. DOI: 10.12354/j.issn.1000-8179.2021.20211122
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Xinxin Zhang, Shuai Li, Chen Wu, Xinfang Hou. Clinical analysis of immunotherapy for advanced gastric/gastroesophageal junction adenocarcinoma[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2021, 48(23): 1208-1214. DOI: 10.12354/j.issn.1000-8179.2021.20211122
Citation: Xinxin Zhang, Shuai Li, Chen Wu, Xinfang Hou. Clinical analysis of immunotherapy for advanced gastric/gastroesophageal junction adenocarcinoma[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2021, 48(23): 1208-1214. DOI: 10.12354/j.issn.1000-8179.2021.20211122
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晚期胃 食管胃结合部腺癌免疫治疗临床分析

Clinical analysis of immunotherapy for advanced gastric/gastroesophageal junction adenocarcinoma

    摘要
  • 摘要:
      目的  探讨晚期胃/食管胃结合部（gastric/gastroesophageal junction，G/GEJ）腺癌中程序性细胞死亡受体（programmed cell death protein 1, PD-1）单抗临床疗效分析。
      方法  收集2018年9月至2020年9月就诊于河南省肿瘤医院接受PD-1单抗治疗晚期胃/食管胃结合部腺癌患者的临床数据资料。
      结果  收集123例（5例失访）患者，中位随访时间12.6个月。118例患者客观缓解率（overall response rate, ORR)为22.0%，疾病控制率（disease control rate, DCR)为51.7%，中位无进展生存期（progression-free survival, PFS)为5.0个月，中位总生存期(overall survival, OS)为8.9个月。一线 vs. 二线 vs. 三线及以上ORR为（37.0% vs. 20.5% vs. 14.9%，P=0.002），DCR为（81.5% vs. 54.5% vs. 29.8%，P<0.001），中位PFS为（9.9个月 vs. 4.8个月 vs. 3.2个月），中位OS为（19.0 个月vs. 7.8个月 vs. 7.3个月）。PD-1单抗联合化疗 vs. 抗血管 vs. 化疗及抗血管治疗中位PFS为（5.8个月 vs. 4.4个月 vs. 5.0个月）及中位OS为（11.4个月 vs. 8.2个月 vs. 8.2个月）。免疫联合化疗一线（22例）vs.二线（20例）中位PFS为（9.0个月 vs. 4.7个月，P=0.003），中位OS为（NR vs. 7.8个月，P=0.007）。程序性死亡配体(programmed cell death-ligand 1, PD-L1)表达（CPS≥1% vs. CPS<1%）中ORR为(37.1% vs. 13.3%)，DCR为(65.7% vs. 46.7%)，中位PFS为（5.8个月 vs. 4.7个月），中位OS为(11.3个月 vs. 9.3个月)。多因素分析显示年龄、ECOG评分、转移灶数目、腹膜转移及免疫治疗线数是患者OS独立影响因素（P<0.05），且年龄为保护性因素（HR=0.498，95%CI：0.255～0.974）。
      结论  晚期胃/食管胃结合部腺癌早期采用PD-1单抗联合治疗可有效延长患者PFS及OS。PD-1单抗联合化疗及抗血管治疗均有一定优势，但具体时机尚需进一步探索研究。

     

    Abstract:
      Objective  To evaluate the clinical efficacy of programmed cell death protein 1 (PD-1) antibody for advanced gastric/gastroesophageal junction (G/GEJ) adenocarcinoma.
      Methods  Clinical data of patients with advanced G/GEJ adenocarcinoma treated with PD-1 monoclonal antibody at Henan Cancer Hospital were collected from September 2018 to September 2020.
      Results  Overall, 123 patients were examined, among whom 5 were lost to follow-up. The median follow-up time was 12.6 months. In 118 patients, the objective response rate (ORR) was 22.0%, the disease control rate (DCR) was 51.7%, median progression-free survival (PFS) was 5.0 months, and median overall survival (OS) was 8.9 months. The ORRs to first-, second-, and third-line treatment and beyond were 37.0%, 20.5%, and 14.9%, respectively (P=0.002); the DCRs were 81.5%, 54.5%, and 29.8%, respectively (P<0.001); the median PFS were 9.9, 4.8, and 3.2 months, respectively; and the median OS were 19.0, 7.8, and 7.3 months, respectively. After receiving anti-PD-1 therapy combined with chemotherapy, anti-vascular, and chemotherapy and anti-vascular therapy, the median PFS were 5.8, 4.4, and 5.0 months, respectively, and the median OS were 11.4, 8.2, and 8.2 months, respectively. Immunization combined with chemotherapy as first-line (22 cases) and second-line (20 cases) treatment resulted in a median PFS of 9.0 and 4.7 months, respectively (P=0.003) and a median OS of no reach and 7.8 months, respectively (P=0.007). Patients with PD-L1 expression (CPS≥1% vs. <1%) had ORRs of 37.1% and 13.3%, respectively; DCRs of 65.7% and 46.7%, respectively; median PFS of 5.8 and 4.7 months, respectively, and median OS of 11.3 and 9.3 months, respectively. Multivariate analysis showed that age, ECOG score, number of metastases, peritoneal metastasis, and number of immunotherapy lines were independent influencing factors of OS (P<0.05), and patient age was a protective factor (HR=0.498, 95%CI:0.255–0.974).
      Conclusions  Early treatment of advanced G/GEJ adenocarcinoma with anti-PD-1 combination therapy can effectively prolong PFS and OS. Anti-PD-1 combined with chemotherapy and anti-vascular therapy have certain advantages but warrant further exploration and research.

     

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