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预测接受二线纳武利尤单抗单药治疗的晚期胃癌患者生存的预后因素 - 旭川胃癌队列研究(AGCC)。

Prognostic factors to predict the survival in patients with advanced gastric cancer who receive later-line nivolumab monotherapy-The Asahikawa Gastric Cancer Cohort Study (AGCC).

机构信息

Department of Gastroenterology, Asahikawa Kosei Hospital, Asahikawa Hokkaido, Japan.

Division of Metabolism and Biosystemic Science, Gastroenterology and Hematology/Oncology Department of Medicine, Asahikawa Medical University, Asahikawa Hokkaido, Japan.

出版信息

Cancer Med. 2022 Jan;11(2):406-416. doi: 10.1002/cam4.4461. Epub 2021 Nov 29.

Abstract

BACKGROUND

Chemotherapy for advanced gastric cancer is recommended in the guidelines; however, later-line treatment remains controversial. Since immune checkpoint inhibitors have been used for the treatment of various malignancies, trials have been performed for gastric cancer. A phase 3 trial indicated the survival benefit of nivolumab monotherapy for gastric cancer patients treated with prior chemotherapy regimens.

PATIENTS AND METHODS

A regional cohort study was undertaken to determine the real-world data of nivolumab treatment for patients with advanced or recurrent gastric cancer. The patients were enrolled for 2 years from October 2017 to October 2019 and were prospectively followed for 1 year to examine the overall survival (OS). The patient characteristics were analyzed in a multivariate analysis and a nomogram to predict the probability of survival was generated.

RESULTS

In total, 70 patients who received nivolumab as ≥third-line chemotherapy were included in the Asahikawa Gastric Cancer Cohort. The median OS was 7.5 (95% CI, 4.8-10.2) months and the response rate was 18.6%. Diffuse type classification, bone metastasis, high neutrophil/lymphocyte ratio, and high CRP were associated with poor OS/prognosis in the multivariate analysis. A nomogram was developed based on these clinical parameters and the concordance index was 0.80 (95% CI, 0.68-0.91). The responders were aged and were frequently diagnosed with intestinal type gastric cancer, including patients with a HER2-positive status (27.3%) or microsatellite instability-high (27.3%) status.

CONCLUSIONS

The regional cohort study of nivolumab monotherapy for gastric cancer patients revealed prognostic factors and a nomogram was developed that could predict the probability of survival.

摘要

背景

晚期胃癌的治疗推荐采用化疗,但后线治疗仍存在争议。由于免疫检查点抑制剂已被用于多种恶性肿瘤的治疗,因此针对胃癌开展了相关临床试验。一项 3 期临床试验表明,纳武利尤单抗单药治疗先前接受过化疗方案的胃癌患者具有生存获益。

患者和方法

进行了一项区域性队列研究,以确定纳武利尤单抗治疗晚期或复发性胃癌患者的真实世界数据。从 2017 年 10 月至 2019 年 10 月,连续入组患者 2 年,并前瞻性随访 1 年,以评估总生存期(OS)。采用多变量分析和列线图对患者特征进行分析,以预测生存概率。

结果

共纳入 70 例接受纳武利尤单抗作为≥三线化疗的患者。中位 OS 为 7.5 个月(95%CI,4.8-10.2),客观缓解率为 18.6%。弥漫型分类、骨转移、高中性粒细胞/淋巴细胞比值和高 C 反应蛋白与多变量分析中的 OS 预后不良相关。基于这些临床参数建立了列线图,一致性指数为 0.80(95%CI,0.68-0.91)。应答者年龄较大,常被诊断为肠型胃癌,包括 HER2 阳性(27.3%)或微卫星不稳定高(27.3%)状态的患者。

结论

本项纳武利尤单抗治疗胃癌患者的区域性队列研究揭示了预后因素,并建立了列线图,可预测生存概率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8b3/8729046/b81a009dd389/CAM4-11-406-g001.jpg

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