研究动态
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基于抗程序性死亡 1 抗体的联合疗法对中国晚期或转移性胃癌或胃食管交界癌患者的疗效和安全性:一项真实世界研究。

Efficacy and safety of anti-programmed death-1 antibody-based combination therapy in advanced or metastatic gastric or gastroesophageal junction cancer in Chinese patients: A real-world study.

发表日期:2024
作者: Yifan Gao, Haoqian Li, Lei Qiu, Hongtu Yuan, Qing Fan, Zuoxing Niu, Ligang Xing, Mingxing Li, Dandan Yuan
来源: Cellular & Molecular Immunology

摘要:

程序性死亡1抗体联合化疗已获得批准用于治疗(人表皮生长因子受体2阴性的局部晚期或转移性胃或胃食管结合部癌)。本研究旨在分析抗程序性死亡1抗体联合化疗的有效性和安全性在现实环境中,对中国患有晚期或转移性胃癌或胃食管交界癌的患者进行化疗或抗血管生成治疗。2019年4月至12月期间,总共有122名患者接受了基于抗程序性死亡1抗体的联合治疗对 2021 年的临床结果和安全性进行了测量和分析。在整个队列中,中位总生存期为 17.2 个月,中位无进展生存期为 10.9 个月,中位缓解持续时间为 9.4 个月。一线患者中,中位总生存期未达到,中位无进展生存期为14.8个月,客观缓解率为68.4%。二线组的中位总生存期、中位无进展生存期、中位缓解持续时间和客观缓解率分别为 10.9 个月、5.9 个月、4.5 个月和 41.5%。在整个队列中,28.2% 的人观察到任何级别的治疗相关不良事件,主要影响血液学和肝功能。 3 级或 4 级不良事件的主要特征是天冬氨酸转氨酶、丙氨酸转氨酶水平升高,以及淋巴细胞和白细胞减少以及贫血。我们队列中的患者从抗程序性死亡 1 抗体中获得了临床获益。在一线治疗环境中进行联合治疗,并产生可接受的治疗相关不良事件。抗程序性死亡1抗体联合化疗或抗血管生成治疗对二线患者的益处尚需通过大型多中心随机对照临床试验进一步证实。
Programmed death-1 antibody plus chemotherapy has gained approval for the treatment for (human epidermal growth factor receptor 2 negative locally advanced or metastatic gastric or gastroesophageal junction cancer. This study aims to analyze the efficacy and safety of anti-programmed death-1 antibody combined with chemo- or anti-angiogenesis therapy in Chinese patients with advanced or metastatic gastric or gastroesophageal junction cancer in a real-world setting.In total, 122 patients treated with anti-programmed death-1 antibody-based combination therapy between April 2019 and December 2021 were encompassed. Clinical outcomes and safety profile were measured and analyzed.In the whole cohort, median overall survival was 17.2 months, median progression-free survival was 10.9 months, and median duration of response was 9.4 months. Notably, in the first-line patients, the median overall survival was not reached, median progression-free survival was 14.8 months, objective response rate was 68.4%. In the second-line group, median overall survival, median progression-free survival, median duration of response, and objective response rate were 10.9 months, 5.9 months, 4.5 months, and 41.5%, respectively. Treatment-related adverse events of any grade were observed in 28.2% of the overall cohort, primarily affecting the hematological and liver function. Grade 3 or 4 adverse events were mainly characterized by increased levels of aspartate aminotransferase, alanine aminotransferase, along with decreased lymphocyte and white blood cells, as well as anemia.Patients in our cohort experienced a clinical benefit from anti-programmed death-1 antibody-combined treatment in first-line treatment settings, with acceptable treatment-related adverse events. The benefit of anti-programmed death-1 antibody combined with chemo- or anti-angiogenesis treatment to the second-line patients should be further confirmed by large multi-center randomized, controlled clinical trials.