Real-world data on camrelizumab in digestive system cancers: a retrospective observational study

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Abstract

Objective: To explore the clinical efficacy and safety of camrelizumab in the treatment of digestive system malignancies in the real world. Methods: A retrospective study was designed. A total of 34 patients with advanced gastrointestinal cancer who received camrelizumab treatment in the xx hospital from July 2019 to May 2020 were included. The follow-up endpoint was set for October 30, 2020. The primary endpoint was objective response rate (ORR) and safety. Secondary endpoint measures included progression-free survival (PFS), and overall survival (OS). Cox regression was used for the analysis of factors associated with PFS. Results: As the best response, only 5 patients achieved a partial response and 10 patients had disease progression, with an ORR of 14.31%. Compared with gastric cancer, the ORR of esophageal cancer (3.0% vs 0.0%) (P<0.05). The PFS was 4.5 months (2-10 months). OS ranged from 4 to 11 months, and median OS has not been reached. Multivariate Cox regression analysis showed that gastric cancer (HR=1.695, 95% CI:11.216–2.435, P<0.05) was associated with still shorter PFS, and camrelizumab combined with other drugs (HR=0.512, 95% CI: 0.095–0.737, P<0.01) was associated with PFS in patients. The most common AEs were anemia (41.2%, 14/34) in all grades 1 to 2. Grade 3 AEs occurred in 3 patients (2.9%), including 1 case of immune pneumonitis, 1 case of hemangioma, and 1 case of transaminase increased. Other adverse events included diarrhea, nausea, neutropenia, thrombocytopenia, reactive cutaneous capillary proliferation (RCCEP), fatigue, and hypothyroidism, all of which did not exceed 12%. Conclusion: Camrelizumab is effective and safe in the treatment of patients with digestive system malignancies, but the overall response rate is limited.
camrelizumab在消化系统癌症中的实际数据:一项回顾性观察性研究
目的:探讨现实世界中camrelizumab治疗消化系统恶性肿瘤的临床疗效和安全性。方法:设计回顾性研究。纳入2019年7月至2020年5月在xx医院接受camrelizumab治疗的34例晚期胃肠道肿瘤患者。随访终点定于2020年10月30日。主要终点是客观缓解率(ORR)和安全性。次要终点测量包括无进展生存期(PFS)和总生存期(OS)。采用Cox回归分析与PFS相关的因素。结果:作为最佳反应,仅有5例患者获得部分缓解,10例患者出现疾病进展,ORR为14.31%。与胃癌相比,食管癌的ORR为3.0% vs 0.0% (P<0.05)。PFS为4.5个月(2-10个月)。生存期从4到11个月不等,中位生存期尚未达到。多因素Cox回归分析显示,胃癌(HR=1.695, 95% CI:11.216 ~ 2.435, P<0.05)与更短的PFS相关,camrelizumab联合其他药物(HR=0.512, 95% CI: 0.095 ~ 0.737, P<0.01)与患者的PFS相关。1 ~ 2级最常见的不良事件是贫血(41.2%,14/34)。3级ae 3例(2.9%),其中免疫性肺炎1例,血管瘤1例,转氨酶升高1例。其他不良事件包括腹泻、恶心、中性粒细胞减少、血小板减少、反应性皮肤毛细血管增生(RCCEP)、疲劳和甲状腺功能减退,所有这些不良事件均不超过12%。结论:Camrelizumab治疗消化系统恶性肿瘤有效且安全,但总有效率有限。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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