METHODS: We collected data from the hospital medical records of patients with mUC treated with pembrolizumab as second-line therapy at 87 institutions from 22 countries. Patients were assessed for overall survival (OS), progression-free survival (PFS), and overall response rate. We carried out a survival analysis by a Cox regression model.
RESULTS: A total of 802 patients were eligible for this retrospective study; the median follow-up time was 15.3 months. PPI users compared to non-users showed inferior PFS (4.5 vs. 7.2 months, p = 0.002) and OS (8.7 vs. 14.1 months, p < 0.001). Concomitant PPI use remained a significant predictor of PFS and OS after multivariate Cox analysis. The use of statins or metformin was not associated with response or survival.
CONCLUSIONS: Our study results suggest a significant prognostic impact of concomitant PPI use in mUC patients receiving pembrolizumab in the real-world context. The mechanism of this interaction warrants further elucidation.
方法:我们从来自22个国家的87个机构的接受pembrolizumab作为二线治疗的mUC患者的医院病历中收集数据。评估患者的总生存期(OS),无进展生存期(PFS),和总体反应率。我们通过Cox回归模型进行了生存分析。
结果:共有802例患者符合这项回顾性研究的条件;中位随访时间为15.3个月。PPI用户与非用户相比显示较差的PFS(4.5与7.2个月,p=0.002)和OS(8.7vs.14.1个月,p<0.001)。在多变量Cox分析后,伴随使用PPI仍然是PFS和OS的重要预测因子。他汀类药物或二甲双胍的使用与反应或生存无关。
结论:我们的研究结果表明,在真实世界背景下,在接受派姆单抗的mUC患者中,合并使用PPI对预后有显著影响。这种相互作用的机制值得进一步阐明。