METHODS: Patients with platinum-refractory advanced UC who had received pembrolizumab at two hospitals in Japan were included. Univariate and multivariate analyses were performed to identify biomarkers for progression-free survival (PFS) and overall survival (OS).
RESULTS: Forty-one patients were evaluable for this analysis. Their median age was 75 years, and the vast majority of the patients were male (85.4%). The objective response rate was 29.3%, with a median overall survival (OS) of 17.8 months. On multivariate analysis, an Eastern Cooperative Oncology Group performance status (ECOG-PS) ≥ 2 (HR = 6.33, p = 0.03) and a baseline neutrophil-to-lymphocyte ratio (NLR) > 3 (HR = 2.79, p = 0.04) were significantly associated with poor OS. Antibiotic exposure did not have a significant impact on either PFS or OS.
CONCLUSIONS: ECOG-PS ≥ 2 and baseline NLR > 3 were independent risk factors for OS in patients with platinum-refractory advanced UC treated with pembrolizumab. Antibiotic exposure was not a predictor of ICI treatment response.
方法:纳入在日本两家医院接受派姆单抗治疗的铂类难治性晚期UC患者。进行单变量和多变量分析以鉴定无进展生存期(PFS)和总生存期(OS)的生物标志物。
结果:该分析可评估41例患者。他们的平均年龄是75岁,绝大多数患者为男性(85.4%)。客观有效率为29.3%,中位总生存期(OS)为17.8个月。在多变量分析中,东部肿瘤协作组表现状态(ECOG-PS)≥2(HR=6.33,p=0.03)和基线中性粒细胞与淋巴细胞比值(NLR)>3(HR=2.79,p=0.04)与OS差显著相关.抗生素暴露对PFS或OS均无显著影响。
结论:ECOG-PS≥2和基线NLR>3是pembrolizumab治疗的铂类难治性晚期UC患者OS的独立危险因素。抗生素暴露不是ICI治疗反应的预测因子。