Introduction: Immune checkpoint inhibitor (ICI) therapy has significantly improved the prognosis of some patients with advanced urothelial carcinoma (UC), but it does not provide high therapeutic efficacy in all patients. Therefore, identifying predictive biomarkers is crucial in determining which patients are candidates for ICI treatment. This study aimed to identify the predictors of ICI treatment response in patients with platinum-refractory advanced UC treated with pembrolizumab. 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.
引言：免疫检查点抑制剂（ICI）疗法显著改善了部分晚期尿路上皮癌（UC）患者的预后，但并非对所有患者均具有高效疗效。因此，识别预测性生物标志物对于确定适合接受ICI治疗的患者至关重要。本研究旨在探索接受帕博利珠单抗治疗的铂类难治性晚期UC患者对ICI治疗反应的预测因子。 方法：本研究纳入在日本两家医院接受帕博利珠单抗治疗的铂类难治性晚期UC患者。通过单变量和多变量分析，确定与无进展生存期（PFS）和总生存期（OS）相关的生物标志物。 结果：共41例患者纳入分析。中位年龄为75岁，绝大多数患者为男性（85.4%）。客观缓解率为29.3%，中位总生存期（OS）为17.8个月。多变量分析显示，美国东部肿瘤协作组体能状态评分（ECOG-PS）≥2（风险比=6.33，p=0.03）和基线中性粒细胞与淋巴细胞比值（NLR）>3（风险比=2.79，p=0.04）与较差的OS显著相关。抗生素暴露对PFS和OS均无显著影响。 结论：在接受帕博利珠单抗治疗的铂类难治性晚期UC患者中，ECOG-PS≥2和基线NLR>3是OS的独立危险因素。抗生素暴露并非ICI治疗反应的预测因子。
Prognostic Factors of Platinum-Refractory Advanced Urothelial Carcinoma Treated with Pembrolizumab
肿瘤(癌症)患者之家