Akashi Yasunori, Yamamoto Yutaka, Hashimoto Mamoru, Adomi Shogo, Fujita Kazutoshi, Kiba Keisuke, Minami Takafumi, Yoshimura Kazuhiro, Hirayama Akihide, Uemura Hirotsugu
Department of Urology, Kindai University Nara Hospital, Ikoma 630-0293, Japan.
Department of Urology, Kindai University Hospital, Osakasayama 589-8511, Japan.
Cancers (Basel). 2023 Dec 9;15(24):5780. doi: 10.3390/cancers15245780.
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.
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).
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, = 0.03) and a baseline neutrophil-to-lymphocyte ratio (NLR) > 3 (HR = 2.79, = 0.04) were significantly associated with poor OS. Antibiotic exposure did not have a significant impact on either PFS or OS.
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.
免疫检查点抑制剂（ICI）疗法显著改善了一些晚期尿路上皮癌（UC）患者的预后，但并非对所有患者都有高治疗效果。因此，确定预测性生物标志物对于判定哪些患者适合ICI治疗至关重要。本研究旨在确定接受派姆单抗治疗的铂难治性晚期UC患者中ICI治疗反应的预测指标。
纳入在日本两家医院接受派姆单抗治疗的铂难治性晚期UC患者。进行单因素和多因素分析以确定无进展生存期（PFS）和总生存期（OS）的生物标志物。
41例患者可纳入本分析。他们的中位年龄为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。多因素分析显示，东部肿瘤协作组体能状态（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）与较差的OS显著相关。抗生素暴露对PFS或OS均无显著影响。
ECOG-PS≥2和基线NLR> 3是接受派姆单抗治疗的铂难治性晚期UC患者OS的独立危险因素。抗生素暴露不是ICI治疗反应的预测指标。
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