Department of Urology, Hokkaido University Hospital, Sapporo, Japan.
Department of Urology, University of Tsukuba Hospital, Tsukuba, Japan.
Cancer Sci. 2020 Jul;111(7):2460-2471. doi: 10.1111/cas.14449. Epub 2020 Jun 12.
The present study aimed to evaluate the efficacy of the real-world use of axitinib and to develop a prognostic model for stratifying patients who could derive long-term benefit from axitinib. This was a retrospective, descriptive study evaluating the efficacy of axitinib in patients with metastatic renal cell carcinoma that had been treated with 1 or 2 systemic antiangiogenic therapy regimens at 1 of 36 hospitals belonging to the Japan Urologic Oncology Group between January 2012 and February 2019. The primary outcome was overall survival (OS). Using a split-sample method, candidate variables that exhibited significant relationships with OS were chosen to create a model. The new model was validated using the rest of the cohort. In total, 485 patients were enrolled. The median OS was 34 months in the entire study population, whereas it was not reached, 27 months, and 14 months in the favorable, intermediate, and poor risk groups, respectively, according to the new risk classification model. The following 4 variables were included in the final risk model: the disease stage at diagnosis, number of metastatic sites at the start of axitinib therapy, serum albumin level, and neutrophil : lymphocyte ratio. The adjusted area under the curve values of the new model at 12, 36, and 60 months were 0.77, 0.82, and 0.82, respectively. The efficacy of axitinib in routine practice is comparable or even superior to that reported previously. The patients in the new model's favorable risk group might derive a long-term survival benefit from axitinib treatment.
本研究旨在评估阿昔替尼在真实世界中的疗效,并建立一个预测模型,以分层能够从阿昔替尼治疗中获得长期获益的患者。这是一项回顾性描述性研究,评估了在 2012 年 1 月至 2019 年 2 月期间,36 家日本泌尿科肿瘤学集团医院中的 1 家或 2 家医院,1 或 2 种系统抗血管生成治疗方案治疗转移性肾细胞癌患者中阿昔替尼的疗效。主要结局是总生存期(OS)。使用拆分样本方法,选择与 OS 有显著关系的候选变量来建立模型。使用队列的其余部分验证新模型。共纳入 485 例患者。在整个研究人群中,中位 OS 为 34 个月,而根据新的风险分类模型,在有利、中间和不良风险组中,分别为未达到、27 个月和 14 个月。最终风险模型中包含以下 4 个变量:诊断时的疾病分期、阿昔替尼治疗开始时的转移部位数量、血清白蛋白水平和中性粒细胞:淋巴细胞比值。新模型在 12、36 和 60 个月的调整曲线下面积值分别为 0.77、0.82 和 0.82。阿昔替尼在常规实践中的疗效与之前报道的相当甚至更好。新模型的有利风险组患者可能从阿昔替尼治疗中获得长期生存获益。