Medical Oncology Departments: Hospital Universitario Donostia-OSI Donostialdea, Gipuzkoa, Spain.
Hospital Universitario de Navarra, Pamplona, Spain.
Semin Oncol. 2024 Jun-Aug;51(3-4):77-86. doi: 10.1053/j.seminoncol.2024.02.002. Epub 2024 Mar 4.
The current available evidence on the management of metastatic renal cell cancer (mRCC) in real life is scarce in our environment. We present a summary of the existing real-world data and the results of an analysis describing the clinical characteristics, treatments, and health outcomes of patients with mRCC in northern Spain.
Retrospective observational study. Adult patients diagnosed with mRCC between Jan 2007 and Dec 2019 were included. Epidemiological, efficacy and toxicity data were collected. Median overall survival (OS) and progression-free survival (PFS) were determined using the Kaplan-Meier method.
A total of 829 patients were included (median age at diagnosis:63 years;73% men). Median follow-up was 180 months. The preponderant histology was clear cell (85%). In 50% the initial diagnosis was advanced disease. The distribution according to IMDC prognosis was good (24%), intermediate (50%) and poor (26%). The most frequent metastatic locations were lung (68.3%) and lymph node (41.0%). Most patients (95%) received a first line (1L) systemic treatment, 60% were treated with a second line (2L) of therapy and 37% received third line (3L). A VEGFR-TKIs was the most common treatment (1L: 90%, n = 507; 2L: 49%, n = 233; 3L: 54%, n = 156) followed by mTOR inhibitors (1L: 2%, n = 4; 2L: 27%, n = 126; 3L: 23%, n = 68) and immunotherapy (1L: 3.7%, n = 25; 2L: 27%, n = 126). Median OS was 24.5 months in the general population. According to IMDC prognostic groups, OS was 52.5, 25.7 and 9 months respectively. From the start of the 1L, 2L, and 3L treatment, median PFS was: 1L: 7.8 (6.8-9.0); 2L: 4.9 (4.3-5.5); 3L: 4.3 (3.8-4.8) months. No unexpected toxicity was reported.
The Real-World Data on the management of mRCC in Northern Spain are comparable in epidemiology, efficacy, and safety to studies conducted in other areas of the world. The significant reduction in the number of patients receiving second and subsequent lines of therapy hampers the access to new therapies developed in this context.
目前在我们的环境中，关于转移性肾细胞癌（mRCC）实际管理的现有证据很少。我们总结了现有的真实世界数据，并分析了描述西班牙北部 mRCC 患者临床特征、治疗和健康结果的结果。
回顾性观察性研究。纳入 2007 年 1 月至 2019 年 12 月期间诊断为 mRCC 的成年患者。收集了流行病学、疗效和毒性数据。使用 Kaplan-Meier 方法确定中位总生存期（OS）和无进展生存期（PFS）。
共纳入 829 例患者（中位诊断年龄：63 岁；73%为男性）。中位随访时间为 180 个月。主要组织学类型为透明细胞（85%）。50%的初始诊断为晚期疾病。根据 IMDC 预后的分布为良好（24%）、中等（50%）和差（26%）。最常见的转移部位是肺（68.3%）和淋巴结（41.0%）。大多数患者（95%）接受了一线（1L）全身治疗，60%接受了二线（2L）治疗，37%接受了三线（3L）治疗。VEGFR-TKIs 是最常见的治疗方法（1L：90%，n=507；2L：49%，n=233；3L：54%，n=156），其次是 mTOR 抑制剂（1L：2%，n=4；2L：27%，n=126；3L：23%，n=68）和免疫疗法（1L：3.7%，n=25；2L：27%，n=126）。总体人群的中位 OS 为 24.5 个月。根据 IMDC 预后分组，OS 分别为 52.5、25.7 和 9 个月。从 1L、2L 和 3L 治疗开始，中位 PFS 分别为：1L：7.8（6.8-9.0）；2L：4.9（4.3-5.5）；3L：4.3（3.8-4.8）个月。未报告意外毒性。
西班牙北部 mRCC 管理的真实世界数据在流行病学、疗效和安全性方面与世界其他地区的研究相当。接受二线和后续线治疗的患者数量显著减少，阻碍了在这方面开发的新疗法的应用。
