GlaxoSmithKline, Health Economics and Outcomes Research, Rueil Malmaison, France.
INSERM, ECEVE, UMR 1123, Paris, France.
BMC Cancer. 2018 Feb 21;18(1):214. doi: 10.1186/s12885-018-4117-z.
Patient characteristics and survival outcomes in randomized trials may be different from those in real-life clinical practice. The objective of this study was to describe treatment pathways, safety, drug costs and survival in patients with metastatic Renal Cell Carcinoma (mRCC) in a real world setting.
A retrospective analysis was performed using IQVIA real world oncology cross-sectional survey data, a retrospective treatment database collecting anonymized patient-level data in Europe. Data on treatment naïve patients with mRCC who received a first-line targeted therapy in France were extracted for the period 2005-2015. Descriptive analyses were performed on treatment patterns, patient characteristics and safety profiles. Progression Free Survival (PFS) was determined using Kaplan-Meier survival analysis.
One thousand three hundred thirty-one patients with mRCC who received a first-line targeted therapy were included. The male/female sex ratio was 2.5 and 66% of patients were aged > 60 years. 83% of patients had clear cell adenocarcinoma. 83% of patients underwent a surgical procedure, 10% had radiotherapy. In patients who received a first-line targeted therapy, 73% received sunitinib. The mean time from diagnosis to first-line treatment by targeted therapies in patients initially diagnosed with metastatic disease was 3.3 months [95% CI:2.5-4.1]. In patients who received second-line targeted therapy n = 257 (19%), the most frequently observed treatment sequences were sunitinib-everolimus (33%) and sunitinib-sorafenib (27%). Adverse events data were available for 501 patients and adverse events were documented in 70% of patients, most frequently diarrhoea. The overall median PFS was 13 months [95% CI:11.5-16].
Patient characteristics were consistent with the literature. Treatment patterns appeared to follow current practice guidelines. Despite some variations, PFS in our study seems to be consistent with findings from other real world studies. Nevertheless, PFS results were higher than those observed in clinical trials. Due to the use of cross-sectional data, PFS in our study should be interpreted with caution.
随机试验中的患者特征和生存结果可能与真实临床实践中的不同。本研究的目的是描述转移性肾细胞癌（mRCC）患者的治疗途径、安全性、药物费用和生存情况。
使用 IQVIA 真实世界肿瘤横断面调查数据进行回顾性分析，该数据是一个收集欧洲匿名患者水平数据的回顾性治疗数据库。提取了 2005 年至 2015 年期间在法国接受一线靶向治疗的初治 mRCC 患者的数据。对治疗模式、患者特征和安全性进行描述性分析。使用 Kaplan-Meier 生存分析确定无进展生存期（PFS）。
共纳入 1331 例接受一线靶向治疗的 mRCC 患者。男性/女性比例为 2.5，66%的患者年龄>60 岁。83%的患者为透明细胞腺癌。83%的患者接受了手术，10%的患者接受了放疗。在接受一线靶向治疗的患者中，73%的患者接受了舒尼替尼治疗。初诊为转移性疾病的患者从诊断到一线靶向治疗的平均时间为 3.3 个月[95%CI：2.5-4.1]。在接受二线靶向治疗的 257 例患者（19%）中，最常见的治疗序列是舒尼替尼-依维莫司（33%）和舒尼替尼-索拉非尼（27%）。501 例患者有不良反应数据，70%的患者有不良反应记录，最常见的是腹泻。总体中位 PFS 为 13 个月[95%CI：11.5-16]。
患者特征与文献一致。治疗模式似乎符合当前的实践指南。尽管存在一些差异，但本研究的 PFS 似乎与其他真实世界研究的结果一致。然而，PFS 结果高于临床试验观察到的结果。由于使用了横断面数据，因此应谨慎解释本研究中的 PFS。
