Bordeaux PharmacoEpi, Inserm CIC1401, Bordeaux, France.
CHU Bordeaux, Bordeaux, France.
Pharmacoepidemiol Drug Saf. 2017 Dec;26(12):1561-1569. doi: 10.1002/pds.4228. Epub 2017 Jun 1.
To investigate sunitinib in the real-life first-line treatment of metastatic renal cell carcinoma (mRCC).
SANTORIN is a French observational multicentre cohort. Patients initiating sunitinib in first-line mRCC therapy were included (January 2008 to April 2010) and followed for 24 months. Data were collected from medical files. The outcomes were 24-month overall survival (OS) and progression-free survival (PFS), response and safety.
Three hundred two patients were included: median age, 64.8 years; male, 73.2%; clear cell mRCC, 83.1%; prior nephrectomy, 85.4%; >1 metastatic sites, 64.2%; brain metastases, 6.3%; ECOG-PS ≥ 2, 9.9%. Median duration of first-line therapy with sunitinib was 10.7 months. Initial sunitinib dose was 50 mg/day for 83.4% of patients; dose reduction occurred in 65.2%. Sunitinib was discontinued in 73.2% of the patients: for progression (61.1%), death (31.2%) or adverse events (6.8%). More than half (58.3%) had grade ≥3 adverse events, mainly hypertension (12.6%) and hand-foot syndrome (12.3%). The 24-month OS and PFS rates [95%CI] were 49.5% [43.7;55.0] and 16.4% [12.5;20.9], respectively. Median OS was 23.6 months [20.2;-] and median PFS 8.4 months [7.6;9.9]. Overall best response rate was 31.1%.
Results from this large observational study suggest that effectiveness of sunitinib in first-line mRCC as predicted by clinical trials is maintained in real-life clinical practice. The expected benefit in poor-prognosis patients that were not evaluated in the pivotal clinical trial remains; however, questionable and long-term safety monitoring is still warranted. Copyright © 2017 John Wiley & Sons, Ltd.
研究舒尼替尼在转移性肾细胞癌（mRCC）一线治疗中的真实疗效。
SANTORIN 是一项法国的观察性多中心队列研究。纳入了在 mRCC 一线治疗中接受舒尼替尼治疗的患者（2008 年 1 月至 2010 年 4 月），并随访 24 个月。数据来自病历。研究终点为 24 个月总生存率（OS）和无进展生存率（PFS）、缓解率和安全性。
共纳入 302 例患者：中位年龄 64.8 岁；男性占 73.2%；透明细胞 RCC 占 83.1%；既往行肾切除术者占 85.4%；存在 1 个以上转移灶者占 64.2%；脑转移者占 6.3%；ECOG-PS≥2 者占 9.9%。舒尼替尼一线治疗的中位持续时间为 10.7 个月。初始舒尼替尼剂量为 50mg/天的患者占 83.4%；剂量减少者占 65.2%。73.2%的患者停止了舒尼替尼治疗：进展（61.1%）、死亡（31.2%）或不良事件（6.8%）。超过一半（58.3%）的患者发生了≥3 级不良事件，主要为高血压（12.6%）和手足综合征（12.3%）。24 个月 OS 和 PFS 率[95%CI]分别为 49.5%[43.7；55.0]和 16.4%[12.5；20.9]。中位 OS 为 23.6 个月[20.2；-]，中位 PFS 为 8.4 个月[7.6；9.9]。总体最佳缓解率为 31.1%。
这项大型观察性研究的结果表明，舒尼替尼在 mRCC 一线治疗中的疗效与临床试验预测的一致，在真实临床实践中得以维持。在关键临床试验中未评估的预后不良患者中仍可能存在获益，但仍需要长期安全性监测。版权所有 © 2017 约翰威立父子公司
