Department of Urology, Ulm University Medical Centre, Ulm, Germany.
Department of Urology, Diakonissenkrankenhaus, Dessau, Germany.
Eur Urol. 2014 Aug;66(2):275-81. doi: 10.1016/j.eururo.2013.08.055. Epub 2013 Aug 31.
Temsirolimus (TEMSR) was approved for treating advanced renal cell carcinoma (RCC) in 2007. Based on the data from a single phase 3 trial, it is recommended explicitly as first-line therapy for patients with a poor clinical prognosis.
The aim of this prospective multicentre trial (STARTOR) was to examine the effectiveness of TEMSR in daily clinical practice with a broader indication in the treatment of metastatic RCC.
DESIGN, SETTING, AND PARTICIPANTS: Metastatic RCC patients treated with 25mg of TEMSR weekly were submitted to a prospective systematic evaluation and follow-up in 87 German centres between January 2008 and October 2011 using standardised procedures.
All data were centrally analysed by an independent clinical research organisation.
This interim analysis of the STARTOR study included 386 patients. The observed toxicity was tolerable, the median dose intensity was 91% (interquartile range: 79-100%), and the median treatment duration was 20.1 wk (95% confidence interval [CI], 17.0-23.3 wk). Clinical benefit was seen in 157 patients (40.7%); the median progression-free and overall survival were 4.9 mo (95% CI, 4.2-5.6) and 11.6 mo (95% CI, 9.3-13.9), respectively. The effectiveness of TEMSR did not differ significantly in relation to the patient's age, histologic RCC subtype, or line of treatment. The major limitations were the noninterventional study design, limited information about Memorial Sloan-Kettering Cancer Center risk factors and detailed toxicity, and the lack of central radiologic review.
TEMSR is an effective and largely well-tolerated treatment alternative for metastatic RCC patients in daily clinical practice, irrespective of the patient's age, histologic RCC subtype, or line of treatment.
替西罗莫司（TEMSR）于 2007 年被批准用于治疗晚期肾细胞癌（RCC）。基于一项单期 3 期临床试验的数据，它被明确推荐用于预后不良的患者作为一线治疗。
这项前瞻性多中心试验（STARTOR）的目的是在更广泛的转移性 RCC 治疗适应证下，检查替西罗莫司在日常临床实践中的有效性。
设计、地点和参与者：2008 年 1 月至 2011 年 10 月，87 家德国中心的转移性 RCC 患者接受每周 25mg 的替西罗莫司治疗，并通过标准化程序进行前瞻性系统评估和随访。
所有数据均由独立临床研究组织进行中心分析。
STARTOR 研究的中期分析纳入了 386 名患者。观察到的毒性是可耐受的，中位剂量强度为 91%（四分位距：79-100%），中位治疗持续时间为 20.1 周（95%置信区间：17.0-23.3 周）。157 名患者（40.7%）观察到临床获益；无进展生存期和总生存期的中位数分别为 4.9 个月（95%置信区间：4.2-5.6）和 11.6 个月（95%置信区间：9.3-13.9）。替西罗莫司的有效性与患者年龄、组织学 RCC 亚型或治疗线数无关。主要局限性是非干预性研究设计、对 Memorial Sloan-Kettering Cancer Center 危险因素和详细毒性的信息有限，以及缺乏中心放射学审查。
替西罗莫司是一种有效且耐受性良好的治疗转移性 RCC 患者的选择，无论患者的年龄、组织学 RCC 亚型或治疗线数如何。
