Miyake Hideaki, Harada Ken-Ichi, Kumano Masafumi, Fujisawa Masato
Division of Urology, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan,
Int J Clin Oncol. 2014 Aug;19(4):679-85. doi: 10.1007/s10147-013-0617-7. Epub 2013 Sep 10.
To evaluate experience of the use of temsirolimus for metastatic renal cell carcinoma (mRCC) in a single center in Japan.
This study included 55 consecutive patients with mRCC who received temsirolimus in a routine clinical setting, and retrospectively reviewed the comprehensive outcomes of these patients.
Of the 55 patients, 20 had a Karnofsky performance status of ≤80, and 5, 41 and 9 were classified into favorable, intermediate and poor risk groups, respectively, according to the Memorial Sloan-Kettering Cancer Center model. Initially, 25 mg of temsirolimus was applied weekly; however, dose modification was required in 19 patients, resulting in a relative dose intensity of 90.5 % throughout this series. As the best responses to temsirolimus, 4, 44 and 7 were judged to have a partial response, stable disease and progressive disease, respectively. The median progression-free survival (PFS) and overall survival (OS) of these patients following the introduction of temsirolimus was 7.0 and 25.0 months, respectively. Of several factors examined, only the pretreatment C-reactive protein level was shown to be independently associated with both PFS and OS. The common adverse events related to temsirolimus corresponding to ≥grade 3 were anemia in 4, thrombocytopenia in 3, stomatitis in 3 and hyperglycemia in 3. Quality of life analysis using 36-Item Short Form showed that there were no significant differences in any scale scores between surveys performed before and 3 months after the introduction of temsirolimus.
Temsirolimus was well tolerated and facilitated comparatively favorable cancer control in Japanese patients with mRCC.
评估在日本一家单中心使用替西罗莫司治疗转移性肾细胞癌（mRCC）的经验。
本研究纳入了55例在常规临床环境中接受替西罗莫司治疗的连续性mRCC患者，并回顾性分析了这些患者的综合结局。
55例患者中，20例卡氏评分≤80，根据纪念斯隆凯特琳癌症中心模型，5例、41例和9例分别被分类为低危、中危和高危组。最初，替西罗莫司每周应用25mg；然而，19例患者需要调整剂量，导致本系列患者的相对剂量强度为90.5%。作为对替西罗莫司的最佳反应，分别有4例、44例和7例被判定为部分缓解、病情稳定和病情进展。替西罗莫司治疗后这些患者的中位无进展生存期（PFS）和总生存期（OS）分别为7.0个月和25.0个月。在检查的几个因素中，仅预处理时的C反应蛋白水平显示与PFS和OS均独立相关。与替西罗莫司相关的≥3级常见不良事件包括贫血4例、血小板减少3例、口腔炎3例和高血糖3例。使用36项简明健康调查问卷进行的生活质量分析显示，在开始使用替西罗莫司前和使用后3个月进行的调查中，任何量表评分均无显著差异。
替西罗莫司耐受性良好，在日本mRCC患者中有助于实现相对良好的癌症控制。
