Objective To evaluate the efficacy and safety profile of temsirolimus in Chinese renal cell carcinoma patients.Methods From June 2008 to December 2008, 12 patients with renal cell carcinoma were enrolled and received temsirolimus 25 mg IV qw until disease appeared progression or intolerable side effects occurred.Results 9 (75% ) out of the 12 patients were at intermediate or high risk according to the MSKCC criterion. 10 (83. 3% ) patients were heavily pretreated. The median treatment duration is 5. 8 months. 2 ( 16. 7% ) patients achieved PR, 8 (61. 5% ) achieved SD as their best response. 6 (50% ) additional patients had tumor shrinkage less than 30% . The clinical benefit rate ( CR + PR + SD^24 weeks) was 41.7% (5/12) , with a median PFS of 8.4 months and median OS of 16.4 months for the whole cohort. 4 patients failed with previous sorafenib had PFS of 9, 15, 2.2 and 18.8 months respectively. The most common side effects included skin rash, itch, nail disorder, pyrexia, oral mucositis, hyperglycemia, and hypertriglyceri-demia. 1 patient developed grade V interstitial lung disease. 6 additional patients had radiographic lung abnormalities on their follow-up CT scan during treatment.Conclusion Temsirolimus is an active agent for metastatic renal cell carcinoma. Metabolic abnormality and interstitial lung disease should be monitored carefully.%目的 探讨替西罗莫司治疗转移性肾细胞癌的效果.方法 2008年6月4日至2008年12月18日共入组12例转移性肾细胞癌患者,接受替西罗莫司单药治疗,25mg,静脉滴注30～50分钟,每周1次,直至肿瘤进展或出现不可耐受的毒副作用.结果 12例患者中,按MSKCC评分中高危占75%(9/12),其中10例为多程治疗失败.最佳疗效:PR 2例(16.7%),另有6(50%)例患者出现不同程度的肿瘤缩小,PD2例(16.7%).临床受益率(CR+PR+SD≥24周)为41.7%(5/12).中位PFS为 8.4个月,中位OS16.4个月.4例索拉非尼失败的患者的PFS分别为9个月、15个月、2.2个月和18.8个月.主要不良反应包括:皮疹、瘙痒、指甲改变、发热、口腔溃疡、高血糖、胆固醇和甘油三酯升高等.1例患者发生了V度间质性肺炎.结论 替西罗莫司治疗转移性肾癌有效,对索拉非尼或舒尼替尼失败的患者的疗效值得进一步研究.代谢异常和间质性肺炎是需要重视的不良反应.
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