Department of Urology, Peking University First Hospital, Beijing 100034, China.
Chin Med J (Engl). 2013;126(15):2826-9.
Sunitinib has been proved an effective new option for treatment of metastatic renal cell carcinoma (mRCC). Analysis of clinical data of 22 patients, who were exposed to sunitinib for at least 1 year, was conducted to evaluate the long-term efficacy and safety of sunitinib for the treatment of mRCC.
A total of 54 patients with mRCC were treated with sunitinib malate, 50 mg/d orally, on a 4-weeks-on and 2-weeks-off dosing schedule in Peking University First Hospital. Treatment continued until disease progression, unacceptable adverse events (AEs), or death. Among them, 22 patients continued treatment for at least 1 year. The clinical data of these 22 patients were prospectively collected for analysis. AEs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0. Tumor response was evaluated in accordance with the Response Evaluation Criteria in Solid Tumors.
Median progression-free survival was 19.5 months until last follow-up. The best efficacy results achieved were complete response, partial response, and stable disease for 2, 9, and 11 patients, respectively. Objective response rate was 50%. The most common AEs were hand-foot syndrome (95%) and hypertension (91%). Other common AEs were thyroid-stimulating hormone elevation (82%), platelet decrease (77%), and loss of appetite (77%). Only one patient withdrew from treatment for cardiac infarction. Another nine patients experienced dose modifications or short-term suspensions.
Long-term exposure to sunitinib malate showed encouraging efficacy in the treatment of mRCC. At the same time, the tolerability was good.
舒尼替尼已被证明是治疗转移性肾细胞癌（mRCC）的一种有效新选择。对至少接受舒尼替尼治疗 1 年的 22 例患者的临床数据进行分析，以评估舒尼替尼治疗 mRCC 的长期疗效和安全性。
北京大学第一医院对 54 例 mRCC 患者采用舒尼替尼马来酸盐，50mg/d 口服，4 周给药，2 周停药。治疗持续到疾病进展、不能耐受的不良反应（AE）或死亡。其中，22 例患者至少接受了 1 年的治疗。前瞻性收集这些 22 例患者的临床资料进行分析。AE 根据美国国立癌症研究所不良事件通用术语标准，版本 3.0 进行评估。根据实体瘤反应评价标准评价肿瘤反应。
截至最后随访时，中位无进展生存期为 19.5 个月。最佳疗效结果分别为完全缓解、部分缓解和稳定疾病的患者各 2、9 和 11 例，客观缓解率为 50%。最常见的 AE 为手足综合征（95%）和高血压（91%）。其他常见 AE 为促甲状腺激素升高（82%）、血小板减少（77%）和食欲下降（77%）。仅 1 例患者因心肌梗死退出治疗。另有 9 例患者因剂量调整或短期停药。
长期使用舒尼替尼马来酸盐治疗 mRCC 显示出令人鼓舞的疗效，同时耐受性良好。
