舒尼替尼治疗晚期肾细胞癌随访研究

Follow-up study of the safety and efficacy of sunitinib treatment for patients with advanced renal cell carcinoma

目的研究舒尼替尼治疗晚期肾细胞癌的疗效及安全性。方法回顾性分析2008年7月至2011年11月在解放军总医院接受舒尼替尼治疗的晚期肾细胞癌患者的临床资料,记录舒尼替尼治疗的剂量、疗程、疗效、不良反应发生情况及转归等,并对不同分组患者的疗效进行比较。结果共有62例患者接受治疗,其中男性46例,女性16例,平均年龄（53.2＋14.5）岁。曾接受病灶切除者57例,经穿刺确诊者5例。病理类型：肾透明细胞癌57例、肾乳头状细胞癌3例、嗜酸细胞癌1例、肾原始神经外胚叶癌1例。ECOG评分均为0～1分。转移部位：肺35例、肝脏4例、脑2例、骨12例、淋巴结14例、肾上腺4例、其他2例,其中单发转移10例、多发转移52例。接受舒尼替尼治疗初始剂量50.0mg 4/2周方案52例,37.5mg持续给药方案8例,其他2例。平均接受治疗时间22.6个月,疾病控制率88.9%,客观缓解率29.4%,中位无进展生存期14.9个月,中位总生存期28个月,死亡30例。主要不良反应有高血压、血小板减低、白细胞减低、甲状腺功能低下等,3～4级不良反应发生率29.8%,因不良反应中止治疗2例。结论舒尼替尼治疗晚期肾细胞癌具有良好的有效性和安全性。对于MSKCC评分低危或中危、单发转移灶尤其是单纯肺转移患者,接受舒尼替尼治疗后有望获得更好的临床疗效。而手足皮肤反应、高血压、甲状腺功能低下以及中性粒细胞减少等不良发应的发生可能与疗效相关。

Objective The effect of sunitinib in the treatment of metastatic renal cell carcinoma has been verified by many clinical trails.A retrospective analysis was made for metastatic renal cell carcinoma （mRCC）patients treated with Sunitinib .The history,disease characteristics,efficacy and side effects of targeted therapy and clinical outcomes were studied,and the possible predictive factors of response to Sunitinib were explored. Methods Sixty-two mRCC patients were treated with Sunitinib from Jul.2008 to Nov.2011.The history,disease characteristics,efficacy and side effects of targeted therapy,clinical outcomes were collected.Trying to find the possible predictive factors of response to Sunitinib by compa-ring with the reported in the literature. Results Forty-six male and sixteen female patients were ana-lyzed.The average age was 5 3 .2 years old.Fifty-seven cases received radical nephrectomy and five re-ceived puncture biopsy.Pathological examination showed clear cell carcinoma in fifty-seven cases, papillary renal cell carcinoma in three cases,PNET in one case and chromophobe carcinoma in one case.ECOG score was 0 or 1 .Thirty-five cases were pulmonary metastasis and fourteen were retro-peritoneal lymph node metastasis.Fifty-two patients received Sunitinib 50 mg Qd,4/2 weeks sched-ule primarily,eight patients received 37.5 mg Qd,6 weeksschedule.The average treatment time was 22.6 months.mPFS was 14.9 months,mOS was 28 months,and thirty patients died.The main adverse reaction （AE）included thrombopenia,leucopenia,hand-foot reaction,hypothyroidismand hypertension. Conclusions The results of this study demonstrate that Sunitinib has good efficacy and safety in treatment of mRCC.The patients with low or middle risk by MSKCC,single metastasis or lung metastasis,will receive longer survival by Sunitinb treatment.