舒尼替尼治疗转移性肾癌的疗效及安全性评价

Efficacy and safety of sunitinib in the treatment of metastatic renal cell carcinoma

目的 评价舒尼替尼治疗转移性肾癌的疗效及安全性. 方法转移性肾癌患者15例.男10例,女5例.中位年龄56（37～73）岁.曾行原发肿瘤切除术13例,行CT引导下肿瘤穿刺活检术2例.组织学类型为透明细胞癌14例,乳头状细胞癌1例.舒尼替尼50 mg/d连续给药4周,停药2周方案4例;37.5 mg/d持续口服方案11例.评价肿瘤治疗疗效、患者无疾病进展生存时间及总体生存时间,同时观察治疗相关不良反应. 结果中位随访时间13（2～24）个月,15例均可评价疗效,其中部分缓解8例、疾病稳定5例、疾病进展2例.总客观缓解率53%（8/15）,疾病控制率87%（13/15）.由于随访时间短,尚不能报告中位无进展生存时间和总生存时间.常见不良反应包括手足皮肤反应11例（73%）,头发颜色改变10例（67%）,口腔溃疡、脱发各9例（60%）,腹泻、中性粒细胞减少各8例（53%）.多数不良反应为1～2级,且所有不良反应均可逆. 结论舒尼替尼治疗晚期转移性肾癌疗效显著,具有较高的肿瘤客观缓解率,大多数不良反应较轻且可逆,患者多可耐受,安全性较好,但长期疗效及安全性需进一步随访.

Objective To investigate the efficacy and side effects of the molecular targeted drug sunitinib in the treatment of metastatic renal cell carcinoma（mRCC）. Methods Fifteen patients with histopathological confirmed mRCC,including 10 males and 5 females,were enrolled in the study.The median age was 56（range from 37 to 73 years）.Fourteen cases of clear-cell RCC and 1 papillary RCC were diagnosed.Thirteen patients had prior nephrectomy,and 6 patients were treated with cytokines previously.All of the patients were given sunitinib at a dosage of either 50 mg daily（4 weeks on/2 weeks off）or 37.5 mg daily continuously.Objective response rate（ORR）,progressive-free survival（PFS）and overall survival（OS）were evaluated,and adverse events were also observed. Results The median follow-up was 13 months（2-24 months）.According to RECIST,partial response could be evaluated in 8 patients and stable was found in another 5 patients.Only 2 patients were confirmed disease progression.The ORR was 53% with the disease control rate of 87%,However,the median PFS and OS were not yet available due to the short-term follow-up.During the treatment,the most common adverse events experienced by patients were hand-foot syndrome 11/15（73%）,changes in hair color 10/15（67%）,mucositis 9/15（60%）,alopecie 9/15（60%）,diarrhea 8/15（53%）and neutropenia 8/15 （53%）. All of adverse events were manageable and reversible. Conclusions Sunitinib as a single agent in the treatment for Chinese mRCC patient is efficient and the side effects are reversible. Further long-term follow-up and expanded samples should be expected to confirm the efficacy and safety of sunitinib.