舒尼替尼一线治疗转移性肾细胞癌的临床观察

Clinical observation of Sunitinib as first line treatment in metastatic renal cell carcinoma

目的:观察舒尼替尼一线治疗转移性肾细胞癌的有效性及安全性。方法:16例未经治疗的转移性肾细胞癌患者接受舒尼替尼治疗。14例患者口服舒尼替尼50mg/d,服用4周休息2周,6周重复;2例患者口服37.5mg/d,持续服用。结果:16例患者均可评价疗效和毒性。PR 5例,SD 9例,PD 2例;ORR为31.3%(5/16),DCR为87.5%(14/16)。中位PFS和OS分别为10.5(95%CI:1.5～19.5)和17.5个月(95%CI:1.6～33.4)。常见非血液学不良反应为手足综合征(12/16,75.0%)、乏力(11/16,68.8%)、口腔炎(8/16,50.0%)、高血压(8/16,50.0%)、纳差(9/16,56.3%)以及蛋白尿(6/16,37.5%);血液学主要不良反应为白细胞下降(10/16,62.5%)、血小板下降(9/16,56.3%)。3～4级不良反应主要有口腔炎(3/16,18.8%)、高血压(2/16,12.5%)、手足综合征(2/16,12.5%)、白细胞减少(2/16,12.5%)和血小板减少(2/16,12.5%)。结论:舒尼替尼对未经治疗的中国人晚期肾细胞癌疗效确切,毒副反应可预见、可控制和可逆转,值得临床推荐使用。

OBJECTIVE：To observe the effectiveness and safety of sunitinib as first line treatment in metastatic renal cell carcinoma. METHODS： Sixteen patients with previously untreated metastatic renal cell carcinoma were treated with sunitinib. Forteen patients received sunitinib 50 mg daily for 4 weeks,followed 2 weeks off, every 6 weeks repeat; and 2 patients received sunitinib 37.5 mg daily continuously. RESULTS： Sixteen patients were included in efficacy and toxicity analyses. Five patients achieved PR, nine patients achieved SD, 2. patients PD, the ORR was 31.3% （5/16）, and the DCR was 87.5%（14/16）. The median PFS and median OS were 10.5 months （95%CI： 1.5--19.5） and 17.5 months （95%CI： 1.6- 33.4）. Common non-hematological toxicities included hand-foot syndrome （12/16,75.0%）, fatigue （11/16,68.8%）, stomatitis （8/16,50.0%）, hypertension （8/16,50.0%）, anorexia （9/16, 56.3%） and proteinuria （6/16,37.5%）. Common hematological toxicities included leucopenia （10/16,62.5%） and thrombocytopenia （9/16, 56.3%）. 3/4 grade toxicities included stomatitis （3/16, 18.8%）, hypertension （2/16, 12.5%）, hand-foot syndrome （2/16,12.5 % ）, leueopenia （2/16,12.5 % ） and thrombocytopenia （2/16,12.5 % ）. CONCLUSIONS： Sunitinib is effective for previously untreated chinese patients with metastatic renal cell carcinoma, and the toxicities are predictable and controllable and reversible. It was recommendable for clinical use.