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目的:探讨舒尼替尼相关性血液学不良反应与晚期肾细胞癌的预后关系。方法:选取2010年6月~2014年6月上海长征医院泌尿外科收治的56例晚期肾癌患者,29例行肾脏原发病灶切除术,病理诊断为肾透明细胞癌。治疗方案:舒尼替尼50mg,1次/d,采用4/2方案,即每治疗4周停2周为1个周期;每治疗1个周期或2个周期通过CT或MRI评价药物疗效。每周期血常规、肝肾功能检查评价不良反应。结果:中性粒细胞减少组,完全缓解(CR)2例(5.5%),部分缓解(PR)9例(25.0%),疾病稳定(SD)11例(30.6%),ORR为30.6%(8例);中性粒细胞正常组,CR 1例(5.0%),PR 2例(10.0%),SD 8例(40.0%),ORR为15.0%(3例)。中性粒细胞减少组患者的ORR高于中性粒细胞正常组患者的ORR,但差异无统计学意义。中性粒细胞减少组无进展生存期(12.2个月,95%CI:10.8~13.6)较正常组(8.7个月,95%CI:6.9~10.4)显著延长(P=0.007)。血小板下降组相较血小板正常组患者中位疾病无进展时间明显延长(P=0.011),中性粒细胞/淋巴细胞比率(<2)较中性粒细胞/淋巴细胞比率(≥2)的患者中位疾病无进展时间明显延长(P=0.008)。结论:在舒尼替尼治疗中出现一些血液学不良反应的晚期肾细胞癌患者的中位无疾病进展时间更长,这些血液学不良反应可以作为预测药物疗效的有效指标。
Objective: To investigate the relationship between sunitinib-related hematologic adverse reactions and the prognosis of advanced renal cell carcinoma. Methods: From June 2010 to June 2014, 56 patients with advanced renal cell carcinoma admitted to Department of Urology, Shanghai Changzheng Hospital were enrolled. Twenty-nine patients underwent primary resection of kidney and the pathological diagnosis was renal clear cell carcinoma. Treatment regimens: sunitinib 50mg, 1 / d, using 4/2 program, that is, every treatment for 4 weeks to stop for 2 weeks for a cycle; every treatment period of 1 or 2 cycles by CT or MRI evaluation of drug efficacy. Every cycle of blood, liver and kidney function tests to assess adverse reactions. Results: In neutropenia group, there were 2 cases (5.5%) of complete remission (CR), 9 cases of partial remission (PR), 11 cases of stable disease (SD) and 30.6% 8 cases). The normal neutrophil group had CR (5.0%), PR 2 (10.0%), SD 8 cases (40.0%) and ORR 15.0% (3 cases). The ORR of neutropenic patients was higher than that of normal neutrophils patients, but the difference was not statistically significant. Progression-free survival (12.2 months, 95% CI: 10.8 to 13.6) in the neutropenia group was significantly longer (P = 0.007) than in the normal group (8.7 months, 95% CI: 6.9 to 10.4). Patients with thrombocytopenia had significantly longer median progression-free disease (p = 0.011), neutrophil / lymphocyte ratio (<2), and neutrophil / lymphocyte ratio (≥2) compared with those in the normal platelet group Median disease progression time was significantly longer (P = 0.008). Conclusions: Patients with advanced renal cell carcinoma who have some hematologic adverse reactions during sunitinib therapy have a longer median progression-free disease and these hematologic adverse reactions may be useful predictors of drug efficacy.