吉西他滨联合奥沙利铂治疗尿路上皮肿瘤的临床疗效及安全性

Clinical out comes and safety of gemcitabine combined with oxaliplatin in treatment of urothelial tumor

目的观察吉西他滨联合奥沙利铂治疗尿路上皮肿瘤的临床疗效及安全性。方法对31例有可测量或不可测量病灶的尿路上皮肿瘤患者采用GEMOX方案(吉西他滨1250mg/m2,第1、8天;奥沙利铂100mg/m2,第2天)治疗,21d为1个周期。1个周期治疗结束时观察有无毒副反应;两个周期治疗结束时评价该方案的疗效,并观察有无无法耐受的毒副反应发生。GEMOX方案一般最多治疗6个周期,根据RECIST实体瘤评价标准评价其疗效,根据世界卫生组织(WHO)不良反应分级标准评定不良反应。结果 31例患者中,4例仅完成1个疗程的治疗,故不能评价疗效。余27例可评价疗效,其中完全缓解5例(18.5%)、部分缓解11例(40.7%)、病情稳定9例(33.3%)、病情进展2例(7.4%),治疗有效率为59.3%(16/27)。治疗有效时间为2.5～46个月,中位有效时间为5个月。31例患者均进行毒性反应评估,其中Ⅲ～Ⅳ度中性粒细胞减少4例(12.9%),Ⅲ～Ⅳ度血小板减少6例(19.4%),均为可逆性;Ⅲ度疲乏4例(12.9%),Ⅳ度肝脏毒性1例(3.2%)。治疗前内生肌酐清除率水平为(61.7±23.4)mL/min,治疗后为(65.0±23.1)mL/min,治疗前后的差异无统计学意义(P>0.05)。结论吉西他滨联合奥沙利铂一线治疗尿路上皮癌的疗效较好,安全性高,对肾功能无明显影响。

Objective To observe the therapeutic effect and safety of gemcitabine combined with oxaliplatin in the patients with urothelial cancer. Methods Totally 31 patients with measurable or immeasurable lesion received GEMOX treatment （gemcitabine 1 250 mg/m2on day 1 and 8 and oxaliplatin 100 mg/m2 on day 2, 21 days for a cycle）. The safety was evaluated every cycle and the therapeutic effect was evaluated every two cycles to observe the unbearable side-effect. Usually the treatment lasted no more than 6 cycles. Standard Response Evaluation Criteria in Solid Tumors （RECIST） criteria were used to assess effect and WHO criteria for safety. Results Four patients only underwent one-cycle treatment and were not evaluated. In the other 27 patients, there were 5 complete response （CR, 18.5% ）, 11 partial response （PR, 40.7%）, 9 stable disease （SD, 33.3%） and 2 progressive disease （PD, 7.4%）. The overall response rate was 59.3% （16l27）. The median effective time for treatment was 5 months （ranging 2.5 to 46 months）. Toxicity was assessed in all the 31 patients. There were 4 patients with gradeⅢ-Ⅳ neutropenia （12.9%）, 6 with grade Ⅲ-Ⅳ thrombocytopenia （19.4%）, 4 with gradeasthenia （12.9%） and 1 with grade IV hepatotoxicity （3.2%）. Neutropenia and thrombocytopenia were recoverable. There were no significant differences in Ccr levels before and after treatment （[61.7＋23.4] mLlmin vs. [65. 0 ±23.11 mLlmin, P〉0.05）. Conclusion The combination ofgemcitabine and oxaliplatin as a fist-line treatment for urothelial cancer can acquire a better therapeutic effect and greater safety without renal impairment. （Shanghai Med J, 2012, 35： 238-241）