奈达铂治疗不能手术食管癌患者的临床观察

Nedaplatin in the treatment of patients with inoperable esophageal carcinoma

目的:比较奈达铂(nedaplatin,NEP)与顺铂(DDP)分别联合氟尿嘧啶(5-FU)治疗不能手术的食管癌患者的临床疗效、安全性及毒性反应。方法:45例食管癌患者根据入选标准随机分组,23例进入奈达铂(NEP)联合5-FU组(NEP组),22例进入顺铂(DDP)联合5-FU组(DDP组)。NEP组化疗为:NEP 80～100 mg/m^2,第1天,5-FU 500 mg/m^2,第1～5天,每3周为1个周期,至少化疗2个周期;DDP组化疗为:5-FU 500 mg/m^2,第1～5天,顺铂20 mg/m^2(FD方案),第1～5天,每3周为1个周期,至少化疗2个周期。结果:NEP组和DDP组的有效率分别为47．6%(10/21)和40．9%(9/22),2组无统计学差异(P＞0．05)。但对既往铂类药物治疗失败的食管癌患者,NEP组仍有一定疗效;NEP组的骨髓抑制(白细胞和血小板减少)和肝功能损害较DDP组明显,而DDP组消化道反应较NEP组明显。结论:NEP联合5-FU化疗治疗食管癌疗效与FD方案相似,毒副反应可以耐受,但治疗中应注意监测血象和肝功能。

Objective： To evaluate therapeutic efficacy, safety, and toxicity of nedaplatin（NEP）/5-fluorouracil（5-FU） and cisplatin （DDP）/5-FU therapy for patients with inoperable esophageal carcinoma. Methods： Fourty five patients with inoperable esophageal carcinoma were divided randomly into two groups. NEP group composed of 23 cases were treated with NEP/5-FU regimen, and DDP group including 22 cases was treated with DDP/5-FU regimen. Patients in NEP/5-FU group were given NEP 80-100 mg/m^2 on d 1 and 5-FU 500 mg/m^2 from d 1 to d 5. Patients in DDP group were given 5-FU 500 mg/m^2 from d 1 to d 5 and FD 20 mg/m^2 from d 1 to d 5. Three weeks as one cycle. Both NEP/5-FU and DDP/5-FU therapy lasted for 2 cycles. Results：The overal response rate （complete response-f-partial response） were 47.6% in the 23 patients treated with NEP/S-FU regimen, and 40.9% in the 22 patients treated with DDP/5-FU regimen. There was no statistically difference between the two group （P〉0.05）. But for patients with esophageal carcinoma who had failed in the previous DDP-based chemotherapy, the NEP/5-FU regimen was still effective. The myelosuppression （leukopenia and thrombocytopenia） and liver toxicity in NEP/5- FU regimen were more severe than DDP/5-FU regimen. The nausea and vomiting in DDP/5-FU group were more apparent than that in NEP/5-FU group. Conclusion： The response rate of NEP/5-FU regimen for patients with esophageal carcinoma is similar to DDP/5-FU regimen and its adverse toxicity is tolerable. The blood smear and liver function must be monitored closely during chemotherapy.