紫杉醇联合草酸铂、卡培他滨三药方案治疗晚期转移性鼻咽癌的临床研究

Combined Treatment of Patients with Advanced Nasopharyngeal Carcinoma with Paclitaxel,Capecitabine and Oxaliplatin

目的探讨紫杉醇联合草酸铂、卡培他滨三药方案治疗晚期转移性鼻咽癌的疗效及不良反应。方法2002年1月至2005年1月,110例晚期转移性鼻咽癌病人入组:试验组55例患者,第1天应用紫杉醇135 mg/m2、草酸铂130 mg/m2静脉滴注,口服卡培他滨1650 mg/m2/d,连服1～14 d,每3周为一个周期,连用2～4个周期;对照组55例患者,第1～5天应用DDP 20 mg/m2、5-Fu 0.5 g/m2静脉注射,3周为一个周期,连用2～4个周期;治疗结束2～4周后评价疗效。结果试验组疗效可评价55例,对照组疗效可评价53例。试验组与对照组有效率分别为(CR+PR)50.9%(28例)和32.1%(17例),两者差异有统计学意义(P<0.05)。试验组和对照组中位生存时间为10.6个月和8.6个月,两者差异有统计学意义(t<0.05)。安全性方面:试验组Ⅳ反应主要为手足综合征8例(14.5%)、骨髓抑制2例(3.6%)和消化道毒性4例(7.3%);对照组Ⅳ反应主要为消化道毒性8例(15.1%)、骨髓抑制2例(3.8%)。结论紫杉醇联合草酸铂、卡培他滨三药方案对晚期转移性鼻咽癌的疗效较DDP+5-Fu有优势,且不良反应可以耐受。

Objective To evaluate the efficacy and adverse effects of paclitaxel combined with capecitabine and oxaliplatin on patients with advanced nasopharyngeal carcinoma （NPC）. Method This study was conducted between Jan. 2002 and Jan. 2005. 110 patients with advanced NPC were equally and randomly divided into two groups. In the treatment group, the patients were treated with paclitaxel 135 mg/m^2 and oxaliplatin 130 mg/m^2 by infusion on dl, and oral capecitabine 1650 mg/m^2/d from dl to d14. The treatment was repeated every three weeks for two to four cycles. In the control group, patients received similar cycle of treatment with DDP20 mg/m^2 and 5-Fu 0.5 g/m^2 by infusion from dl to 5. The efficacy was evaluated at two to four weeks after the completion of chemotherapy. Result 55 subjects in the treatment group and 53 subjected in the control group were assessed after chemotherapy. The success rate of treatment （CR ＋ PR） in the treatment group （50.9%, 28 cases） was significantly higher than the control group （32.1%, 17 cases, P〈0.05）. The median survival time of the treatment group （ 10.6 months） was also significantly higher than the control group （8.6 months, t〈0.05）. Grade IV toxicity symptoms, such as hand-foot syndrome （8 cases, 14.5%）, myelosuppression （2 cases, 3.6%） and GI discomfortable （4 cases, 7.3%） were observed in the treatment group. In the control group, Grade IV toxicity is GI discomfortable （8 cases, 15.1%） and myelosuppression （2 cases, 3.8%）. Conclusion Paclitaxel combined with Capecitabine and Oxaliplatin is suitable for patients with advanced NPC and the toxicity is tolerable.