多西他赛联合顺铂与多西他赛单药治疗复治晚期食管癌的临床研究

Docetaxel plus cisplatin and docetaxel clone in treatment of patients with advanced esophageal cancer

目的:通过对比多西他赛联合顺铂与多西他赛单药治疗复治晚期食管癌的客观疗效和不良反应,寻求复治晚期食管癌更有效的治疗方法。方法:全组59例患者,其中食管鳞癌50例,食管低分化癌6例,食管腺鳞癌3例,均为复治患者。入选患者非随机分组接受相应治疗。A组:应用TP方案(多西他赛75mg/m2,静脉滴入,d1;DDP30mg/m2,d1-3,静脉滴入。B组用T方案(多西他赛的剂量及用法与A组完全相同)。每21d重复,每例患者接受2个周期以上方可评价疗效。结果:A组与B组的有效率分别为25.0%(8/32)和18.5%(5/27),两组比较无统计学意义(P>0.05);疾病控制率为62.5%(20/32)和51.9%(14/27),两组比较无统计学意义(P>0.05);中位TTP分别为4.7个月和4.1个月,两组比较有统计学差异(P<0.05)。两组主要不良反应为骨髓抑制、消化道反应和脱发。TP方案与T方案的胃肠道反应比较有统计学意义(P<0.05)。结论:TP方案与T方案治疗复治晚期食管癌疗效肯定,近期有效率相似,不良反应可耐受,增加顺铂只有增加患者的胃肠道不良反应。

Objective： To compare the efficacy and toxicity of the regimen TP （docetaxel ＋ cisplatin） with the regimen T （docetaxel） in the treatment of patients with advanced esophageal cancer. Methods： A total of 59 cases with advanced esophageal cancer were enrolled.The patients were nonrandomly divided into two groups,group A with 32 cases and group B with 27 cases.The patients in group A received TP regimen： docetaxel 75 mg/m2 iv 1 h,d1;DDP 30 mg/m2 iv d1-3, and every 21 days as 1 cycle. The patients in group B received T regimen. dose, application and intermission of docetaxel iwas same as group A. All the patients received over two cycles of chemotherapy. Results： All patients were evaluable for response and toxicity. The total response rate and disease control rate of TP regimen were 25.0%（8/32）and 62.5%（20/32） respectively. Total response rate and disease control rate of T regimen were 18.5%（5/27）and 51.9%（14/27） respectively. The median time of tumor progression （TTP） in TP regimen and T regimen were 4.7 months and 4.1 months respectively. There was no significant difference of the total response rate and the disease control rate between these two regimens（P0.05）. But there was significant difference of the TTP between these two regimens（P0.05）.The major adverse reactions were bone marrow suppression, nausea and vomiting, and baldness. There was significant difference of the nausea and vomiting between these two regimens（P0.05）. Conclusion： Both TP and T regimens are effective for advanced esophageal cancer patients treated previously and have no significant difference. The side effect of the two regimens are tolerable. But cisplatin in the TP regimen increases gastrointestinal toxicity in patients.