紫杉醇与顺铂同期放疗治疗晚期食管鳞癌的Ⅱ期临床研究

Treatment of squamous esophageal carcinoma in advanced stage by concurrent radiotherapy and chemotherapy with paclitaxel and cisplatin:a phase Ⅱ study

目的研究紫杉醇联合顺铂同期放疗治疗局部食管癌的毒副反应和近期疗效。方法入组标准:初治、Ⅱ～Ⅳ期、≤75岁的食管鳞癌患者。进行根治性同期放化疗:放疗剂量60～70 Gy。放疗第1 d开始化疗,紫杉醇175 mg/m2,d1;顺铂25 mg/m2,d 1～3,每21 d一周期,共4周期。结果从2007年12月～2010年7月共入组37例,男性32例,女性5例,中位年龄58(44～69)岁。除1例患者拒绝完成放疗外,其余都顺利完成放疗。化疗完成1、2、3和4个周期者分别有4、5、5和23例。3～4级白细胞下降59.5%(22/37)、中性粒细胞下降67.5%(25/37),血小板下降8.1%(3/37),脱发发生率为73%(27/37);3级放射性食管炎和放射性肺炎均为8.1%(3/37)。中位随访时间16(2～24)个月,1年生存率70%。结论本次小样本的研究表明,紫杉醇联合顺铂同期放疗治疗食管癌,患者能很好耐受,且有较好疗效。

Objective To study the toxic and adverse reaction and short term curative effect of concurrent radiotherapy and chemotherapy with paclitaxol and cisplatin on patients with local esophageal cancer. Methods Patients selected in the research included those with squamous esophageal cancer at the initial treatment, in stage Ⅱ - Ⅳ, and ≤ 75 years old. They received the concurrent radiotherapy and chemotherapy with the radiotherapy dosage of 60 - 70 Gy. At the first day of radiotherapy, chemotherapy was carried out with 175 mg/m2 paclitaxol on d 1 and with 25 mg/m2 cisplatin on d 1 - 3. Every 21 days was a period,and there was totally 4 periods. Results From December 2007 to July 2010,37 patients were enrolled with 32 male and 5 female ones, and the median age was 58 years old （ranging from 44 to 69 years old）. Except that one patient refused to complete the radiotherapy, others all successfully did. There were 4,5,5, and 23 cases who respectively completed the 1,2,3, and 4 period chemotherapy. There were decreasing of 59.5 % level 3 - 4 leucopenia （ 22/37 ）, 67.5 % neutrophil （ 25/37 ）, and 8.1% thrombocyte （ 3/37 ）. The incidence of alopecia was 73% （27/37）. The incidences of level 3 radioactive esophagitis and pneumonia were both 8.1% （3/37）. The median follow - up time was 16 months（ranging from 2 - 24 months）. The one - year survival rate was 70%. Conclusion This study demonstrates that the patients with esophageal cancer treated by concurrent chemo - and radiotherapy with pachtaxol and cisplatin have good tolerance and curative effect.