奈达铂联合5-氟脲嘧啶/四氢叶酸治疗晚期食管癌临床研究

目的：评价奈达铂联合氟脲嘧啶/四氢叶酸治疗晚期复发耐药食管癌的疗效及不良反应。方法：30例晚期复发耐药食管癌均经病理学或细胞学确诊。奈达铂100 mg/m2,静脉滴注,第1天;氟脲嘧啶500 mg/m2,静脉滴注,维持6～8小时,第1～5天;四氢叶酸200 mg,静脉滴注,第1～5天,21天为一周期,连续用2周期后评价疗效及不良反应。结果：30例均完成2个周期以上化疗,共接受86周期化疗,全部病例均可评价疗效及不良反应。无CR病例,PR 13例（43.3%）,SD 7例（23.3%）,PD 10例（33.3%）,有效率为43.3%,TTP 4.0月,MST8.3月。不良反应主要是骨髓抑制,恶心、呕吐,全组无IV度不良反应。结论：奈达铂联合氟脲嘧啶/四氢叶酸治疗晚期复发耐药食管癌有确切疗效,不良反应轻,耐受性好,值得临床进一步推广应用。

Clinical Study of Nedaplatin plus 5-Fluorouracil/Folinic Acid for the Treatment of Advanced Esophageal Cancer

Objective： To evaluate the efficacy and adverse events of Nedaplatin（NDP） in combination with 5-Fluorouracil（5-Fu）/Folinic Acid（FA） in the treatment of patients with advanced recurrent or refractory esophageal cancer.Methods： Of 30 patients with advanced recurrent or refractory esophageal cancer consisting of 17 males and 13 females with a median age of 58 years were included,there were 26 squamous cell carcinomas,4 adeno-squamous cell carcinomas;3 stage Ⅲ and 27 stage IV.The regimen was administered as following： NDP 100 mg/㎡,IV,d1;5-Fu 500mg/㎡,IV,d1～5;FA 200 mg,IV,d1-5,every 21 days as a cycle.The efficacy was evaluated after two cycles of chemotherapy.Results： Eighty-six cycles were carried out in these 30 patients.The efficacy and adverse events were evaluated in all patients.The overall response rate was 43.3（13/30）,including 0 case of CR,13 cases of PR,7 cases of SD,10 cases of PD,respectively.The median time to progression（TTP） was 4.0 months and median survival time（MST） was 83 months.The major adverse events were bone marrow suppression,nausea and vomiting.There was no grade IV adverse event.Conclusion： Nedaplatin in combination with 5-Fluorouracil/Folinic Acid is effective and tolerable in treating patients with advanced recurrent or refractory esophageal cancer.Such regimen is valuable for clinical practicing.