阿托氟啶治疗胃肠道恶性肿瘤Ⅱ期临床研究

Phase Ⅱ clinical trial of atofluding in the treatment of advanced gastrointestinal cancer

目的 :评价国产抗癌新药阿托氟啶 (atofluding ,ATFU)对胃癌、食管癌、大肠癌及肝癌的临床疗效、不良反应及对免疫功能的影响。方法 :单药组采用开放非随机试验 ,联合治疗组中心内配对随机对照。单药组给予ATFU 75 0mg·m- 2 ·d- 1 ,分 3次口服 ,连用 4～ 8周 ,第 4周结束时评价疗效。联合治疗给予化疗药加ATFU (治疗组 )或替加氟 (FT 2 0 7,对照组 ) ,均 5 0 0mg·m- 2 ·d- 1 ,分 4次口服 ,连用 2周 ,2组同一类型肿瘤联合用化疗药物相同 ,均每 3周为 1周期 ,连用 2～ 3周期 ,从第 2周期始 ,每周期前评价疗效。以上治疗达CR ,PR ,NC者继续用药至8周 (单药组 )或 3周期 (联合化疗组 )停药。结果 :入组 2 4例患者有 2 3例可评价疗效。接受ATFU治疗的患者有3例 (单药组 1例 ,治疗组 2例 )达PR ,总有效率 15 % ,其中单药组和治疗组有效率分别为 12 .5 %和 16 .7% ;对照组3例中无有效病例。疗前疗后免疫学指标测定表明 ,ATFU对免疫功能无影响或有所改善。ATFU血液学毒性轻微 ,均为I度 ;非血液学不良反应主要表现为恶心、呕吐、腹泻、脱发、粘膜炎、肝功损害 ,多为I度。结论 :国产抗癌新药ATFU对胃癌、食管癌均有一定疗效 ,不良反应轻微 ,无免疫抑制作用 ,是一有价值及治疗前景的抗癌新药。

Objective:To evaluate the efficacy, toxicity,and immunological change of a new anticancer agent atofluding(ATFU) in the treatment of advanced gastrointestinal cancer.Methods:Single agent group was performed with open non randomized trial and combination agent group was performed with randomized compared trial in the center.All patients in single agent group were treated with ATFU 750mg·m -2 ·d -1 orally for 4～8 weeks.The patients in combination agent group were treated with ATFU(AC group) or tegafur(FT 207,FC group) 500mg·m -2 ·d -1 orally for 2 weeks and both were combined with same anticancer agents for same type of gastrointestinal cancer,it was repeated every 3 weeks for 2～3 cycles.Treatment should be continued until the 8th week(single agent group) or third cycle(combination agent group) unless disease progresses.Results:Among 23 evaluable cases, there were 3 PR achieved with treatment of ATFU, which included 1 in single agent group and 2 in AC group, the overall response rate was 15%.There was no response case in FC group. Hematologic toxicities were all grade I and the most of non hematologic adverse reactions included nausea,vomiting,diarrhea,mucocitis,alopecin,liver function impairment at grade I in single agent group.Conclusion:ATFU is an effective agent in both advanced stomach and esophageal cancer.The toxicities were mild and no immunosuppression was observed. ATFU has been proved to be evaluable and demonstrated promising prospect in clinical treatment.