【摘要】 目的评价庚铂(c is-m a lonato p latinum,H etap latin)单药和联合治疗晚期胃癌的安全性和有效性。方法多中心、开放式、前瞻性随机对照Ⅱ期临床研究;单药组:庚铂360 m g/m2,第1天;庚铂联合氟尿嘧啶和亚叶酸钙(5-FU/CF)试验组:庚铂用法同单药组,5-FU 375 m g/m2静脉输注,第1~5天,CF 200 m g/m2静脉输注,第1~5天;顺铂(DDP)联合5-FU/CF对照组:DDP 25 m g/m2稀释于生理盐水500 m l,第1~3天,5-FU/CF用法同庚铂联合试验组。以上三个方案每3周重复一次,为一疗程。采用WHO实体瘤近期疗效标准评价,于第2个疗程后第三周进行疗效评价:采用加拿大国家癌症研究所CTG补充常用毒性标准评价安全性。结果200例可评价疗效的患者中,庚铂单药组总有效率(CR+PR)14.9%;庚铂联合试验组总有效率为22.8%;顺铂联合对照组总有效率为22.0%;两联合组疗效之间差异无显著性。在庚铂单药治疗组,血液学毒性轻微,非血液学毒性包括较严重的恶心、呕吐和食欲下降;庚铂联合试验组与DDP联合对照组相比,前者血液学不良反应低,而非血液学不良反应略高,但差异均无显著性。结论治疗晚期胃癌庚铂单药安全有效;庚铂加5-FU/CF联合治疗疗效与DDP加5-FU/CF相当;药物不良反应相似。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of Hetaplatin and combination therapy in patients with advanced gastric cancer.Method An open prospective randomized controlled phase Ⅱ clinical trial on Hetaplatin was conducted multicenterally.In H group the patients were treated with Hetaplatin 360 mg/m~2 d1,in H/5-FU/CF group the patients were treated with Hetaplatin in combination with 5-FU and Folinic acid,and in C/5-FU/CF group the patients were treated with Cisplatin combined with 5-FU/CF.In last two groups 5-FU 375 mg/m~2 and CF 200 mg/m~2 were given as infusion for 5 consecutive days;in H/5-FU/CF group 360 mg/m~2Hetaplatin was given in d1,and in C/5-FU/CF group Cisplatin 25 mg/m~2was solved in 0.9% normal saline 500 ml and given as infusion for 3 consecutive days.In all three groups treatment was recycled every 3 weeks.The response to treatment was evaluated according to WHO criteria in the third week after two courses,and the safety was evaluated according to NCIC CTG criteria.Results Two hundred patients were analyzed for response,the overall response rates were 14.9%,22.8% and 22.0% in sole Hetaplatin,combination trial and combination control groups,respectively;there were no significant differences between two combination groups.The hematologic toxicity was mild and non-hematologic toxic responses were strong including nausea/vomiting and declined appetite in Hetaplatin sole group.The hematologic toxicity in H/5-FU/CF group was lower and non-hematologic toxicity was higher compared with those of C/5-FU/CF group,however there were no statistical significant differences between two groups.Conclusions Hetaplatin is safe and effective in treatment of patients with advanced gastric cancer.The response rate and side effect are similar in combination of Hetaplatin or Cisplatin with 5-FU/CF for the treatment of advanced gastric cancer.更多还原