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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。
Objective To evaluate the safety and efficacy of cetopamine (H etap latin) monotherapy and combined treatment of advanced gastric cancer. Methods: A multicenter, open, and prospective randomized controlled phase II study. Single drug group: Heptaplatin 360 mg / m2 on day 1; Heptaplatin combined with 5-fluorouracil and leucovorin (5-FU / Platinum use with the single drug group, 5-FU 375 mg / m2 intravenous infusion, 1 to 5 days, CF 200 mg / m2 intravenous infusion, 1st to 5th days; cisplatin (DDP) combined with 5-FU / CF The control group: DDP 25 mg / m2 diluted in saline 500 ml, 1 to 3 days, 5-FU / CF combined with heptapenyl platinum test group. The above three programs are repeated every 3 weeks for a course of treatment. The WHO solid tumor recent efficacy standard evaluation, in the third week after the second course of treatment efficacy evaluation: Canadian National Cancer Institute CTG supplemented with commonly used toxicity standards for the evaluation of safety. Results The total effective rate (CR + PR) was 14.9% in the 200 patients with evaluable curative effect. The total effective rate was 22.8% in the combination group and 22.0% in the cisplatin combined control group. No significant difference between the two combined groups efficacy. In the hepa platinum monotherapy group, hematologic toxicity was mild and non-hematologic toxicity included more severe nausea, vomiting and loss of appetite. Compared with the DDP combination control group, the combination of heptaplatin and platinum in the experimental group had a lower hematologic adverse reaction than the control group Hematologic adverse reactions slightly higher, but the difference was not significant. Conclusions The treatment of advanced gastric cancer heptaplatin single drug safe and effective; Heptaplatin plus 5-FU / CF combination therapy and DDP plus 5-FU / CF equivalent; adverse drug reactions similar.