奥沙利铂联合羟基喜树碱和氟尿嘧啶及亚叶酸钙治疗晚期胃癌的临床研究

Clinical study of oxaliplatin combination chemotherapy with hydroxycamptothecin, fluorouracil and leucovorin in advanced gastric cancer

目的:观察以奥沙利铂(LOHP)、羟基喜树碱(HCPT)、氟尿嘧啶(5FU)及亚叶酸钙(LV)组成的HLOF方案和顺铂(DDP)、HCPT、5FU及LV组成的HLPF方案治疗晚期胃癌的疗效与安全性。方法:61例患者随机分组,试验组32例给予HLOF方案化疗,LOHP130mg/m2,静脉滴入2h,d1;HCPT6mg/m2,静脉滴入,d1～d5;5FU500mg/m2,静脉滴入,d1～d3;LV100mg/m2,静脉滴入,d1～d3。对照组29例给予HLPF方案化疗,除用DDP替代LOHP外余同对照组。DDP用法:30mg/m2,静脉滴入,d1～d3。以上方案均每21～28d重复。每例至少完成2个周期化疗方可评价疗效。结果:试验组CR2例,PR17例,SD8例,PD5例,有效率为59.4%(19/32);对照组PR12例,SD11例,PD6例,有效率为41.4%。两组总有效率差异无统计学意义,P>0.05。不良反应HLOF组食欲下降、恶心、呕吐的发生率较对照组低,P<0.05;神经毒性发生率高于对照组。KPS评分HLOF组升高幅度高于对照,P<0.05。两组疾病无进展时间(timetoprogress,TTP)及生存期比较,差异均无统计学意义,P>0.05。结论:治疗晚期胃癌,两者均为有效、低毒的化疗方案。在改善生活质量和减轻消化道反应方面,HLOF优于HLPF方案。

OBJECTIVE：To evaluate the effects and safety of oxaliplatin （L-OHP）, hydroxylcamptothecin （HCPT）, Fluorouracil （5-FU） and leucovorin （LV） combined HLOF regimen, compared with Cisplatin （DDP）, HCPT, 5-FU and LV combined HLOF regimen in the treatment of patients with advanced and metastatic gastric cancer. METHODS： Sixty-one cases were randomly grouped, and 32 cases were treated as study group with HI.OF regimen while 29 cases were treated with HLPF regimen as control; L OHP 130 mg/m^2 iv gtt 2 hours dl , HCPT 6 mg/m^2 iv gtt d1 -d5, DDP 30 mg/m^2 iv gtt d1-d3, 5 FU 500 mg/m^2 iv gtt d1-d3, gv 100 mg/m^2 iv gtt d1- d3, Both regiment were repeated in 21-28 days. All patients completed at least two cycles for evaluation. RE SULTS： There were 2 cases of CR, 17 cases of PR,8 cases of SD and 5 cases of PD in HLOF regimen group with overall response rate （ORR） of 59. 4%, and 12 cases PR,11 cases of SD and 6 cases PD with ORR of 41.4% in HLPF regimen group, respectively. There was no statistically significant difference of ORR and RR of initial treatment and retreatment between the two groups, P〉0.05. The decreased appetite, nausea and vomiting were lower in HLOF group than in HLPF group, P 〈 0. 05; but neurotoxicity was more common in HLOF regimen group. The post-therapy KPS score in both groups increased in a large number of patients but HLOF regimen group seemed achieved higher score grade, P〈0.05. No differences were found between the two groups in time to progress （TTP） and survival time, both P〉0. 05. CONCLUSIONS： Both regimens are efficient and low toxic in the treatment of advanced gastric cancer. The patients would be more likely benefit from HLOF regimen than from HLPF regimen for decreasing gastrointestinal discomfort and increasing quantity of life （QOL）.