PLF方案与FOLFOX4方案治疗进展期胃癌临床对比研究

Clinical comparative study of PLF regimen and FOLFOX4 regimen on advanced gastric carcinoma

目的:回顾性观察并比较PLF(DDP/CF/5-FU)方案和FOLFOX4(L-OHP/CF/5-FU)方案治疗进展期胃癌的近、远期疗效和毒副反应。方法:68例进展期胃癌患者随机分组,35例患者接受PLF方案化疗:顺铂(DDP)75 mg/m2,静脉滴入,d1,亚叶酸钙(CF)120 mg/m2,静脉滴入(先)d2～d6,5-氟尿嘧啶(5-FU)350 mg/m2,静脉滴入(后)d2～d6,21 d为1个周期。33例患者接受FOLFOX4方案化疗:奥沙利铂(L-OHP)85 mg/m2静脉滴入2 h d1,CF 200 mg/m2,静脉滴入,d1、d2,5-FU400 mg/m2,静脉冲入,d1、d2,5-FU600 mg/m2持续静脉滴入22 h,d1、d2,14 d为1个周期。对两组的总有效率、临床获益率、无进展生存期以及毒副反应进行分析比较。结果:PLF组和FOLFOX4组的总有效率分别为37.1%(13/35)和42.4%(14/33),差异无统计学意义,χ2=0.198,P=0.656。临床获益率分别为60.0%(21/35)和81.8%(27/35),差异有统计学意义,χ2=3.895,P=0.048。中位无进展生存期分别为6和8个月,差异有统计学意义,χ2=3.926,P=0.042。两组主要不良反应为白细胞减少、血红蛋白减少、口腔炎、血清肌酐上升、脱发和神经毒性,差异有统计学意义。结论:PLF方案和FOLFOX4方案均是治疗进展期胃癌的有效方案,但后者的近、远期疗效优于前者,并且总体毒副反应轻微,值得临床进一步研究应用。

OBJECTIVE： To retrospectively observe and compare the efficacy and toxicity of PLF regimen and FOL FOX4 regimen in the treatment on patients with advanced gastric earcinoma（AGC）. METHODS： A total of 68 patients with AGC were randamly divided. 35 patients with AGC received PLF regimen： DDP 75 mg/m^2 ivgtt d1, CF 120 mg/m^2 ivgtt （before） d2 -d6,5-FU 350 mg/m^2 ivgtt（after） d2-d6, 21 days as one cycle; 33 patients with AGC received FOLFOX4 regi men： L-OHP 85 mg/m^2 ivgtt 2 h d1, CF 200 mg/m^2 iv, d1, d2 , 5-FU 400 mg/m^2 iv, d1, d2 , 5-FU 600 mg/m^2 CIV 22 h, d1, d2, 14 days as one cycle. The overall rate of response, clinical benefit response rate, progression-free survival and toxicity for the two regimens were compared and analysed. RESULTS： The response rates of PLF and FOLFOX4 were 37.1% （13/35） and 42.4% （14/33）, respectively. There was no significant difference （X^2 = 0. 198, P 0. 656）. The clinical benefit response rates of PLF and FOLFOX4 were 60.0% （21/35） and 81.8% （27/35）, respectively. There was a significant difference （X^2 = 3. 895, P= 0. 048）. The progression-free survivals of PLF and FOLFOX4 were 6 months and 8 months, respectively. There was a significant difference （X^2= 3. 926,P=0. 042）. The major toxicities of the two groups had significant difference, for example, aleukocytosis, nausea and vomiting, alopecia, stomatitis, and so on. CONCLUSIONS： PLF regimen and FOLFOX4 regimen show good efficacy in AGC. On the CBR and PFS, FOL FOX4 regimen is better than PLF regimen. Moreover, the toxicity of FOLFOX4 regimen is mild. It is worthy to confirm the results in further clinical trials.