FOLFOX4方案治疗晚期胃癌临床研究

目的观察奥沙利铂（L-OHP）联合氟尿嘧啶（5-Fu）、亚叶酸钙（CF）双周（FOLFOX4）方案治疗晚期胃癌的疗效及不良反应。方法45例晚期胃癌患者接受FOLFOX4方案化疗，至少化疗2个周期后评价疗效、不良反应和总有效率，计算疾病进展时间（time to progression，TTP）和总生存期（overall survival，OS）。结果全组男性30例，女性15例，中位年龄53岁（25～74岁），全身状况ECOG评分均为0-2分，其中ECOG0分和1分者占53．3％。中位化疗4个周期（2—12个周期），完全缓解（complete response，CR）2例，部分缓解（partial response，PR）14例，疾病稳定（stable disease，SD）15例，疾病进展（progressive disease，PD）14例。中位随访8个月（2～20个月），共有2例失访，11例存活，32例死亡。中位TTP8个月（1～19个月），中位OS9个月（2～20个月）。Cox回归分析显示OS的预测因素是ECOG评分，TTP的预测因素包括ECOG评分和化疗疗效。最常见的不良反应是血白细胞减低（73．3％）和消化道反应（71．1％），其次为周围神经毒性（11．1％）。结论FOLFOX4方案治疗晚期胃癌近期疗效较好，不良反应可以接受，但与传统化疗方案相比，生存期无明显优势。

Treatment of the advanced gastric cancer with FOLFOX4 regimen

Objective To evaluate the efficacy and safety of an oxaliplatin(L-OHP),fluorouracil (5-Fu)and folinic acid(CF)combination chemotherapy in patients with advanced gastric cancer. Methods Forty-five patents with advanced gastric cancer received L-OHP 85mg/m~2 intravenous infu- sion d1,CF 200 mg/m~2 intravenous infusion lasting two hours d1,2,and then 5-Fu 400 mg/m~2 bolus infusion followed by 600 mg/m~2 continuous intravenous infusion lasting twenty-two hours d1,2 every fourteen days.Results Patients(male:female=30:15)had a median age of 54 years(range,25 to 74 years),among them 53.3% had an ECOG PS 0-1 score.All patients had histologically confirmed adenocarcinoma.A median of 4 cycles(range,2-12)chemotherapy per patient had been adminis- tered,the best response rate were 2 complete response(CR),14 partial response(PR),15 stable dis- ease(SD),and progression of disease(PD)happened in other fourteen patients.After a median fol- low-up of 8 months(range,2-20 months),32 patients have died,two out of contact and eleven still alive.The median time to progression(TTP)was 8 months(range,1-19 months),the median over- all survival(OS)was 9 months(range,2-20 months).The predicting factor of TTP were ECOG per- formance status(PS)score and chemotherapy response,and the factor of OS was ECOG PS score alone according to the Cox regression analysis.Neutropenia and gastrointestinal adverse events had occurred in 73.3% and 71.1% of patients,respectively,and 11.1% had peripheral nerve toxicity.Conclusions The L-OHP,5-Fu,and CF combination chemotherapy regimen administered biweekly has a good effi- cacy and an acceptable toxicity in patients with advanced gastric cancer.