FOLFOX4方案治疗晚期胃癌临床研究

Treatment of the advanced gastric cancer with FOLFOX4 regimen

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,TIP)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ECOG 0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(com- plete response,CR)2例,部分缓解(partial response,PR)14例,疾病稳定(stable dis- ease,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OS 9个月(2～20个月)。Cox回归分析显示OS的预测因素是ECOG评分,TIP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。

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 infusion dl, CF 200 mg,/m^2 intravenous infusion lasting two hours dl infusion followed by 600 mg/m^2 continuous intravenous infusion 2, and then 5 - Fu 400 mg/m^2 bolus lasting twenty -two hours dl, 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 administered, the best response rate were 2 complete response （CR）, 14 partial response （PR）, 15 stable disease （ SD）, and progression of disease （PD） happened in other fourteen patients. After a median follow - 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 （TrP） was 8 months （range, 1 -19 months）, the median overall survival （OS） was 9 months （range, 2 - 20 months）. The predicting factor of TFP were ECOG performance 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 efficacy and an acceptable toxicity in patients with advanced gastric cancer.