局部进展期胃癌根治术后同期放化疗与单纯化疗的临床比较

Clinical randomzied study of postoperative radiochemotherapy compared with chemotherapy alone in the treatment of locally advanced gastric cancer

目的比较局部进展期胃癌根治术后同期放化疗（RCT）与单纯化疗（CT）的疗效和不良反应。方法83例患者随机分为RCT组（43例）和CT组（40例）。RCT组采用三维适形放疗45Gy同期口服卡培他滨化疗（1600mg／m^2），放疗结束2周后继续用FOLFOX4方案巩固化疗4-6周期。CT组采用FOLFOX4方案化疗6～8周期。Kaplan—Meier法计算生存率等并Logrank检验。结果随访率为96％，RCT和CT组随访时间满2、3年者分别为37、12例和31、10例。RCT组和CT组1、2、3年局部控制率分别为100％、97％、94％和95％、87％、73％（X^2=4．54，P=0．033），生存率分别为98％、86％、81％和93％、80％、64％（x。=3．96，P=0．047）。RCT组和CT组治疗期间〉13级白细胞下降发生率分别为23％和15％（X^2=0．93，P=0．630），≥3级胃肠道反应发生率分别为16％和10％（x^2=0．95，P=0．624）。结论局部进展期胃癌根治术后RCT比cT可提高患者局部控制率和生存率，不良反应可耐受。

Objective To investigate the efficacy and toxicity of postoperative radiochemotherapy compared with chemotherapy alone in the treatment of locally advanced gastric cancer. Methods A total of 83 patients with resected adenocarcinoma of the stomach were randomly assigned to postoperative radiochemotherapy group （RCT） （ n = 43 ） or chemotherapy alone group （CT） （ n = d0）. Patients in RCT group received radiotherapy concurrent with capecitabine chemotherapy then followed by 4 - 6 cycles of FOLFOX4 chemotherapy. The total dose of radiation was 45 Gy. The dose of capecitabine was 1600 mg/m2 per day. In the CT group, patients received 6 - 8 cycles FOLFOX4 chemotherapy. Survival was analyzed using Kaplan-Meier method and Logrank test. Results The follow-up rate was 96%. The number of patients who had a minimum of 2-,3-year follow-up time were 37,12 in the RCT group and 31,10 in the CT group. The 1-,2-,3-year local control rates for RCT and CT groups were 100% ,97% ,94% and 95% ,87%, 73% （X^2=4. 54,P =0. 033）, respectively. The 1-,2-,3-year survival rates were 98% ,86% ,81% in the RCT group, with 93%, 80%, 64% in the CT group （ X^2 = 3.96, P = 0. 047）. The incidence of grade 3 hematological toxicity in the RCT and CT group was 23% vs 15% （ X^2 = 0. 93, P = 0. 630）, and grade 3 gastrointestinal toxicity was 16% vs 10% （ X^2 = 0. 95, P = 0. 624 ）. Conclusions Compared with chemotherapy alone, postoperative radiochemotherapy can improve survival of locally advanced gastric cancer patients with acceptable toxicities.