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目的:比较GEMOX方案(吉西他滨、奥沙利铂)与FAM方案(氟尿嘧啶、阿霉素、丝裂霉素)肝动脉化疗栓塞TACE联合三维适形放疗(3DCRT)治疗局部晚期原发性肝癌的疗效和不良反应。方法:经病理或影像学明确诊断的138例晚期原发性肝癌患者随机分为:研究组70例,采用GEMOX方案(吉西他滨0.8-1.0 g/m~2、奥沙利铂85-100 mg/m~2加入超液化碘油10~30 mL)TACE治疗,每月1次,连用2-3次,经TACE治疗后3-4周行3DCRT,总剂量DT48~60Gy,每次4~5Gy,隔天1次,每周3次,连续4周;对照组68例,采用FAM方案(5-氟尿嘧啶500-1000 mg注入靶动脉,然后将阿霉素50 mg/m~2,丝裂霉素12 mg/m~2与超液化碘油10-30 mL充分混合后缓慢注入,再用明胶海绵颗粒栓塞靶动脉)TACE治疗,每月1次,连用2-3次;经TACE治疗后3-4周行3DCRT,方案同研究组。结果:治疗中研究组2例、对照组1例患者于3DCRT后3-4个月死亡,未进行即期疗效评价。研究组68例患者中CR3例(4.4%),PR 48例(70.6%),SD10例(14.7%),PD7例(10.3%),总有效率(CR+PR)为75.0%(51/67);对照组67例患者中CR1例(1.5%),PR36例(53.7%),SD13例(19.4%),PD17例(25.4%),总有效率(CR+PR)为55.2%(37/67);总有效率研究组明显优于对照组,两组比较有显著统计学意义(X~2=20.973,P<0.001)。总生存时间中位数研究组14.0月(95%CI 11.5~16.5)优于对照组的11.0月(95%CI 9.7~12.3),两组比较有显著统计学意义(X~2=6.093,P=0.014);无进展生存时间中位数研究组7.0月(95%CI,5.6~8.3),对照组6.0月(95%CI 5.1~6.8),两组比较有显著统计学意义(X~2=5.460,P=0.019)。1、2、3年生存率研究组分别为63.4%、39.7%、23.5%,明显高于对照组的46.3%、23.9%、10.5%;两组比较有显著统计学意义(P<0.05)。两组常见的不良反应主要表现为白细胞减少、血小板减少、贫血、恶心、呕吐和发热等,患者均可耐受。结论:TACE联合3DCRT治疗晚期原发性肝癌疗效GEMOX方案明显优于FAM方案,不良反应可相当,有待进一步研究。
OBJECTIVE: To compare the efficacy of GEMOX regimen (gemcitabine, oxaliplatin) and FAM regimen (fluorouracil, doxorubicin, mitomycin) in the treatment of locally advanced primary hepatocellular carcinoma treated with transcatheter hepatic arterial chemoembolization combined with three dimensional conformal radiotherapy (3DCRT) And adverse reactions. Methods: One hundred and thirty-eight patients with advanced primary hepatocellular carcinoma diagnosed by pathology or imaging were randomly divided into study group (70 cases), GEMOX (gemcitabine 0.8-1.0 g / m 2, oxaliplatin 85-100 mg / m ~ 2 added ultra-liquefied lipiodol 10 ~ 30 mL) TACE treatment, once a month, once every 2-3 times, after TACE 3-4 weeks after the line 3DCRT, total dose DT48 ~ 60Gy, each 4 ~ 5Gy, Once a day, 3 times a week for 4 weeks. In the control group, 68 cases were treated with FAM regimen (500-1000 mg of 5-Fluorouracil) into the target artery, and then doxorubicin 50 mg / m ~ 2 and mitomycin 12 mg / m ~ 2 and ultra-liquefied iodized oil 10-30 mL mixed slowly after injection, and then gelatin sponge particles embolism target artery) TACE treatment, once a month, once every 2-3 times; after TACE treatment of 3- 4 weeks line 3DCRT, program with the study group. Results: Two patients in the study group and one patient in the control group died after 3-4 months after 3DCRT, and no immediate effect was evaluated. Among the 68 patients in the study group, CR 3 (4.4%), PR 48 (70.6%), SD 10 (14.7%) and PD 7 (10.3%) and CR + PR 75.0% ); CR1 (53.7%), SD13 (19.4%), PD17 (25.4%) and CR (PR) were 67.2% 67). The total effective rate in the study group was significantly better than that in the control group. There was significant difference between the two groups (X ~ 2 = 20.973, P <0.001). The median overall survival time was 14.0 months (95% CI 11.5-16.5), which was significantly higher than that of the control group (95% CI 9.7-12.3). There was significant difference between the two groups (X 2 = 6.093, P = 0.014). The median progression-free survival time was 7.0 months (95% CI 5.6 ~ 8.3) and 6.0 months (95% CI 5.1 ~ 6.8) in the median progression-free survival time = 5.460, P = 0.019). The 1, 2, 3-year survival rates were 63.4%, 39.7% and 23.5% in the study group, which were significantly higher than those in the control group (46.3%, 23.9% and 10.5%, respectively). There was significant difference between the two groups (P <0.05). Two groups of common adverse reactions mainly as leukopenia, thrombocytopenia, anemia, nausea, vomiting and fever, patients can tolerate. Conclusion: TACE combined with 3DCRT for the treatment of advanced primary liver cancer GEMOX regimen was significantly better than the FAM regimen, adverse reactions can be quite, pending further study.