| 刘学芬,冉文华,彭 东,任必勇,张卜娟,莫小飞.GEMOX栓塞化疗联合三维适形放疗治疗局部晚期原发性肝癌临床研究[J].,2017,17(4):720-724 |
| GEMOX栓塞化疗联合三维适形放疗治疗局部晚期原发性肝癌临床研究 |
| Clinical Research of Transcatheter Arterial Chemoembolization with GEMOX Regimen combined with Three-dimensional Conformal Radiotherapy for Advanced Primary Hepatocellular Carcinoma |
| 投稿时间：2016-06-29 修订日期：2016-07-15 |
| DOI：10.13241/j.cnki.pmb.2017.04.031 |
| 中文关键词: 原发性肝癌 动脉化疗栓塞 三维适形放疗 奥沙利铂 吉西他滨 |
| 英文关键词: Primary hepatocellular carcinoma Transcatheter arterial chemoembolization Three-dimensional conformal radiotherapy Oxaliplatin Gemcitabine |
| 基金项目:重庆市医学重点研究室建设项目（渝卫科教〔2007〕14号）；重庆市2013年万州区第一批科技计划项目（201303031） |
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| 中文摘要: |
| 摘要 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/m2、奥沙利铂85-100 mg/m2 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/m2，丝裂霉素12 mg/m2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（χ2=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(χ2=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（χ2=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。 |
| 英文摘要: |
| ABSTRACT Objective: To compare the clinical effects and adverse reactions of transcatheter arterial chemoembolization(TACE)with regimen GEMOX and FAM combined with three-dimensional conformal radiotherapy(3DCRT)for the treatment of advanced inoperable primary hepatocellular carcinoma(HCC). Methods: A total of 138 patients with pathologically or imaging confirmed advanced inoperable primary HCC were enrolled in this study, which were randomly divided into the study group of 70 cases, TACE with GEMOX regimen(gemcitabine 0.8-1.0 g/m2, oxaliplatin 85-100 mg/m2, plus super liquefactive iodized oil 10-30 mL was carried out once a month in all patients for 2-3 successive months. Three to four weeks after TACE, 3DCRT was conducted with a total dose of 48-64Gy, 4-5Gy per fraction at an interval of 48 hours and 3 fractions were given every week; The control group of 68 cases, TACE with FAM regimen(5-fluorouracil 500-1000 mg, adriamycin 50 mg/m2, mitomycin 12 mg/m2 plus super liquefactive iodized oil 10-30 mL) was carried out once a month in all patients for 2-3 successive months, Three to four weeks after TACE, 3DCRT was conducted, the same study group scheme. The clinical results were analyzed. Results: Two cases in the study group and one patient in control group died 3-4 months after 3DCRT was completed.The study group of 68 patients in CR 3 cases (4.4%), PR 48 cases (70.6%), SD10 cases (14.7%), PD 7 cases (10.3%), the total effective rate(CR+PR)was 75% (51/67); the control group of 67 patients CR 1 cases(1.5%), PR 36 cases(53.7%), SD13 cases(19.4%), PD17 cases(25.4%), the total effective rate(CR+PR)was 55.2% (37/67); the total efficiency of study group was significantly better than the control group, two groups was statistically significant(χ2=20.973, P<0.001). The median overall survival time of study group was 14 months(95%CI 11.5~16.5)which was better than that of the control group (11 months 95%CI 9.7~12.3), the two groups was statistically significant(χ2=6.093,P=0.014); The median PFS of study group was 7.0 months(95%CI,5.6~8.3), which was better than that of the control group(6 months 95%CI 5.1~6.8), the two groups was statistically significant (χ2=5.460, P=0.019). The overall survival rates at 1,2 and 3 years in the study group were respectively 63.4%, 39.7%, 23.5%, significantly higher than which in the control group were respectively 46.3%, 23.9%,10.5%; two groups was statistically significant(P<0.05). Two groups of common adverse reactions mainly included leucopenia, thrombocytopenia, anemia, nausea, vomiting and fever,which could be tolerated by the patients. Conclusion: The clinical effect of TACE with GEMOX regimen combined with 3DCRT in the treatment of advanced primary hepatocellular cancer is obviously superior to the FAM scheme of TACE combined with 3DCRT therapy, and its adverse reactions can be tolerated by the patients. It is an ideal method for comprehensive treatment. |
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