节点文献
食管癌患者同期放化疗顺铂加氟尿嘧啶方案Ⅱ期临床试验
Phase Ⅱ Clinical Trial of Concurrent Chemoradiotherapy(Cisplatin Plus 5-Fluorouracil) for Esophageal Cancer
【摘要】 背景与目的:国外已有研究表明,同期放化疗是局部晚期食管癌的标准治疗方案,但国内文献报道同期放化疗的疗效不尽相同,同期放化疗能否提高生存率尚无定论。本研究目的是评价PF方案同期放化疗对食管癌的疗效,并观察毒性。方法:44例食管鳞癌患者随机分为同期放化疗组(简称同期组)和后程加速超分割组(简称后超组)。同期组22例,全程常规分割照射,每天一次,每次2.0Gy,每周5次,25分割,总剂量50Gy。于放疗的第1天开始化疗:顺铂52.5mg/m2d1,氟尿嘧啶700mg/m2d1~d5,每28d重复,共4周期。后超组22例:总剂量60Gy,前半程30Gy同放化疗组,3周完成;后半程30Gy加速超分割照射,每日2次,间隔至少6h,每次1.5Gy,每周10次,2周完成。结果:同期组有效率高于后超组,分别为95.5%和86.4%,但差异无统计学意义(P=0.607)。同期组2年局控率和2年生存率分别为72.2%和56.7%,后超组分别为39.0%和31.6%。同期组获得了更高的局控率和生存率,但只有局控率差异有统计学意义(P=0.014)。两组的主要急性反应为放射性食管炎、放射性肺炎,晚期反应为食管和肺损伤。两组的急性和晚期反应均较轻。结论:同期放化疗与后程加速超分割相比,显著提高了食管癌局控率,有提高生存率的趋势,毒性可以耐受。
【Abstract】 BACKGROUND & OBJECTIVE:Concurrent chemoradiotherapy is a standard treatment for local advanced esophageal cancer in overseas countries;however,the treatment outcomes are various in China.This study was to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin plus 5-fluorouracil(PF) regimen on esophageal cancer,and observe the adverse events.METHODS:Forty-four patients with esophageal squamous cell carcinoma(ESCC) were randomized into two groups.Twenty-two patients in concurrent chemoradiotherapy(CRT) group received conventional fractionated radiotherapy of 50 Gy during 5 weeks,with 5 daily fractions of 2.0 Gy per week.Chemotherapy was started on the first day of irradiation:cisplatin 52.5 mg/m2 at Day 1,5-fluorouracil 700 mg/m2 at Days 1-5,repeated 4 times every 28 days.Twenty-two patients in late course accelerated hyperfractionated radiotherapy(LCAF) group received conventional fractionated radiotherapy of 30 Gy during 3 weeks(the same scheme as that of CRT group),followed by accelerated hyperfractionated radiotherapy of 30 Gy during 2 weeks:twice a day,1.5 Gy per fraction,with a minimal interval of 6 h between fractions,10 fractions per week.RESULTS:The response rate was 95.5% in CRT group and 86.4% in LCAF group(P=0.607).The 2-year local control rate and 2-year survival rate were 72.2% and 56.7% in CRT group,and 39.0% and 31.6% in LCAF group.Compared with LCAF group,CRT group obtained higher local control rate and survival rate,but only the difference of local control rate was significant(P=0.014).Major acute adverse events in the two groups were radiation-induced esophagitis and radiation-induced pneumonia,while late adverse events were late injury in the esophagus and lung.Both acute and late adverse events in the two groups were mild.CONCLUSIONS:Compared with LACF,CRT can significantly improve local control rate of ESCC,and may enhance survival rate.The adverse events are tolerable.
【Key words】 Esophageal neoplasm; Concurrent chemoradiotherapy; Cisplatin; 5-Fluorouracil; Clinical trial;
- 【文献出处】 癌症 ,Chinese Journal of Cancer , 编辑部邮箱 ,2008年10期
- 【分类号】R735.1
- 【被引频次】21
- 【下载频次】322