王海荣,朱卫国,秦珊珊,郭佳妮,王海东,李涛,陶光州,吉福志,周锡垒,韩济华,于长华.高危早期宫颈癌术后放疗联合不同化疗方案随机对照研究[J].中华放射医学与防护杂志,2013,33(1):50-54
高危早期宫颈癌术后放疗联合不同化疗方案随机对照研究
A randomized, controlled study of different chemotherapy regimens combined with postoperative radiotherapy for patients with high-risk early stage cervical cancer
投稿时间:2012-08-13  
DOI:10.3760/cma.j.issn.0254-5098.2013.01.013
中文关键词:  高危早期宫颈癌  术后联合放化疗  总生存率  无复发生存率
英文关键词:Early stage cervical cancer  Concurrent chemoradiotherapy  Overall survival rate  Recurrence-free survival rate
基金项目:江苏省淮安市科技支撑计划(HAS2010030)
作者单位E-mail
王海荣 223300 南京医科大学附属淮安第一医院  
朱卫国 223300 南京医科大学附属淮安第一医院 jshazwg@126.com 
秦珊珊 223300 南京医科大学附属淮安第一医院  
郭佳妮 223300 南京医科大学附属淮安第一医院  
王海东 223300 南京医科大学附属淮安第一医院  
李涛 223300 南京医科大学附属淮安第一医院  
陶光州 223300 南京医科大学附属淮安第一医院  
吉福志 223300 南京医科大学附属淮安第一医院  
周锡垒 223300 南京医科大学附属淮安第一医院  
韩济华 223300 南京医科大学附属淮安第一医院  
于长华 223300 南京医科大学附属淮安第一医院  
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中文摘要:
      目的 探讨多西他赛加顺铂(TP)方案联合同步放疗较顺铂单药联合同步放疗能否提高具有高危因素早期宫颈癌术后患者的总生存率和无复发生存率。方法 285例符合入组条件的具有高危因素的早期(Ⅰb和Ⅱa期)宫颈癌术后患者,信封法随机分为顺铂联合放疗组(C-R组)和TP方案联合放疗组(TP-R组)。外照射剂量46~54 Gy,外照射结束后补腔内放疗12~24 Gy。C-R组化疗方案采用顺铂单药(30 mg/m2),TP-R组化疗方案采用多西他赛25 mg/m2,顺铂25 mg/m2,放疗期间2组均每周给药1次,共5个周期。结果 C-R组140例,TP-R组145例。C-R组与TP-R组5年总生存率分别为74.3%和82.8%(P>0.05),TP-R组死亡风险比(HR)为0.65(95%CI: 0.39~1.09)。2组无复发生存率分别为69.3%和79.3%(P>0.05),TP-R组死亡风险比(HR)为0.64(95%CI: 0.40~1.03)。C-R组与TP-R组2组复发率相似(C-R组27例,TP-R组18例,P>0.05);TP-R组3级以上的不良反应明显高于C-R组(χ2=6.88, P<0.05)。结论 多西他赛加顺铂联合放疗较顺铂单药联合放疗未能进一步提高具有高危因素早期宫颈癌术后患者的总生存率,有提高无复发生存率的趋势;联合方案明显增加了3级以上的不良反应。
英文摘要:
      Objective To investigate whether docetaxel plus cisplatin combined with radiotherapy(TP-R) compared with cisplatin-only combined radiotherapy(C-R) could increase overall survival and recurrence-free survival on patients with high-risk early stage cervical cancer.Methods Eligible high-risk patients with stage Ⅰb and Ⅱa cervical cancer were randomly assigned to C-R and TP-R group. The external irradiation dose was 46-54 Gy, following 12-24 Gy of intracavitary brachytherapy. In C-R group, chemotherapy regimens consisted of cisplatin 30 mg/m2 (weekly, with 5 cycles). In TP-R group, chemotherapy regimens consisted of cisplatin 25 mg/m2 and of docetaxel 25 mg/m2 (weekly, with 5 cycles). Results A total of 285 patients entered final analysis. There were 140 cases in C-R group and 145 in TP-C group, respectively. The 5-year overall survival rate was 74.3% in C-R group and 82.8% in TP-R group(P>0.05). The hazard ratio for death on TP-R group was 0.65(95%CI: 0.39-1.09). The 5-year recurrence survival rates were 69.3% in C-R group and 79.3% in TP-R group(P>0.05), respectively. And the hazard ratio for death on TP-R group was 0.64(95%CI: 0.40-1.03). Recurrence rates were similar in two groups(P>0.05).Rate of ≥ grade 3 adverse events was higher in TP-R group(χ2=6.88, P<0.05). Conclusions Docetaxel plus cisplatin combined with radiotherapy fails to increase overall survival rates compared with cisplatin-only combined with radiotherapy for patients with high-risk stageⅠb and Ⅱa cervical cancer, though there is a trend to increase recurrence-free survival rates.
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