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46～54Gy，外照射结束后补腔内放疗12—24Gy。C—R组化疗方案采用顺铂单药（30mg／m^2），TP-R组化疗方案采用多西他赛25mg／m^2，顺铂25mg/m^2，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（／-IR）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（X。=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。
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 In 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/m^2（weekly, with 5 cycles）. In TP-R group, chemotherapy regimens consisted of cisplatin 25 mg/m2 and of doeetaxel 25 mg/m^2 （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 O. 65（95% CI： O. 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： O. 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 （X~ = 6. 88, P 〈 0.05 ）. Conclusions Docetaxel plus eisplatin combined with radiotherapy fails to increase overall survival rates compared with eisplatin-only combined with radiotherapy for patients with high-risk stage Ib and Ⅱa cervical cancer, though there is a trend to increase recurrence-free survival rates.
出处
《中华放射医学与防护杂志》
CAS
CSCD
北大核心
2013年第1期50-54,共5页
Chinese Journal of Radiological Medicine and Protection
基金
江苏省淮安市科技支撑计划
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
Early stage cervical cancer
Concurrent chemoradiotherapy
Overall survival rate
Recurrence-free survival rate
