CAJ | 학술논문

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(x2=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.
목적 탐토다서타새가순박(TP)방안연합동보방료교순박단약연합동보방료능부제고구유고위인소조기궁경암술후환자적총생존솔화무복발생존솔.방법 285례부합입조조건적구유고위인소적조기(Ⅰb화Ⅱa기)궁경암술후환자,신봉법수궤분위순박연합방료조(C-R조)화TP방안연합방료조(TP-R조).외조사제량46～54 Gy,외조사결속후보강내방료12 ～ 24 Gy.C-R조화료방안채용순박단약(30 mg/m2),TP-R조화료방안채용다서타새25 mg/m2,순박25 mg/m2,방료기간2조균매주급약1차,공5개주기.결과 C-R조140례,TP-R조145례.C-R조여TP-R조5년총생존솔분별위74.3％화82.8％ (P ＞0.05),TP-R조사망풍험비(HR)위0.65(95％ CI:0.39～1.09).2조무복발생존솔분별위69.3％화79.3％(P＞0.05),TP-R조사망풍험비(HR)위0.64(95％ CI:0.40～ 1.03).C-R조여TP-R조2조복발솔상사(C-R조27례,TP-R조18례,P ＞0.05)；TP-R조3급이상적불량반응명현고우C-R조(x2=6.88,P＜0.05).결론 다서타새가순박연합방료교순박단약연합방료미능진일보제고구유고위인소조기궁경암술후환자적총생존솔,유제고무복발생존솔적추세；연합방안명현증가료3급이상적불량반응.
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 Ⅰ b 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 l40 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 (x2 =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 stage Ⅰb and Ⅱa cervical cancer,though there is a trend to increase recurrence-free survival rates.