摘要
目的系统评价术后放疗对早期子宫内膜癌的有效性、安全性及成本-效果。方法电子检索Cochrane图书馆、MEDLINE、EMbase、CancerLit、CBMdisc、VIP、万方学位论文数据库、CNKI,并辅以手工检索。检索时间截至2007年3月,收集子宫内膜癌(EC)术后放疗的随机对照试验(RCT)。由两名研究者按Cochrane系统评价方法,独立选择试验,提取资料、评价纳入研究的方法学质量,并提取有效数据进行Meta分析。结果共纳入7个RCT,包括2084例患者,其中5个为术后放疗(盆腔和/或阴道)与术后非放疗比较,包括1254例患者;1个为阴道放疗不同剂量间的比较(2.5Gyvs5.0Gy),包括290例患者;1个为两种放疗方式的比较(阴道+盆腔vs阴道),包括540例患者。Meta分析结果显示:⑴手术vs手术+放疗:①手术vs手术+盆腔放疗:5、8、10年局部复发率及5、8年总体复发率,手术+盆腔放疗组低于单纯手术组;两组5、8年远处复发率及5、8、10年总体生存率差异无统计学意义;10年远处复发率手术+盆腔放疗组高于单纯手术组;两组10年总体复发率差异无统计学意义;②手术vs手术+阴道放疗:5、10年总体生存率及5、10年无瘤生存率,两组差异无统计学意义。⑵手术+内分泌治疗vs手术+盆腔放疗:两组局部及远处复发率、总体生存率及无瘤生存率(<2年)差异均无统计学意义。⑶术后阴道放疗两种不同剂量(2.5Gyvs5.0Gy)的比较:5年复发率(局部、远处、总体)及5年总体生存率、毒性反应,两组差异均无统计学意义。⑷手术+阴道放疗vs手术+阴道放疗+盆腔放疗:5年局部复发率联合放疗组低于单独阴道放疗组,5年远处复发率联合放疗组高于单独阴道放疗组,5年总体生存率两组无统计学差异。⑸成本-效果分析:术后放疗比复发后放疗虽增加了成本但却提高了总体生存率,术后高剂量近距离放疗成本-效果价值较好。结论术后放疗对于子宫内膜癌Ⅰ期患者,能有效降低其局部复发率,但对远处复发率、总体生存率、无瘤生存率无明显改善,疗效和单纯手术效果相似;放疗的副作用较单纯手术大。因各试验纳入研究人群不完全一致,且亚组分析发现内膜癌的死因绝大多数并非由子宫内膜癌本身或治疗引起,而是死于其合并症,故放疗对子宫内膜癌患者的总体生存率、无瘤生存率的效果有待进一步大样本、高质量的多中心随机双盲对照试验加以证实。
Objective To assess the clinical effectiveness, safety and cost-effectiveness of adjuvant radiotherapy （RT） for endometrial cancer compared to other treatmen. Method The following electronic databases were searched： MEDLINE, EMBAS, CancerLit, CBMdisc, CNKI. The Cochrane Library （Issue 3, 2007）. Correlative websites, such as ＇google＇, were searched by hand. The studies included in the references of eligible studies were additionally searched RCTs of adjuvant radiotherapy before March, 2007 comparing adjuvant radiotherapy with other treatment for endometrial cancer were included. Eligible RCTs were assessed for quality by two reviewers independently： criteria of concealment of treatment, blinding, standard validity and reliability of outcome measures, withdraw rate, intention-to-treat analysis and homogeneity between centers were analyzed for each study. All data were performed by a meta-analysis. Result Seven RCTs met the inclusion criteria/Methodological quality was level B. Five RCTs were compared adjuvant radiotherapy （external beam radiotherapy （EBRT） and/or intracavitary radiotherapy （ICRT） with other treatment, Two RCTs including one RCT was compared two different fractionation schedules for postoperative vagina high-dose-rate（HDR） irradiation in endometrial carcinoma the other RCT was compared two different radiotherapy method （pelvic radiotherapy and vagina radiotherapy vs vagina radiotherapy） for endometrial carcinoma. No survival different were identified; none of the studies was powered enough to show a survival benefit. But who received RT had fewer local （pelvic and/or vagina） recurrences compared to women not receiving RT. Adverse effects is found more often in RT than in not RT, there is less local recurrences in combined radiotherapy （pelvic radiotherapy and vagina radiotherapy） than in vagina radiotherapy, lowdose vagina radiotherapy had few vagina shortening than high-dose radiotherapy, there are the same 5-overall surviva, local recurrences and distant recurrences. Conclusions Adjuvant radiotherapy for endometrial can cer can better control local recurrences than observation for postoperative endometrial cancer. Effects about overall survival, distant recurrences and disease-free survival are similar; low-dose vagina radiotherapy has few vagina shortening than high-dose radiotherapy, there are the same 5-years overall survival, local recurrences and distant recurrences for endometrial cancer, there is less local recurrences in combined radiotherapy （pelvic radiotherapy plus vagina radiotherapy） than in vagina radiotherapy for endometrial cancer; postoperative high-dose brachytherapy can get good cost-effectiveness; Effect of adjuvant radiotherapy for overall survival and disease-flee survival of endometrial carcinoma are needed to further assessed by rigorously designs, randomized, double-blind, placebo-controlled trials adjuvant radiotherapy for endometrial carcinoma.
出处
《中国循证医学杂志》
CSCD
2009年第4期465-475,共11页
Chinese Journal of Evidence-based Medicine
关键词
辅助性放疗
子宫内膜癌
系统评价
随机对照试验
META分析
Adjuvant radiotherapy
Endometrial carcinoma
Meta-analysis
Randomized controlled trials
Systematic review
