Kong A, Johnson N, Cornes P, Simera I, Collingwood M, Williams C, Kitchener H
St Bartholomew's Hospital, Radiotherapy Department, London, UK, EC1A 7BE.
Cochrane Database Syst Rev. 2007 Apr 18(2):CD003916. doi: 10.1002/14651858.CD003916.pub2.
The role of adjuvant radiotherapy (both pelvic external beam radiotherapy and vaginal intracavity brachytherapy) in stage I endometrial cancer following total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH and BSO) remains unclear.
To assess the efficacy of adjuvant radiotherapy following surgery for stage I endometrial cancer.
The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CancerLit, Physician Data Query (PDQ) of National Cancer Institute. Handsearching was also carried out where appropriate.
Randomised controlled trials (RCTs) which compared adjuvant radiotherapy versus no radiotherapy following surgery for patients with stage I endometrial cancer were included.
Quality of the studies was assessed and data collected using a predefined data collection form. The primary endpoint was overall survival. Secondary endpoints were locoregional recurrence, distant recurrence and endometrial cancer death. Data on quality of life (QOL) and morbidity were also collected. A meta-analysis on included trials was performed using the Cochrane Collaboration Review Manager Software 4.2.
The meta-analysis was performed on four trials (1770 patients). The addition of pelvic external beam radiotherapy to surgery reduced locoregional recurrence, a relative risk (RR) of 0.28 (95% confidence interval (CI) 0.17 to 0.44, p < 0.00001), which is a 72% reduction in the risk of pelvic relapse (95% CI 56% to 83%) and an absolute risk reduction of 6% (95% CI of 4 to 8%). The number needed to treat (NNT) to prevent one locoregional recurrence is 16.7 patients (95% CI 12.5 to 25). The reduction in the risk of locoregional recurrence did not translate into either a reduction in the risk of distant recurrence or death from all causes or endometrial cancer death. A subgroup analysis of women with multiple high risk factors (including stage 1c and grade 3) showed a trend toward the reduction in the risk of death from all causes and endometrial cancer death in patients who underwent adjuvant external beam radiotherapy.
AUTHORS' CONCLUSIONS: Patients with stage I endometrial carcinoma have different risks of local and distant recurrence depending on the presence of risk factors including stage 1c, grade 3, lymphovascular space invasion and age. Though external beam pelvic radiotherapy reduced locoregional recurrence by 72%, there is no evidence to suggest that it reduced the risk of death. In patients with multiple high risk factors, including stage 1c and grade 3, there was a trend towards a survival benefit and adjuvant external beam radiotherapy may be justified. For patients with only one risk factor, grade 3 or stage 1c, no definite conclusion can be made and data from ongoing studies ( ASTEC; Lukka) are awaited. External beam radiotherapy carries a risk of toxicity and should be avoided in stage 1 endometrial cancer patients with no high risk factors.
辅助放疗（包括盆腔外照射放疗和阴道腔内近距离放疗）在全腹子宫切除及双侧输卵管卵巢切除（TAH和BSO）术后I期子宫内膜癌中的作用仍不明确。
评估I期子宫内膜癌术后辅助放疗的疗效。
Cochrane对照试验中心注册库（CENTRAL）、医学期刊数据库（MEDLINE）、荷兰医学文摘数据库（EMBASE）、癌症文献数据库（CancerLit）、美国国立癌症研究所的医师数据查询（PDQ）。并在适当情况下进行手工检索。
纳入比较I期子宫内膜癌患者术后辅助放疗与不放疗的随机对照试验（RCT）。
评估研究质量，并使用预定义的数据收集表收集数据。主要终点为总生存期。次要终点为局部区域复发、远处复发及子宫内膜癌死亡。还收集了生活质量（QOL）和发病率的数据。使用Cochrane协作网综述管理软件4.2对纳入试验进行荟萃分析。
对四项试验（1770例患者）进行了荟萃分析。手术加盆腔外照射放疗可降低局部区域复发率，相对危险度（RR）为0.28（95%置信区间（CI）0.17至0.44，p<0.00001），即盆腔复发风险降低72%（95%CI 56%至83%），绝对风险降低6%（95%CI 4%至8%）。预防一例局部区域复发所需治疗人数（NNT）为16.7例患者（95%CI 12.5至25）。局部区域复发风险的降低并未转化为远处复发风险、全因死亡风险或子宫内膜癌死亡风险的降低。对具有多个高危因素（包括1c期和3级）的女性进行的亚组分析显示，接受辅助外照射放疗的患者全因死亡和子宫内膜癌死亡风险有降低趋势。
I期子宫内膜癌患者根据是否存在包括1c期、3级、淋巴管间隙浸润和年龄等危险因素，局部和远处复发风险不同。尽管盆腔外照射放疗使局部区域复发率降低了72%，但没有证据表明其降低了死亡风险。在具有多个高危因素（包括1c期和3级）的患者中，有生存获益趋势，辅助外照射放疗可能是合理的。对于仅有一个危险因素（3级或1c期）的患者，无法得出明确结论，有待正在进行的研究（ASTEC；Lukka）的数据。外照射放疗有毒性风险，对于无高危因素的I期子宫内膜癌患者应避免使用。
