Goodwin Annabel, Parker Sharon, Ghersi Davina, Wilcken Nicholas
Cancer Genetics, Westmead Hospital, Hawksberry Road, Westmead, NSW, Australia, 2145.
Cochrane Database Syst Rev. 2009 Jan 21(1):CD000563. doi: 10.1002/14651858.CD000563.pub4.
The addition of radiotherapy (RT) following breast conserving surgery (BCS) was first shown to reduce the risk of ipsilateral recurrence in the treatment of invasive breast cancer. Ductal carcinoma in situ (DCIS) is a pre-invasive lesion. Recurrence of ipsilateral disease following BCS can be either DCIS or invasive breast cancer. Randomised controlled trials (RCTs) have shown that RT can reduce the risk of recurrence, but assessment of potential long-term complications from addition of RT following BSC for DCIS has not been reported for women participating in RCTs.
To summarise the data from RCTs testing the addition of RT to BCS for treatment of DCIS to determine the balance between the benefits and harms.
We searched the Cochrane Breast Cancer Group Specialised Register (January 2008), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 1), MEDLINE (February 2008), and EMBASE (February 2008). Reference lists of articles and handsearching of ASCO (2007), ESMO (2002 to 2007), and St Gallen (2005 to 2007) conferences were performed.
RCTs of breast conserving surgery with and without radiotherapy in women at first diagnosis of pure ductal carcinoma in situ (no invasive disease present).
Two authors independently assessed each potentially eligible trial for inclusion and its quality. Two authors also independently extracted data from published Kaplan-Meier analysis (survival curves) and reported summary statistics. Data were extracted and pooled for four trials. Data for planned subgroups were extracted and pooled for analysis.There were insufficient data to pool for long-term toxicity from radiotherapy.
Four RCTs involving 3925 women were identified and included in this review. All were high quality with minimal risk of bias. Three trials compared the addition of RT to BCS. One trial was a two by two factorial design comparing the use of RT and tamoxifen, each separately or together, in which participants were randomised in at least one arm. Analysis confirmed a statistically significant benefit from the addition of radiotherapy on all ipsilateral breast events (hazards ratio (HR) 0.49; 95% CI 0.41 to 0.59, P < 0.00001) and ipsilateral DCIS recurrence (HR 0.64; 95% CI 0.41 to 1.01, P = 0.05). Pooled analysis for invasive recurrence did not reach statistical significance. All the subgroups analysed benefited from addition of radiotherapy. No significant long-term toxicity from radiotherapy was found. No information about short-term toxicity from radiotherapy or quality of life data were reported.
AUTHORS' CONCLUSIONS: This review confirms the benefit of adding radiotherapy to breast conserving surgery for the treatment of all women diagnosed with DCIS. No long-term toxicity from use of radiotherapy was identified.
保乳手术（BCS）后加用放疗（RT）首次被证明可降低浸润性乳腺癌治疗中同侧复发的风险。导管原位癌（DCIS）是一种癌前病变。BCS后同侧疾病复发可能是DCIS或浸润性乳腺癌。随机对照试验（RCT）表明，放疗可降低复发风险，但对于参与RCT的女性，尚未报道BCS后加用放疗潜在的长期并发症评估情况。
总结RCT数据，这些试验测试了BCS加用放疗治疗DCIS的效果，以确定利弊平衡。
我们检索了Cochrane乳腺癌专业注册库（2008年1月）、Cochrane对照试验中心注册库（CENTRAL）（《Cochrane图书馆》2008年第1期）、MEDLINE（2008年2月）和EMBASE（2008年2月）。还查阅了文章的参考文献列表，并对美国临床肿瘤学会（2007年）、欧洲肿瘤内科学会（2002年至2007年）和圣加伦（2005年至2007年）会议进行了手工检索。
首次诊断为单纯导管原位癌（无浸润性疾病）的女性接受或不接受放疗的保乳手术RCT。
两位作者独立评估每项可能符合纳入标准的试验及其质量。两位作者还独立从已发表的Kaplan-Meier分析（生存曲线）中提取数据，并报告汇总统计数据。从四项试验中提取并汇总数据。提取并汇总计划亚组的数据进行分析。放疗长期毒性的数据不足，无法进行汇总。
确定了四项涉及3925名女性的RCT并纳入本综述。所有试验质量都很高，偏倚风险最小。三项试验比较了BCS加用放疗的情况。一项试验是二乘二析因设计，比较放疗和他莫昔芬单独使用或联合使用的情况，其中至少有一组参与者是随机分组的。分析证实，加用放疗对所有同侧乳腺事件（风险比（HR）0.49；95%置信区间0.41至0.59，P < 0.00001）和同侧DCIS复发（HR 0.64；95%置信区间0.41至1.01，P = 0.05）有统计学显著益处。浸润性复发的汇总分析未达到统计学显著性。分析的所有亚组都从加用放疗中获益。未发现放疗有显著的长期毒性。未报告放疗短期毒性或生活质量数据的信息。
本综述证实，对于所有诊断为DCIS的女性，保乳手术加用放疗有益。未发现放疗使用有长期毒性。
