Rogers Linda, Siu Shing Shun N, Luesley David, Bryant Andrew, Dickinson Heather O
Pan-Birmingham Gynaecological Cancer Centre, City Hospital, Dudley Road, Birmingham, UK, B18 7QH.
Cochrane Database Syst Rev. 2009 Oct 7(4):CD007583. doi: 10.1002/14651858.CD007583.pub2.
There is an ongoing debate about the indications for, and value of, adjuvant pelvic radiotherapy after radical surgery in women with early cervical cancer. Certain combinations of pathologic risk factors are thought to represent sufficient risk for recurrence, that they justify the use of post-operative pelvic radiotherapy, though this has never been shown to improve overall survival, and use of more than one type of treatment (surgery and radiotherapy) increases the risks of side-effects and complications.
To evaluate the effectiveness and safety of adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, chemoradiation) after radical hysterectomy for early stage cervical cancer (FIGO stages IB1, IB2 or IIA).
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 4, 2008. The Cochrane Gynaecological Cancer Group Trials Register, MEDLINE (January 1950 to November 2008), EMBASE (1950 to November 2008). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field.
Randomised controlled trials (RCTs) that compared adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, or chemoradiation) with no radiotherapy or chemoradiation, in women with a confirmed histological diagnosis of early cervical cancer who had undergone radical hysterectomy and dissection of the pelvic lymph nodes.
Two review authors independently abstracted data and assessed risk of bias. Information on grade three and four adverse events was collected from the trials. Results were pooled using random effects meta-analyses.
Two RCTs, which compared adjuvant radiotherapy with no adjuvant radiotherapy, met the inclusion criteria; they randomised and assessed 397 women. Meta-analysis of these two RCTs indicated no significant difference in survival at five years between women who received radiation and those who received no further treatment (Relative risk (RR) = 0.8, 95% Confidence interval (CI): 0.3 to 2.4). However, women who received radiation had a significantly lower risk of disease progression at five years (RR = 0.6, 95% CI 0.4 to 0.9).Although the risk of serious adverse events was consistently higher if women received radiotherapy rather than no further treatment, these increased risks were not statistically significant, probably because the rate of adverse events was low.
AUTHORS' CONCLUSIONS: We found evidence, of moderate quality, that radiation decreases the risk of disease progression compared with no further treatment, but little evidence that it might improve overall survival. The evidence on serious adverse events was equivocal.
对于早期宫颈癌女性患者根治性手术后辅助盆腔放疗的指征及价值,目前仍存在争议。某些病理危险因素的特定组合被认为具有足够的复发风险,足以证明术后盆腔放疗的使用是合理的,尽管从未证明其能提高总生存率,且使用不止一种治疗方式(手术和放疗)会增加副作用和并发症的风险。
评估早期宫颈癌(国际妇产科联盟(FIGO)分期为IB1、IB2或IIA期)根治性子宫切除术后辅助治疗(放疗、化疗后放疗、同步放化疗)的有效性和安全性。
我们检索了Cochrane对照试验中心注册库(CENTRAL),2008年第4期。Cochrane妇科癌症小组试验注册库、医学期刊数据库(MEDLINE,1950年1月至2008年11月)、荷兰医学文摘数据库(EMBASE,1950年至2008年11月)。我们还检索了临床试验注册库、科学会议摘要、纳入研究的参考文献列表,并联系了该领域的专家。
随机对照试验(RCT),比较辅助治疗(放疗、化疗后放疗或同步放化疗)与不放疗或不进行放化疗,研究对象为经组织学确诊为早期宫颈癌且已接受根治性子宫切除术和盆腔淋巴结清扫术的女性。
两位综述作者独立提取数据并评估偏倚风险。从试验中收集三级和四级不良事件的信息。结果采用随机效应荟萃分析进行汇总。
两项比较辅助放疗与不放辅助放疗的RCT符合纳入标准;它们共纳入并评估了397名女性。对这两项RCT的荟萃分析表明,接受放疗的女性与未接受进一步治疗的女性在五年生存率上无显著差异(相对危险度(RR)=0.8,95%置信区间(CI):0.3至2.4)。然而,接受放疗的女性在五年时疾病进展风险显著较低(RR = 0.6,95%CI 0.4至0.9)。尽管接受放疗的女性严重不良事件风险始终高于未接受进一步治疗的女性,但这些增加的风险无统计学意义,可能是因为不良事件发生率较低。
我们发现中等质量的证据表明,与不进行进一步治疗相比,放疗可降低疾病进展风险,但几乎没有证据表明其能改善总生存率。关于严重不良事件的证据不明确。