May Katie, Bryant Andrew, Dickinson Heather O, Kehoe Sean, Morrison Jo
Nuffield Department of Obstetrics and Gynaecology, University of Oxford, Women's Centre, John Radcliffe Hospital, Oxford, UK, OX3 9DU.
Cochrane Database Syst Rev. 2010 Jan 20(1):CD007585. doi: 10.1002/14651858.CD007585.pub2.
Endometrial carcinoma is the most common gynaecological cancer in western Europe and North America. Lymph node metastases can be found in approximately 10% of women who clinically have cancer confined to the womb prior to surgery and removal of all pelvic and para-aortic lymph nodes (lymphadenectomy) is widely advocated. Pelvic and para-aortic lymphadenectomy is part of the FIGO staging system for endometrial cancer. This recommendation is based on non-randomised controlled trials (RCTs) data that suggested improvement in survival following pelvic and para-aortic lymphadenectomy. However, treatment of pelvic lymph nodes may not confer a direct therapeutic benefit, other than allocating women to poorer prognosis groups. Furthermore, a systematic review and meta-analysis of RCTs of routine adjuvant radiotherapy to treat possible lymph node metastases in women with early-stage endometrial cancer, did not find a survival advantage. Surgical removal of pelvic and para-aortic lymph nodes has serious potential short and long-term sequelae and most women will not have positive lymph nodes. It is therefore important to establish the clinical value of a treatment with known morbidity.
To evaluate the effectiveness and safety of lymphadenectomy for the management of endometrial cancer.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) Issue 2, 2009. Cochrane Gynaecological Cancer Review Group Trials Register, MEDLINE (1966 to June 2009), Embase (1966 to June 2009). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field.
RCTs and quasi-RCTs that compared lymphadenectomy with no lymphadenectomy, in adult women diagnosed with endometrial cancer.
Two review authors independently abstracted data and assessed risk of bias. Hazard ratios (HRs) for overall and progression-free survival and risk ratios (RRs) comparing adverse events in women who received lymphadenectomy or no lymphadenectomy were pooled in random effects meta-analyses.
Two RCTs met the inclusion criteria; they randomised 1945 women, and reported HRs for survival, adjusted for prognostic factors, based on 1851 women.Meta-analysis indicated no significant difference in overall and recurrence-free survival between women who received lymphadenectomy and those who received no lymphadenectomy (pooled HR = 1.07, 95% CI: 0.81 to 1.43 and HR = 1.23, 95% CI: 0.96 to 1.58 for overall and recurrence-free survival respectively).We found no statistically significant difference in risk of direct surgical morbidity between women who received lymphadenectomy and those who received no lymphadenectomy. However, women who received lymphadenectomy had a significantly higher risk of surgically related systemic morbidity and lymphoedema/lymphocyst formation than those who had no lymphadenectomy (RR = 3.72, 95% CI: 1.04 to 13.27 and RR = 8.39, 95% CI: 4.06, 17.33 for risk of surgically related systemic morbidity and lymphoedema/lymphocyst formation respectively).
AUTHORS' CONCLUSIONS: We found no evidence that lymphadenectomy decreases the risk of death or disease recurrence compared with no lymphadenectomy in women with presumed stage I disease. The evidence on serious adverse events suggests that women who receive lymphadenectomy are more likely to experience surgically related systemic morbidity or lymphoedema/lymphocyst formation.
子宫内膜癌是西欧和北美的最常见妇科癌症。约10%临床诊断为局限于子宫的癌症患者在手术前可发现淋巴结转移,广泛提倡切除所有盆腔和腹主动脉旁淋巴结(淋巴结清扫术)。盆腔和腹主动脉旁淋巴结清扫术是国际妇产科联盟(FIGO)子宫内膜癌分期系统的一部分。该推荐基于非随机对照试验(RCT)数据,这些数据提示盆腔和腹主动脉旁淋巴结清扫术后生存率有所提高。然而,盆腔淋巴结治疗可能不会带来直接治疗益处,只会将患者归入预后较差的组。此外,一项对早期子宫内膜癌女性常规辅助放疗以治疗可能的淋巴结转移的RCT系统评价和Meta分析未发现生存优势。手术切除盆腔和腹主动脉旁淋巴结有严重的潜在短期和长期后遗症,且大多数女性并无阳性淋巴结。因此,确定一种已知有发病率的治疗方法的临床价值很重要。
评估淋巴结清扫术治疗子宫内膜癌的有效性和安全性。
我们检索了《Cochrane系统评价数据库》2009年第2期、Cochrane妇科癌症综述组试验注册库、MEDLINE(1966年至2009年6月)、Embase(1966年至2009年6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。
比较淋巴结清扫术与未行淋巴结清扫术的RCT和半RCT,纳入成年女性子宫内膜癌患者。
两名综述作者独立提取数据并评估偏倚风险。将接受淋巴结清扫术或未接受淋巴结清扫术女性的总生存率和无进展生存率的风险比(HR)以及不良事件风险比(RR)汇总进行随机效应Meta分析。
两项RCT符合纳入标准;共纳入1945例女性,基于1851例女性报告了校正预后因素后的生存HR。Meta分析表明,接受淋巴结清扫术的女性与未接受淋巴结清扫术的女性在总生存率和无复发生存率方面无显著差异(总生存率汇总HR = 1.07,95%CI:0.81至1.43;无复发生存率HR = 1.23,95%CI:0.96至1.58)。我们发现接受淋巴结清扫术的女性与未接受淋巴结清扫术的女性在直接手术发病率风险方面无统计学显著差异。然而,接受淋巴结清扫术的女性发生手术相关全身并发症和淋巴水肿/淋巴囊肿形成的风险显著高于未接受淋巴结清扫术的女性(手术相关全身并发症风险RR = 3.72,95%CI:1.确4至13.27;淋巴水肿/淋巴囊肿形成风险RR = 8.39,95%CI:4.06至17.33)。
我们未发现证据表明与未行淋巴结清扫术相比,淋巴结清扫术可降低假定为I期疾病女性的死亡风险或疾病复发风险。关于严重不良事件的证据表明,接受淋巴结清扫术的女性更有可能发生手术相关全身并发症或淋巴水肿/淋巴囊肿形成。