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局部晚期宫颈癌的术前手术主动脉旁淋巴结评估

Pre-treatment surgical para-aortic lymph node assessment in locally advanced cervical cancer.

作者信息

Brockbank Elly, Kokka Fani, Bryant Andrew, Pomel Christophe, Reynolds Karina

机构信息

Gynaecological Oncology, St. Bartholomew's Hospital, Barts and The London Trust, West Smithfiled, London, UK, EC1A 7BE.

出版信息

Cochrane Database Syst Rev. 2011 Apr 13(4):CD008217. doi: 10.1002/14651858.CD008217.pub2.

Abstract

BACKGROUND

Cervical cancer is the most common cause of death from gynaecological cancers worldwide. Locally advanced cervical cancer, FIGO stage equal or more than IB1 is treated with chemotherapy and external beam radiotherapy followed by brachytherapy. If there is metastatic para-aortic nodal disease radiotherapy is extended to additionally cover this area. Due to increased morbidity, ideally extended-field radiotherapy is given only when para-aortic nodal disease is proven. Therefore accurate assessment of the extent of the disease is very important for planning the most appropriate treatment.

OBJECTIVES

To evaluate the effectiveness and safety of pre- treatment surgical para-aortic lymph node assessment for woman with locally advanced cervical cancer (FIGO stage IB2 to IVA).

SEARCH STRATEGY

We searched the Cochrane Gynaecological Cancer Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 1), MEDLINE and EMBASE (up to January 2011). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field.

SELECTION CRITERIA

Randomised controlled trials (RCTs) that compared surgical para-aortic lymph node assessment and dissection with radiological staging techniques, in adult women diagnosed with locally advanced cervical cancer.

DATA COLLECTION AND ANALYSIS

Two reviewers independently assessed whether potentially relevant trials met the inclusion criteria, abstracted data and assessed risk of bias. One RCT was identified so no meta-analyses were performed.

MAIN RESULTS

We found only one trial, which included 61 women, that met our inclusion criteria. This trial reported data on surgical versus clinical staging and an assessment of the two surgical staging techniques; laparoscopic (LAP) versus extraperitoneal (EXP) surgical staging. The clinical staging was either a contrast-enhanced CT scan or MRI scan of the abdomen and pelvis to determine nodal status.In this trial, clinical staging appeared to significantly prolong overall and progression-free survival compared to surgical staging. There was no statistically significant difference in the number of women who experienced severe (grade 3 or 4) toxicity.There was no statistically significant difference in the risk of death, disease recurrence or progression, blood loss, severe toxicity and the duration of the operational procedure between LAP and EXP surgical staging techniques.The strength of the evidence is weak in this review as it is based on one small trial which was at moderate risk of bias.

AUTHORS' CONCLUSIONS: From the one available RCT we found insufficient evidence that pre-treatment surgical para-aortic lymph node assessment for locally advanced cervical cancer is beneficial, and it may actually have an adverse effect on survival. However this conclusion is based on analysis of a small single trial and therefore definitive guidance or recommendations for clinical practice cannot be made.Therefore the decision to offer surgical pre-treatment assessment of para-aortic lymph nodes in locally advanced cervical cancer needs to be individualised. The uncertainty regarding any impact on survival from pre-treatment para-aortic lymph node assessment should be discussed openly with the women.

摘要

背景

宫颈癌是全球妇科癌症死亡的最常见原因。局部晚期宫颈癌(国际妇产科联盟(FIGO)分期为IB1期及以上)采用化疗和外照射放疗,随后进行近距离放疗。如果存在转移性腹主动脉旁淋巴结疾病,则扩大放疗范围以覆盖该区域。由于发病率增加,理想情况下仅在证实存在腹主动脉旁淋巴结疾病时才给予扩大野放疗。因此,准确评估疾病范围对于规划最合适的治疗非常重要。

目的

评估术前手术评估腹主动脉旁淋巴结对局部晚期宫颈癌(FIGO分期为IB2至IVA期)女性的有效性和安全性。

检索策略

我们检索了Cochrane妇科癌症组试验注册库、Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》2011年第1期)、MEDLINE和EMBASE(截至2011年1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。

选择标准

比较手术评估和清扫腹主动脉旁淋巴结与放射学分期技术的随机对照试验(RCT),纳入被诊断为局部晚期宫颈癌的成年女性。

数据收集与分析

两名评价员独立评估潜在相关试验是否符合纳入标准,提取数据并评估偏倚风险。仅识别出一项RCT,因此未进行荟萃分析。

主要结果

我们仅发现一项符合纳入标准的试验,该试验纳入了61名女性。该试验报告了手术分期与临床分期的数据,以及对两种手术分期技术(腹腔镜(LAP)与腹膜外(EXP)手术分期)的评估。临床分期为腹部和盆腔的增强CT扫描或MRI扫描以确定淋巴结状态。在该试验中,与手术分期相比,临床分期似乎显著延长了总生存期和无进展生存期。经历严重(3级或4级)毒性的女性数量无统计学显著差异。LAP和EXP手术分期技术在死亡风险、疾病复发或进展、失血、严重毒性和手术时间方面无统计学显著差异。由于本综述基于一项存在中度偏倚风险的小型试验,证据强度较弱。

作者结论

从现有的一项RCT中,我们发现没有足够的证据表明术前手术评估局部晚期宫颈癌的腹主动脉旁淋巴结是有益的,实际上它可能对生存期有不利影响。然而,这一结论基于对一项小型单一试验的分析,因此无法为临床实践提供明确的指导或建议。因此,对于局部晚期宫颈癌是否进行腹主动脉旁淋巴结术前手术评估的决定需要个体化。应与女性患者公开讨论术前腹主动脉旁淋巴结评估对生存期的任何影响的不确定性。

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