Intervention Review
Surgical interventions for early squamous cell carcinoma of the vulva
Editorial Group: Cochrane Gynaecological Cancer Group
Published Online: 16 JUL 2008
Assessed as up-to-date: 8 MAR 2008
DOI: 10.1002/14651858.CD002036
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Database Title
Additional Information
How to Cite
Ansink AC, Stegeman M, van der Velden J, Collingwood M. Surgical interventions for early squamous cell carcinoma of the vulva. Cochrane Database of Systematic Reviews 1999, Issue 4. Art. No.: CD002036. DOI: 10.1002/14651858.CD002036.
Publication History
- Publication Status: Edited (no change to conclusions)
- Published Online: 16 JUL 2008
- Abstract
- Article
- Tables
- References
- Cited By
Abstract
Background
Radical surgery has been standard treatment for patients with early vulvar cancer since the mid 1900s. Survival figures are excellent, but complication rates are high. Since 1980, surgery has become more individualised in order to decrease complications in patients with limited disease.
Objectives
To compare the effectiveness and safety of individualised treatment with that of standard extensive surgery.
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 4), MEDLINE (1966 to April 2007) and EMBASE (to April 2007). We also searched our own publication archives, based on prospective handsearching of six leading relevant journals from December 1986. Reference lists of identified studies, gynaecological cancer handbooks and conference abstracts were also scanned.
Selection criteria
Randomized controlled trials (RCTs), case controlled and observational studies on the effectiveness of surgery (local surgery and regional lymph node dissection) on patients with cT1N0M0 squamous cell carcinoma of the vulva.
Outcome measures were overall, disease-specific, disease-free survival (DFS), treatment complications, quality of life (QoL).
Data collection and analysis
Three review authors (AA, JVD, MS) independently assessed study quality and extracted data.
Main results
From three studies, we concluded there was no difference in the incidence of:
1. local recurrent vulvar cancer between radical local excision and radical vulvectomy, or
2. groin recurrence between ipsilateral groin node dissection and bilateral groin node dissection in patients with a well lateralised tumour.
Furthermore, superficial groin node dissection is not as safe as full femoro-inguinal lymph node dissection. The triple incision technique is a safe procedure provided tumour free margins are greater than 8 mm and the slight increase in recurrences does not outweigh the reduction in complications.
Authors' conclusions
The available evidence regarding surgery for early vulvar cancer is generally poor. From the studies of sufficient quality we concluded that radical local excision is a safe alternative to radical vulvectomy for patients with early vulva carcinoma.
Contralateral groin node dissection can be omitted in patients with a lateralized tumour, and the triple incision technique is as safe as an en bloc dissection. However, omission of femoral lymph node dissection results in a higher incidence of groin recurrences.
Further good quality studies are required, though conducting RCTs on vulvar cancer treatment may not be realistic due to the rarity of the disease. However, observational studies of higher quality could provide us with more reliable evidence.
Plain language summary
Less extensive surgery for vulvar cancer appears safe and limits mutilation
Vulvar cancer is rare, affecting mainly older women. Until the 1980s, affected women underwent extensive, mutilating surgery. Groin nodes on both sides as well as all vulvar tissue were removed. Recently surgeons have carried out a smaller operation, leaving as much vulvar tissue as possible behind. No randomized controlled trials (RCTs) have been conducted on the safety of this reduced surgery, but from the available evidence it appears to be safe to perform this smaller operation in most patients.
摘要
背景
術外陰部的初期鱗狀細胞癌的手術治療
從1900年代中期以來,根除性手術一直作為初期外陰癌症病人的標準治療方法,雖然病人有絕佳的存活率,但是也的確有較高的併發症比率。自1980年以來,為降低特定疾病患者的併發症,手術已經變得越來越依照個人化狀況而定。
目標
為了比較個人化治療與標準的廣泛性切除手術之有效性和安全性。
搜尋策略
我們搜尋了Gynaecological Cancer Group's Register、 MEDLINE (1966年到2003年7月) 和 EMBASE (直到2001年8月15日) 等資料庫;從1986年12月起,以6個主要相關雜誌的人工搜尋為基礎上,我們也搜尋了自己的出版物檔案庫,同時也搜尋那些確定納入試驗、婦科癌症手冊及會議摘要的參考文獻。
選擇標準
我們只收納以手術(局部手術及區域的淋巴結切除)治療cT1N0M0鱗狀細胞的外陰癌症病人的「有效性」之隨機對照試驗、病例對照和觀察性研究,其結果以「整體的」、「疾病特異性的」、「無病存活率(DFS)的」、「治療併發症」及「生活品質」為衡量。
資料收集與分析
由2位作者 (AA,和JVD) 獨立進行試驗方法品質的評估及數據的摘錄。
主要結論
從2項研究,我們得出結論,對側邊腫瘤的病人在治療上是沒有差異性: 1. 在局部根除性切除與外陰部根除術(radical vulvectomy)之間相比較,外陰部癌的局部復發沒有差異 2. 同側腹股溝淋巴結切除術與兩側腹股溝淋巴結切除術之間相比較,腹股溝病症復發的情形沒有差異。 此外,表層的腹股溝淋巴結切除術不如全面的股動脈腹股溝淋巴結切除術來的安全。1項臨床上重要的問題:三重切除術就像全面切除術一樣安全嗎?只能由一些未經選擇的試驗(例如:低品質的試驗方法)來回答問題嗎? 由此而知,我們發現到三重切除術和全面切除術間,兩者沒有不同的復發率。
作者結論
目前少有初期外陰部癌手術的客觀參考證據。從具有足夠品質的試驗方法方面,我們認為局部根除性切除術是一種較安全方法,可替代外陰部根除術來治療初期外陰部癌病人。對於側邊腫瘤的病人,可以省略不作對側的腹股溝的淋巴結切除術,而三重切除術就像全面切除術一樣安全。然而,由於省略不作股動脈的淋巴結切除術,因而導致較高的腹股溝病症復發率。擁有良好品質的試驗方法是必需的。由於疾病的罕見性,所以對治療外陰部癌進行隨機對照試驗可能是不切合實際的,不過較高品質的觀察性試驗可提供給我們更可靠的證據。
翻譯人
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。
總結
較小範圍的手術治療外陰部癌是安全的,且限定切除外陰部癌症的破壞範圍,可以對年長婦女產生很少的影響作用。直到1980年代,癌症婦女才接受廣泛性切除手術,就是切除病人的雙側腹股溝淋巴結和所有的外陰部組織,近來,外科醫師操作較小範圍的手術,盡可能留下較多的外陰部組織,雖然沒有相關於手術安全方面上的隨機對照試驗,但是從有效的證據顯示較小範圍的手術對大部分病人都是安全的。
