Intervention Review

Adjuvant platinum-based chemotherapy for early stage cervical cancer

  1. Daniela D Rosa1,*,
  2. Lídia RF Medeiros2,
  3. Maria I Edelweiss3,
  4. Mary C Bozzetti4,
  5. Paula R Pohlmann5,
  6. Airton T Stein6,
  7. Heather O Dickinson7

Editorial Group: Cochrane Gynaecological Cancer Group

Published Online: 8 JUL 2009

Assessed as up-to-date: 7 JAN 2009

DOI: 10.1002/14651858.CD005342.pub2

Database Title

Additional Information

How to Cite

Rosa DD, Medeiros LRF, Edelweiss MI, Bozzetti MC, Pohlmann PR, Stein AT, Dickinson HO. Adjuvant platinum-based chemotherapy for early stage cervical cancer. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD005342. DOI: 10.1002/14651858.CD005342.pub2.

Author Information

  1. 1

    Hospital Femina - Grupo Hospitalar Conceicao, Porto Alegre, Rio Grande do Sul, Brazil

  2. 2

    Federal University of Rio Grande do Sul, Social Medicine/Epidemiology, Porto Alegre, Rio Grande do Sul, Brazil

  3. 3

    Faculty of Medicine at Federal University of Rio Grande do Sul, Pathology, Rio Grande do Sul, Brazil

  4. 4

    Faculty of Medicine at Federal University of Rio Grande do Sul, Social Medicine, Rio Grande do Sul, Brazil

  5. 5

    Faculty of Medicine at Federal University of Rio Grande do Sul, Medical Sciences, Rio Grande do Sul, Brazil

  6. 6

    Universidade Federal de Ciências da Saúde, Ulbra and Grupo, Department of Public Health, Porto Alegre, Brazil

  7. 7

    Newcastle University, Institute of Health and Society, Newcastle upon Tyne, Tyne & Wear, UK

*Daniela D Rosa, Hospital Femina - Grupo Hospitalar Conceicao, Dinarte Ribeiro 212/83, Porto Alegre, Rio Grande do Sul, 90570-150, Brazil. dornellesrosa@hotmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 8 JUL 2009

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Patients with early stage cervical cancer (stages IA2, IB1 or IIA) with risk factors such as lymph node metastasis, lympho vascular space invasion, depth invasion of more than 10mm, microscopic parametrial invasion, non-squamous histology and positive surgical margins have a high risk of recurrence when compared to patients with early stage cervical cancer with no risk factors for recurrence.

Objectives

To evaluate the effectiveness and safety of platinum-based adjuvant chemotherapy after radical hysterectomy, radiotherapy, or both in the treatment of early stage cervical cancer (stages IA2, IB1 or IIA).

Search methods

We searched the Cochrane Gynaecological Cancer Group Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library Issue 1, 2009), MEDLINE, EMBASE, LILACS, BIOLOGICAL ABSTRACTS and Cancerlit, the National Research Register and Clinical Trials register, with no language restriction. Abstracts of scientific meetings and the citation lists of included studies and other relevant publications were checked through hand searching and experts in the field were contacted to identify further reports of trials.

Selection criteria

Randomised controlled trials (RCTs) comparing adjuvant radiotherapy with adjuvant radiotherapy and cisplatin-chemotherapy after radical surgery for early stage cervix cancer were included.

Data collection and analysis

Two review authors extracted data independently to assess whether the studies met the specified inclusion criteria. Any discrepancies were solved by a third and a forth review author. Meta-analysis was performed using a random effects model, with death and disease progression as outcomes.

Main results

Three trials were included. Two trials enrolling 325 participants, of whom 297 (91%) were assessed and compared radiotherapy and chemotherapy with radiotherapy alone found that adjuvant chemotherapy significantly reduced the risk of death (hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.36 to 0.87) and disease progression (HR = 0.47, 95%CI: 0.30 to 0.74), with no heterogeneity between trials (I2 = 0% for both meta-analyses). One trial assessing 71 participants compared chemotherapy followed by radiotherapy with radiotherapy alone and found no significant difference between the two groups (HR = 1.34; 95%CI: 0.24 to 7.66). The median follow up of patients varied from 29 to 42 months.

Authors' conclusions

The addition of platinum-based chemotherapy to radiotherapy may offer clinical benefit in the adjuvant treatment of early stage cervical cancer with risk factors for recurrence. However, the evidence is limited because the selected studies were quantitatively and qualitatively limited, with small number of patients and limited period of follow-up

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Adjuvant platinum-based chemotherapy for early stage cervical cancer

Cervical cancer is the second most common cancer among women. Disease control for women with operable cervical cancer with risk factors for recurrence such as lymph node metastasis, lympho-vascular space invasion, depth invasion more than 10mm, microscopic parametrial invasion, non-squamous histology and positive surgical margins is difficult. It seems appropriate to offer post-operative treatment with radiotherapy combined to cisplatin-based chemotherapy to these patients. In this systematic review, the overall evidence suggests that the addition of chemotherapy to radiotherapy offers clinical benefit in the adjuvant treatment of patients with operable cervix cancer with risk factors for recurrence. However, the evidence is limited because the selected studies had a small number of patients and a short time of follow-up.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

含鉑類藥物的輔助性化療用於早期子宮頸癌

早期子宮頸癌(第IA2, IB1或IIA期)病患如具有危險因子，包括淋巴結轉移、淋巴血管腔侵犯、深度侵犯超過10mm、顯微鏡觀察發現子宮頸旁組織侵襲、非鱗狀組織型態、手術邊緣腫瘤侵犯等，相較於沒有危險因子的病患而言有較高的復發率。

目標

評估早期(第IA2, IB1或IIA期)子宮頸癌進行根除性子宮切除術後、放射線治療後、或合併這兩種治療之後，以含鉑類藥物進行輔助化療的效果和安全性。

搜尋策略

我們搜尋了Cochrane Gynaecological Cancer Group Trials Register、The Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library Issue 1, 2009)、MEDLINE、EMBASE、LILACS、BIOLOGICAL ABSTRACTS與Cancerlit、National Research Register和Clinical Trials等資料庫，未限制語言。以人工搜尋方式檢視科學會議的摘要，以及納入之研究的參考目錄和其他相關發表，並聯絡此領域的專家以確認進一步的試驗報告。

選擇標準

納入早期子宮頸癌進行根除式手術之後，比較輔助放射線治療以及輔助放射線治療加cisplatin化療的隨機控制試驗(Randomised controlled trials (RCTs))。

資料收集與分析

2位回顧作者獨立進行資料摘要，評估這些研究是否符合特定的納入規範。由第3或第4個回顧作者解決歧見。使用隨機效果模式進行後設分析，探討的結果為死亡與疾病惡化。

主要結論

共納入3篇試驗。其中2篇試驗納入的325名研究對象中，有297人(91%)評估與比較放射線治療加化療和單用放射線治療，發現輔助化療顯著降低死亡風險(hazard ratio (HR) = 0.56, 95%信心區間(confidence interval (CI))為0.36−0.87)，也降低疾病惡化(HR = 0.47, 95%CI: 0.30−0.74)，試驗之間沒有異質性(兩篇後設分析之I2 = 0%)。另1篇試驗評估了71名研究對象，比較化療之後進行放射線治療與單用放射線治療，發現兩組之間並無顯著差異(HR = 1.34; 95%CI: 0.24−7.66)。病患之追蹤期間中位數為29−42個月。

作者結論

將含鉑類藥物的化療加入放射線治療，對於有易復發危險因子之早期子宮頸癌可提供臨床助益。不過，證據有限，因為選定之研究的質與量皆有限，樣本數少且追蹤期有限。

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

子宮頸癌是婦女第2常見的癌症。對於可手術但有復發危險因子如淋巴結轉移、淋巴血管腔侵犯、深度侵犯超過10mm、顯微鏡觀察發現子宮頸旁組織侵襲、非鱗狀組織、陽性手術邊緣之婦女的疾病控制有困難。提供術後放射線治療併用以cisplatin為基礎的化療給這些病患似乎是適當的。在這個系統性回顧中，整體之證據認為，將化療加入放射線治療，可提供臨床利益給可手術且有復發風險之子宮頸癌病患。不過，證據力有限，因為選擇的研究樣本數少且追蹤期短。

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