Intervention Review

Neoadjuvant chemotherapy for locally advanced cervix cancer

  1. Jayne Tierney1,*,
  2. Neoadjuvant Chemotherapy for Cervical Cancer Meta-analysis Collaboration (NACCCMA) Collaboration2

Editorial Group: Cochrane Gynaecological Cancer Group

Published Online: 7 OCT 2009

Assessed as up-to-date: 27 FEB 2006

DOI: 10.1002/14651858.CD001774.pub2

Database Title

Additional Information

How to Cite

Tierney J, Neoadjuvant Chemotherapy for Cervical Cancer Meta-analysis Collaboration (NACCCMA) Collaboration. Neoadjuvant chemotherapy for locally advanced cervix cancer. Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD001774. DOI: 10.1002/14651858.CD001774.pub2.

Author Information

  1. 1

    MRC Clinical Trials Unit, Meta-analysis Group, London, UK

  2. 2

    See acknowledgements section for full list of contributors, UK

*Jayne Tierney, Meta-analysis Group, MRC Clinical Trials Unit, 222 Euston Road, London, NW1 2DA, UK. jt@ctu.mrc.ac.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 7 OCT 2009

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Abstract

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

Background

The impact of neoadjuvant chemotherapy in the treatment of locally advanced cervical cancer remains uncertain.

Objectives

This review of individual patient data (IPD) aimed to assess the effect of;
Neoadjuvant chemotherapy followed by radical radiotherapy compared to the same radiotherapy; and
Neoadjuvant chemotherapy followed by surgery compared to radical radiotherapy.

Search methods

Searches of Medline, CancerLit and trial registers were supplemented by hand-searching conference proceedings and contacting relevant trialists. Searches have been updated to February 2006.

Selection criteria

Trials had to be properly randomised and include patients with locally advanced cervical cancer who had received neoadjuvant chemotherapy either before radiotherapy or surgery (or both).

Data collection and analysis

We collected, validated and re-analysed updated trial data on all randomised patients from all relevant trials. The person responsible for the trial resolved queries and verified the final data. Treatment comparisons 1 and 2 were analysed separately. For all outcomes, we obtained overall hazard ratios using the fixed-effect model. We pre-specified analyses that grouped trials by important aspects of their design and patients by their or their tumour characteristics, to assess whether they might influence the effect of neoadjuvant chemotherapy.

Main results

We obtained data from 18 trials and 2074 patients for the first comparison. Considering these trials together there was a high level of statistical heterogeneity, a substantial amount of which was explained by analyses of trial groups. Trials using chemotherapy cycle lengths shorter than 14 days (HR = 0.83, 95% CI = 0.69 to 1.00, p = 0.046) or cisplatin dose intensities greater than 25 mg/m2 per week (HR = 0.91, 95% CI = 0.78 to 1.05, p = 0.20) tended to show an advantage of neoadjuvant chemotherapy on survival. In contrast, trials using cycle lengths longer than 14 days (HR = 1.25, 95% CI = 1.07 to 1.46, p = 0.005) or cisplatin dose intensities lower than 25 mg/m2 per week (HR = 1.35, 95% CI = 1.11 to 1.14, p = 0.002) showed a detrimental effect of neoadjuvant chemotherapy on survival. In the second comparison, data from 5 trials and 872 patients were obtained. The combined results (HR = 0.65, 95% CI = 0.53 to 0.80, p = 0.0004) indicated a highly significant reduction in the risk of death with neoadjuvant chemotherapy, but with heterogeneity in both the design and results.

Authors' conclusions

The timing and dose intensity of cisplatin-based neoadjuvant chemotherapy appears to have an important impact on whether or not it benefits women with locally advanced cervical cancer and warrants further exploration. Obtaining additional IPD may improve the strength of these conclusions.

 

Plain language summary

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

Chemotherapy before surgery or radiotherapy or both for women with cervical cancer that has spread beyond the cervix to the tissues close by

Surgery, radiotherapy or sometimes both were the best treatments for locally advanced cervical cancer. This is cancer that has spread beyond the cervix (neck of the womb) into the surrounding tissues, such as the vagina, sides of the pelvis or nearby lymph nodes. The exact choice of treatment would have depended on the size and location of the tumour and the preferences of the woman and her doctor.

Nowadays, women with this type of cancer may be given combined chemotherapy (drug treatment) and radiotherapy (x-rays that kill cancer cells) at the same time. Or, they may have surgery (to remove the womb) as well as this combined chemotherapy and radiotherapy. However, giving chemotherapy before these treatments (neoadjuvant chemotherapy) might have a similar benefit, but have less side effects than giving the treatments at the same time.

This review aimed to assess the benefits and risks of giving chemotherapy before surgery, before radiotherapy or before both treatments.

Our first comparison was based on 18 trials and 2074 women. The women who were given chemotherapy either more than a fortnight apart or with a less intense dose of cisplatin before their radiotherapy, did not live as long as those who were only given radiotherapy. However, women given chemotherapy either less than a fortnight apart or with a more intense dose of cisplatin before their radiotherapy, seemed to live longer than those who were only given radiotherapy. These second results are based on less data and are not so convincing. There were very few serious side effects that continued long after treatment and they seemed to be similar whether chemotherapy was given or not.

Our second comparison was based on 5 trials and 872 women. The women who were given chemotherapy before surgery seemed to live longer than those who were only given radiotherapy. However, there was a small amount of data, there were differences between results of trials and other treatments were used. Therefore, it is not clear if the benefit might be for reasons other than the chemotherapy.

Further assessment of neoadjuvant chemotherapy in randomised trials is required. It may be valuable to compare it to a combined chemotherapy and radiotherapy approach or even to use neoadjuvant chemotherapy together with combined chemotherapy and radiotherapy.

 

摘要

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

背景

局部性末期子宮頸癌的新輔助性化療

目前仍無法確定新輔助性化療，對於局部性末期子宮頸癌的治療所造成的影響。

目標

本篇以病人個別資料(individual patient data ，IPD)回顧的目的，是評估(1)新輔助性化療後再進行根治性放射治療的效果，並與相同的放射治療進行比較；以及(2)新輔助性化療後再進行手術的效果，與根治性放射治療進行比較。

搜尋策略

我們搜尋了Medline、CancerLit和試驗登錄資料等資料庫，再輔以人工方式搜尋研討會會議記錄，並聯絡相關的試驗執行者。搜尋的最新日期為2006年2月。

選擇標準

收納於本回顧中的試驗，必須經過適當的隨機分配，而且這些試驗包含放射治療或手術(或兩者)之前，已經先接受新輔助性化療的局部性末期子宮頸癌的病人。

資料收集與分析

我們收集、確認並且重新分析所有相關試驗中，所有隨機分配病人經過更新的試驗數據。我們詢問試驗負責人最終的數據，並請他們確認。我們個別分析第一項及第二項治療比較的結果。我們利用固定效益模型，從所有的結果獲得整體的風險比率。我們根據試驗設計的重要部分，及根據病人或其腫瘤特性，預先指定可根據這些資料將試驗分類的分析分法，以評估它們是否會影響新輔助性化療的效果。

主要結論

我們從18項試驗及2074名病人中，獲得了第一項治療方式的比較結果。由於將這些試驗合併在一起，有很高的統計異質性，所以我們利用試驗組分析來解釋其中許多試驗。使用化療的週期時間短於14天(HR = 0.83，95% CI = 0.69到1.00，p = 0.046)或cisplatin劑量強度高於每星期25 mg/m2(HR = 0.91，95% CI = 0.78到1.05，p = 0.20)的試驗，比較傾向於證實新輔助性化療對於存活率的益處。相反的，化療的週期長度超過14天(HR = 1.25，95% CI = 1.07到1.46，p = 0.005)或cisplatin劑量強度低於每星期25 mg/m2 HR = 1.35，95% CI = 1.11到1.14，p = 0.002)，則顯示新輔助性化療對於存活率有不良的影響。在第二項治療方式的比較中，從5項試驗及872名病人獲得了相關數據。合併的結果(HR = 0.65，95% CI = 0.53到0.80，p = 0.0004)顯示，新輔助性化療使得死亡風險非常顯著地降低了，但是試驗設計和結果都存在著異質性。

作者結論

基於cisplatin的新輔助性化療，其治療時間和劑量強度似乎對於局部性末期子宮頸癌的女性，造成很大的影響，無論其影響是否有益，但還需要進一步調查研究。取得額外的病人個別資料有助於增加這些結論的效力。

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

手術、放射治療，或是有時候同時接受兩種治療，是局部性末期子宮頸癌最佳的治療方法。局部性末期子宮頸癌是指已經擴散到子宮頸外(子宮的頸部)直到周圍組織的癌症，例如陰道、骨盆側邊或附近的淋巴結。確切的治療選擇，需取決於腫瘤大小和位置，以及女性病人和她的醫生的偏好。 如今，罹患這種癌症的女性可以同時接受化療(藥物治療)和放射治療(以X光殺死癌細胞)的合併治療。或者是接受手術(摘除子宮)及合併的化療和放射治療。但是，在這些治療之前先進行化療(新輔助性化療)，可能也具有類似的優點，而且比同時治療所造成的副作用更少。這篇回顧的目的，是評估手術前、放射治療前或兩種治療之前，先為病人進行化療的好處和風險。我們的第一項治療比較，係根據18項試驗和2074名女性的資料。如果女性病人在接受放射治療之前，化療時間超過2個星期或治療的cisplatin劑量強度較低，其存活時間並不如只接受放射治療的病人。然而，如果女性病人在接受放射治療之前，化療時間短於2個星期或治療的cisplatin劑量強度較高，似乎活得比只接受放射治療的病人還久。第二項治療比較所依據的數據較少，所以結果並不那麼具說服力。病人接受治療後，只有很少數的嚴重副作用會持續很長一段時間，而且病人有或沒有接受化療，其副作用似乎無多大影響。我們的第二項治療比較結果，係根據5項試驗和872名女性的資料。手術前接受化療的女性，似乎活得比只接受放射治療的女性久。然而，我們只獲得少量的數據，而且試驗結果和治療方法在不同的試驗之間，存在著差異。所以，目前還不清楚這樣的益處，是否來自於化療以外的因素，還需要在隨機試驗中，進一步評估新輔助性化療的效果。將新輔助性化療與化療和放射治療合併的治療方式進行比較，可能是有價值的，甚至可以利用新輔助性化療加上合併的化療和放射治療，一起去比較。

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