Intervention Review

Pemetrexed disodium in combination with cisplatin versus other cytotoxic agents or supportive care for the treatment of malignant pleural mesothelioma

  1. John A Green1,*,
  2. Yenal Dundar2,
  3. Susanna R Dodd3,
  4. Rumona C Dickson2,
  5. Tom Walley4

Editorial Group: Cochrane Lung Cancer Group

Published Online: 21 JAN 2009

Assessed as up-to-date: 18 OCT 2006

DOI: 10.1002/14651858.CD005574.pub2

Database Title

Additional Information

How to Cite

Green JA, Dundar Y, Dodd SR, Dickson RC, Walley T. Pemetrexed disodium in combination with cisplatin versus other cytotoxic agents or supportive care for the treatment of malignant pleural mesothelioma. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD005574. DOI: 10.1002/14651858.CD005574.pub2.

Author Information

  1. 1

    Clatterbridge Hospital, Clatterbridge Centre for Oncology, Merseyside, UK

  2. 2

    University of Liverpool, Liverpool Reviews and Implementation Group, Liverpool, Merseyside, UK

  3. 3

    University of Liverpool, Centre for Medical Statistics, Liverpool, UK

  4. 4

    University of Liverpool, Pharmacology & Therapeutics, Liverpool, Merseyside, UK

*John A Green, Clatterbridge Centre for Oncology, Clatterbridge Hospital, Merseyside, L63 4JY, UK. J.A.Green@liverpool.ac.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 21 JAN 2009

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Abstract

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

Background

Malignant pleural mesothelioma (MPM) is a highly aggressive malignancy whose incidence is expected to increase in the United Kingdom, Western Europe, and Australia over the next 20 years as a result of occupational exposure to asbestos fibres. Surgery is feasible in only a small proportion of cases, and radiotherapy and cytotoxic chemotherapy are used in palliation. Pemetrexed is the first and only chemotherapy agent that has been granted a marketing approval for use in combination with cisplatin for the treatment of chemo-naïve patients with unresectable MPM.

Objectives

To examine evidence on the clinical effectiveness of pemetrexed disodium used in combination with cisplatin for the treatment of unresectable malignant pleural mesothelioma in chemotherapy naïve patients compared with other cytotoxic agents used alone or in combination, or supportive care.

Search methods

CENTRAL (Issue 2, 2005), EMBASE (1980-2005), MEDLINE (1980-2005), HTA database (1990-2005), Web of Knowledge (1990-2005) and handsearching (including reference lists of retrieved articles and the pharmaceutical company submission to to NICE), up to October 2005.

Selection criteria

Randomised Controlled Trials (RCTs) where the use of pemetrexed disodium in combination with cisplatin is compared with other cytotoxic agents, or supportive care for the treatment of malignant pleural mesothelioma (or non-RCTs, in the absence of RCT data ).

Data collection and analysis

Outcomes included overall survival, tumour response, progression-free survival, toxicity and quality of life. Data extraction and quality assessment of included trials was completed independently. Trial data and quality assessment were tabulated and presented narratively.

Main results

One RCT involving 448 patients and comparing pemetrexed plus cisplatin versus cisplatin alone for the treatment of unresectable malignant mesothelioma was included in the review. In the intention-to-treat study population, the median survival was statistically significantly longer in the combination arm of pemetrexed plus cisplatin when compared with the cisplatin alone arm. (12.1 and 9.3 months, respectively, p=0.002). The incidence of grade 3/4 toxicities was higher in the combination arm compared with the cisplatin alone arm.

Authors' conclusions

Pemetrexed disodium in combination with cisplatin and with folic acid and vitamin B12 supplementation may improve survival when used in combination with cisplatin in good performance status patients. Further studies including patients with poor performance status are needed in order to generalise the treatment findings. Further studies are also needed into the optimum chemotherapy, and a clear definition of what constitutes best supportive care.

 

Plain language summary

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

Pemetrexed disodium (new anticancer drug) significantly increases the length of survival, as well as relieves symptoms of mesothelioma

Mesothelioma is a rare and aggressive type of cancer, usually linked with previous exposure to asbestos. Its most common site is the pleura, a protective lining of the lungs. Currently there is no established standard treatment for mesothelioma. This review found a large clinical trial that examined the effectiveness of pemetrexed disodium, an anticancer drug developed to treat pleural mesothelioma, given in combination with another cancer drug, cisplatin. The results indicate that pemetrexed used in combination with cisplatin significantly increases the length of survival, when compared with cisplatin alone. Further research is needed into the optimum treatment regimen for pleural mesothelioma.

 

摘要

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

背景

Pemetrexed disodium合併鉑類藥物與其他細胞毒殺性藥物或支持性療法在惡性肋膜間皮細胞瘤治療的比較

惡性肋膜間皮細胞瘤是一種具高度侵略性的惡性腫瘤，在英國、西歐和澳洲因職業而暴露於石棉纖維環境的結果，在未來二十年內的發生率預計會增加。手術只有少數案例可以實行，而放射線治療和化學治療只能用於緩解疾病。Pemetrexed是市面上第一個也是唯一的化學治療藥物被准許於和鉑類藥物合併使用於未曾接受化學治療的無法手術切除的惡性肋膜間皮細胞瘤的病人。

目標

對從未接受化學治療且不能手術切除的惡性肋膜間皮細胞瘤的病人，檢視以Pemetrexed disodium合併鉑類藥物相較於單獨或合併使用其他細胞毒殺性藥物或以支持性照護有關臨床效益之實証。

搜尋策略

直到2005年10月，搜尋包括CENTRAL (Issue 2, 2005), EMBASE (1980 – 2005), MEDLINE (1980 – 2005), HTA database (1990 – 2005), Web of Knowledge (1990 – 2005) 等資料庫，以及手動搜尋包括來自檢索文章和製葯公司提供給NICE的參考名單

選擇標準

主要選擇隨機對照試驗:比較Pemetrexed disodium合併鉑類藥物與其他細胞毒殺性藥物或支持性療法在惡性肋膜間皮細胞瘤之治療(若無隨機對照試驗則選擇非隨機對照試驗)

資料收集與分析

結果包括了整體存活期、腫瘤治療反應、無惡化存活期、藥物毒性和生活品質。納入收集的試驗中,其試驗資料之擷取和試驗品質之評估都是獨立完成的。試驗的資料和質量評估以製表方式來呈現和敘述。

主要結論

在回顧性文獻中包含一篇有448位病人之隨機對照試驗,比較Pemetrexed disodium合併鉑類藥和單獨使用鉑類藥物來治療不能切除的惡性肋膜間皮細胞瘤病人。在此意向治療之研究病人中, Pemetrexed disodium合併鉑類藥比起單獨使用鉑類藥物的有統計學上顯著較長的中位存活期(分別是12.1和9.3個月, p值是0.002)。第3到4級藥物毒性發生率在合併藥物組高於單獨使用鉑類藥物組。

作者結論

在體能狀況良好的病人,使用Pemetrexed disodium合併鉑類藥物並補充葉酸和維他命B12可改善存活。吾人需要包含體能狀況不佳病人之進一步試驗才能泛論其治療結果。除此之外,吾人亦需要進一步試驗來驗證最理想之化學治療、並且清楚的界定最佳支持性照護的組成為何。

翻譯人

本摘要由臺北榮民總醫院馮嘉毅翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

Pemetrexed disodium (新的抗癌藥物)有意義的增長存活時間並可減輕間皮細胞瘤的症狀.間皮細胞瘤是一種少見且侵略性高的腫瘤,經常跟過去石綿的職業暴露有關,最常發生的位置是肋膜(肺的保護性內襯)。到目前為止,間皮細胞瘤沒有建立標準的治療。這篇回顧性文獻顯示一個大型的臨床試驗,其檢視Pemetrexed disodium(一種發展來治療肋膜間皮細胞的抗癌藥物)合併其他抗癌藥物如鉑類的療效。結果顯示Pemetrexed disodium合併鉑類藥比單獨使用鉑類藥物有意義的增長存活期。肋膜間皮細胞瘤的理想治療處方需要更多的研究來驗證。

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