Intervention Review

Antitumour antibiotic containing regimens for metastatic breast cancer

  1. Sally Lord2,
  2. Davina Ghersi1,*,
  3. Melina Gattellari1,
  4. Sally Wortley1,
  5. Nicholas Wilcken3,
  6. Charlene E Thornton4,
  7. John Simes2

Editorial Group: Cochrane Breast Cancer Group

Published Online: 18 OCT 2004

Assessed as up-to-date: 2 OCT 2006

DOI: 10.1002/14651858.CD003367.pub2


How to Cite

Lord S, Ghersi D, Gattellari M, Wortley S, Wilcken N, Thornton CE, Simes J. Antitumour antibiotic containing regimens for metastatic breast cancer. Cochrane Database of Systematic Reviews 2004, Issue 4. Art. No.: CD003367. DOI: 10.1002/14651858.CD003367.pub2.

Author Information

  1. 1

    NHMRC Clinical Trials Centre, The University of Sydney, Systematic Reviews and Healthcare Assessment, Camperdown, NSW, Australia

  2. 2

    The University of Sydney, NHMRC Clinical Trials Centre, Camperdown, NSW, Australia

  3. 3

    Westmead and Nepean Hospitals, Medical Oncology, Westmead, NSW, Australia

  4. 4

    The University of Sydney, Systematic Reviews and Healthcare Assessment, NHMRC Clinical Trials Centre, Camperdown, NSW, Australia

*Davina Ghersi, Systematic Reviews and Healthcare Assessment, NHMRC Clinical Trials Centre, The University of Sydney, Locked Bag 77, Camperdown, NSW, 1450, Australia. ghersid@who.int.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 18 OCT 2004

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Abstract

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

Background

Antitumour antibiotics are used in the management of metastatic breast cancer. Some of these agents have demonstrated higher tumour response rates than non-antitumour antibiotic regimens, however a survival benefit has not been established in this setting.

Objectives

To review the randomised evidence comparing antitumour antibiotic containing chemotherapy regimens with regimens not containing an antitumour antibiotic in the management of women with metastatic breast cancer.

Search methods

The Specialised Register maintained by the Cochrane Breast Cancer Group was searched on 3rd October, 2006 using the codes for 'advanced breast cancer' and 'chemotherapy'. Details of the search strategy and coding applied by the Group to create the register are described in the Group's module on The Cochrane Library.

Selection criteria

Randomised trials comparing antitumour antibiotic containing regimens with regimens not containing antitumour antibiotics in women with metastatic breast cancer.

Data collection and analysis

Data were collected from published trials. Studies were assessed for eligibility and quality, and data were extracted by two independent reviewers. Hazard Ratios (HRs) were derived from time-to-event outcomes where possible, and a fixed effect model was used for meta-analysis. Response rates were analysed as dichotomous variables. Quality of life and toxicity data were extracted where present. A primary analysis was conducted for all trials and by class of antitumour antibiotic.

Main results

Thirty-four trials reporting on 46 treatment comparisons were identified. All trials published results for tumour response and 27 trials published time-to-event data for overall survival. The observed 4244 deaths in 5605 randomised women did not demonstrate a statistically significant difference in survival between regimens that contained antitumour antibiotics and those that did not (HR 0.96, 95% CI 0.90 to 1.02, P = 0.22) and no significant heterogeneity. Antitumour antibiotic regimens were favourably associated with time-to-progression (HR 0.84, 95% CI 0.77 to 0.91) and tumour response rates (odds ratio (OR) 1.33, 95% CI 1.21 to 1.48) although statistically significant heterogeneity was observed for these outcomes. These associations were consistent when the analysis was restricted to the 30 trials that reported on anthracyclines. Patients receiving anthracycline containing regimens were also more likely to experience toxic events compared to patients receiving non-antitumour antibiotic regimens. No statistically significant difference was observed in any outcome between mitoxantrone containing and non-antitumour antibiotic-containing regimens.

Authors' conclusions

Compared to regimens without antitumour antibiotics, regimens that contained these agents showed a statistically significant advantage for tumour response and time to progression in women with metastatic breast cancer but were not associated with an improvement in overall survival. The favourable effect on tumour response and time to progression observed in anthracycline containing regimens was also associated with greater toxicity.

 

Plain language summary

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

Antitumour antibiotic containing regimens for metastatic breast cancer

Advanced (metastatic) breast cancer is cancer that has spread beyond the breast. Treatment for metastatic disease usually involves some type of chemotherapy (anti-cancer drugs) to try to reduce the cancer. Chemotherapy drugs can either be given as a single agent or in combination with other chemotherapy drugs. This is done according to a plan or a course of the drug referred to as a regimen. There are many types of chemotherapy drugs which work in various ways. Antitumour antibiotics work by damaging the cancer cells thereby preventing those cells from multiplying. Chemotherapy in general produces a range of side effects or adverse events related to the treatment. The known side effects of antitumour antibiotics include nausea, vomiting, a reduction in the number of white blood cells (known as leukopenia), and in some cases a toxic reaction which alters the working of the heart (called cardiotoxicity).

This review sought to identify and review the randomised evidence comparing courses of chemotherapy containing antitumour antibiotics against courses not containing antitumour antibiotics. This review identified 34 eligible trials involving 5605 women. This review found that for women with advanced breast cancer, taking antitumour antibiotics did not result in better survival than women who took other types of chemotherapy drugs. Despite the lack of evidence of survival benefit, this review demonstrated that women taking these drugs had an advantage in time to progression (the length of time it takes for the cancer to progress after taking the drug) and tumour response (shrinking of the tumour) compared to women who did not take the antitumour antibiotic drugs. In addition however, the risks of side effects including cardiotoxicity, leukopenia and nausea/vomiting were all significantly increased in the women taking the antitumour antibiotics. Given that this review failed to show a benefit in survival for women taking this group of drugs but a higher rate of side effects, the use of these drugs in the management of metastatic breast cancer must be carefully weighed against the risk of these side effects.

 

摘要

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

背景

含抑腫瘤抗生素之處方用於轉移乳癌之療效

含抑腫瘤抗生素之處方已被用於轉移乳癌的治療。某些含有此葯物的處方比不含抑腫瘤抗生素之處方,較具有抑制腫瘤的療效。然而,其對病患存活的好處則尚未獲得確認。

目標

分析隨機分派臨床試驗的証據,比較含抑腫瘤抗生素之處方療法與不含該處方療法,應用於轉移乳癌療效之差異。

搜尋策略

考科藍收錄的專業記錄中,於2006年10月3日,以末期乳癌””(advanced breast cancer)與化學療法””的關鍵字於乳癌研究群組資料中蒐尋。至於其蒐尋細節與資料群組的建立與關鍵字應用方式已詳述於考科藍的群組單元中。

選擇標準

以隨機分派研究含抑腫瘤抗生素之療法與不含該處方療法間療效差異的臨床試驗。

資料收集與分析

資料由已發表之文獻彙集。由兩位獨立的審稿者評估文章的合宜性與品質。可能的話,由時間至事件發生的存活分析中得出風險比率。統合分析採固定校用模式。有效比率以二項變數分析。生活品質與葯物毒性之資料亦加以擷取。原始分析包含所有的臨床試驗,且依不同的抑腫瘤抗生素加以分類。

主要結論

納入分析的臨床試驗共有34個研究,包含了46個治療比較。所有臨床試驗均發表葯物對於抑瘤之效果,有27個研究發表存活的療效。5605位參與隨機分派的受試者中,4244位死亡。葯物處方中是否含抑腫瘤抗生素對於受試者的存活,於統計學上並無差異(風險比率為0.96,95% 信賴區間0.90至1.02, P = 0.22)。這些研究並無有意義之異質性。含抑腫瘤抗生素之處方對於阻止腫瘤擴散與抑瘤反應比率上,均較優於不含抑腫瘤抗生素之處方(風險比率分別為0.84,95% 信賴區間0.77至0.91;1.33,95% 信賴區間1.21至1.48)。這些研究的結果具有統計上顯著之異質性。把研究的葯物侷限於30個包含anthracyclines之處方,其結果依然一致。然而,包含anthracyclines之處方也較不含該葯物之處方,患者有較多的毒性反應。此外,處方中是否包含mitoxantrone對於療效或副作用均無具統計意義之差異。

作者結論

用於治療已轉移之乳癌婦女,相較於未含抑腫瘤抗生素之療法,含抑腫瘤抗生素之處方對於抑制腫瘤進展與抑瘤之反應比率上均有具統計意義之療效。然而卻對於整體之存活率沒有幫助。含anthracyclines之處方對於抑制腫瘤擴散與抑瘤之反應比率上均有較佳之療效,但其毒性也更大。

翻譯人

本摘要由中山醫學大學附設醫院鄧博仁翻譯。

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

總結

含抑腫瘤抗生素之處方用於轉移乳癌之療效: 末期(轉移)乳癌係指已癌細胞已擴散至乳房外之乳癌。治療轉移性乳癌常須使用化學療法(抗腫瘤治劑)以治療癌症。化學療法可使用單種處方或合併多種抑癌葯物之處方。這些治療依治療計劃或於療程中被使用。有許多不同機轉的葯物被使用。抑腫瘤抗生素藉著其破壞癌細胞之機制來防止癌細胞增生。化學治療常伴隨著不同程度的副作用,而抑腫瘤抗生素常見的副作用為噁心,嘔吐,白血球下降(白血球缺乏症),有些個案改變心臟之運作(心臟毒性)。這篇回顧經由統合已發表之隨機分派試驗的証據,比較了含抑腫瘤抗生素之處方與不含該處方療法間之效果差異。此篇回顧包含了34個符合條件的臨床試驗,受試者達5605位婦女。結果顯示: 對於末期乳癌患者,含抑腫瘤抗生素之處方相較於未含該葯物的處方,並無証據顯示其可延長患者的存活時間。雖然如此,含抑腫瘤抗生素之處方可以延緩腫瘤的擴散(服葯後腫瘤擴散的時間),且可以改善抑瘤反應之比率(腫瘤的縮小)。然而,副作用的風險如心臟毒性,白血球缺乏症與噁心嘔吐等,在服用含抑腫瘤抗生素之處方的病患均較顯著。基於無明顯証據顯示該處方對於轉移乳癌婦女在存活上有幫助,且有較高的副作用,臨床上使用該葯物治療轉移乳癌須小心地評估其效果與副作用。