Intervention Review

Granulopoiesis-stimulating factors to prevent adverse effects in the treatment of malignant lymphoma

  1. Julia Bohlius1,*,
  2. Christine Herbst1,
  3. Marcel Reiser2,
  4. Guido Schwarzer3,
  5. Andreas Engert1

Editorial Group: Cochrane Haematological Malignancies Group

Published Online: 8 OCT 2008

Assessed as up-to-date: 22 APR 2008

DOI: 10.1002/14651858.CD003189.pub4


How to Cite

Bohlius J, Herbst C, Reiser M, Schwarzer G, Engert A. Granulopoiesis-stimulating factors to prevent adverse effects in the treatment of malignant lymphoma. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD003189. DOI: 10.1002/14651858.CD003189.pub4.

Author Information

  1. 1

    University Hospital of Cologne, Cochrane Haematological Malignancies Group - Department of Internal Medicine 1, Cologne, Germany

  2. 2

    University Hospital of Cologne, Department of Internal Medicine 1, Cologne, Germany

  3. 3

    German Cochrane Center, Department of Medical Biometry and Statistics, Freiburg, Germany

*Julia Bohlius, Cochrane Haematological Malignancies Group - Department of Internal Medicine 1, University Hospital of Cologne, Kerpener Str. 62, Cologne, 50924, Germany. julia.bohlius@uk-koeln.de. jbohlius@ispm.unibe.ch.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 8 OCT 2008

SEARCH

 

Abstract

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

Background

Granulopoiesis-stimulating factors, such as granulocyte-colony-stimulating factor (G-CSF) and granulocyte-macrophage-colony-stimulating factor (GM-CSF), are being used to prevent febrile neutropenia and infection in patients undergoing treatment for malignant lymphoma. The question of whether G-CSF and GM-CSF improve dose intensity, tumour response, and overall survival in this patient population has not been answered yet. Since the results from single studies are inconclusive, a systematic review was undertaken.

Objectives

To determine the effectiveness of G-CSF and GM-CSF in patients with malignant lymphoma with respect to preventing neutropenia, febrile neutropenia and infection; improving quality of life, adherence to treatment protocol, tumour response, freedom from treatment failure (FFTF) and overall survival (OS); and adverse effects.

Search methods

We searched The Cochrane Library, MEDLINE, EMBASE, CancerLit, and other relevant literature databases; Internet databases of ongoing trials; and conference proceedings of the American Society of Clinical Oncology and the American Society of Hematology (1980 - 2007). We included full-text and abstract publications as well as unpublished data.

Selection criteria

Randomised controlled trials comparing prophylaxis with G-CSF or GM-CSF versus placebo/no prophylaxis in adult patients with malignant lymphoma undergoing chemotherapy were included for review. Both study arms had to receive identical chemotherapy and supportive care.

Data collection and analysis

Trial eligibility and quality assessment, data extraction and analysis were done by two reviewers independently. Authors were contacted to obtain missing data.

Main results

We included 13 eligible randomised controlled trials with 2607 randomised patients. Compared with no prophylaxis, both G-CSF and GM-CSF did not improve overall survival (hazard ratio 0.97; 95% CI 0.87 to 1.09) or FFTF (hazard ratio 1.11; 95% CI 0.91 to 1.35). Prophylaxis significantly reduced the relative risk (RR) for severe neutropenia (RR 0.67; 95% confidence interval (CI) 0.60 to 0.73), febrile neutropenia (RR 0.74; 95% CI 0.62 to 0.89) and infection (RR 0.74; 95% CI 0.64 to 0.85). There was no evidence that either G-CSF or GM-CSF reduced the number of patients requiring intravenous antibiotics (RR 0.82; 95%CI 0.57 to 1.18); lowered infection related mortality (RR 0.93; 95% CI 0.51 to 1.71); or improved complete tumour response (RR 1.03; 95% CI 0.95 to 1.10).One study evaluated quality of life parameters and found no differences between the treatment groups.

Authors' conclusions

G-CSF and GM-CSF, when used as a prophylaxis in patients with malignant lymphoma undergoing conventional chemotherapy, reduce the risk of neutropenia, febrile neutropenia and infection. However, based on the randomised trials currently available, there is no evidence that either G-CSF or GM-CSF provide a significant advantage in terms of complete tumour response, FFTF or OS.

 

Plain language summary

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

Granulopoiesis-stimulating factors in the prevention of adverse effects during the therapeutic treatment of malignant lymphoma.

Lymphoma is a cancer that begins in the lymph nodes. It can be treated with chemotherapy (anti-cancer drugs), but this disrupts the immune system and lowers white cell counts. This can increase a person's risk of infection and limit the amount of chemotherapy that can be given. Granulopoiesis-stimulating factors (GSF) can increase the body's production of white cells. The review found that treatment with GSF increases white cell counts and reduces the risk of infection in people receiving chemotherapy for lymphoma. However, GSF treatment did not improve survival. More research is needed to improve GSF treatments.

 

摘要

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

背景

利用顆粒球造血刺激因子來預防惡性淋巴癌治療所產生的副作用

顆粒球造血刺激因子,如顆粒球刺激因子(GCSF)及顆粒球巨嗜細胞刺激因子(GMCSF),在惡性淋巴癌病患已被用來預防中性球低下發燒症和感染。使用GCSF和GMCSF是否能強化劑量強度,改善腫瘤反應和整體存活仍未有答案。因為單一的研究結果並沒有定論,所以我們進行這個系統性回顧分析。

目標

為了決定惡性淋巴癌病患使用GCSF和GMCSF在預防中性球低下,中性球低下發燒症和感染的效果。能否改善生活品質,繼續治療療程,以及改善腫瘤反應率,並減少治療失敗,改善整體存活率(OS)及副作用。

搜尋策略

我們搜尋考科藍圖書館(The Cochrane Library),MEDLINE,EMBASE,Cancer Lit,及其他相關文獻資料庫,網路上的進行中試驗,以及從1980年到2003年美國臨床癌症學會(American Society of Clinical Oncology)和美國血液學會(American Society of Hematology)的會議資料。我們涵蓋出版的全文,摘要和未出版的資料。

選擇標準

我們搜尋包括針對進行化學治療的惡性淋巴癌成人患者比較使用預防性GCSF或GMCSF和安慰劑組/無預防的隨機對照試驗。兩個比較組必須接受相同的化學治療和支持性照顧。

資料收集與分析

試驗的合適性及品質評估,資料收集及分析都會雙重確認。也會和作者聯絡以獲得遺失的資料。

主要結論

我們收集12個適合的隨機對照試驗總共1823位病患。和無預防組比較,GCSF和GMCSF兩個都會有意義地降低嚴重中性球低下(RR 0.67,95% CI 0.60 – 0.73),中性球低下發燒症(RR 0.74,95% CI 0.62 – 0.89)及感染(RR 0.74,95%CI 0.64 – 0.85)的相對風險。目前並無證據支持GCSF或GMCSF可以降低接受靜脈抗生素的病患數目(RR 0.82,95% CI0.57 – 1.18),降低感染相關死亡率(RR 1.37,95% CI 0.66 – 2.82),也無法改善完全腫瘤反應率(RR 1.02,95% CI 0.94 – 1.11),無法減少治療失敗率(風險比 1.11,95% CI 0.91 – 1.35)及整體存活率(風險比 1.00,95% CI 0.86 – 1.16)。只有一個研究評估生活品質指標,並且發現治療與否兩組並無差異。

作者結論

當GCSF和GMCSF預防性用於接受傳統化學治療的惡性淋巴癌病患,可以降低中性球低下,中性球低下發燒和感染的風險。然而根據這些目前已知的隨機試驗,並無證據顯示GCSF或GMCSF可以有意義地提供改善腫瘤反應,治療失敗率或整體存活率的好處。

翻譯人

本摘要由慈濟醫院黃冠博翻譯。

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

總結

利用顆粒球造血刺激因子來預防惡性淋巴癌治療所產生的副作用。淋巴癌是起源於淋巴結的癌症。它能以化學藥物(抗癌藥物)治療,但是治療可能會干擾免疫系統並降低白血球數目。它會增加個人感染風險並限制化學治療所能給予的數量。顆粒球造血刺激因子(GSF)能夠使身體增加製造白血球。這篇回顧發現在接受化學治療的淋巴癌病患使用GSF治療會增加白血球數目並降低感染風險。然而GSF治療並不會改善存活。這需要更多研究來改善GSF的治療。