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Brief Summary

GUIDELINE TITLE

The role of colony-stimulating factor (CSF) in patients receiving myelosuppressive chemotherapy for the treatment of cancer.

BIBLIOGRAPHIC SOURCE(S)

  • Campbell C, Bramwell V, Charette M, Oliver T. Role of colony-stimulating factor in patients receiving myelosuppressive chemotherapy for treatment of cancer. Curr Oncol 2003;10(2):102-26.


  • Systemic Treatment Disease Site Group. Campbell C, Bramwell V, Charette M, Oliver T. The role of colony-stimulating factor (CSF) in patients receiving myelosuppressive chemotherapy for the treatment of cancer [full report]. Toronto (ON): Cancer Care Ontario (CCO); 2003 Dec [online update]. 33 p. (Practice guideline report; no. 12-2). [76 references]

GUIDELINE STATUS

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • January 24, 2008, Leukine (sargramostim): Voluntary market suspension of the current liquid formulation of sargramostim, a granulocyte-macrophage colony-stimulating factor (GM-CSF), because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting). The lyophilized form of the drug is not affected. See the U.S. Food and Drug Administration (FDA) web site for more information.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

  1. In the setting of standard-dose chemotherapy for solid tumours, the risk of neutropenic fever is insufficient to justify routine use of colony stimulating factor (CSF, which includes both granulocyte and granulocyte macrophage colony-stimulating factors) as primary prophylaxis. If a patient experiences an episode of febrile neutropenia or prolonged neutropenia, dose reductions and/or delays of chemotherapy remain the standard initial approach. It is reasonable to use CSF to avoid multiple dose reductions or delays in circumstances where randomized controlled trials have shown improved survival with maintenance of dose intensity.
  2. The use of CSF to support the delivery of dose-intensified chemotherapy regimens can only be recommended in the context of randomized controlled trials evaluating regimens that seek to improve progression-free, disease-free, and/or overall survival.
  3. Although data are limited, it is reasonable to use CSF to decrease duration of fever, antibiotic use, or hospitalization in patients with febrile neutropenia. Further studies are warranted to establish specific recommendations in this situation.
  4. It is not possible to make firm recommendations for a specific type of CSF. More data are available for granulocyte colony-stimulating factor (G-CSF), but further comparative studies of both agents are warranted.
  5. There are insufficient data to support specific recommendations for dose/schedules of CSF that differ from those currently recommended by the manufacturer. However, some schedules in which CSF is delayed or abbreviated are promising and could be cost-effective. Therefore, this issue deserves further study.
  6. There is preliminary evidence that CSF helps prevent or treat mucositis. However, the Systemic Treatment Disease Site Group felt there were insufficient data on which to make a recommendation for its use in these settings.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are supported by randomized trials and clinical practice guidelines.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Campbell C, Bramwell V, Charette M, Oliver T. Role of colony-stimulating factor in patients receiving myelosuppressive chemotherapy for treatment of cancer. Curr Oncol 2003;10(2):102-26.


  • Systemic Treatment Disease Site Group. Campbell C, Bramwell V, Charette M, Oliver T. The role of colony-stimulating factor (CSF) in patients receiving myelosuppressive chemotherapy for the treatment of cancer [full report]. Toronto (ON): Cancer Care Ontario (CCO); 2003 Dec [online update]. 33 p. (Practice guideline report; no. 12-2). [76 references]

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2003 Aug 20 (revised online 2003 Dec)

GUIDELINE DEVELOPER(S)

Program in Evidence-based Care - State/Local Government Agency [Non-U.S.]

GUIDELINE DEVELOPER COMMENT

The Practice Guidelines Initiative (PGI) is the main project of the Program in Evidence-based Care (PEBC), a Province of Ontario initiative sponsored by Cancer Care Ontario and the Ontario Ministry of Health and Long-Term Care.

SOURCE(S) OF FUNDING

Cancer Care Ontario
Ontario Ministry of Health and Long-Term Care

GUIDELINE COMMITTEE

Provincial Systemic Treatment Disease Site Group

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Members of the Systemic Treatment Disease Site Group disclosed potential conflict of interest information.

GUIDELINE STATUS

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

PATIENT RESOURCES

None available

NGC STATUS

This summary was completed by ECRI on January 5, 1999. The information was verified by the guideline developer as of February 22, 1999. This NGC summary was updated by ECRI on March 20, 2003. The information was verified by the guideline developer on May 8, 2003. This NGC summary was updated again by ECRI on May 14, 2004. The updated information was verified by the guideline developer on June 2, 2004. This summary was updated by ECRI Institute on February 26, 2008 following the U.S. Food and Drug Administration advisory/voluntary market withdrawal of the liquid formulation of Leukine (sargramostim).

COPYRIGHT STATEMENT

DISCLAIMER

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