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Brief Summary

GUIDELINE TITLE

Treatment of chronic myeloid leukemia with imatinib.

BIBLIOGRAPHIC SOURCE(S)

  • Hematology Disease Site Group. Walker I, Makarski J, Stevens A, Meyer RM. Treatment of chronic myeloid leukemia with imatinib. Toronto (ON): Cancer Care Ontario (CCO); 2004 Jul 16. 27 p. (Practice guideline report; no. 6-15). [39 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.

  • October 19, 2006, Gleevec (imatinib mesylate): Revisions to the PRECAUTIONS section of the prescribing information, describing the occasional occurrence of severe congestive heart failure and left ventricular dysfunction in patients taking Gleevec.

BRIEF SUMMARY CONTENT

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

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

  • Imatinib is recommended as first-line therapy in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia. The initial recommended dose of therapy is 400 milligrams (mg), given orally, once daily. For patients who do not demonstrate a complete hematologic response after three months of therapy or at least a minor cytogenetic response after 12 months of therapy, the dose of imatinib should be increased to 400 mg, given orally, twice daily.
  • Imatinib is recommended for patients who have become refractory to or intolerant of previous therapy (e.g., interferon +/- cytarabine, hydroxyurea) or who have disease progression to accelerated or myeloid blastic phases of the disease. For patients with accelerated or myeloid blastic phases of the disease, the starting dose of imatinib should be 600 mg, given orally, once daily with an increase in dose to 400 mg, given orally, twice daily, if an adequate hematologic or cytogenetic response is not observed.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are supported by non-randomized trials, a randomized controlled trial and a systematic review.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Hematology Disease Site Group. Walker I, Makarski J, Stevens A, Meyer RM. Treatment of chronic myeloid leukemia with imatinib. Toronto (ON): Cancer Care Ontario (CCO); 2004 Jul 16. 27 p. (Practice guideline report; no. 6-15). [39 references]

ADAPTATION

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

DATE RELEASED

2004 Jul 16

GUIDELINE DEVELOPER(S)

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

GUIDELINE DEVELOPER COMMENT

The Program in Evidence-based Care (PEBC) is a project supported 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 Hematology Disease Site Group

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Members of the Hematology 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 September 9, 2005. The information was verified by the guideline developer on October 3, 2005. This summary was updated by ECRI on November 13, 2006 following the FDA advisory on Gleevec (imatinib mesylate).

COPYRIGHT STATEMENT

DISCLAIMER

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Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
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