Welcome to NGC. Skip directly to: Search Box, Navigation, Content.

Brief Summary

GUIDELINE TITLE

Imatinib mesylate (Gleevec™) for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours: a clinical practice guideline.

BIBLIOGRAPHIC SOURCE(S)

  • Verma S, Younus J, Stys-Norman D, Haynes AE, Blackstein M, Sarcoma Disease Site Group. Imatinib mesylate (Gleevec) for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours: a clinical practice guideline. Toronto (ON): Cancer Care Ontario (CCO); 2006 Apr 6. 23 p. (Evidence-based series; no. 11-7). [46 references]

GUIDELINE STATUS

This is the current release of the guideline.

The EVIDENCE-BASED SERIES report, initially the full original Guideline, over time will expand to contain new information emerging from their reviewing and updating activities.

Please visit the Cancer Care Ontario Web site for details on any new evidence that has emerged and implications to the guidelines.

** 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

  • In patients with KIT-expressing (CD117+) unresectable or metastatic gastrointestinal stromal tumours (GIST), treatment with imatinib is a recommended therapy.
  • Until additional data become available, the initial dose of imatinib should be prescribed at a dose of 400 mg daily. A dose of 400 mg twice daily may be considered in patients who demonstrate progression on the lower dose.
  • The optimal duration of therapy in responding patients or in those patients who achieve a complete clinical and/or radiologic remission has not yet been defined. Phase III trials have demonstrated benefit for up to two years of continued therapy.
  • Eligible patients with gastrointestinal stromal tumours who do not respond adequately to optimum doses of imatinib should be considered for entry into a clinical trial.

CLINICAL ALGORITHM(S)

None provided

Top^

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are supported by phase II and III randomized trials.

Top^

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Verma S, Younus J, Stys-Norman D, Haynes AE, Blackstein M, Sarcoma Disease Site Group. Imatinib mesylate (Gleevec) for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours: a clinical practice guideline. Toronto (ON): Cancer Care Ontario (CCO); 2006 Apr 6. 23 p. (Evidence-based series; no. 11-7). [46 references]

ADAPTATION

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

DATE RELEASED

2006 Apr 6

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 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 Sarcoma Disease Site Group

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

For a current list of past and present members, please see the Cancer Care Ontario Web site.

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Members of the Sarcoma Disease Site Group disclosed information on potential conflict of interest. All members reported that they had no potential conflict of interest.

GUIDELINE STATUS

This is the current release of the guideline.

The EVIDENCE-BASED SERIES report, initially the full original Guideline, over time will expand to contain new information emerging from their reviewing and updating activities.

Please visit the Cancer Care Ontario Web site for details on any new evidence that has emerged and implications to the guidelines.

GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the Cancer Care Ontario Web site.

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on June 9, 2006. The information was verified by the guideline developer on June 26, 2006. This summary was updated by ECRI on November 13, 2006 following the FDA advisory on Gleevec (imatinib mesylate).

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Please refer to the Copyright and Disclaimer Statements posted at the Program in Evidence-Based Care section of the Cancer Care Ontario Web site.

Top^

DISCLAIMER

NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion.aspx .

NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

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

 


Search Help
Detailed Search
Frequent Searches

Summary

Brief Summary
Complete Summary
XML View
Full Text
Palm Download
MS Word
Adobe PDF

Browse

» Disease / Condition
» Treatment / Intervention
» Measures
» Organization
» Guideline Index
» Guidelines In Progress
» Guideline Archive

Compare

» View My Collection
» Add to My Collection
» Guideline Syntheses

 

   
DHHS Logo