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Brief Summary

GUIDELINE TITLE

Imatinib for the treatment of unresectable and/or metastatic gastrointestinal stromal tumours.

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Imatinib for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours. London (UK): National Institute for Clinical Excellence (NICE); 2004 Oct. 38 p. (Technology appraisal; no. 86).

GUIDELINE STATUS

This is the current release of the guideline.

** 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 treatment at 400 mg/day is recommended as first-line management of people with KIT (CD117)-positive unresectable and/or KIT (CD117)-positive metastatic gastro-intestinal stromal tumours (GISTs).
  • Continuation with imatinib therapy is recommended only if a response to initial treatment (as defined below) is achieved within 12 weeks.
  • Responders should be assessed at intervals of approximately 12 weeks thereafter. Continuation of treatment is recommended at 400 mg/day until the tumour ceases to respond, as defined below.
  • An increase in the dose of imatinib is not recommended for people receiving imatinib who develop progressive disease after initially responding (see below).
  • For the purpose of this guidance, response to imatinib treatment should be assessed on the basis of the results of diagnostic imaging to assess size and density of the tumour(s), patients' symptoms, and other factors, in accordance with the Southwest Oncology Group (SWOG) criteria detailed in Appendix D of the original guideline document. For the purpose of this guidance, response to therapy is defined as the SWOG classifications of complete response, partial response, or stable disease.
  • The use of imatinib should be supervised by cancer specialists with experience in the management of people with unresectable and/or metastatic GISTs.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically stated.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Imatinib for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours. London (UK): National Institute for Clinical Excellence (NICE); 2004 Oct. 38 p. (Technology appraisal; no. 86).

ADAPTATION

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

DATE RELEASED

2004 Oct

GUIDELINE DEVELOPER(S)

National Institute for Health and Clinical Excellence (NICE) - National Government Agency [Non-U.S.]

SOURCE(S) OF FUNDING

National Institute for Health and Clinical Excellence (NICE)

GUIDELINE COMMITTEE

Appraisal Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Dr Anthony Ades, MRC Senior Scientist, MRC Health Services Research Collaboration, University of Bristol; Dr Tom Aslan, General Practitioner, Stockwell, London; Professor David Barnett (Chair), Professor of Clinical Pharmacology, University of Leicester; Professor Sheila M Bird, MRC Biostatistics Unit, Cambridge; Professor Rosamund Bryar, Professor of Community and Primary Care Nursing, St Bartholomew's School of Nursing and Midwifery, London; Dr Rodney Burnham, Consultant Physician and Gastroenterologist, Oldchurch Hospital, Romford; Dr Gary Butler, Consultant Paediatrician/Endocrinologist, Leeds General Infirmary; Dr Karl Claxton, Health Economist, University of York; Dr Richard Cookson, Senior Lecturer, Health Economics, School of Medicine, Health Policy and Practice, University of East Anglia, Norwich; Dr Christopher Eccleston, Director, Pain Management Unit, University of Bath; Professor Terry Feest, Clinical Director & Consultant Nephrologist, Richard Bright Renal Unit, & Chair of UK Renal Registry, Bristol; Ms Alison Forbes, Chief Executive, Hoffman de Visme Foundation, London; Professor Gary A Ford, Professor of Pharmacology of Old Age/Consultant Physician, Newcastle upon Tyne Hospitals NHS Trust; Ms Bethan George, Interface Liaison Pharmacist, Tower Hamlets PCT and Royal London Hospital, Whitechapel; Professor John Geddes, Professor of Epidemiological Psychiatry, University of Oxford; Dr Trevor Gibbs, Head, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline; Mr John Goulston, Director of Finance, Bart's and the London NHS Trust; Mr Adrian Griffin, Health Outcomes Manager, Johnson & Johnson Medical Ltd; Dr Elizabeth Haxby, Lead Clinician in Clinical Risk Management, Royal Brompton Hospital, London; Professor Philip Home, Professor of Diabetes Medicine, University of Newcastle upon Tyne; Dr Catherine Jackson, Clinical Lecturer in Primary Care Medicine, Alyth Health Centre, Angus; Dr Terry John, General Practitioner, The Firs, London; Professor Robert Kerwin, Professor of Psychiatry and Clinical Pharmacology, Institute of Psychiatry, London; Mr Muntzer Mughal, Consultant Surgeon, Lancashire Teaching Hospitals NHS Trust, Chorley; Judith Paget, Chief Executive, Caerphilly Local Health Board, Wales; Dr Katherine Payne; Health Economist, Nowgen: The North West Genetics Knowledge Park, St Mary's Hospital, Manchester; Mr James Partridge, Chief Executive, Changing Faces; Mrs Kathryn Roberts, Nurse Practitioner, Hyde, Cheshire; Professor Philip Routledge, Professor of Clinical Pharmacology, College of Medicine, University of Wales, Cardiff; Ms Anne Smith, Trustee, Long-Term Medical Conditions Alliance; Dr Debbie Stephenson, Head of HTA Strategy, Eli Lilly and Company; Professor Andrew Stevens (Vice-Chair), Professor of Public Health, University of Birmingham; Dr Cathryn Thomas, General Practitioner, and Senior Lecturer, Department of Primary Care and General Practice, University of Birmingham; Dr Norman Vetter, Reader, Department of Epidemiology, Statistics and Public Health, College of Medicine, University of Wales, Cardiff; Dr Paul Watson, Medical Director, Essex Strategic Health Authority; Dr David Winfield, Consultant Haematologist, Royal Hallamshire Hospital, Sheffield

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site.

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. 11 Strand, London, WC2N 5HR.

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. 11 Strand, London, WC2N 5HR.

Additionally, Audit Criteria can be found in Appendix C of the original guideline document.

PATIENT RESOURCES

The following is available:

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC STATUS

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

NGC DISCLAIMER

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