Imatinib for the Treatment of Unresectable and/or Metastatic Gastro-intestinal Stromal Tumours (TA86 [Partially Updated by TA209])

Technology Appraisal Guidance No. 86

Source: National Institute for Health and Clinical Excellence

This guidance has been partially updated by ‘Imatinib for the treatment of unresectable and/or metastatic gastrointestinal stromal tumours’ (NICE technology appraisal guidance 209) [TA209]. The recommendation that has been updated is indicated in section 1 below. See TA209 ( for details of the new recommendations and evidence considered.

1. Guidance

1.1 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).

1.2 Continuation with imatinib therapy is recommended only if a response to initial treatment (as defined in Section 1.5) is achieved within 12 weeks.

1.3 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 in Section 1.5.

1.4 This recommendation has been updated and replaced by NICE technology appraisal guidance 209.

1.5 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. For the purpose of this guidance, response to therapy is defined as the SWOG classifications of complete response, partial response or stable disease.

1.6 The use of imatinib should be supervised by cancer specialists with experience in the management of people with unresectable and/or metastatic GISTs.

The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at

Copies of the document can also be obtained by contacting 0845 003 7783 or emailing and quoting reference number N0552. 

This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

© Copyright National Institute for Health and Clinical Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Clinical Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email:

Imatinib for the Treatment of Unresectable and/or Metastatic Gastro-intestinal Stromal Tumours.
Issue Date: October 2004
Review Date: October 2007

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