Evidence-based recommendations on trastuzumab (Herceptin) for treating early HER2-positive breast cancer in adults.
The NICE guideline CG80 updates the recommendations in this appraisal.
October 2006: It has been brought to our attention that this guidance contained an error in section 1.3, where it stated that:
‘Cardiac functional assessments should be repeated every 3 months during trastuzumab treatment. If the LVEF drops by 10% from baseline and to below 50% then trastuzumab treatment should be suspended…″
This has now been amended so that it follows more closely the summary of product characteristics for trastuzumab, as follows:
″Cardiac functional assessments should be repeated every 3 months during trastuzumab treatment. If the LVEF drops by 10 percentage (ejection) points or more from baseline and to below 50% then trastuzumab treatment should be suspended…’
Update to guidance
NICE and the Department of Health are currently reviewing the future position on updating technology appraisals within clinical guidelines, with particular reference to implications for the funding direction on technology appraisals. In the meantime, the technology appraisal guidance remains available and should continue to be followed. The statutory funding direction remains in place for the recommendations contained in the technology appraisal guidance.
Guidance development process
Is this guidance up to date?
The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.