Date Published: 9 June 2006

NICE issues draft guidance on trastuzumab (Herceptin) for early breast cancer

The UK National Institute for Clinical Excellence (NICE) has published draft guidance about Herceptin, just two weeks after the drug was licensed by the regulatory authorities for use in early breast cancer. The draft guidance recommends the drug for women with early stage HER2-positive breast cancer, except where there are concerns about the woman's cardiac function. Final guidance is expected to be issued at the beginning of July 2006, assuming there are no appeals.

NICE Chief Executive Andrew Dillon said:

" These proposals are very good news for women with HER2 positive breast cancer. Herceptin, for these women is clinically and cost effective in the early stage of the disease and we look forward to being able to issue final guidance, subject to any appeal against our recommendations, in a few weeks time."

The draft recommendations are as follows:

1. Trastuzumab, given at 3-week intervals for 1 year or until disease recurrence (whichever is the shorter period), is recommended as a treatment option for women with early-stage HER2-positive breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).
   
2. Cardiac function should be assessed prior to the commencement of therapy and trastuzumab treatment should not be offered to women who have a left ventricular ejection fraction (LVEF) of 55% or less, or who have any of the following:
   • a history of documented congestive heart failure
   • high-risk uncontrolled arrhythmias
   • angina pectoris requiring medication
   • clinically significant valvular disease
   • evidence of transmural infarction on electrocardiograph (ECG)
   • poorly controlled hypertension.
     
3. 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. A decision to resume trastuzumab therapy should be based on a further cardiac assessment and a fully informed discussion of the risks and benefits between the individual patient and their clinician.

The draft recommendations are subject to an appeal period which closes on 28 June 2006. During this period registered stakeholder organisations including those representing healthcare professionals, patients and carers can decide if they wish to appeal against the draft guidance. Final guidance is expected to be issued at the beginning of July 2006, assuming there are no appeals.

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