Medicine - Xagena

NICE has recommended Herceptin ( Trastuzumab ) for women with early stage HER2-positive breast cancer, except where there are concerns about the woman’s cardiac function.

The recommendations are as follows:

1.1 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 ).

1.2 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.

1.3 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.

Source: NICE, 2006


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