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Recommendations for use of Trastuzumab (Herceptin®)

Clinical practice recommendations

Recommendations to individuals should be based on their risks without trastuzumab treatment, the absolute benefits, and harms of treatment, and their preference. Recommendations should also take account of any uncertainties about the long-term effects of trastuzumab treatment.

RECOMMENDATIONS LEVEL OF EVIDENCE TRIAL AND REFERENCE
Patients should be informed of the potential side effects of trastuzumab and any uncertainties about long-term effects    
Patients receiving trastuzumab should be reviewed regularly and monitored for side effects by clinicians familiar with the drug    
For patients with HER2-positive early breast cancer following surgery:
Combination with chemotherapy    
Adjuvant trastuzumab should be off ered with chemotherapy following surgery in patients with node-positive or node-negative tumours larger than 1 cm II BCIRG 006;4 HERA;7
NCCTG-N9831;6 NSABP-B316
Trastuzumab concurrently with an anthracycline is not recommended due to risk of cardiotoxicity II M77001;11 Slamon12
Combination with radiotherapy    
Trastuzumab can be offered to patients who require radiotherapy, although long-term toxicity is unknown II NCCTG-N983118
Optimal dose schedule and duration of administration    
Recommended regimens based on current evidence are: Weekly: loading dose of 4 mg/kg then 2 mg/kg or 3-weekly: loading dose of 8 mg/kg then 6 mg/kg for 1 year with chemotherapy following surgery II HERA;7 NCCTG-N9831;6 NSABP-B316
For patients with HER2-positive locally advanced or inflammatory breast cancer:
Trastuzumab with preoperative chemotherapy can be offered to patients with locally advanced or inflammatory breast cancer III Hurley20
For patients with HER2-positive breast cancer undergoing preoperative chemotherapy:
The use of trastuzumab following neoadjuvant chemotherapy and surgery can be offered to patients with breast cancers that are 2–5 cm in size II HERA7
For patients with HER2-positive metastatic breast cancer:
Combination with other systemic therapies
Trastuzumab with paclitaxel or docetaxel should be recommended as first-line therapy where chemotherapy is indicated II M77001;11 Slamon12
Trastuzumab concurrently with an anthracycline is not recommended due to risk of cardiotoxicity II Slamon12
Trastuzumab can be used with other single-agent therapies when treatment with taxanes is inappropriate; participation in relevant clinical trials should be considered III Burstein;23,24 Jahanzeb;25 O’Shaughnessy;26 Papaldo;27
TAnDEM22
Single-agent trastuzumab
Trastuzumab can be used as single-agent therapy where combination with systemic therapy is not appropriate II Vogel15
Optimal dose schedule and duration of administration  
Trastuzumab should be continued to disease progression in the absence of unacceptable toxicity II M77001;11
Slamon;12
Vogel15
Where the disease has progressed on first-line therapy containing trastuzumab, inclusion in appropriate clinical trials should be considered    
Recommended regimens are:
Weekly: loading dose of 4 mg/kg then 2 mg/kg
3-weekly: loading dose of 8 mg/kg then 6 mg/kg
II
III

Vogel;15
Baselga31
Cardiac monitoring:  
Patients with significant pre-exisitng cardiac dysfunctionĂ‚± should not receive trastuzumab therapy    
Patients receiving adjuvant trastuzumab should be assessed for signs of cardiac dysfunction by multi-gated acquisition (MUGA) of echocardiogram prior to treatment and reveiwed clinically and by echocardiography at 3-monthly intervals during treatment II HERA;7 NCCTG-N9831;6 NSABP-B316
Similar monitoring can be applied to patients with metastatic breast cancer if clinically appropriate
Patients who develop asymptomatic cardiac dysfunction during the course of treatment warrant more frequent monitoring, and review by a cardiologist should be considered
Consideration should be given to ceasing adjuvant trastuzumab if left ventricular ejection fraction (LVEF) is reduced by 10-15% of baseline and below normal LVEF II HERA;7
NCCTG-N9831;6
NSABP-B316

Ă‚±Pre-existing cardiac dysfunction (LVEF less than 50) is defined as a history of documented congestive heart failure, coronary artery disease with previous Q-wave myocardial infraction, angina pectoris requiring medication, uncontrolled hypertension, clinically significant valvular disease, and unstable arrhythmias.6

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