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Five Year Update of Cardiac Dysfunction in NSABP B-31A Randomized Trial of AC Paclitaxel vs. AC Paclitaxel with Trastuzumab in HER2- Postive, Node Positive, Operable Breast
Cancer
Authors: Rastogi et al.
Reviewer: Dr Sunil VermaDate posted: June 21, 2007
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RTreatment A: AC q3wk x 4
Paclitaxel q3wk x 4* or Paclitaxel qwk x 12*
Treatment B: AC q3wk x 4
Paclitaxel q3wk x 4* Or Paclitaxel qwk x 12* + Trastuzumab qwk x 52
Operable breast\cancer Her-
2Positivetumour
PathologicalPositive Axillary
nodes
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RESULTS
• About 6.5% of patients randomized to the Herceptin containing arm did not receive Herceptin related to cardiac dysfunction with four cycles of AC
• 3 year data (previously reported) on Cardiac EventsNo herceptin 0.8%Herceptin 4.1%
• 5 year update (current presentation at ASCO 2007)No herceptin 0.9%Herceptin 3.8%
• The following factors were found to be predictive for cardiac toxicity• Age• Use of Hypertension medications• LVEF
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STUDY COMMENTARY
• This was a 5 year update on cardiac toxicity associated with Herceptin as per the NSABP B-31 Trial
• There doesn’t seem to be increased cardiac toxicity with longer follow-up
• There was a predictive model presented to better predict the risk of cardiac toxicity
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BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS
• It is important to address modifiable cardiac risk factors prior to initiating therapy
• The risk of cardiac toxicity is dependent of many patient related factors
• It is prudent to review these factors in the context of tumor profile and make the decision on the need for Herceptin on an individual basis
• Long term follow up is still needed as most of these cardiac events may occur later
• We still don’t know the long term effect of asymptomatic LV dysfunction