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Reviewer: Dr Sunil Verma Date posted: June 21, 2007

Five Year Update of Cardiac Dysfunction in NSABP B-31 A 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 Verma Date posted: June 21, 2007. Treatment A: AC q3wk x 4

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Reviewer: Dr Sunil Verma Date posted: June 21, 2007

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  1. 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 CancerAuthors: Rastogi et al. Reviewer: Dr Sunil Verma Date posted: June 21, 2007

  2. Treatment A: AC q3wk x 4 Paclitaxel q3wk x 4* or Paclitaxel qwk x 12* R Treatment B: AC q3wk x 4 Paclitaxel q3wk x 4* Or Paclitaxel qwk x 12* + Trastuzumab qwk x 52 Operable breast\ cancer Her-2Positive tumour Pathological Positive Axillary nodes

  3. 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 Events • No 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

  4. 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

  5. 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

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