www.OncologyEducation.ca

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

www.OncologyEducation.ca

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

www.OncologyEducation.ca

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

www.OncologyEducation.ca

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

www.OncologyEducation.ca

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