October 28, 2005Journal of Clinical Oncology

Assessment of Cardiac Dysfunction in a Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed by Paclitaxel, With or Without Trastuzumab As Adjuvant Therapy in Node-Positive, Human Epidermal Growth Factor Receptor 2–Overexpressing Breast Cancer: NSABP B-31

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Why the study?

Does adding trastuzumab to paclitaxel after doxorubicin and cyclophosphamide increase the risk of cardiac events in patients with node-positive, HER2-positive breast cancer?

Population

1,664 patients with node-positive, HER2-positive breast cancer and normal post-AC left ventricular ejection…

Comparison

Doxorubicin and cyclophosphamide followed by… vs Doxorubicin and cyclophosphamide followed by…

Design

RCT, Randomized, Blind review of source documents by an independent panel of…

Follow-up

3 years

Authors

ETElizabeth Tan-ChiuCancer Institute of Florida GYGreg YothersUniversity of Pittsburgh EREdward H. RomondDartmouth–Hitchcock Medical Center

Discussion

Member takes

Implication

Warrants close cardiac monitoring with trastuzumab after anthracyclines; confirms cardiotoxicity risk in node-positive HER2-positive breast cancer.

Structured PICO

Does adding trastuzumab to paclitaxel after doxorubicin and cyclophosphamide increase the risk of cardiac events in patients with node-positive, HER2-positive breast cancer?

Population

1,664 patients with node-positive, HER2-positive breast cancer and normal post-AC left ventricular ejection fraction

Intervention

Doxorubicin and cyclophosphamide (AC) followed by paclitaxel plus 52 weeks of trastuzumab beginning concurrently with paclitaxel

Comparator

Doxorubicin and cyclophosphamide (AC) followed by paclitaxel

Outcome

Cardiac event (CE), defined as New York Heart Association class III or IV congestive heart failure or possible/probable cardiac deathsafety

The addition of trastuzumab to paclitaxel after anthracycline therapy in HER2-positive breast cancer significantly increases the risk of congestive heart failure and cardiac dysfunction.

Cite This Study

Tan-Chiu et al. (2005) studied this question.

synapsesocial.com/papers/69fbd6c6df6507d4845ddade https://doi.org/10.1200/jco.2005.02.4091

Topics

Heart failure HFrEF treatment

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Implication

Warrants close cardiac monitoring with trastuzumab after anthracyclines; confirms cardiotoxicity risk in node-positive HER2-positive breast cancer.

Assessment of Cardiac Dysfunction in a Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed by Paclitaxel, With or Without Trastuzumab As Adjuvant Therapy in Node-Positive, Human Epidermal Growth Factor Receptor 2–Overexpressing Breast Cancer: NSABP B-31

Discussion

Member takes

Implication

Structured PICO

Cite This Study

Topics

Assessment of Cardiac Dysfunction in a Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed by Paclitaxel, With or Without Trastuzumab As Adjuvant Therapy in Node-Positive, Human Epidermal Growth Factor Receptor 2–Overexpressing Breast Cancer: NSABP B-31

Discussion

Member takes

Implication

Structured PICO

Cite This Study

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