What question did this study set out to answer?

To evaluate the long-term cardiac safety of trastuzumab in women with HER2-positive early breast cancer.

September 22, 2015Journal of Clinical OncologyOpen Access

Long-Term Cardiac Safety Analysis of NCCTG N9831 (Alliance) Adjuvant Trastuzumab Trial

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Why the study?

Does the addition of trastuzumab to adjuvant chemotherapy increase the long-term risk of cardiac events in women with HER2-positive breast cancer?

Population

1,944 women with HER2-positive breast cancer who proceeded to post-doxorubicin and cyclophosphamide therapy

Comparison

Trastuzumab added to paclitaxel vs Weekly paclitaxel alone following doxorubicin…

Design

RCT

Follow-up

median 9.2 years

Authors

PAPooja AdvaniMayo Clinic KBKarla V. BallmanRutgers, The State University of New Jersey TDTravis DockterMayo Clinic

Discussion

Member takes

Implication

Minimal late cardiac events after trastuzumab support ongoing use; extends RCT evidence for low long-term risk in HER2-positive breast cancer.

Key Points

To evaluate the long-term cardiac safety of trastuzumab in women with HER2-positive early breast cancer.
Compared adjuvant doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in N9831 trial.
Evaluated cumulative incidence of cardiac events and left ventricular ejection fraction in 1,944 women post-AC therapy.
Identified risk factors for trastuzumab-induced cardiac toxicity using Cox regression models.
6-year cumulative incidence of cardiac events was 0.6% in arm A, 2.8% in arm B, and 3.4% in arm C.
At 9.2 years follow-up, only two additional CHF cases were reported among 1,046 patients.
Increased risk factors for cardiac events included age ≥ 60 years, LVEF < 65%, and antihypertensive medication use.

Structured PICO

Does the addition of trastuzumab to adjuvant chemotherapy increase the long-term risk of cardiac events in women with HER2-positive breast cancer?

Population

1,944 women with HER2-positive breast cancer who proceeded to post-doxorubicin and cyclophosphamide (AC) therapy

Intervention

Trastuzumab added to paclitaxel (either sequentially [arm B] or concurrently followed by trastuzumab alone [arm C])

Comparator

Weekly paclitaxel alone (arm A) following doxorubicin and cyclophosphamide

Outcome

Cumulative incidence of cardiac events (CE) and left ventricular ejection fraction (LVEF)safety

Long-term follow-up confirms that while trastuzumab increases the initial risk of cardiac events, late-onset cardiotoxicity is rare and LVEF typically recovers, supporting its favorable benefit-risk ratio.

Cite This Study

Advani et al. (2015) studied this question.

synapsesocial.com/papers/69fbd6c6df6507d4845ddacd https://doi.org/10.1200/jco.2015.61.8413

Topics

HFrEF treatment Women and heart disease Heart failure Cardiovascular prevention

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Implication

Minimal late cardiac events after trastuzumab support ongoing use; extends RCT evidence for low long-term risk in HER2-positive breast cancer.

Long-Term Cardiac Safety Analysis of NCCTG N9831 (Alliance) Adjuvant Trastuzumab Trial

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Topics

Long-Term Cardiac Safety Analysis of NCCTG N9831 (Alliance) Adjuvant Trastuzumab Trial

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

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