Key result
The addition of trastuzumab to adjuvant anthracycline and taxane-based chemotherapy did not result in long-term worsening of cardiac function, with significant LVEF decline occurring in 3.4% of the trastuzumab group compared to 4.5% of the control group.
Why the study?
Does the addition of trastuzumab to adjuvant anthracycline and taxane-based chemotherapy worsen long-term cardiac function and quality of life in patients with HER2-positive early-stage breast cancer?
RCT (n=407)
Open-label
Yes
Yes
Does the addition of trastuzumab to adjuvant anthracycline and taxane-based chemotherapy worsen long-term cardiac function and quality of life in patients with HER2-positive early-stage breast cancer?
Absolute Event Rate: 3.4% vs 4.5%
The addition of trastuzumab to adjuvant chemotherapy for HER2-positive breast cancer does not cause long-term worsening of cardiac function or quality of life in patients without baseline cardiac disease.
May support trastuzumab cardiac safety in HER2-positive disease; leaves open prospective randomized confirmation of long-term outcomes.
Purpose Early cardiac toxicity is a risk associated with adjuvant chemotherapy plus trastuzumab. However, objective measures of cardiac function and health-related quality of life are lacking in long-term follow-up of patients who remain cancer free after completion of adjuvant treatment. Patients and Methods Patients in NSABP Protocol B-31 received anthracycline and taxane chemotherapy with or without trastuzumab for adjuvant treatment of node-positive, human epidermal growth factor receptor 2-positive early-stage breast cancer. A long-term follow-up assessment was undertaken for patients who were alive and disease free, which included measurement of left ventricular ejection fraction by multigated acquisition scan along with patient-reported outcomes using the Duke Activity Status Index (DASI), the Medical Outcomes Study questionnaire, and a review of current medications and comorbid conditions. Results At a median follow-up of 8.8 years among eligible participants, five (4.5%) of 110 in the control group and 10 (3.4%) of 297 in the trastuzumab group had a > 10% decline in left ventricular ejection fraction from baseline to a value < 50%. Lower DASI scores correlated with age and use of medications for hypertension, cardiac conditions, diabetes, and hyperlipidemia, but not with whether patients had received trastuzumab. Conclusion In patients without underlying cardiac disease at baseline, the addition of trastuzumab to adjuvant anthracycline and taxane-based chemotherapy does not result in long-term worsening of cardiac function, cardiac symptoms, or health-related quality of life. The DASI questionnaire may provide a simple and useful tool for monitoring patient-reported changes that reflect cardiac function.
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Ganz et al. (2017) conducted an RCT in Node-positive, HER2-positive early-stage breast cancer (n=407). Trastuzumab vs. Doxorubicin and cyclophosphamide (AC) followed by paclitaxel was evaluated on Significant LVEF decline (absolute drop from baseline ≥ 10% to a value < 50%) at long-term follow-up. The addition of trastuzumab to adjuvant anthracycline and taxane-based chemotherapy did not result in long-term worsening of cardiac function, with significant LVEF decline occurring in 3.4% of the trastuzumab group compared to 4.5% of the control group.
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