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Randomized Controlled Trial
. 2017 Dec 10;35(35):3942-3948.
doi: 10.1200/JCO.2017.74.1165. Epub 2017 Oct 26.

Long-Term Follow-Up of Cardiac Function and Quality of Life for Patients in NSABP Protocol B-31/NRG Oncology: A Randomized Trial Comparing the Safety and Efficacy of Doxorubicin and Cyclophosphamide (AC) Followed by Paclitaxel With AC Followed by Paclitaxel and Trastuzumab in Patients With Node-Positive Breast Cancer With Tumors Overexpressing Human Epidermal Growth Factor Receptor 2

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Free PMC article
Randomized Controlled Trial

Long-Term Follow-Up of Cardiac Function and Quality of Life for Patients in NSABP Protocol B-31/NRG Oncology: A Randomized Trial Comparing the Safety and Efficacy of Doxorubicin and Cyclophosphamide (AC) Followed by Paclitaxel With AC Followed by Paclitaxel and Trastuzumab in Patients With Node-Positive Breast Cancer With Tumors Overexpressing Human Epidermal Growth Factor Receptor 2

Patricia A Ganz et al. J Clin Oncol. .
Free PMC article

Abstract

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.

Figures

Fig 1.
Fig 1.
Flow of participants of NSABP (National Surgical Adjuvant Breast and Bowel Project) B-31 long-term cardiac follow-up. AC, doxorubicin and cyclophosphamide; H, trastuzumab; LTF, long-term follow-up; MUGA, multigated acquisition; P, paclitaxel; PRO, patient-reported outcome.
Fig 2.
Fig 2.
Mean left ventricular ejection fraction (LVEF) measurements over time for National Surgical Adjuvant Breast and Bowel Project B-31 long-term cardiac follow-up participants and those who were eligible but did not consent. Vertical bars represent 95% CIs. AC, doxorubicin and cyclophosphamide; H, trastuzumab; LTF, long-term follow-up; P, paclitaxel.

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