Long-Term Follow-up of Cardiac Function After Adjuvant Therapy With Trastuzumab in Early Breast Cancer
As reported by Ganz et al in the Journal of Clinical Oncology, long-term follow-up of patients in the National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-31/NRG Oncology trial showed no worsening of cardiac function or quality of life with the addition of adjuvant trastuzumab (Herceptin) to anthracycline and taxane chemotherapy in patients with node-positive HER2-positive early breast cancer.
Study Details
Patients in NSABP Protocol B-31 received adjuvant doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab. In the current analysis, patients who were alive and disease-free were evaluated for left-ventricular ejection fraction using multigated acquisition scans and for patient-reported outcomes using the Duke Activity Status Index (DASI), Medical Outcomes Study questionnaire, and review of current medications and comorbid conditions.
Long-Term Follow-up
Median follow-up was 8.8 years among eligible patients. Overall, 5 of 110 patients (4.5%) in the control group and 10 of 297 (3.4%) in the trastuzumab group had a > 10% decline in left-ventricular ejection fraction from baseline to a value < 50%. Lower DASI scores were associated with use at follow-up of medications for hypertension (P < .001), congestive heart failure (P < .001), diabetes (P = .02), and hyperlipidemia (P =003).
On a multivariate analysis, lower DASI scores were associated with increasing age at study entry (odds ratio [OR] = 1.10, P < .001) and use of hypertension medication at baseline (OR = 2.38, P = .007) but not with treatment group (OR = 0.59, P = .07, for trastuzumab vs control group). No significant differences were found between treatment groups in any individual cardiac symptom or condition or for overall comorbidity score.
The investigators concluded: “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.”
The study was supported by the National Cancer Institute, Breast Cancer Research Foundation, Susan G. Komen for the Cure, and Genentech.
Edward H. Romond, MD, of the Markey Cancer Center, University of Kentucky, Lexington, is the corresponding author of the Journal of Clinical Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
