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LONG TREM SAFETY OF HERCEPTIN

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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 (< .001), congestive heart failure (P < .001), diabetes (= .02), and hyperlipidemia (=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.”

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