OT2-01-04: Cardiac Safety of Anthracycline-Containing Adjuvant Chemotherapy of Early Breast Cancer: OSCAR/ABC Ongoing, Observational, Multicentric Study.

Abstract

Abstract BACKGROUND: Among the different chemotherapeutic options available for adjuvant treatment of early breast cancer (EBC), anthracycline-containing regimens represent prevalent choices. OSCAR/ABC is an observational, prospectic, multicentric study aimed at evaluating, in the clinical practice, the relevance of cardiac dysfunction and congestive heart failure (CHF) associated to “free choice”, anthracycline-containing adjuvant regimens and to identify patients at increased cardiac risk. PATIENTS AND METHODS: patients candidate to receive adjuvant anthracycline-containing chemotherapy, will be enrolled in the study. Data on demographic and clinical characteristics of patients (age, cardio-vascular comorbidity) tumor features (TNM, histotype, ER and PgR status, Ki67, and HER2 status), type of adjuvant regimen and tolerability of treatment will be collected and centrally registered at the Consorzio Interuniversitario Nazionale per ***1a Bio-Oncologia (CINBO) using e-CRFs. Data on type, sites and doses of radiotherapy performed will be collected, to evaluate the possible impact on cardiac function. Primary aim of the study is to evaluate the prevalence of cardiac dysfunction and CHF among the whole population enrolled, particularly according to risk criteria and type of administered chemotherapy. Cardiac dysfunction is defined as limiting cardio-vascular toxicity (≥ Grade 3 dyspnea, arrhytmia, hypertension) and/or asymptomatic LVEF reduction ≥20% (if >50% at the baseline) or ≥10% (if ≤50% at baseline); CHF is defined as clinical diagnosis and/or symptomatic LVEF reduction ≥20% (if >50% at the baseline) or ≥10% (if ≤50% at baseline). Assessment of cardiac risk involves the evaluation of age (< vs ≥ 65 years), cardio-vascular comorbidities (requiring treatment or not) and Left-Ventricular Ejection Fraction LVEF (> vs ≤ 55%) at diagnosis. Clinical and instrumental cardiac evaluation (ECG, Ecocardiography) will be performed at study entry, on-treatment and up to 5 years thereafter. Secondary objective of the study is to evaluate the clinical properness of different adjuvant anthracyclines-containing chemotherapy options, with regard to prevalence of therapeutic regimens, safety, efficacy (DFS and OS) and costs analysis. Cardiac safety and general toxicity on-treatment will be evaluated according to NCI criteria. The expected enrollment is 1,200 patients in 36 months. From September 2010 to May 2011, 7 of the 13 Centers involved in the study are active, with 65 enrolled patients. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr OT2-01-04.