303P - Cardiac Safety Assessment of Adjuvant Nonpegylated Liposomal Doxorubicin (Npld) Plus Cyclophosphamide (C) Followed By Paclitaxel (P) in Elderly Breast Cancer (Ebc) Women

Abstract

ABSTRACT Background: doxorubicin is effective in early breast cancer but concerns about higher incidence of cardiac toxicity in older patients (pts) (Swain SM, Cancer 2003) have contributed to limit its use in this setting. NPLD is active in advanced disease and has much less cardiotoxicity than doxorubicin. Methods: In order to explore the feasibility of adjuvant NPLD in terms of cardiac safety, we are conducting a phase II pilot study in high risk EBC pts older than 65 years with NPLD 60mg/sqm day 1 plus C 600mg/sqm day 1 q 21 for 3 cycles followed by P 80 mg/sqm weekly for 9 weeks. Hormonal therapy and radiotherapy post chemotherapy when indicated. Cardiac safety is evaluated by comparison between the basal left ventricular ejection fraction (LVEF) assessed with echocardiogram (ECHO) and LVEF at the end of NPLD + C, after P and every 6 months for 2 years. Cardiac events are defined as appearance of congestive heart failure and/or grade 3-4 LVEF decline, asymptomatic LVEF decline below 50% or an absolute drop > 15%. Results: Up to today 47 pts have been enrolled with a median follow up of 11.0+ months (range 2.3+ - 28.0 +) Main pts characteristics are: median age = 73 (range, 67-83), ECOG-PS 0/1 = 38/9, basal LVEF >50% in all pts and no relevant cardiac co-morbidities. Basal median LVEF is 60% (range, 55%-76%). 141 cycles of NPLD + C have been administered. After NPLD + C the median LVEF is unchanged with a value of 60% (range, 56%-74%), as well as median LVEF after weekly P, with a value of 60% (range, 50%-72%). 18 pts were evaluable for LVEF at 6 months after the end of chemotherapy: median LVEF is unchanged with a value of 60% (range, 50%-69%). No pts had cardiac events as above defined. One patient discontinued NPLD + C after the first cycle for an episode of asymptomatic arrhythmia and one patient had a 10% drop of LVEF above 50%. Toxicities ≥3 were not observed. Conclusions: These preliminary data suggest the feasibility of adjuvant NPLD + C followed by P in EBC pts older than 65 years of age. Disclosure: All authors have declared no conflicts of interest.