142P Effectiveness and safety of pegylated liposomal doxorubicin- cyclophosphamide vs. epirubicin-cyclophosphamide as adjuvant chemotherapy for stage I and II HER2-negative breast cancer: An interim analysis of phase II randomized trial

BackgroundDoxorubicin is a cornerstone drug for breast cancer treatment. Epirubicin an effective epimer of doxorubicin with less cardiotoxicity, and pegylated liposomal (PLD), formulation lower toxicity than doxorubicin. We report the interim efficacy safety results from first phase II randomized trial aimed to compare PLD-based epirubicin-based adjuvant chemotherapy stage I-II Her2-negative cancer.MethodsEligible patients I or invasive adenocarcinoma were 1:1 receive cyclophosphamide 600mg/m2 followed by liposomal-doxorubicin (Lipo-Dox®) 37.5mg/m2 Q3W, 5 cycles (LC arm) epirubicin 90mg/m2 4 (EC arm). Randomization was stratified lymph node, ER & PR status. The primary endpoint disease-free survival (DFS), secondary endpoints overall (OS), profiles, quality life (using EORTC QLQ-C30 QLQ-BR23). data cutoff date analysis December 31, 2020.ResultsA total 256 LC (n=148) EC (n=108). There no difference in 2-year DFS rate between 2 arms (LC: 0.96; EC: 0.97, p=0.59), regardless whether taxane used. OS, mean change LVEF, BNP screening treatment after 3 weeks arms. Compared EC, there grade 3-4 AE for: neutropenia (13.1% vs 34.3%), leukopenia (2.8% 24.8%), vomiting (0 3.8%) (All p<0.05). major event arm are mucosal dermal toxicities, whereas arm, main toxicities hematological alopecia. had significantly better QoL score during and/or symptoms including fatigue, nausea vomiting, systemic therapy side effects.ConclusionsThis showed comparable PLD cancer. In addition, trend favorable symptom scales observed arm. Final will be performed using longer data.Clinical identificationNCT01210768. First posted: September 28, 2010.Legal entity responsible studyTTY Biopharm Company Ltd.FundingTTY Ltd.DisclosureAll authors have declared conflicts interest. Doxorubicin MethodsEligible 2020. Eligible ResultsA effects. A ConclusionsThis data. This