Abstract
Background: Doxorubicin is a cornerstone drug for breast cancer treatment. Epi-
rubicin is an effective epimer of doxorubicin with less cardiotoxicity, and pegylated liposomal doxorubicin (PLD), is a liposomal formulation with lower toxicity than doxorubicin. We report the interim efficacy and safety results from the first phase II randomized trial aimed to compare PLD-based and epirubicin-based adjuvant chemotherapy for stage I-II Her2-negative breast cancer.
Methods: Eligible patients with Her2-negative stage I or II invasive breast adeno-
carcinoma were randomized 1:1 to receive adjuvant cyclophosphamide 600mg/m2 followed by pegylated liposomal-doxorubicin (Lipo-DoxÒ) 37.5mg/m2 Q3W, 5 cycles (LC arm) or epirubicin 90mg/m2 Q3W, 4 cycles (EC arm). Randomization was stratified by lymph node, ER & PR status. The primary endpoint was disease-free survival (DFS), and secondary endpoints were overall survival (OS), safety profiles, and quality of life (using EORTC QLQ-C30 & QLQ-BR23). The data cutoff date for the interim analysis was December 31, 2020.
Results: A total of 256 patients were randomized to LC (n¼148) and EC (n¼108).
There was no difference in 2-year DFS rate between 2 arms (LC: 0.96; EC: 0.97,
p¼0.59), regardless of whether taxane was used. There was no difference in 2-year OS, mean change in LVEF, and BNP from screening to treatment after 3 weeks be- tween the 2 arms. Compared to EC, there was less grade 3-4 AE in LC for: neutropenia (13.1% vs 34.3%), leukopenia (2.8% vs 24.8%), and vomiting (0 vs 3.8%) (All pThe major event in the LC arm are mucosal and dermal toxicities, whereas in the EC arm, the main toxicities are hematological and alopecia. The LC arm had a significantly better QoL score during and/or after treatment in symptoms including fatigue, nausea and vomiting, and systemic therapy side effects.
Conclusions: This interim analysis showed comparable efficacy and safety between adjuvant PLD and epirubicin for stage I-II Her2-negative breast cancer. In addition, less grade 3-4 AE and a trend of favorable QoL symptom scales were observed in the LC arm. Final analysis will be performed using longer survival data.
rubicin is an effective epimer of doxorubicin with less cardiotoxicity, and pegylated liposomal doxorubicin (PLD), is a liposomal formulation with lower toxicity than doxorubicin. We report the interim efficacy and safety results from the first phase II randomized trial aimed to compare PLD-based and epirubicin-based adjuvant chemotherapy for stage I-II Her2-negative breast cancer.
Methods: Eligible patients with Her2-negative stage I or II invasive breast adeno-
carcinoma were randomized 1:1 to receive adjuvant cyclophosphamide 600mg/m2 followed by pegylated liposomal-doxorubicin (Lipo-DoxÒ) 37.5mg/m2 Q3W, 5 cycles (LC arm) or epirubicin 90mg/m2 Q3W, 4 cycles (EC arm). Randomization was stratified by lymph node, ER & PR status. The primary endpoint was disease-free survival (DFS), and secondary endpoints were overall survival (OS), safety profiles, and quality of life (using EORTC QLQ-C30 & QLQ-BR23). The data cutoff date for the interim analysis was December 31, 2020.
Results: A total of 256 patients were randomized to LC (n¼148) and EC (n¼108).
There was no difference in 2-year DFS rate between 2 arms (LC: 0.96; EC: 0.97,
p¼0.59), regardless of whether taxane was used. There was no difference in 2-year OS, mean change in LVEF, and BNP from screening to treatment after 3 weeks be- tween the 2 arms. Compared to EC, there was less grade 3-4 AE in LC for: neutropenia (13.1% vs 34.3%), leukopenia (2.8% vs 24.8%), and vomiting (0 vs 3.8%) (All pThe major event in the LC arm are mucosal and dermal toxicities, whereas in the EC arm, the main toxicities are hematological and alopecia. The LC arm had a significantly better QoL score during and/or after treatment in symptoms including fatigue, nausea and vomiting, and systemic therapy side effects.
Conclusions: This interim analysis showed comparable efficacy and safety between adjuvant PLD and epirubicin for stage I-II Her2-negative breast cancer. In addition, less grade 3-4 AE and a trend of favorable QoL symptom scales were observed in the LC arm. Final analysis will be performed using longer survival data.
Original language | Undefined/Unknown |
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Pages (from-to) | S604 |
Journal | Annals of Oncology |
Volume | 33 |
DOIs | |
Publication status | Published - 2022 |