Reduced Cardiotoxicity and Comparable Efficacy in a Phase III Trial of Pegylated Liposomal Doxorubicin HCl (CAELYX/Doxil) Versus Conventional Doxorubicin for First-Line Treatment of Metastatic Breast Cancer

    March 2004 in “ Annals of oncology
    Mary O’Brien, N. Wigler, Moshe Inbar, Riccardo Rosso, Eva‐Maria Grischke, Armando Santoro, Raphael Catane, D. G. Kieback, Piotr Tomczak, Stephen P. Ackland, F. Orlandi, L. Mellars, Leila Alland, Craig Tendler
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    TLDR Pegylated liposomal doxorubicin is as effective as conventional doxorubicin but causes fewer heart problems and side effects.
    In a phase III trial involving 509 women with metastatic breast cancer, pegylated liposomal doxorubicin (PLD) demonstrated comparable efficacy to conventional doxorubicin in terms of progression-free survival (6.9 vs. 7.8 months) and overall survival (21 vs. 22 months). However, PLD significantly reduced the risk of cardiotoxicity (HR = 3.16; P<0.001) and had fewer side effects such as alopecia (20% vs. 66%), nausea (37% vs. 53%), vomiting (19% vs. 31%), and neutropenia (4% vs. 10%). Despite higher rates of palmar-plantar erythrodysesthesia, stomatitis, and mucositis, PLD offered a safer profile with similar efficacy compared to conventional doxorubicin for treating metastatic breast cancer.
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