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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