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Pegylated Liposomal Doxorubicin

A Review of its use in Metastatic Breast Cancer, Ovarian Cancer, Multiple Myeloma and AIDS-Related Kaposi’s Sarcoma

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Abstract

Pegylated liposomal doxorubicin (Caelyx™, Doxil®) represents an improved formulation of conventional doxorubicin, with reduced cardiotoxicity and an improved pharmacokinetic profile. This article reviews the efficacy and tolerability of pegylated liposomal doxorubicin in metastatic breast cancer, progressive ovarian cancer, relapsed or refractory multiple myeloma and AIDS-related Kaosi’s sarcoma, as well as summarizing its pharmacological properties.

In three randomized, open-label, multicentre trials, monotherapy with pegylated liposomal doxorubicin was as effective as doxorubicin or capecitabine in the first-line treatment of metastatic breast cancer, and as effective as vinorelbine or combination mitomycin plus vinblastine in taxane-refractory metastatic breast cancer.

Pegylated liposomal doxorubicin alone was as effective as topotecan or gemcitabine alone in patients with progressive ovarian cancer resistant or refractory to platinum- or paclitaxel-based therapy, according to the results of three randomized multicentre trials. In addition, in patients with progressive ovarian cancer who had received prior platinum-based therapy, progression-free survival was significantly longer with pegylated liposomal doxorubicin plus carboplatin than with paclitaxel plus carboplatin, according to the results of a randomized, open-label multicentre trial.

Combination therapy with pegylated liposomal doxorubicin plus bortezomib was more effective than bortezomib alone in patients with relapsed or refractory multiple myeloma, according to the results of a randomized, open-label, multinational trial. Randomized multinational trials also demonstrated the efficacy of pegylated liposomal doxorubicin in patients with advanced AIDS-related Kaposi’s sarcoma.

Pegylated liposomal doxorubicin exhibited a relatively favourable safety profile compared with conventional doxorubicin and other available chemotherapy agents. The most common treatment-related adverse events included myelosuppression, palmar-plantar erythrodysesthesia and stomatitis, although these are manageable with appropriate supportive measures.

To conclude, pegylated liposomal doxorubicin is a useful option in the treatment of various malignancies, including metastatic breast cancer, ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma.

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    Sean T. Duggan & Gillian M. Keating

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Correspondence to Sean T. Duggan.

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Various sections of the manuscript reviewed by: G. Ferrandina, Department of Oncology, Catholic University of the Sacred Heart, Campobasso, Italy; J.P. Kesterson, Division of Gynecologic Oncology, Roswell Park Cancer Institute, Buffalo, NY, USA; D. Lorusso, Department of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome, Italy; F. Muggia, New York University Cancer Institute, New York University Langone Medical Center, New York, NY, USA.

Data Selection

Sources: Medical literature (including published and unpublished data) on ‘pegylated liposomal doxorubicin’ was identified by searching databases since 1992 (including MEDLINE and EMBASE and in-house AdisBase), bibliographies from published literature, clinical trial registries/databases and websites (including those of regional regulatory agencies and the manufacturer). Additional information (including contributory unpublished data) was also requested from the company developing the drug.

Search strategy: MEDLINE search terms were ‘doxorubicin’ and ‘pegylated’ and ‘liposomal’ and (‘breast cancer’ or ‘breast neoplasms’ or ‘ovarian cancer’ or ‘ovarian neoplasms’ or ‘myeloma’ or ‘multiple myeloma’). EMBASE search terms were ‘liposomal doxorubicin’ and ‘pegylated’ and (‘breast cancer’ or ‘ovarian cancer’ or ‘ovary cancer’ or ‘myeloma’ or ‘multiple myeloma’). AdisBase search terms were ‘pegylated liposomal doxorubicin’ and (‘breast cancer’ or ‘ovarian cancer’ or ‘myeloma’ or ‘multiple myeloma’). Searches were last updated on 21 November 2011.

Selection: Studies in patients with breast cancer, ovarian cancer or multiple myeloma who received pegylated liposomal doxorubicin. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Pegylated liposomal doxorubicin, metastatic breast cancer, ovarian cancer, multiple myeloma, Kaposi’s sarcoma, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.

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Duggan, S.T., Keating, G.M. Pegylated Liposomal Doxorubicin. Drugs 71, 2531–2558 (2011). https://doi.org/10.2165/11207510-000000000-00000

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