Abstract
Doxorubicin (DOX) is an anthracycline widely used for the treatment of solid and hematological tumors. The aim of this study was to assess the adverse event profiles of conventional DOX and liposomal DOX. This is the first study to evaluate the effect of a liposomal formulation of DOX using spontaneous reporting system (SRS) databases. The SRS used was the US Food and Drug Administration Adverse Event Reporting System (FAERS). This study relied on definitions of preferred terms provided by the Medical Dictionary for Regulatory Activities (MedDRA) and the standardized MedDRA Queries (SMQ) database. We also calculated the reporting odds ratios (RORs) of suspected drugs (conventional DOX; PEGylated-liposome DOX; non-PEGylated-liposome DOX). The FAERS database contained 7,561,254 reports from January 2004 to December 2015. The number of reported AE cases for conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX was 5039, 3780, and 349, respectively. Conventional DOX and liposomal DOX have potential risks of causing myelosuppression, cardiotoxicity, alopecia, nausea, and vomiting, among other effects. The RORs (95% CI) from SMQ for haematopoietic leucopenia associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 12.75 (11.89–13.68), 6.43 (5.81–7.13), and 14.73 (11.42–18.99), respectively. Liposomal DOX formulations were associated with lower RORs with regard to myelosuppression, cardiotoxicity, and alopecia than the conventional DOX was. The RORs (95% CI) for palmar-plantar erythrodysesthesia (PPE) associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 6.56 (4.74–9.07), 64.77 (56.84–73.80), and 28.76 (15.77–52.45), respectively. This study is the first to evaluate the relationship between DOX liposomal formulations and their adverse event profiles. The results indicate that careful observation for PPE is recommended with the use of liposomal DOX, especially PEGylated-liposome DOX formulations.
Highlights
Doxorubicin (DOX) is an anthracycline widely used for the treatment of solid and hematological tumors such as metastatic breast cancer, advanced ovarian cancer, acquired immunodeficiency syndrome-related Kaposi’s sarcoma, and acute myeloblastic leukemia
The reporting odds ratios (RORs) for cardiotoxicity associated with the use of conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 24.73 (17.50–34.94), 8.82 (4.58–17.00), and not applicable, respectively, whereas the corresponding values for alopecia were 2.24 (1.79–2.80), 1.09 (0.75–1.57), and 0.81 (0.20–3.25), respectively
The RORs of standardized MedDRA Queries (SMQ) for haematopoietic leucopenia associated with the use of conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 12.75 (11.89– 13.68), 6.43 (5.81–7.13), and 14.73 (11.42–18.99), respectively
Summary
Doxorubicin (DOX) is an anthracycline widely used for the treatment of solid and hematological tumors such as metastatic breast cancer, advanced ovarian cancer, acquired immunodeficiency syndrome-related Kaposi’s sarcoma, and acute myeloblastic leukemia. Due to the insufficient tissue preference of conventional DOX, it is distributed to the entire body. Conventional DOX is toxic to most major organs and causes a number of serious side effects including cardiotoxicity, hematological disorders, and myelosuppression [1]. The most challenging issue in pharmaceutical engineering is the development of new drug delivery systems (DDSs), which enhance the therapeutic effects of drugs and reduce drug toxicity to organs. These systems usually work by either increasing drug concentration in tumor cells or decreasing the exposure of normal tissues to drugs. Several liposomal formulations of DOX (liposomal DOX) are available for clinical use [2]
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