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      Evaluation of cardiotoxicity of anthracycline‐containing chemotherapy regimens in patients with bone and soft tissue sarcomas: A study of the FDA adverse event reporting system joint single‐center real‐world experience

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          Abstract

          Objectives

          To assess the occurrence of cardiotoxicity in patients with tumors receiving anthracycline‐based chemotherapy, especially for sarcomas.

          Methods

          This study summarized the types and frequency of adverse events (AEs) for three anthracyclines from the FDA adverse event reporting system (FAERS) database. FAERS data from January 2004 to June 2022 were collected and analyzed. Disproportionality analyses, logistic regression, and descriptive analysis were used to compare the differences in cardiac disorders. A retrospective cohort study was conducted in a single center between December 2008 and May 2022. Our hospital‐treated patients with bone and soft tissue sarcomas (BSTSs) with anthracycline‐containing chemotherapy were analyzed. Serum markers, echocardiography, and electrocardiography have been used to evaluate cardiotoxic events.

          Results

          One hundred thousand and seventy‐five AE reports were obtained for doxorubicin (ADM), epirubicin (EPI), and liposome doxorubicin (L‐ADM) from the FAERS database. ADM (OR = 3.1, p < 0.001), EPI (OR = 1.5, p < 0.001), and sarcomas (OR = 1.8, p < 0.001) may increase the probability of cardiac disorders. Cardiac failure, cardiotoxicity, and cardiomyopathy were anthracyclines' top 3 frequent AEs. Among patients receiving ADM‐containing therapy, those with ADM applied at doses ≥75 mg/m 2/cycle were more likely to develop cardiac disorders than the other subgroups (OR = 3.5, p < 0.001). Patients younger than 18 are more likely to benefit from dexrazoxane prevention of cardiac failure. Six hundred and eighty‐three patients with BSTSs receiving anthracycline‐based chemotherapy were analyzed in our center. Patients receiving ADM‐containing chemotherapy were likelier to experience abnormalities in serum troponin‐T and left ventricular ejection fraction ( p < 0.05). 2.0% (6/300) of patients receiving ADM‐containing chemotherapy required adjustment of the chemotherapy regimen because of cardiotoxicity, whereas none were in the EPI or L‐ADM groups.

          Conclusions and Relevance

          Among patients receiving anthracycline‐containing therapy, patients with BSTSs were more likely to develop cardiac disorders than other tumors. In addition, patients with BSTSs receiving ADM chemotherapy had a higher likelihood of cardiotoxic events than those receiving EPI or L‐ADM.

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          Most cited references45

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          A new concept for macromolecular therapeutics in cancer chemotherapy: mechanism of tumoritropic accumulation of proteins and the antitumor agent smancs.

          We previously found that a polymer conjugated to the anticancer protein neocarzinostatin, named smancs, accumulated more in tumor tissues than did neocarzinostatin. To determine the general mechanism of this tumoritropic accumulation of smancs and other proteins, we used radioactive (51Cr-labeled) proteins of various molecular sizes (Mr 12,000 to 160,000) and other properties. In addition, we used dye-complexed serum albumin to visualize the accumulation in tumors of tumor-bearing mice. Many proteins progressively accumulated in the tumor tissues of these mice, and a ratio of the protein concentration in the tumor to that in the blood of 5 was obtained within 19 to 72 h. A large protein like immunoglobulin G required a longer time to reach this value of 5. The protein concentration ratio in the tumor to that in the blood of neither 1 nor 5 was achieved with neocarzinostatin, a representative of a small protein (Mr 12,000) in all time. We speculate that the tumoritropic accumulation of these proteins resulted because of the hypervasculature, an enhanced permeability to even macromolecules, and little recovery through either blood vessels or lymphatic vessels. This accumulation of macromolecules in the tumor was also found after i.v. injection of an albumin-dye complex (Mr 69,000), as well as after injection into normal and tumor tissues. The complex was retained only by tumor tissue for prolonged periods. There was little lymphatic recovery of macromolecules from tumor tissue. The present finding is of potential value in macromolecular tumor therapeutics and diagnosis.
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            Doxil®--the first FDA-approved nano-drug: lessons learned.

            Doxil®, the first FDA-approved nano-drug (1995), is based on three unrelated principles: (i) prolonged drug circulation time and avoidance of the RES due to the use of PEGylated nano-liposomes; (ii) high and stable remote loading of doxorubicin driven by a transmembrane ammonium sulfate gradient, which also allows for drug release at the tumor; and (iii) having the liposome lipid bilayer in a "liquid ordered" phase composed of the high-T(m) (53 °C) phosphatidylcholine, and cholesterol. Due to the EPR effect, Doxil is "passively targeted" to tumors and its doxorubicin is released and becomes available to tumor cells by as yet unknown means. This review summarizes historical and scientific perspectives of Doxil development and lessons learned from its development and 20 years of its use. It demonstrates the obligatory need for applying an understanding of the cross talk between physicochemical, nano-technological, and biological principles. However, in spite of the large reward, ~2 years after Doxil-related patents expired, there is still no FDA-approved generic "Doxil" available. Copyright © 2012 Elsevier B.V. All rights reserved.
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              Early detection of anthracycline cardiotoxicity and improvement with heart failure therapy.

              Three types of anthracycline-induced cardiotoxicities are currently recognized: acute, early-onset chronic, and late-onset chronic. However, data supporting this classification are lacking. We prospectively evaluated incidence, time of occurrence, clinical correlates, and response to heart failure therapy of cardiotoxicity.
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                Author and article information

                Contributors
                jiang_yu@scu.edu.cn
                Journal
                Cancer Med
                Cancer Med
                10.1002/(ISSN)2045-7634
                CAM4
                Cancer Medicine
                John Wiley and Sons Inc. (Hoboken )
                2045-7634
                06 December 2023
                December 2023
                : 12
                : 24 ( doiID: 10.1002/cam4.v12.24 )
                : 21709-21724
                Affiliations
                [ 1 ] Division of Medical Oncology, Cancer Center, West China Hospital Sichuan University Chengdu China
                [ 2 ] Department of Oncology The People's Hospital of Qiannan Duyun Guizhou China
                Author notes
                [*] [* ] Correspondence

                Yu Jiang, Division of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No.37 Guoxue Alley, Wuhou District, Chengdu City, Sichuan Province, China.

                Email: jiang_yu@ 123456scu.edu.cn

                Author information
                https://orcid.org/0000-0002-0476-7618
                https://orcid.org/0000-0002-6266-4449
                https://orcid.org/0000-0003-0716-4334
                Article
                CAM46730 CAM4-2023-08-4035.R1
                10.1002/cam4.6730
                10757145
                38054208
                60f544fa-2bc2-47b3-aaf4-23cf55b3db93
                © 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 24 October 2023
                : 18 August 2023
                : 07 November 2023
                Page count
                Figures: 6, Tables: 2, Pages: 16, Words: 7384
                Funding
                Funded by: Medical science and technology project of Sichuan Provincial Health Commission
                Award ID: 21PJ005
                Categories
                Research Article
                RESEARCH ARTICLES
                Clinical Cancer Research
                Custom metadata
                2.0
                December 2023
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.3.6 mode:remove_FC converted:30.12.2023

                Oncology & Radiotherapy
                adm,anthracyclines,bone and soft tissue sarcomas,cardiotoxicity,fda adverse event reporting system

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