Tolerability and toxicological profile of pixantrone (Pixuvri®) in juvenile mice. Comparative study with doxorubicin

Reproductive Toxicology

Volumn 46, Issue , 2014, Pages 20-30

  Longo, Monica ^a   Torre, Paola Della ^a   Allievi, Cecilia ^b   Morisetti, Alberto ^b   Al Fayoumi, Suliman ^c   Singer, Jack W ^c  

^a Accelera Srl   (Italy)

^b Cell Therapeutics Inc ^*  (Italy)

^c Cell Therapeutics Inc   (United States)

Author keywords

Anticancer; Doxorubicin; Juvenile; Pixantrone; Pixuvri; Preclinical

Indexed keywords

CREATININE; DOXORUBICIN; NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN; PIXANTRONE; UREA; ANTINEOPLASTIC ANTIBIOTIC; GYRASE INHIBITOR; ISOQUINOLINE DERIVATIVE;

ANIMAL EXPERIMENT; ANIMAL TISSUE; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; BONE MARROW TOXICITY; CARDIOTOXICITY; COMPARATIVE STUDY; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DRUG BLOOD LEVEL; DRUG TOLERABILITY; DRUG TOXICITY; FEMALE; HEART WEIGHT; HISTOPATHOLOGY; JUVENILE ANIMAL; KIDNEY; LIVER; MALE; MAXIMUM PLASMA CONCENTRATION; MORTALITY; MOUSE; NEWBORN; NONHUMAN; PERINATAL PERIOD; REPRODUCTIVE TOXICITY; SURVIVAL; THYMUS DISEASE; UREA BLOOD LEVEL; ANIMAL; BONE MARROW; CHEMICALLY INDUCED; DRUG EFFECTS; HEART DISEASE; INSTITUTE FOR CANCER RESEARCH MOUSE; KIDNEY DISEASE; ORGAN SIZE; PATHOLOGY; TOXICITY;

ANIMALS; ANTIBIOTICS, ANTINEOPLASTIC; BODY WEIGHT; BONE MARROW; DOXORUBICIN; FEMALE; HEART DISEASES; ISOQUINOLINES; KIDNEY DISEASES; MALE; MICE; MICE, INBRED ICR; ORGAN SIZE; TOPOISOMERASE II INHIBITORS;

EID: 84896479365     PISSN: 08906238     EISSN: 18731708     Source Type: Journal    
DOI: 10.1016/j.reprotox.2014.02.006     Document Type: Article

References (24)

1. Hagemeister F.B. Treatment of relapsed aggressive lymphomas: regimens with and without high-dose therapy and stem cell rescue. Cancer Chemotherapy and Pharmacology 2002, 49:13-20.
2. Cavalletti E., Crippa L., Mainardi P., Oggioni N., Cavagnoli R., Bellini O., et al. Pixantrone (BBR 2778) has reduced cardiotoxic potential in mice pretreated with doxorubicin: comparative studies against doxorubicin and mitoxantrone. Investigational New Drugs 2007, 25:187-195.
3. Pettengell R., Bertrand C., Narayanan G., Hurtado de Mendoza F., Digumarti R., Gomez H., et al. Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre, open-label, randomised trial. Lancet Oncology 2012, 13:696-706.
4. Borchman P., Scnell R., Knippertz R., Staak J.O., Camboni M.G., Bernareggi A., et al. Phase I study of BBR 2778, a new aza-anthracenedione, in advanced or refractory non-Hodgkin's lymphoma. Annals of Oncology 2001, 12:661-667.
5. SEER Cancer Statistics Review, 1975-2004 2007, National Cancer Institute, Bethesda.
6. Izarzugaza M.I., Steliarova-Foucher E., Martos M.C., Zivkovic S. Non-Hodgkin's lymphoma incidence and survival in European children and adolescents (1978-1997): report from the automated childhood cancer information system project. European Journal of Cancer 2006, 42:2050-2063.
7. Zhu W., Show W., Payne R.M., Caldwell R., Field L.J. A mouse model for juvenile doxorubicin-induced cardiac dysfunction. Pediatric Research 2008, 64:488-494.
8. Huang C., Zhang X., Ramil J.M., Rikka S., Kim L., Lee Y., et al. Juvenile exposure to anthracyclines impairs cardiac progenitor cell function and vascularization resulting in greater susceptibility to stress-induced myocardial injury in adult mice. Circulation 2010, 121:675-683.
9. O'Brien P.J., Smith D.E.C., Knechtel T.J., Marchak M.A., Pruimboom-Brees I., Brees D.J., et al. Cardiac Troponin I is a sensitive, specific biomarker of cardiac injury in laboratory animals. Laboratory Animals 2006, 40:153-171.
10. Husdan H., Rapoporf A. Estimation of creatinine by the Jaffè reaction. Clinical Chemistry 1968, 14:222-238.
11. Mori K., Nakao K. Neutrophil gelatinase-associated lipocalin as the real-time indicator of active kidney damage. Kidney International 2007, 71:967-970.
12. Kuwabara T., Mori K., Mukoyama M., Kasahara M., Yokoi H., Saito Y., et al. Urinary neutrophil gelatinase-associated lipocalin levels reflect damage to glomeruli, proximal tubules, and distal nephrons. International Society of Nephrology 2009, 75:285-294.
13. Bertazzoli C., Bellini O., Magrini U., Tosana G. Quantitative experimental evaluation of adriamycin cardiotoxicity in the mouse. Cancer Treatment Reports 1979, 63:1877-1883.
14. Tang-Liu D.D.-S., Burke P.J. The effect of azone on ocular levobunolol absorption: calculating the area under the curve and its standard error using tissue sampling compartments. Pharmaceutical Research 1988, 5:238-241.
15. FDA guidance for industry nonclinical safety evaluation of pediatric drug products CDER February. Pharmacology and Toxicology 2006.
16. European Medicines Agency Guideline on the Need for Non-clinical Testing in Juvenile Animals of Pharmaceuticals for Pediatric Indications 2008, London, [Doc. Ref. EMEA/CHMP/SWP/169215/2005].
17. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), E 11: Clinical Investigation of Medicinal Products in the Paediatric Population - Step 5 2001, [CPMP/ICH/2711/99].
18. Mitchell K.M., Futscher B.W., McQueen C.A. Developmental expression of N-acetyltransferases in C57BI/6 mice. Drug Metabolism & Disposition 1999, 27:261-264.
19. Estrada L., Kanelakis K.C., Levy G.N., Weber W.W. Tissue- and gender-specific expression of N-acetyltransferase 2 (Nat2*) during development of the outbred mouse strain CD-1. Drug Metabolism & Disposition 2000, 28:139-146.
20. Saghir S.A., Khan S.A., McCoy A.T. Ontogeny of mammalian metabolizing enzymes in humans and animals used in toxicological studies. Critical Reviews in Toxicology 2012, 42:323-357.
21. Freireich E.J., Gehan E.A., Rall D.P., Schmidt L.H., Skipper H.E. Quantitative comparison of toxicity of anticancer agents in mouse, rat, hamster, dog, monkey, and man. Cancer Chemotherapy Reports 1966, 50:219-245.
22. FDA guidance for industry estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers CDER. Pharmacology & Toxicology 2005.
23. 2000 CDC Growth Charts for the United States: Methods and Development 2002, Department of Health and Human Services. Centers for Disease Control and Prevention. National Center for Health Statistics. Vital and Health Statistics Series 11N.246, http://www.cdc.gov/growthcharts/2000growthchart-us.pdf.
24. Routledge P.A. Pharmacokinetics in children. Journal of Antimicrobial Chemotherapy 1994, 34:19-24.