Pharmacokinetic, pharmacodynamic and covariate analysis of subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma.
作者： Philippe Moreau , Ievgenii I. Karamanesht , Natalia Domnikova , Maryna Y. Kyselyova , Kateryna V. Vilchevska
DOI: 10.1007/S40262-012-0010-0
关键词:
摘要: Background and Objectives The proteasome inhibitor bortezomib is approved for the treatment of multiple myeloma (MM) and, in US, mantle cell lymphoma following at least one prior therapy; recommended dose schedule 1.3 mg/m2 on days 1, 4, 8 11 21-day cycles, routes administration US prescribing information are by intravenous a recent update, subcutaneous injection. Findings from phase III study demonstrated that bortezomib, using same schedule, resulted similar efficacy with an improved systemic safety profile (including significantly lower rates peripheral neuropathy) versus patients relapsed MM. The objectives this report were to present comprehensive analysis pharmacokinetics pharmacodynamics evaluate impact site, injection concentration demographic characteristics pharmacodynamics.
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Ashok Nimgade, Stefan H. Thomke, Millennium Pharmaceuticals, Inc. (A) ,(1999)
Eric S Lightcap, Teresa A McCormack, Christine S Pien, Vincent Chau, Julian Adams, Peter J Elliott, Proteasome Inhibition Measurements: Clinical Application Clinical Chemistry. ,vol. 46, pp. 673- 683 ,(2000) , 10.1093/CLINCHEM/46.5.673
Andrzej Hellmann, Simon Rule, Jan Walewski, Ofer Shpilberg, Huaibao Feng, Helgi van de Velde, Hamina Patel, Donna M. Skee, Suzette Girgis, Vernon J. Louw, Effect of cytochrome P450 3A4 inducers on the pharmacokinetic, pharmacodynamic and safety profiles of bortezomib in patients with multiple myeloma or non-Hodgkin's lymphoma. Clinical Pharmacokinectics. ,vol. 50, pp. 781- 791 ,(2011) , 10.2165/11594410-000000000-00000
Ticiana B. Leal, Scot C. Remick, Chris H. Takimoto, Ramesh K. Ramanathan, Angela Davies, Merrill J. Egorin, Anne Hamilton, Patricia A. LoRusso, Stephen Shibata, Heinz-Josef Lenz, James Mier, John Sarantopoulos, Sridhar Mani, John J. Wright, S. Percy Ivy, Rachel Neuwirth, Lisa von Moltke, Karthik Venkatakrishnan, Daniel Mulkerin, Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study Cancer Chemotherapy and Pharmacology. ,vol. 68, pp. 1439- 1447 ,(2011) , 10.1007/S00280-011-1637-5
Karthik Venkatakrishnan, Michael Rader, Ramesh K. Ramanathan, Suresh Ramalingam, Eric Chen, William Riordan, William Trepicchio, Michael Cooper, Michael Karol, Lisa von Moltke, Rachel Neuwirth, Merrill Egorin, Gurkamal Chatta, Effect of the CYP3A inhibitor ketoconazole on the pharmacokinetics and pharmacodynamics of bortezomib in patients with advanced solid tumors: a prospective, multicenter, open-label, randomized, two-way crossover drug-drug interaction study. Clinical Therapeutics. ,vol. 31, pp. 2444- 2458 ,(2009) , 10.1016/J.CLINTHERA.2009.11.012
David I. Quinn, John Nemunaitis, Jyotsna Fuloria, Carolyn D. Britten, Nashat Gabrail, Lorrin Yee, Milin Acharya, Kai Chan, Nadine Cohen, Assen Dudov, Effect of the Cytochrome P450 2C19 Inhibitor Omeprazole on the Pharmacokinetics and Safety Profile of Bortezomib in Patients with Advanced Solid Tumours, Non-Hodgkin’s Lymphoma or Multiple Myeloma Clinical Pharmacokinectics. ,vol. 48, pp. 199- 209 ,(2009) , 10.2165/00003088-200948030-00006
Philip R. Greipp, Jesus San Miguel, Brian G.M. Durie, John J. Crowley, Bart Barlogie, Joan Bladé, Mario Boccadoro, J. Anthony Child, Hervé Avet-Loiseau, Robert A. Kyle, Juan J. Lahuerta, Heinz Ludwig, Gareth Morgan, Raymond Powles, Kazuyuki Shimizu, Chaim Shustik, Pieter Sonneveld, Patrizia Tosi, Ingemar Turesson, Jan Westin, International staging system for multiple myeloma. Journal of Clinical Oncology. ,vol. 23, pp. 3412- 3420 ,(2005) , 10.1200/JCO.2005.04.242
P. Moreau, V. Coiteux, C. Hulin, X. Leleu, H. van de Velde, M. Acharya, J.-L. Harousseau, Prospective comparison of subcutaneous versus intravenous administration of bortezomib in patients with multiple myeloma Haematologica. ,vol. 93, pp. 1908- 1911 ,(2008) , 10.3324/HAEMATOL.13285
Patricia M. LoRusso, Karthik Venkatakrishnan, Ramesh K. Ramanathan, John Sarantopoulos, Daniel Mulkerin, Stephen I. Shibata, Anne Hamilton, Afshin Dowlati, Sridhar Mani, Michelle A. Rudek, Chris H. Takimoto, Rachel Neuwirth, Dixie-Lee Esseltine, Percy Ivy, Pharmacokinetics and Safety of Bortezomib in Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction: Phase I NCI Organ Dysfunction Working Group Study NCI-6432 Clinical Cancer Research. ,vol. 18, pp. 2954- 2963 ,(2012) , 10.1158/1078-0432.CCR-11-2873
Jeanette Lundin, Eva Kimby, Magnus Björkholm, Per-Anders Broliden, Fredrik Celsing, Viktoria Hjalmar, Lars Möllgård, Peppy Rebello, Geoff Hale, Herman Waldmann, Håkan Mellstedt, Anders Österborg, Phase II trial of subcutaneous anti-CD52 monoclonal antibody alemtuzumab (Campath-1H) as first-line treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL). Blood. ,vol. 100, pp. 768- 773 ,(2002) , 10.1182/BLOOD-2002-01-0159