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REFERENCES Agathocleous A, Rohatiner A, Rule S, et al, “Weekly Versus Twice Weekly Bortezomib Given in Conjunction With Rituximab, in Patients With Recurrent follicular Lymphoma, Mantle Cell Lymphoma and Waldenström Macroglobulinaemia,” Br J Haematol , 2010, 151(4):346-53. [PubMed 20880120 ] Andre P, Cisternino S, Chiadmi F, et al, “Stability of Bortezomib 1-mg/mL Solution in Plastic Syringe and Glass Vial,” Ann Pharmacother , 2005, 39(9):1462-6. [PubMed 15985470 ] Arnulf B, Pylypenko H, Grosicki S, et al, “Updated survival Analysis of a Randomized, Phase 3 Study of Subcutaneous versus Intravenous Bortezomib in Patients With Relapsed Multiple Myeloma,” Haematologica , 2012, 97(12):1925-8. [PubMed 22689676 ] Boccadoro M, Bringhen S, Gaidano G, et al, “Bortezomib, Melphalan, Prednisone, and Thalidomide (VMPT) Followed by Maintenance With Bortezomib and Thalidomide (VT) for Initial Treatment of Elderly Multiple Myeloma Patients,” J Clin Oncol , 2010, 28(7s):8013 [abstract 8013 from 2010 ASCO Annual Meeting]. Bringhen S, Larocca A, Rossi D, et al, “Efficacy and Safety of Once-Weekly Bortezomib in Multiple Myeloma Patients,” Blood , 2010, 116(23):4745-53. [PubMed 20807892 ] Cavo M, Pantani L, Petrucci MT, et al, “Bortezomib-Thalidomide-Dexamethasone Is Superior to Thalidomide-Dexamethasone as Consolidation Therapy After Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma,” Blood , 2012, 120(1):9-19. [PubMed 22498745 ] Cavo M, Tacchetti P, Patriarca F, et al, “Bortezomib With Thalidomide Plus Dexamethasone Compared With Thalidomide Plus Dexamethasone as Induction Therapy Before, and Consolidation Therapy After, Double Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: A Randomised Phase 3 Study,” Lancet , 2010, 376(9758):2075-85. [PubMed 21146205 ] Chanan-Khan AA, Kaufman JL, Mehta J, et al, “Activity and Safety of Bortezomib in Multiple Myeloma Patients With Advanced Renal Failure: A Multicenter Retrospective Study,” Blood , 2006, 109(9):2604-6. [PubMed 17138816 ] Chanan-Khan A, Sonneveld P, Schuster MW, et al, "Analysis of Herpes Zoster Events Among Bortezomib-Treated Patients in the Phase III APEX Study," J Clin Oncol , 2008, 26(29):4784-90. [PubMed 18711175 ]
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Fowler N, Kahl BS, Lee P, et al, “Bortezomib, Bendamustine, and Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma: The Phase II VERTICAL Study,” J Clin Oncol , 2011, 29(25):3389-95. [PubMed 21810687 ] Friedberg JW, Vose JM, Kelly JL, et al, “The Combination of Bendamustine, Bortezomib, and Rituximab for Patients With Relapsed/Refractory Indolent and Mantle Cell Non-Hodgkin Lymphoma,” Blood , 2011, 117(10):2807-12. [PubMed 21239695 ] Ghobrial IM, Hong F, Padmanabhan S, et al, “Phase II Trial of Weekly Bortezomib in Combination With Rituximab in Relapsed or Relapsed and Refractory Waldenstrom Macroglobulinemia,” J Clin Oncol , 2010, 28(8):1422-8. [PubMed 20142586 ] Gilbar PJ and Seger AC, “Fatalities Resulting From Accidental Intrathecal Administration of Bortezomib: Strategies for Prevention,” J Clin Oncol , 2012, 30(27):3427-8. [PubMed 22851559 ] Golden EB, Lam PY, Kardosh A, et al, “Green Tea Polyphenols Block the Anticancer Effects of Bortezomib and Other Boronic Acid-Based Proteasome Inhibitors,” Blood , 2009, 113(23):5927-37. [PubMed 19190249 ] Harousseau JL, Attal M, Avet-Loiseau H, et al, “Bortezomib Plus Dexamethasone is Superior to Vincristine Plus Doxorubicin Plus Dexamethasone as Induction Treatment Prior to Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: Results of the IFM 2005-01 Phase III Trial,” J Clin Oncol , 2010, 28(30):4621-9. [PubMed 20823406 ] Harousseau JL, Palumbo A, Richardson PG, et al, “Superior Outcomes Associated With Complete Response in Newly Diagnosed Multiple Myeloma Patients Treated With Nonintensive Therapy: Analysis of the Phase 3 VISTA Study of Bortezomib Plus Melphalan-Prednisone Versus Melphalan-Prednisone,” Blood , 2010, 116(19):3743-50. [PubMed 20628153 ] Iwamoto T, Ishibashi M, Fujieda A, et al, “Drug Interaction Between Itraconazole and Bortezomib: Exacerbation of Peripheral Neuropathy and Thrombocytopenia Induced by Bortezomib,” Pharmacotherapy , 2010, 30(7):661-5. [PubMed 20575631 ] Jacobson JO, Polovich M, McNiff KK, et al, “American Society of Clinical Oncology/ Oncology Nursing Society Chemotherapy Administration Safety Standards,” J Clin Oncol , 2009, 27(32):5469-75. [PubMed 19786650 ]
Iwamoto T, Ishibashi M, Fujieda A, et al, “Drug Interaction Between Itraconazole and Bortezomib: Exacerbation of Peripheral Neuropathy and Thrombocytopenia Induced by Bortezomib,” Pharmacotherapy , 2010, 30(7):661-5. [PubMed 20575631 ] Jacobson JO, Polovich M, McNiff KK, et al, “American Society of Clinical Oncology/ Oncology Nursing Society Chemotherapy Administration Safety Standards,” J Clin Oncol , 2009, 27(32):5469-75. [PubMed 19786650 ] Jagannath S, Barlogie B, Berenson JR, et al, “Bortezomib in Recurrent and/or Refractory Multiple Myeloma; Initial Clinical Experience in Patients With Impaired Renal Function,” Cancer , 2005, 103(6):1195-200. [PubMed 15690325 ] Kastritis E, Anagnostopoulos A, Bamias A, et al, “Reversibility of Renal Failure in Newly Diagnosed Patients With Multiple Myeloma Treated With High-Dose Dexamethasone Containing Regimens and the Impact of Novel Agents,” Blood , 2006, 108(11):3586 [abstract 3586 from 2006 ASH Annual Meeting]. Kastritis E, Wechalekar AD, Dimopoulos MA, et al, “Bortezomib With or Without Dexamethasone in Primary Systemic (Light Chain) Amyloidosis,” J Clin Oncol , 2010, 28(6):1031-7. [PubMed 20085941 ] Khan ML, Reeder CB, Kumar SK, et al, “A Comparison of Lenalidomide/Dexamethasone versus Cyclophosphamide/Lenalidomide/Dexamethasone versus Cyclophosphamide/Bortezomib/Dexamethasone in Newly Diagnosed Multiple Myeloma,” Br J Haematol , 2012, 156(3):326-33. [PubMed 22107129 ] Lamm W, Willenbacher W, Lang A, et al, "Efficacy of the Combination of Bortezomib and Dexamethasone in Systemic AL Amyloidosis," Ann Hematol , 2011, 90(2):201-6. [PubMed 20821326 ] Leal TB, Remick SC, Takimoto CH, et al, “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 Chemother Pharamcol , 2011, 68(6):1439-47. [PubMed 21479634 ] LoRusso PM, Venkatakrishnan K, Ramanathan RK, et al, “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,” Clin Cancer Res , 2012, 18(10):2954-63. [PubMed 22394984 ]
Leal TB, Remick SC, Takimoto CH, et al, “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 Chemother Pharamcol , 2011, 68(6):1439-47. [PubMed 21479634 ] LoRusso PM, Venkatakrishnan K, Ramanathan RK, et al, “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,” Clin Cancer Res , 2012, 18(10):2954-63. [PubMed 22394984 ] Mateos MV, Richardson PG, Schlag R, et al, “Bortezomib Plus Melphalan and Prednisone Compared With Melphalan and Prednisone in Previously Untreated Multiple Myeloma: Updated Follow-up and Impact of Subsequent Therapy in the Phase III VISTA Trial,” J Clin Oncol , 2010, 28(13):2259-66. [PubMed 20368561 ] Mikhael JR, Belch AR, Prince HM, et al, “High Response Rate to Bortezomib With or Without Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma: Results of a Global Phase 3b Expanded Access Program,” Br J Haematol , 2009, 144(2):169-75. [PubMed 19036114 ] Moreau P, Coiteux V, Hulin C, et al, “Prospective Comparison of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma,” Haematologica , 2008, 93(12):1908-11. [PubMed 18768528 ] Moreau P, Pylypenko H, Grosicki S, et al, “A Phase 3 Prospective Randomized International Study (MMY-3021) Comparing Subcutaneous and Intravenous Administration of Bortezomib In Patients With Relapsed Multiple Myeloma, Blood , 2010, 116(21):312 [abstract 312 from 2010 ASH Annual Meeting]. Moreau P, Pylypenko H, Grosicki S, et al, "Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Relapsed Multiple Myeloma: A Randomised, Phase 3, Non-Inferiority Study," Lancet Oncol , 2011, 12(5):431-40. [PubMed 21507715 ] National Institute for Occupational Safety and Health (NIOSH), "NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012." Available at file://www.cdc.gov/niosh/docs/2012-150/pdfs/2012-150.pdf . Accessed January 21, 2013. O'Connor OA, Wright J, Moskowitz C, et al “Phase II Clinical Experience With the Novel Proteasome Inhibitor Bortezomib in Patients With Indolent Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma,” J Clin Oncol , 2005, 23(4):676-84. [PubMed 15613699 ]
National Institute for Occupational Safety and Health (NIOSH), "NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012." Available at file://www.cdc.gov/niosh/docs/2012-150/pdfs/2012-150.pdf . Accessed January 21, 2013. O'Connor OA, Wright J, Moskowitz C, et al “Phase II Clinical Experience With the Novel Proteasome Inhibitor Bortezomib in Patients With Indolent Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma,” J Clin Oncol , 2005, 23(4):676-84. [PubMed 15613699 ] Orlowski RZ, Nagler A, Sonneveld P, et al, "Randomized Phase III Study of Pegylated Liposomal Doxorubicin Plus Bortezomib Compared With Bortezomib Alone in Relapsed or Refractory Multiple Myeloma: Combination Therapy Improves Time to Progression," J Clin Oncol , 2007, 25(25):3892-901. [PubMed 17679727 ] Palumbo A, Bringhen S, Rossi D, et al, “Bortezomib, Melphalan, Prednisone and Thalidomide (VMPT) Followed by Maintenance With Bortezomib and Thalidomide for Initial Treatment of Elderly Multiple Myeloma Patients,” Blood , 2009, 114(22):128 [abstract 128 from ASH 2009 Annual Meeting]. Pekol T, Daniels JS, Labutti J, et al, “Human Metabolism of the Proteasome Inhibitor Bortezomib: Identification of Circulating Metabolites,” Drug Metab Dispos , 2005, 33(6):771-7. [PubMed 15764713 ] Perrone G, Hideshima T, Ikeda H, et al, “Ascorbic Acid Inhibits Activity of Bortezomib in vivo ,” Leukemia , 2009, 23(9):1679-86. [PubMed 19369963 ] Reece DE, Hegenbart U, Sanchorawala V, et al, "Efficacy and Safety of Once-Weekly and Twice-Weekly Bortezomib in Patients With Relapsed Systemic AL Amyloidosis: Results of a Phase 1/2 Study," Blood , 2011. [PubMed 21562045 ] Reeder CB, Reece DE, Kukreti V, et al, “Once- versus Twice-Weekly Bortezomib Induction Therapy With CyBorD in Newly Diagnosed Multiple Myeloma," Blood , 2010, 115(16):3416-7. [PubMed 20413666 ] Richardson PG, Sonneveld P, Schuster M, et al, “Extended Follow-up of a Phase 3 Trial in Relapsed Multiple Myeloma: Final Time-to-Event Results of the APEX Trial,” Blood , 2007, 110(10):3557-60. [PubMed 17690257 ] Richardson PG, Sonneveld P, Schuster MW, et al, “Reversibility of Symptomatic Peripheral Neuropathy With Bortezomib in the Phase III APEX Trial in Relapsed Multiple Myeloma: Impact of a Dose-Modification Guideline,” Br J Haematol , 2009, 144(6):895-903. [PubMed 19170677 ]
Richardson PG, Sonneveld P, Schuster M, et al, “Extended Follow-up of a Phase 3 Trial in Relapsed Multiple Myeloma: Final Time-to-Event Results of the APEX Trial,” Blood , 2007, 110(10):3557-60. [PubMed 17690257 ] Richardson PG, Sonneveld P, Schuster MW, et al, “Reversibility of Symptomatic Peripheral Neuropathy With Bortezomib in the Phase III APEX Trial in Relapsed Multiple Myeloma: Impact of a Dose-Modification Guideline,” Br J Haematol , 2009, 144(6):895-903. [PubMed 19170677 ] Richardson PG, Sonneveld P, Schuster MW, et al, “Bortezomib or High-Dose Dexamethasone for Relapsed Multiple Myeloma,” N Engl J Med , 2005, 352(24):2487-98. [PubMed 15958804 ] San-Miguel JF, Richardson PG, Sonneveld P, et al, “Efficacy and Safety of Bortezomib in Patients With Renal Impairment: Results from the APEX Phase 3 Study,” Leukemia , 2008, 22(4):842-9. [PubMed 18200040 ] San Miguel JF, Schlag R, Khuageva N, et al, “Bortezomib Plus Melphalan and Prednisone for Initial Treatment of Multiple Myeloma,” N Engl J Med , 2008, 359(9):906-17. [PubMed 18753647 ] Sonneveld P, Schmidt-Wolf IG, van der Holt B, et al, “Bortezomib Induction and Maintenance Treatment in Patients With Newly Diagnosed Multiple Myeloma: Results of the Randomized Phase III HOVON-65/ GMMG-HD4 Trial,” J Clin Oncol , 2012, 30(24):2946-55. [PubMed 22802322 ] Treon SP, Ioakimidis L, Soumerai JD, et al, “Primary Therapy of Waldenström Macroglobulinemia With Bortezomib, Dexamethasone, and Rituximab: WMCTG Clinical Trial 05-180,” J Clin Oncol , 2009, 27(23):3830-5. [PubMed 19506160 ] Uttamsingh V, Lu C, Miwa G, et al, ”Relative Contributions of the Five Major Hyman Cytochromes P450, 1A2, 2C9, 2C19, and 3A4, to the Hepatic Metabolism of the Proteosome Inhibitor Bortezomib,” Drug Metab Dispos , 2005, 33(11):1723-8. [PubMed 16103134 ] Vanderloo JP, Pomplun ML, Vermeulen LC, et al, “Stability of Unused Reconstituted Bortezomib in Original Manufacturer Vials,” J Oncol Pharm Pract , 2011, 17(4):400-2. [PubMed 20926455 ] Zinzani PL, Musuraca G, Tani M, et al, “Phase II Trial of Proteasome Inhibitor Bortezomib in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma,” J Clin Oncol , 2007, 25(27):4293-7. [PubMed 17709797 ] Topic 8509 Version 44.0
Vanderloo JP, Pomplun ML, Vermeulen LC, et al, “Stability of Unused Reconstituted Bortezomib in Original Manufacturer Vials,” J Oncol Pharm Pract , 2011, 17(4):400-2. [PubMed 20926455 ] Zinzani PL, Musuraca G, Tani M, et al, “Phase II Trial of Proteasome Inhibitor Bortezomib in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma,” J Clin Oncol , 2007, 25(27):4293-7. [PubMed 17709797 ] Topic 8509 Version 44.0 © 2013 UpToDate, Inc. All rights reserved. | Subscription and License Agreement | Release: 21.6- C21.56 Licensed to: AsanBook Dig. Med. Lib. | Support Tag: [1003-200.167.4.114-B6D75EF485-S244013.14]