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Gällande vårdprogram myelom

Fastställt av Regionala cancercentrum i samverkan 2018-02-27.

22. Referenser

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8.Kastritis E, Terpos E, Moulopoulos L, Spyropoulou-Vlachou M, Kanellias N, Eleftherakis-Papaiakovou E, et al. Extensive bone marrow infiltration and abnormal free light chain ratio identifies patients with asymptomatic myeloma at high risk for progression to symptomatic disease. Leukemia. 2013;27(4):947-53.

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17.Kyle RA, Durie BG, Rajkumar SV, Landgren O, Blade J, Merlini G, et al. Monoclonal gammopathy of undetermined significance (MGUS) and smoldering (asymptomatic) multiple myeloma: IMWG consensus perspectives risk factors for progression and guidelines for monitoring and management. Leukemia. 2010;24(6):1121-7.

18.Turesson I, Kovalchik SA, Pfeiffer RM, Kristinsson SY, Goldin LR, Drayson MT, et al. Monoclonal gammopathy of undetermined significance and risk of lymphoid and myeloid malignancies: 728 cases followed up to 30 years in Sweden. Blood. 2014;123(3):338-45.

19.Perez-Persona E, Vidriales MB, Mateo G, Garcia-Sanz R, Mateos MV, de Coca AG, et al. New criteria to identify risk of progression in monoclonal gammopathy of uncertain significance and smoldering multiple myeloma based on multiparameter flow cytometry analysis of bone marrow plasma cells. Blood. 2007;110(7):2586-92.

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24.Fayers PM, Palumbo A, Hulin C, Waage A, Wijermans P, Beksac M, et al. Thalidomide for previously untreated elderly patients with multiple myeloma: meta-analysis of 1685 individual patient data from 6 randomized clinical trials. Blood. 2011;118(5):1239-47.

25.Rawstron AC, Orfao A, Beksac M, Bezdickova L, Brooimans RA, Bumbea H, et al. Report of the European Myeloma Network on multiparametric flow cytometry in multiple myeloma and related disorders. Haematologica. 2008;93(3):431-8.

26.Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Grishunina M, et al. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. The Lancet Oncology. 2011;12(5):431-40.

27.Morabito F, Bringhen S, Larocca A, Wijermans P, Victoria Mateos M, Gimsing P, et al. Bortezomib, melphalan, prednisone (VMP) versus melphalan, prednisone, thalidomide (MPT) in elderly newly diagnosed multiple myeloma patients: A retrospective case-matched study. American journal of hematology. 2014;89(4):355-62.

28.Mateos MV, Oriol A, Martinez-Lopez J, Gutierrez N, Teruel AI, de Paz R, et al. Bortezomib, melphalan, and prednisone versus bortezomib, thalidomide, and prednisone as induction therapy followed by maintenance treatment with bortezomib and thalidomide versus bortezomib and prednisone in elderly patients with untreated multiple myeloma: a randomised trial. The Lancet Oncology. 2010;11(10):934-41.

29.Morgan GJ, Davies FE, Gregory WM, Russell NH, Bell SE, Szubert AJ, et al. Cyclophosphamide, thalidomide, and dexamethasone (CTD) as initial therapy for patients with multiple myeloma unsuitable for autologous transplantation. Blood. 2011;118(5):1231-8.

30.Song MK, Chung JS, Shin HJ, Moon JH, Lee JJ, Yoon SS, et al. Cyclophosphamide-containing regimen (TCD) is superior to melphalan-containing regimen (MPT) in elderly multiple myeloma patients with renal impairment. Annals of hematology. 2012;91(6):889-96.

31.Palumbo A, Hajek R, Delforge M, Kropff M, Petrucci MT, Catalano J, et al. Continuous lenalidomide treatment for newly diagnosed multiple myeloma. The New England journal of medicine. 2012;366(19):1759-69.

32.Zweegman S, van der Holt B, Mellqvist UH, Salomo M, Bos GM, Levin MD, et al. Melphalan, prednisone, and lenalidomide versus melphalan, prednisone, and thalidomide in untreated multiple myeloma. Blood. 2016;127(9):1109-16.

33.Reeder CB, Reece DE, Kukreti V, Chen C, Trudel S, Laumann K, et al. Once- versus twice-weekly bortezomib induction therapy with CyBorD in newly diagnosed multiple myeloma. Blood. 2010;115(16):3416-7.

34.Facon T ea. Final analysis of overall survival from the FIRST-trial.  ASH Annual meeting; San Diego2016. p. 128(22).

35.Durie BG, Hoering A, Abidi MH, Rajkumar SV, Epstein J, Kahanic SP, et al. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial. Lancet (London, England). 2017;389(10068):519-27.

36.Sonneveld P, Avet-Loiseau H, Lonial S, Usmani S, Siegel D, Anderson KC, et al. Treatment of multiple myeloma with high-risk cytogenetics: a consensus of the International Myeloma Working Group. Blood. 2016;127(24):2955-62.

37.Kumar S, Flinn I, Richardson PG, Hari P, Callander N, Noga SJ, et al. Randomized, multicenter, phase 2 study (EVOLUTION) of combinations of bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in previously untreated multiple myeloma. Blood. 2012;119(19):4375-82.

38.Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, et al. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. The New England journal of medicine. 1996;335(2):91-7.

39.Child JA, Morgan GJ, Davies FE, Owen RG, Bell SE, Hawkins K, et al. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. The New England journal of medicine. 2003;348(19):1875-83.

40.Cavo M, Tacchetti P, Patriarca F, Petrucci MT, Pantani L, Galli M, 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 (London, England). 2010;376(9758):2075-85.

41.Sonneveld P, Schmidt-Wolf IG, van der Holt B, El Jarari L, Bertsch U, Salwender H, 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. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2012;30(24):2946-55.

42.Ludwig H, Viterbo L, Greil R, Masszi T, Spicka I, Shpilberg O, et al. Randomized phase II study of bortezomib, thalidomide, and dexamethasone with or without cyclophosphamide as induction therapy in previously untreated multiple myeloma. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2013;31(2):247-55.

43.Rosinol L, Oriol A, Teruel AI, Hernandez D, Lopez-Jimenez J, de la Rubia J, et al. Superiority of bortezomib, thalidomide, and dexamethasone (VTD) as induction pretransplantation therapy in multiple myeloma: a randomized phase 3 PETHEMA/GEM study. Blood. 2012;120(8):1589-96.

44.Moreau P, Avet-Loiseau H, Facon T, Attal M, Tiab M, Hulin C, et al. Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma. Blood. 2011;118(22):5752-8; quiz 982.

45.Cavo M, Pantani L, Pezzi A, Petrucci MT, Patriarca F, Di Raimondo F, et al. Bortezomib-thalidomide-dexamethasone (VTD) is superior to bortezomib-cyclophosphamide-dexamethasone (VCD) as induction therapy prior to autologous stem cell transplantation in multiple myeloma. Leukemia. 2015;29(12):2429-31.

46.Bensinger WI, Jagannath S, Vescio R, Camacho E, Wolf J, Irwin D, et al. Phase 2 study of two sequential three-drug combinations containing bortezomib, cyclophosphamide and dexamethasone, followed by bortezomib, thalidomide and dexamethasone as frontline therapy for multiple myeloma. British journal of haematology. 2010;148(4):562-8.

47.Reeder CB, Reece DE, Kukreti V, Chen C, Trudel S, Hentz J, et al. Cyclophosphamide, bortezomib and dexamethasone induction for newly diagnosed multiple myeloma: high response rates in a phase II clinical trial. Leukemia. 2009;23(7):1337-41.

48.Roussel M, Lauwers-Cances V, Robillard N, Hulin C, Leleu X, Benboubker L, et al. Front-line transplantation program with lenalidomide, bortezomib, and dexamethasone combination as induction and consolidation followed by lenalidomide maintenance in patients with multiple myeloma: a phase II study by the Intergroupe Francophone du Myelome. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2014;32(25):2712-7.

49.Attal M, Lauwers-Cances V, Hulin C, Leleu X, Caillot D, Escoffre M, et al. Lenalidomide, Bortezomib, and Dexamethasone with Transplantation for Myeloma. The New England journal of medicine. 2017;376(14):1311-20.

50.Morgan GJ, Davies FE, Gregory WM, Bell SE, Szubert AJ, Cook G, et al. Long-term follow-up of MRC Myeloma IX trial: Survival outcomes with bisphosphonate and thalidomide treatment. Clinical cancer research : an official journal of the American Association for Cancer Research. 2013;19(21):6030-8.

51.Wu P, Davies FE, Horton C, Jenner MW, Krishnan B, Alvares CL, et al. The combination of cyclophosphomide, thalidomide and dexamethasone is an effective alternative to cyclophosphamide - vincristine - doxorubicin - methylprednisolone as induction chemotherapy prior to autologous transplantation for multiple myeloma: a case-matched analysis. Leukemia & lymphoma. 2006;47(11):2335-8.

52.Attal M, Harousseau JL, Facon T, Guilhot F, Doyen C, Fuzibet JG, et al. Single versus double autologous stem-cell transplantation for multiple myeloma. The New England journal of medicine. 2003;349(26):2495-502.

53.Cavo M ea. Double versus single autologous stem cell transplantation after bortezomib-based induction regimens for multiple myeloma: an integrated analysis of patient-level data from phase III European studies. Blood; 2013. p. 122(21).

54.Mellqvist UH, Gimsing P, Hjertner O, Lenhoff S, Laane E, Remes K, et al. Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial. Blood. 2013;121(23):4647-54.

55.Leleu X, Fouquet G, Hebraud B, Roussel M, Caillot D, Chretien ML, et al. Consolidation with VTd significantly improves the complete remission rate and time to progression following VTd induction and single autologous stem cell transplantation in multiple myeloma. Leukemia. 2013;27(11):2242-4.

56.Cavo M, Pantani L, Petrucci MT, Patriarca F, Zamagni E, Donnarumma D, 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.

57.Attal M, Roussel M. Maintenance therapy for myeloma: how much, how long, and at what cost? American Society of Clinical Oncology educational book / ASCO American Society of Clinical Oncology Meeting. 2012:515-22.

58.Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, et al. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. The New England journal of medicine. 2012;366(19):1782-91.

59.Palumbo A, Cavallo F, Gay F, Di Raimondo F, Ben Yehuda D, Petrucci MT, et al. Autologous transplantation and maintenance therapy in multiple myeloma. The New England journal of medicine. 2014;371(10):895-905.

60.McCarthy PL, Owzar K, Hofmeister CC, Hurd DD, Hassoun H, Richardson PG, et al. Lenalidomide after stem-cell transplantation for multiple myeloma. The New England journal of medicine. 2012;366(19):1770-81.

61.McCarthy PL, Holstein SA, Petrucci MT, Richardson PG, Hulin C, Tosi P, et al. Lenalidomide Maintenance After Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: A Meta-Analysis. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2017;35(29):3279-89.

62.D'Sa S, Abildgaard N, Tighe J, Shaw P, Hall-Craggs M. Guidelines for the use of imaging in the management of myeloma. British journal of haematology. 2007;137(1):49-63.

63.M. Hughes, R. Soutar, H. Lucraft, R. Owen, J. Bird.  Guidelines on the diagnosis and management of solitary plasmacytoma of bone,extramedullary plasmacytoma and multiple solitary plasmacytomas: 2009 update. Prepared by a working group of UKMF Guidelines Working Group. BCSH guidelines. [Läst: 2014-12-02]. Tillgänglig: http://www.bcshguidelines.com.

64.Tsang RW, Gospodarowicz MK, Pintilie M, Bezjak A, Wells W, Hodgson DC, et al. Solitary plasmacytoma treated with radiotherapy: impact of tumor size on outcome. International journal of radiation oncology, biology, physics. 2001;50(1):113-20.

65.Ozsahin M, Tsang RW, Poortmans P, Belkacemi Y, Bolla M, Dincbas FO, et al. Outcomes and patterns of failure in solitary plasmacytoma: a multicenter Rare Cancer Network study of 258 patients. International journal of radiation oncology, biology, physics. 2006;64(1):210-7.

66.Reed V, Shah J, Medeiros LJ, Ha CS, Mazloom A, Weber DM, et al. Solitary plasmacytomas: outcome and prognostic factors after definitive radiation therapy. Cancer. 2011;117(19):4468-74.

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68.Dimopoulos MA, Moulopoulos LA, Maniatis A, Alexanian R. Solitary plasmacytoma of bone and asymptomatic multiple myeloma. Blood. 2000;96(6):2037-44.

69.Creach KM, Foote RL, Neben-Wittich MA, Kyle RA. Radiotherapy for extramedullary plasmacytoma of the head and neck. International journal of radiation oncology, biology, physics. 2009;73(3):789-94.

70.Alexiou C, Kau RJ, Dietzfelbinger H, Kremer M, Spiess JC, Schratzenstaller B, et al. Extramedullary plasmacytoma: tumor occurrence and therapeutic concepts. Cancer. 1999;85(11):2305-14.

71.Weber DM. Solitary bone and extramedullary plasmacytoma. Hematology / the Education Program of the American Society of Hematology American Society of Hematology Education Program. 2005:373-6.

72.Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, et al. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. The New England journal of medicine. 2007;357(21):2123-32.

73.Richardson PG, Barlogie B, Berenson J, Singhal S, Jagannath S, Irwin D, et al. A phase 2 study of bortezomib in relapsed, refractory myeloma. The New England journal of medicine. 2003;348(26):2609-17.

74.Dimopoulos MA, Petrucci MT, Foa R, et al. Analysis of second-line lenalidomide following initial relapse in the MM-015 Trial. Blood 2012;120:944a.

75.Glasmacher A, Hahn C, Hoffmann F, Naumann R, Goldschmidt H, von Lilienfeld-Toal M, et al. A systematic review of phase-II trials of thalidomide monotherapy in patients with relapsed or refractory multiple myeloma. British journal of haematology. 2006;132(5):584-93.

76.Reece DE, Leitch HA, Atkins H, Voralia M, Canning LA, LeBlanc R, et al. Treatment of relapsed and refractory myeloma. Leukemia & lymphoma. 2008;49(8):1470-85.

77.San Miguel J, Weisel K, Moreau P, Lacy M, Song K, Delforge M, et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. The Lancet Oncology. 2013;14(11):1055-66.

78.Dimopoulos MA, Moreau P, Palumbo A, Joshua D, Pour L, Hajek R, et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. The Lancet Oncology. 2016;17(1):27-38.

79.Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Spicka I, Oriol A, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. The New England journal of medicine. 2015;372(2):142-52.

80.San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, et al. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial. The Lancet Oncology. 2014;15(11):1195-206.

81.Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, et al. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. The New England journal of medicine. 2015;373(7):621-31.

82.Lonial S, Weiss BM, Usmani SZ, Singhal S, Chari A, Bahlis NJ, et al. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet (London, England). 2016;387(10027):1551-60.

83.Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, et al. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. The New England journal of medicine. 2016;375(14):1319-31.

84.Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, et al. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma. The New England journal of medicine. 2016;375(8):754-66.

85.Moreau P, Masszi T, Grzasko N, Bahlis NJ, Hansson M, Pour L, et al. Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. The New England journal of medicine. 2016;374(17):1621-34.

86.Lonial S, Mitsiades CS, Richardson PG. Treatment options for relapsed and refractory multiple myeloma. Clinical cancer research : an official journal of the American Association for Cancer Research. 2011;17(6):1264-77.

87.Ludwig H, Sonneveld P, Davies F, Blade J, Boccadoro M, Cavo M, et al. European perspective on multiple myeloma treatment strategies in 2014. The oncologist. 2014;19(8):829-44.

88.Bjorkstrand BB, Ljungman P, Svensson H, Hermans J, Alegre A, Apperley J, et al. Allogeneic bone marrow transplantation versus autologous stem cell transplantation in multiple myeloma: a retrospective case-matched study from the European Group for Blood and Marrow Transplantation. Blood. 1996;88(12):4711-8.

89.Garban F, Attal M, Michallet M, Hulin C, Bourhis JH, Yakoub-Agha I, et al. Prospective comparison of autologous stem cell transplantation followed by dose-reduced allograft (IFM99-03 trial) with tandem autologous stem cell transplantation (IFM99-04 trial) in high-risk de novo multiple myeloma. Blood. 2006;107(9):3474-80.

90.Bruno B, Rotta M, Patriarca F, Mordini N, Allione B, Carnevale-Schianca F, et al. A comparison of allografting with autografting for newly diagnosed myeloma. The New England journal of medicine. 2007;356(11):1110-20.

91.Moreau P, Garban F, Attal M, Michallet M, Marit G, Hulin C, et al. Long-term follow-up results of IFM99-03 and IFM99-04 trials comparing nonmyeloablative allotransplantation with autologous transplantation in high-risk de novo multiple myeloma. Blood. 2008;112(9):3914-5.

92.Rosinol L, Perez-Simon JA, Sureda A, de la Rubia J, de Arriba F, Lahuerta JJ, et al. A prospective PETHEMA study of tandem autologous transplantation versus autograft followed by reduced-intensity conditioning allogeneic transplantation in newly diagnosed multiple myeloma. Blood. 2008;112(9):3591-3.

93.Bjorkstrand B, Iacobelli S, Hegenbart U, Gruber A, Greinix H, Volin L, et al. Tandem autologous/reduced-intensity conditioning allogeneic stem-cell transplantation versus autologous transplantation in myeloma: long-term follow-up. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2011;29(22):3016-22.

94.Krishnan A, Pasquini MC, Logan B, Stadtmauer EA, Vesole DH, Alyea E, 3rd, et al. Autologous haemopoietic stem-cell transplantation followed by allogeneic or autologous haemopoietic stem-cell transplantation in patients with multiple myeloma (BMT CTN 0102): a phase 3 biological assignment trial. The Lancet Oncology. 2011;12(13):1195-203.

95.Lokhorst HM, van der Holt B, Cornelissen JJ, Kersten MJ, van Oers M, Raymakers R, et al. Donor versus no-donor comparison of newly diagnosed myeloma patients included in the HOVON-50 multiple myeloma study. Blood. 2012;119(26):6219-25; quiz 399.

96.Gahrton G, Iacobelli S, Bjorkstrand B, Hegenbart U, Gruber A, Greinix H, et al. Autologous/reduced-intensity allogeneic stem cell transplantation vs autologous transplantation in multiple myeloma: long-term results of the EBMT-NMAM2000 study. Blood. 2013;121(25):5055-63.

97.de Lavallade H, El-Cheikh J, Faucher C, Furst S, Stoppa AM, Coso D, et al. Reduced-intensity conditioning allogeneic SCT as salvage treatment for relapsed multiple myeloma. Bone marrow transplantation. 2008;41(11):953-60.

98.Efebera YA, Qureshi SR, Cole SM, Saliba R, Pelosini M, Patel RM, et al. Reduced-intensity allogeneic hematopoietic stem cell transplantation for relapsed multiple myeloma. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation. 2010;16(8):1122-9.

99.Karlin L, Arnulf B, Chevret S, Ades L, Robin M, De Latour RP, et al. Tandem autologous non-myeloablative allogeneic transplantation in patients with multiple myeloma relapsing after a first high dose therapy. Bone marrow transplantation. 2011;46(2):250-6.

100.Patriarca F, Einsele H, Spina F, Bruno B, Isola M, Nozzoli C, et al. Allogeneic stem cell transplantation in multiple myeloma relapsed after autograft: a multicenter retrospective study based on donor availability. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation. 2012;18(4):617-26.

101.McCloskey EV, MacLennan IC, Drayson MT, Chapman C, Dunn J, Kanis JA. A randomized trial of the effect of clodronate on skeletal morbidity in multiple myeloma. MRC Working Party on Leukaemia in Adults. British journal of haematology. 1998;100(2):317-25.

102.Berenson JR, Lichtenstein A, Porter L, Dimopoulos MA, Bordoni R, George S, et al. Long-term pamidronate treatment of advanced multiple myeloma patients reduces skeletal events. Myeloma Aredia Study Group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 1998;16(2):593-602.

103.Berenson JR, Rosen LS, Howell A, Porter L, Coleman RE, Morley W, et al. Zoledronic acid reduces skeletal-related events in patients with osteolytic metastases. Cancer. 2001;91(7):1191-200.

104.Rosen LS, Gordon D, Kaminski M, Howell A, Belch A, Mackey J, et al. Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial. Cancer. 2003;98(8):1735-44.

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