Characterization of haematological parameters with bortezomib-melphalan-prednisone versus melphalan-prednisone in newly diagnosed myeloma, with evaluation of long-term outcomes and risk of thromboembolic events with use of erythropoiesis-stimulating agents: Analysis of the VISTA trial

British Journal of Haematology

Volumn 153, Issue 2, 2011, Pages 212-221

  Richardson, Paul G ^a   Schlag, Rudolf ^b   Khuageva, Nuriet ^c   Dimopoulos, Meletios ^d   Shpilberg, Ofer ^e   Kropff, Martin ^f   Vekemans, Marie Christiane ^g   Petrucci, Maria Teresa ^h   Rossiev, Viktor ⁱ   Hou, Jian ^j   Robak, Tadeusz ^k   Mateos, Maria Victoria ^l   Anderson, Kenneth ^a   Esseltine, Dixie Lee ^m   Cakana, Andrew ⁿ   Liu, Kevin ^o   Deraedt, William ⁿ   van de Velde, Helgi ⁿ   San Miguel, Jesús F ^l  

^a DANA FARBER CANCER INSTITUTE   (United States)

^b Praxisklinik Dr Schlag   (Germany)

^c SP Botkin Moscow City Clinical Hospital   (Russian Federation)

^d UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

^e RABIN MEDICAL CENTER   (Israel)

^f UNIVERSITY OF MÜNSTER   (Germany)

^g CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^h SAPIENZA UNIVERSITY OF ROME   (Italy)

ⁱ Samara Region Clinical Hospital   (Russian Federation)

^j SECOND MILITARY MEDICAL UNIVERSITY   (China)

^k MEDICAL UNIVERSITY OF LODZ   (Poland)

^l Centro de Investigacion del Cancer   (Spain)

^m MILLENNIUM PHARMACEUTICALS INC   (United States)

ⁿ JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^o JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

more..

Author keywords

Bortezomib; Erythropoiesis stimulating agents; Melphalan; Myeloma; Prednisone

Indexed keywords

ANTIANEMIC AGENT; BORTEZOMIB; GRANULOCYTE COLONY STIMULATING FACTOR; MELPHALAN; PREDNISONE;

ANEMIA; ARTICLE; BLEEDING; BLOOD TOXICITY; DRUG DOSE REDUCTION; DRUG MEGADOSE; DRUG WITHDRAWAL; ERYTHROCYTE TRANSFUSION; FEBRILE NEUTROPENIA; HUMAN; LYMPHOCYTOPENIA; MULTIPLE MYELOMA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL (TOPIC); POST HOC ANALYSIS; PRIORITY JOURNAL; THROMBOCYTOPENIA; THROMBOEMBOLISM; TREATMENT OUTCOME;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BORONIC ACIDS; DISEASE-FREE SURVIVAL; ERYTHROCYTE TRANSFUSION; FEMALE; HEMATINICS; HUMANS; INCIDENCE; MALE; MELPHALAN; MIDDLE AGED; MULTIPLE MYELOMA; PREDNISOLONE; PYRAZINES; SURVIVAL RATE; THROMBOEMBOLISM;

EID: 79953088636     PISSN: 00071048     EISSN: 13652141     Source Type: Journal    
DOI: 10.1111/j.1365-2141.2011.08569.x     Document Type: Article

References (47)

1. Arbuckle, R.B., Griffith, N.L., Iacovelli, L.M., Johnson, P.E., Jorgenson, J.A., Kloth, D.D., Lucarelli, C.D. & Muller, R.J. (2008) Continued challenges with the use of erythropoiesis-stimulating agents in patients with cancer: perspectives and issues on policy-guided health care. Pharmacotherapy, 28, 1S-15S.
2. Armoiry, X., Aulagner, G. & Facon, T. (2008) Lenalidomide in the treatment of multiple myeloma: a review. Journal of Clinical Pharmacy and Therapeutics, 33, 219-226.
3. Baz, R., Walker, E., Choueiri, T.K., Abou, J.R., Brand, C., McGowan, B., Yiannaki, E., Andresen, S. & Hussein, M.A. (2007) Recombinant human erythropoietin is associated with increased overall survival in patients with multiple myeloma. Acta Haematologica, 117, 162-167.
4. Bennett, C.L., Silver, S.M., Djulbegovic, B., Samaras, A.T., Blau, C.A., Gleason, K.J., Barnato, S.E., Elverman, K.M., Courtney, D.M., McKoy, J.M., Edwards, B.J., Tigue, C.C., Raisch, D.W., Yarnold, P.R., Dorr, D.A., Kuzel, T.M., Tallman, M.S., Trifilio, S.M., West, D.P., Lai, S.Y. & Henke, M. (2008) Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin administration for the treatment of cancer-associated anemia. The Journal of the American Medical Association, 299, 914-924.
5. Birgegard, G., Gascon, P. & Ludwig, H. (2006) Evaluation of anaemia in patients with multiple myeloma and lymphoma: findings of the European Cancer Anaemia Survey. European Journal of Haematology, 77, 378-386.
6. Blade, J., Samson, D., Reece, D., Apperley, J., Bjorkstrand, B., Gahrton, G., Gertz, M., Giralt, S., Jagannath, S. & Vesole, D. (1998) Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. British Journal of Haematology, 102, 1115-1123.
7. Bohlius, J., Wilson, J., Seidenfeld, J., Piper, M., Schwarzer, G., Sandercock, J., Trelle, S., Weingart, O., Bayliss, S., Djulbegovic, B., Bennett, C.L., Langensiepen, S., Hyde, C. & Engert, A. (2006) Recombinant human erythropoietins and cancer patients: updated meta-analysis of 57 studies including 9353 patients. Journal of the National Cancer Institute, 98, 708-714.
8. Bohlius, J., Brillant, C., Clarke, M., Kluge, S., Napoli, M., Piper, M., Rades, D., Ray-Coquard, I., Schmidlin, K., Schumacher, M., Schwarzer, G., Seidenfeld, J., Steensma, D.P., Trelle, S., Untch, M., Weingart, O., Zwahlen, M., Egger, M. & Engert, A. (2008) Recombinant human erythropoiesis stimulating agents in cancer patients: individual patient data meta-analysis on behalf of the EPO IPD meta-analysis collaborative group. Blood (ASH Annual Meeting Abstracts), 112, LBA-6.
9. Caro, J.J., Salas, M., Ward, A. & Goss, G. (2001) Anemia as an independent prognostic factor for survival in patients with cancer: a systemic, quantitative review. Cancer, 91, 2214-2221.
10. Cella, D. (2006) Quality of life and clinical decisions in chemotherapy-induced anemia. Oncology (Williston Park), 20, 25-28.
11. Cella, D., Zagari, M.J., Vandoros, C., Gagnon, D.D., Hurtz, H.J. & Nortier, J.W. (2003) Epoetin alfa treatment results in clinically significant improvements in quality of life in anemic cancer patients when referenced to the general population. Journal of Clinical Oncology, 21, 366-373.
12. Chen, C., Reece, D.E., Siegel, D., Niesvizky, R., Boccia, R.V., Stadtmauer, E.A., Abonour, R., Richardson, P., Matous, J., Kumar, S., Bahlis, N.J., Alsina, M., Vescio, R., Coutre, S.E., Pietronigro, D., Knight, R.D., Zeldis, J.B. & Rajkumar, V. (2009) Expanded safety experience with lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma. British Journal of Haematology, 146, 164-170.
13. Durie, B.G., Kyle, R.A., Belch, A., Bensinger, W., Blade, J., Boccadoro, M., Child, J.A., Comenzo, R., Djulbegovic, B., Fantl, D., Gahrton, G., Harousseau, J.L., Hungria, V., Joshua, D., Ludwig, H., Mehta, J., Morales, A.R., Morgan, G., Nouel, A., Oken, M., Powles, R., Roodman, D., San, M.J., Shimizu, K., Singhal, S., Sirohi, B., Sonneveld, P., Tricot, G. & Van, N.B. (2003) Myeloma management guidelines: a consensus report from the Scientific Advisors of the International Myeloma Foundation. The Hematology Journal, 4, 379-398.
14. Facon, T., Mary, J.Y., Hulin, C., Benboubker, L., Attal, M., Pegourie, B., Renaud, M., Harousseau, J.L., Guillerm, G., Chaleteix, C., Dib, M., Voillat, L., Maisonneuve, H., Troncy, J., Dorvaux, V., Monconduit, M., Martin, C., Casassus, P., Jaubert, J., Jardel, H., Doyen, C., Kolb, B., Anglaret, B., Grosbois, B., Yakoub-Agha, I., Mathiot, C. & vet-Loiseau, H. (2007) Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. The Lancet, 370, 1209-1218.
15. Finnish Medical Society Duodecim. (2007) Thrombocytopenia. EBM Guidelines. Evidence-Based Medicine [Internet] Wiley Interscience. John Wiley & Sons, Helsinki, Finland.
16. Gillespie, T.W. (2002) Effects of cancer-related anemia on clinical and quality-of-life outcomes. Clinical Journal of Oncology Nursing, 6, 206-211.
17. Godwin, J. & Braden, C. (2009) Neutropenia. Available at: Accessed December 2010.
18. Groopman, J.E. & Itri, L.M. (1999) Chemotherapy-induced anemia in adults: incidence and treatment. Journal of the National Cancer Institute, 91, 1616-1634.
19. Harousseau, J., Jagannath, S., Richardson, P.G., Sonneveld, P., Schuster, M.W., Esseltine, D.L. & Anderson, K.C. (2006) Bortezomib in combination with high-dose dexamethasone (HD dex) and erythropoietin (EPO) does not result in an increased risk of thromboembolic complications. Blood (ASH Annual Meeting Abstracts), 108, 3543.
20. Henke, M., Laszig, R., Rube, C., Schafer, U., Haase, K.D., Schilcher, B., Mose, S., Beer, K.T., Burger, U., Dougherty, C. & Frommhold, H. (2003) Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. The Lancet, 362, 1255-1260.
21. Juneja, V., Keegan, P., Gootenberg, J.E., Rothmann, M.D., Shen, Y.L., Lee, K.Y., Weiss, K.D. & Pazdur, R. (2008) Continuing reassessment of the risks of erythropoiesis-stimulating agents in patients with cancer. Clinical Cancer Research, 14, 3242-3247.
22. Katodritou, E., Verrou, E., Hadjiaggelidou, C., Gastari, V., Laschos, K., Kontovinis, L., Kapetanos, D., Constantinou, N., Terpos, E. & Zervas, K. (2008) Erythropoiesis-stimulating agents are associated with reduced survival in patients with multiple myeloma. American Journal of Hematology, 83, 697-701.
23. Kaufman, R.M. & Anderson, K.C. (2003) Hematologic complications and blood bank support. In: Cancer Medicine 6 (ed. by D. Kufe, R. Pollock, R. Weichselbaum, R.C. Bast Jr., T.S. Gansler, J.F. Holland, E. Frei III), pp. 2489-2506. BC Decker, Hamilton, ON, Canada.
24. Knight, K., Wade, S. & Balducci, L. (2004) Prevalence and outcomes of anemia in cancer: a systematic review of the literature. American Journal of Medicine, 116, 11S-26S.
25. Knight, R., DeLap, R.J. & Zeldis, J.B. (2006) Lenalidomide and venous thrombosis in multiple myeloma. The New England Journal of Medicine, 354, 2079-2080.
26. Leyland-Jones, B. (2003) Breast cancer trial with erythropoietin terminated unexpectedly. The Lancet Oncology, 4, 459-460.
27. Lonial, S., Waller, E.K., Richardson, P.G., Jagannath, S., Orlowski, R.Z., Giver, C.R., Jaye, D.L., Francis, D., Giusti, S., Torre, C., Barlogie, B., Berenson, J.R., Singhal, S., Schenkein, D.P., Esseltine, D.L., Anderson, J., Xiao, H., Heffner, L.T. & Anderson, K.C. (2005) Risk factors and kinetics of thrombocytopenia associated with bortezomib for relapsed, refractory multiple myeloma. Blood, 106, 3777-3784.
28. Lonial, S., Richardson, P.G., San Miguel, J., Sonneveld, P., Schuster, M.W., Blade, J., Cavenagh, J., Rajkumar, S.V., Jakubowiak, A.J., Esseltine, D.L., Anderson, K.C. & Harousseau, J.L. (2008) Characterisation of haematological profiles and low risk of thromboembolic events with bortezomib in patients with relapsed multiple myeloma. British Journal of Haematology, 143, 222-229.
29. Ludwig, H., Van, B.S., Barrett-Lee, P., Birgegard, G., Bokemeyer, C., Gascon, P., Kosmidis, P., Krzakowski, M., Nortier, J., Olmi, P., Schneider, M. & Schrijvers, D. (2004a) The European Cancer Anaemia Survey (ECAS): a large, multinational, prospective survey defining the prevalence, incidence, and treatment of anaemia in cancer patients. European Journal of Cancer, 40, 2293-2306.
30. Ludwig, H., Pohl, G. & Osterborg, A. (2004b) Anemia in multiple myeloma. Clinical Advances in Hematology and Oncology, 2, 233-241.
31. Ludwig, H., Anderson, K., Dammacco, F., Hedenus, M., Osterborg, A. & Durie, B. (2008) ESAs not the culprit: more studies required. American Journal of Hematology, 83, 880-881.
32. Menon, S.P., Rajkumar, S.V., Lacy, M., Falco, P. & Palumbo, A. (2008) Thromboembolic events with lenalidomide-based therapy for multiple myeloma. Cancer, 112, 1522-1528.
33. Miceli, T., Colson, K., Gavino, M. & Lilleby, K. (2008) Myelosuppression associated with novel therapies in patients with multiple myeloma: consensus statement of the IMF Nurse Leadership Board. Clinical Journal of Oncology Nursing, 12, 13-20.
34. Mittelman, M., Zeidman, A., Kanter, P., Katz, O., Oster, H., Rund, D. & Neumann, D. (2004) Erythropoietin has an anti-myeloma effect - a hypothesis based on a clinical observation supported by animal studies. European Journal of Haematology, 72, 155-165.
35. National Cancer Institute. (2006) National Cancer Institute Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events, Version 3.0. Available at: Accessed 11 February 2011.
36. National Comprehensive Cancer Network (NCCN). (2009) NCCN Clinical Practice Guidelines in Oncology, Multiple Myeloma (v1.2011). Available at: Accessed 11 February 2011.
37. National Comprehensive Cancer Network (NCCN). (2010) NCCN Clinical Practice Guidelines in Oncology, Cancer- and Chemotherapy-induced Anemia (v.2.2011). Available at: Accessed 11 February 2011.
38. Niesvizky, R., Spencer, A. & Wang, M. (2006) Increased risk of thrombosis with lenalidomide in combination with dexamethasone and erythropoietin. Journal of Clinical Oncology, 24, Abstract 7506, 423s.
39. Osterborg, A., Brandberg, Y. & Hedenus, M. (2005) Impact of epoetin-beta on survival of patients with lymphoproliferative malignancies: long-term follow up of a large randomized study. British Journal of Haematology, 129, 206-209.
40. Palazzuoli, A., Silverberg, D., Iovine, F., Capobianco, S., Giannotti, G., Calabro, A., Campagna, S.M. & Nuti, R. (2006) Erythropoietin improves anemia exercise tolerance and renal function and reduces B-type natriuretic peptide and hospitalization in patients with heart failure and anemia. American Heart Journal, 152, 1096.e9-e15.
41. Rizzo, J.D., Somerfield, M.R., Hagerty, K.L., Seidenfeld, J., Bohlius, J., Bennett, C.L., Cella, D.F., Djulbegovic, B., Goode, M.J., Jakubowski, A.A., Rarick, M.U., Regan, D.H. & Lichtin, A.E. (2008) Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update. Journal of Clinical Oncology, 26, 132-149.
42. San Miguel, J.F., Schlag, R., Khuageva, N.K., Dimopoulos, M.A., Shpilberg, O., Kropff, M., Spicka, I., Petrucci, M.T., Palumbo, A., Samoilova, O.S., Dmoszynska, A., Abdulkadyrov, K.M., Schots, R., Jiang, B., Mateos, M.-V., Anderson, K.C., Esseltine, D.L., Liu, K., Cakana, A., van de Velde, H. & Richardson, P.G. (2008a) Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. The New England Journal of Medicine, 359, 906-917.
43. San Miguel, J., Schlag, R., Khuageva, N., Dimopoulos, M.A., Shpilberg, O., Kropff, M.H., Spicka, I., Petrucci, M.T., Palumbo, A., Samoilova, O.S., Dmoszynska, A., Abdulkadyrov, K.M., Schots, R., Jiang, B., Mateos, M.V., Anderson, K.C., Esseltine, D.L., Liu, K., Cakana, A., van de Velde, H. & Richardson, P. (2008b) Updated follow-up and results of subsequent therapy in the phase lll VISTA trial: Bortezomib plus melphalan-prednisone versus melphalan-prednisone in newly diagnosed multiple myeloma. Blood (ASH Annual Meeting Abstracts), 112, 650.
44. Shehata, N., Walker, I., Meyer, R., Haynes, A.E. & Imrie, K. (2008) The use of erythropoiesis-stimulating agents in patients with non-myeloid hematological malignancies: a systematic review. Annals of Hematology, 87, 961-973.
45. Silvestris, F., Cafforio, P., Tucci, M. & Dammacco, F. (2002) Negative regulation of erythroblast maturation by Fas-L(+)/TRAIL(+) highly malignant plasma cells: a major pathogenetic mechanism of anemia in multiple myeloma. Blood, 99, 1305-1313.
46. Witzig, T.E., Silberstein, P.T., Loprinzi, C.L., Sloan, J.A., Novotny, P.J., Mailliard, J.A., Rowland, K.M., Alberts, S.R., Krook, J.E., Levitt, R. & Morton, R.F. (2005) Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy. Journal of Clinical Oncology, 23, 2606-2617.
47. Zuckerman, K.S. (1998) Hematopoietic abnormalities in patients with cancer. Cancer Control, 5, 6-11.