Home > Publications database > Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMG-HD4 trial. > print

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024 7 _ |a 10.1038/leu.2017.211
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024 7 _ |a 1476-5551
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037 _ _ |a DKFZ-2018-00163
041 _ _ |a eng
082 _ _ |a 610
100 1 _ |a Goldschmidt, Hartmut
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245 _ _ |a Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMG-HD4 trial.
260 _ _ |a Basingstoke
|c 2018
|b Nature Publ. Group
336 7 _ |a article
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336 7 _ |a ARTICLE
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520 _ _ |a The Dutch-Belgian Cooperative Trial Group for Hematology Oncology Group-65/German-speaking Myeloma Multicenter Group-HD4 (HOVON-65/GMMG-HD4) phase III trial compared bortezomib (BTZ) before and after high-dose melphalan and autologous stem cell transplantation (HDM, PAD arm) compared with classical cytotoxic agents prior and thalidomide after HDM (VAD arm) in multiple myeloma (MM) patients aged 18-65 years. Here, the long-term follow-up and data on second primary malignancies (SPM) are presented. After a median follow-up of 96 months, progression-free survival (censored at allogeneic transplantation, PFS) remained significantly prolonged in the PAD versus VAD arm (hazard ratio (HR)=0.76, 95% confidence interval (95% CI) of 0.65-0.89, P=0.001). Overall survival (OS) was similar in the PAD versus VAD arm (HR=0.89, 95% CI: 0.74-1.08, P=0.24). The incidence of SPM were similar between the two arms (7% each, P=0.73). The negative prognostic effects of the cytogenetic aberration deletion 17p13 (clone size ⩾10%) and renal impairment at baseline (serum creatinine >2 mg dl-1) on PFS and OS remained abrogated in the PAD but not VAD arm. OS from first relapse/progression was similar between the study arms (HR=1.02, P=0.85). In conclusion, the survival benefit with BTZ induction/maintenance compared with classical cytotoxic agents and thalidomide maintenance is maintained without an increased risk of SPM.
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700 1 _ |a Lokhorst, H. M.
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700 1 _ |a Mai, E. K.
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700 1 _ |a van der Holt, B.
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700 1 _ |a Blau, I. W.
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700 1 _ |a Zweegman, S.
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700 1 _ |a Weisel, K. C.
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700 1 _ |a Vellenga, E.
|b 7
700 1 _ |a Pfreundschuh, M.
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700 1 _ |a Kersten, M. J.
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700 1 _ |a Scheid, C.
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700 1 _ |a Croockewit, S.
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700 1 _ |a Raymakers, R.
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700 1 _ |a Hose, D.
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700 1 _ |a Potamianou, A.
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700 1 _ |a Jauch, A.
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700 1 _ |a Hillengass, J.
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700 1 _ |a Stevens-Kroef, M.
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700 1 _ |a Raab, M. S.
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700 1 _ |a Broijl, A.
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700 1 _ |a Lindemann, H. W.
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700 1 _ |a Bos, G. M. J.
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700 1 _ |a Brossart, P.
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700 1 _ |a van Marwijk Kooy, M.
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700 1 _ |a Ypma, P.
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700 1 _ |a Duehrsen, U.
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700 1 _ |a Schaafsma, R. M.
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700 1 _ |a Bertsch, U.
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700 1 _ |a Hielscher, Thomas
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700 1 _ |a Jarari, Le
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700 1 _ |a Salwender, H. J.
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700 1 _ |a Sonneveld, P.
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773 _ _ |a 10.1038/leu.2017.211
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