Journal Article

DKFZ-2018-00163

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMG-HD4 trial.

Goldschmidt, H.Extern* ; Lokhorst, H. M. ; Mai, E. K. ; van der Holt, B. ; Blau, I. W. ; Zweegman, S. ; Weisel, K. C. ; Vellenga, E. ; Pfreundschuh, M. ; Kersten, M. J. ; Scheid, C. ; Croockewit, S. ; Raymakers, R. ; Hose, D. ; Potamianou, A. ; Jauch, A. ; Hillengass, J.Extern* ; Stevens-Kroef, M. ; Raab, M. S.Extern* ; Broijl, A. ; Lindemann, H. W. ; Bos, G. M. J. ; Brossart, P. ; van Marwijk Kooy, M. ; Ypma, P. ; Duehrsen, U. ; Schaafsma, R. M. ; Bertsch, U. ; Hielscher, T.DKFZ* ; Jarari, L. ; Salwender, H. J. ; Sonneveld, P.

2018
Nature Publ. Group Basingstoke

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Please use a persistent id in citations: doi:10.1038/leu.2017.211

Abstract: 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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Contributing Institute(s):

1. Biostatistik (C060)

Research Program(s):

1. 313 - Cancer risk factors and prevention (POF3-313) (POF3-313)

Appears in the scientific report 2018

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Database coverage:
; BIOSIS Previews ; Current Contents - Life Sciences ; Ebsco Academic Search ; IF >= 10 ; JCR ; NCBI Molecular Biology Database ; SCOPUS ; Science Citation Index ; Science Citation Index Expanded ; Thomson Reuters Master Journal List ; Web of Science Core Collection

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