Journal Article

DKFZ-2017-03074

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma.

Mai, E. K. ; Bertsch, U. ; Dürig, J. ; Kunz, C.DKFZ* ; Haenel, M. ; Blau, I. W. ; Munder, M. ; Jauch, A. ; Schurich, B. ; Hielscher, T.DKFZ* ; Merz, M. ; Huegle-Doerr, B. ; Seckinger, A. ; Hose, D. ; Hillengass, J. ; Raab, M. S. ; Neben, K. ; Lindemann, H.-W. ; Zeis, M. ; Gerecke, C. ; Schmidt-Wolf, I. G. H. ; Weisel, K. ; Scheid, C. ; Salwender, H. ; Goldschmidt, H.

2015
Nature Publ. Group Basingstoke

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Please use a persistent id in citations: doi:10.1038/leu.2015.80

Abstract: We aimed at demonstrating non-inferiority of bortezomib/cyclophosphamide/dexamethasone (VCD) compared to bortezomib/doxorubicin/dexamethasone (PAd) induction therapy with respect to very good partial response rates or better (⩾VGPR) in 504 newly diagnosed, transplant-eligible multiple myeloma patients. VCD was found to be non-inferior to PAd with respect to ⩾VGPR rates (37.0 versus 34.3%, P=0.001). The rates of progressive disease (PD) were 0.4% (VCD) versus 4.8% (PAd; P=0.003). In the PAd arm, 11 of 12 patients with PD had either renal impairment (creatinine ⩾2 mg/dl) at diagnosis or the cytogenetic abnormality gain 1q21, whereas no PD was observed in these subgroups in the VCD arm. Leukocytopenia/neutropenia (⩾3°) occurred more frequently in the VCD arm (35.2% versus 11.3%, P<0.001). Neuropathy rates (⩾2°) were higher in the PAd group (14.9 versus 8.4%, P=0.03). Serious adverse events, both overall and those related to thromboembolic events, were higher in the PAd group (32.7 versus 24.0%, P=0.04 and 2.8 versus 0.4%, P=0.04). Stem cell collection was not impeded by VCD. VCD is as effective as PAd in terms of achieving ⩾VGPR rates with fewer PD and has a favorable toxicity profile. Therefore, VCD is preferable to PAd as induction therapy.

Keyword(s): Boronic Acids ; Pyrazines ; Bortezomib ; Dexamethasone ; Doxorubicin ; Cyclophosphamide

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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 2015

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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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