Universität zu Köln

Mai, E. K., Bertsch, U., Duerig, J., Kunz, C., Haenel, M., Blau, I. W., Munder, M., Jauch, A., Schurich, B., Hielscher, T., 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. and Goldschmidt, H. (2015). Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma. Leukemia, 29 (8). S. 1721 - 1730. LONDON: NATURE PUBLISHING GROUP. ISSN 1476-5551

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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 degrees) occurred more frequently in the VCD arm (35.2% versus 11.3%, P<0.001). Neuropathy rates (>= 2 degrees) 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Mai, E. K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bertsch, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Duerig, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kunz, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Haenel, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Blau, I. W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Munder, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jauch, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schurich, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hielscher, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Merz, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Huegle-Doerr, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Seckinger, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hose, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hillengass, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Raab, M. S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Neben, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lindemann, H-W UNSPECIFIED UNSPECIFIED UNSPECIFIED Zeis, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gerecke, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmidt-Wolf, I. G. H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Weisel, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Scheid, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Salwender, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Goldschmidt, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-398191
DOI:	10.1038/leu.2015.80
Journal or Publication Title:	Leukemia
Volume:	29
Number:	8
Page Range:	S. 1721 - 1730
Date:	2015
Publisher:	NATURE PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	1476-5551
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language STEM-CELL TRANSPLANTATION; UNTREATED MULTIPLE-MYELOMA; THALIDOMIDE PLUS DEXAMETHASONE; HIGH RESPONSE RATES; INDUCTION THERAPY; PERIPHERAL NEUROPATHY; LENALIDOMIDE; COMBINATION; MAINTENANCE; DIFFERENCE Multiple languages Oncology; Hematology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/39819