Universität zu Köln

Goldschmidt, H., 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., Stevens-Kroef, M., Raab, M. S., Broijl, A., Lindemann, H. W., Bos, G. M. J., Brossart, P., Kooy, M. van Marwijk, Ypma, P., Duehrsen, U., Schaafsma, R. M., Bertsch, U., Hielscher, T., Jarari, Le, Salwender, H. J. and Sonneveld, P. (2018). Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMGHD-4 trial. Leukemia, 32 (2). S. 383 - 391. LONDON: NATURE PUBLISHING GROUP. ISSN 1476-5551

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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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Goldschmidt, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lokhorst, H. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mai, E. K. UNSPECIFIED UNSPECIFIED UNSPECIFIED van der Holt, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Blau, I. W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zweegman, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Weisel, K. C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Vellenga, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pfreundschuh, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kersten, M. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Scheid, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Croockewit, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Raymakers, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hose, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Potamianou, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jauch, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hillengass, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stevens-Kroef, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Raab, M. S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Broijl, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lindemann, H. W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bos, G. M. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Brossart, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kooy, M. van Marwijk UNSPECIFIED UNSPECIFIED UNSPECIFIED Ypma, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Duehrsen, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schaafsma, R. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bertsch, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hielscher, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jarari, Le UNSPECIFIED UNSPECIFIED UNSPECIFIED Salwender, H. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sonneveld, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-196581
DOI:	10.1038/leu.2017.211
Journal or Publication Title:	Leukemia
Volume:	32
Number:	2
Page Range:	S. 383 - 391
Date:	2018
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; DIAGNOSED MULTIPLE-MYELOMA; 2ND PRIMARY MALIGNANCIES; RANDOMIZED-TRIAL; DEXAMETHASONE COMBINATION; INTERGROUPE FRANCOPHONE; MAINTENANCE TREATMENT; PLUS DEXAMETHASONE; STAGING SYSTEM; DELETION 17P Multiple languages Oncology; Hematology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/19658