Journal Article

DKFZ-2017-03825

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Rituximab maintenance improves survival in male patients with diffuse large B-cell lymphoma. Results of the HD2002 prospective multicentre randomized phase III trial.

Witzens-Harig, M. ; Benner, A.DKFZ* ; McClanahan, F. ; Klemmer, J. ; Brandt, J. ; Brants, E. ; Rieger, M. ; Meissner, J. ; Hensel, M. ; Neben, K.DKFZ* ; Dreger, P. ; Lengfelder, E. ; Schmidt-Wolf, I. ; Krämer, A.DKFZ* ; Ho, A. D.

2015
Wiley-Blackwell55962 Oxford [u.a.]

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Please use a persistent id in citations: doi:10.1111/bjh.13652

Abstract: In the multicentre prospective randomized HD2002 trial, rituximab maintenance therapy (375 mg/m(2) every 3 months for 2 years) versus observation was evaluated for CD20(+) B-cell lymphoma. Out of 321 patients [161 randomized to the treatment group (TG), 160 to the observation group (OG)], 295 data sets were evaluable for statistical analysis. Estimated 5-year relapse-free survival (RFS) was 81% in the TG and 70% in the OG (logrank test, P = 0·047). In the diffuse large B-cell lymphoma (DLBCL) subgroup (n = 152), 5-year RFS was excellent, at 87% in the TG and 84% in the OG (logrank test, P = 0·35). Of note, only in male patients of the DLBCL subgroup was RFS significantly superior in the TG in comparison to the OG (5-year RFS: 88% vs. 74%; logrank test, P = 0·05). Cox regression analysis showed a significant interaction between treatment and gender regarding overall survival (OS) (P = 0·006) and RFS (P = 0·02), with a lower hazard in females than males in the OG [OS: hazard ratio (HR) (female:male) = 0·11; 95% confidence interval (CI) = 0·00-1·03; RFS: HR (female:male) = 0·27; 95% CI = 0·05-0·97], and no significant differences between males and females in the TG. We conclude that Rituximab maintenance therapy improves survival in male patients with DLBCL.

Keyword(s): Antineoplastic Agents ; Rituximab

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Contributing Institute(s):

1. Biostatistik (C060)
2. KKE Molekulare Hämatologie/Onkologie (G330)

Research Program(s):

1. 317 - Translational cancer research (POF3-317) (POF3-317)

Appears in the scientific report 2015

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Database coverage:
; BIOSIS Previews ; Current Contents - Clinical Medicine ; Current Contents - Life Sciences ; Ebsco Academic Search ; IF >= 5 ; 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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