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Rituximab maintenance improves survival in male patients with diffuse large B-cell lymphoma: results of the HD2002 prospective multicentre randomized phase III trial

In the multicentre prospective randomized HD2002 trial, rituximab maintenance therapy (375 mg/m2 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...

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Main Authors: Witzens-Harig, Mathias (Author) , Klemmer, Jennifer (Author) , Brandt, Julia (Author) , Brants, Elke (Author) , Meißner, Julia (Author) , Dreger, Peter (Author) , Lengfelder, Eva (Author) , Krämer, Alwin (Author) , Ho, Anthony Dick (Author)
Format: Article (Journal)
Language:English
Published: 9 October 2015
In: British journal of haematology
Year: 2015, Volume: 171, Issue: 5, Pages: 710-719
ISSN:1365-2141
DOI:10.1111/bjh.13652
Online Access:Verlag, Volltext: http://dx.doi.org/10.1111/bjh.13652
Verlag, Volltext: http://onlinelibrary.wiley.com.ezproxy.medma.uni-heidelberg.de/doi/10.1111/bjh.13652/abstract
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Author Notes:Mathias Witzens-Harig, Axel Benner, Fabienne McClanahan, Jennifer Klemmer, Julia Brandt, Elke Brants, Michael Rieger, Julia Meissner, Manfred Hensel, Kai Neben, Peter Dreger, Eva Lengfelder, Ingo Schmidt-Wolf, Alwin Krämer and Anthony D. Ho
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Summary:In the multicentre prospective randomized HD2002 trial, rituximab maintenance therapy (375 mg/m2 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.
Item Description:Gesehen am 12.12.2017
Physical Description:Online Resource
ISSN:1365-2141
DOI:10.1111/bjh.13652

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