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024 7 _ |a 10.1111/bjh.13652
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024 7 _ |a 0007-1048
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037 _ _ |a DKFZ-2017-03825
041 _ _ |a eng
082 _ _ |a 610
100 1 _ |a Witzens-Harig, Mathias
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245 _ _ |a Rituximab maintenance improves survival in male patients with diffuse large B-cell lymphoma. Results of the HD2002 prospective multicentre randomized phase III trial.
260 _ _ |a Oxford [u.a.]
|c 2015
|b Wiley-Blackwell55962
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520 _ _ |a 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.
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650 _ 7 |a Antineoplastic Agents
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650 _ 7 |a Rituximab
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700 1 _ |a Benner, Axel
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700 1 _ |a McClanahan, Fabienne
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700 1 _ |a Klemmer, Jennifer
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700 1 _ |a Brandt, Julia
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700 1 _ |a Brants, Elke
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700 1 _ |a Rieger, Michael
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700 1 _ |a Meissner, Julia
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700 1 _ |a Hensel, Manfred
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700 1 _ |a Neben, Kai
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700 1 _ |a Dreger, Peter
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700 1 _ |a Lengfelder, Eva
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700 1 _ |a Schmidt-Wolf, Ingo
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700 1 _ |a Krämer, Alwin
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700 1 _ |a Ho, Anthony D
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773 _ _ |a 10.1111/bjh.13652
|g Vol. 171, no. 5, p. 710 - 719
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