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Rituximab maintenance improves survival in male patients with diffuse large B‐cell lymphoma. Results of the HD 2002 prospective multicentre randomized phase III trial
Author(s) -
WitzensHarig Mathias,
Benner Axel,
McClanahan Fabienne,
Klemmer Jennifer,
Brandt Julia,
Brants Elke,
Rieger Michael,
Meissner Julia,
Hensel Manfred,
Neben Kai,
Dreger Peter,
Lengfelder Eva,
SchmidtWolf Ingo,
Krämer Alwin,
Ho Anthony D.
Publication year - 2015
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.13652
Subject(s) - hazard ratio , medicine , rituximab , log rank test , proportional hazards model , diffuse large b cell lymphoma , randomized controlled trial , subgroup analysis , confidence interval , lymphoma , survival analysis , prospective cohort study , progression free survival , oncology , gastroenterology , chemotherapy , surgery
Summary In the multicentre prospective randomized HD 2002 trial, rituximab maintenance therapy (375 mg/m 2 every 3 months for 2 years) versus observation was evaluated for CD 20 + 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 .