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document
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/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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Intervention_Pharmacological
Rituximab
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Intervention_Pharmacological
rituximab maintenance therapy
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Intervention_Control
observation
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Outcome_Mortality
5-year relapse-free survival ( RFS )
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Participant_Sex
male
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Participant_Condition
diffuse large B-cell lymphoma
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Participant_Sample-size
321 patients
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Participant_Sample-size
161 randomized
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Participant_Sample-size
160
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Participant_Sex
male
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Participant_Sex
male