title: Rituximab maintenance improves survival in male patients with diffuse large B-cell lymphoma. Results of the HD2002 prospective multicentre randomized phase III trial.
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.
authors.affiliation: Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
authors.forename: Mathias
authors.initials: M
authors.lastname: Witzens-Harig
authors.affiliation: Division of Biostatistics, German Cancer Research Centre, Heidelberg, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Benner
authors.affiliation: Centre for Haemato-Oncology, Barts Cancer Institute - a CR-UK Centre of Excellence, London, UK.
authors.forename: Fabienne
authors.initials: F
authors.lastname: McClanahan
authors.affiliation: Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Klemmer
authors.affiliation: Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Brandt
authors.affiliation: Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
authors.forename: Elke
authors.initials: E
authors.lastname: Brants
authors.affiliation: Onkologische Schwerpunktpraxis Darmstadt, Darmstadt, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Rieger
authors.affiliation: Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Meissner
authors.affiliation: Mannheimer Onkologie Praxis, Mannheim, Germany.
authors.forename: Manfred
authors.initials: M
authors.lastname: Hensel
authors.affiliation: Klinikum Mittelbaden, Baden-Baden, Germany.
authors.forename: Kai
authors.initials: K
authors.lastname: Neben
authors.affiliation: Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Dreger
authors.affiliation: Haematology and Oncology, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Lengfelder
authors.affiliation: Department of Medicine III, Centre for Integrated Oncology (CIO), University of Bonn, Bonn, Germany.
authors.forename: Ingo
authors.initials: I
authors.lastname: Schmidt-Wolf
authors.affiliation: Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
authors.forename: Alwin
authors.initials: A
authors.lastname: Krämer
authors.affiliation: Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
authors.forename: Anthony D
authors.initials: AD
authors.lastname: Ho
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069283:Rituximab / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000069283:Rituximab
keywords: diffuse large B-cell lymphoma; gender differences; multicentre prospective randomized trial; rituximab maintenance therapy