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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.
- Source :
-
British journal of haematology [Br J Haematol] 2015 Dec; Vol. 171 (5), pp. 710-9. Date of Electronic Publication: 2015 Oct 09. - Publication Year :
- 2015
-
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.<br /> (© 2015 John Wiley & Sons Ltd.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Antineoplastic Agents adverse effects
Drug Administration Schedule
Female
Humans
Lymphoma, Large B-Cell, Diffuse mortality
Male
Middle Aged
Prospective Studies
Rituximab adverse effects
Treatment Outcome
Antineoplastic Agents administration & dosage
Lymphoma, Large B-Cell, Diffuse drug therapy
Rituximab administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1365-2141
- Volume :
- 171
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- British journal of haematology
- Publication Type :
- Academic Journal
- Accession number :
- 26449739
- Full Text :
- https://doi.org/10.1111/bjh.13652