Murawski, N., Pfreundschuh, M., Zeynalova, S., Poeschel, V., Haenel, M., Held, G., Schmitz, N., Viardot, A., Schmidt, C., Hallek, M., Witzens-Harig, M., Truemper, L., Rixecker, T. and Zwick, C. (2014). Optimization of rituximab for the treatment of DLBCL (I): dose-dense rituximab in the DENSE-R-CHOP-14 trial of the DSHNHL. Ann. Oncol., 25 (9). S. 1800 - 1807. OXFORD: OXFORD UNIV PRESS. ISSN 1569-8041

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Abstract

Background: To improve outcome of elderly patients with diffuse large B-cell lymphoma, dose-dense rituximab was evaluated in the prospective DENSE-R-CHOP-14 trial. Patients and methods: Rituximab (375 mg/m(2)) was given on days 0, 1, 4, 8, 15, 22, 29, 43, 57, 71, 85, and 99 together with six CHOP-14 cycles. Results were to be compared with patients who had received the same chemotherapy in combination with eight 2-week applications of rituximab in RICOVER-60. Results: One hundred twenty-four patients are assessable. Dose-dense rituximab resulted in considerably higher serum levels during the first 50 days of treatment, but rituximab exposure time was not prolonged. Grade 3 and 4 infections were exceptionally high in the first 20 patients without anti-infective prophylaxis, but decreased after introduction of prophylaxis with aciclovir and cotrimoxazole in the remaining 104 patients (from 13% to 6% per cycle and from 35% to 18% per patient; P = 0.007 and P = 0.125, respectively). Patients with international prognostic index = 3-5 had higher complete response/ complete response unconfirmed rates (82% versus 68%; P = 0.033) than in the respective RICOVER-60 population, but this did not translate into better long-term outcome, even though male hazard was decreased (event-free survival: from 1.5 to 1.1; progression-free survival: from 1.7 to 1.1; overall survival: from 1.4 to 1.0). Conclusions: Dose-dense rituximab achieved higher rituximab serum levels, but was not more effective than eight 2-week applications in the historical control population, even though minor improvements in poor-prognosis and male patients cannot be excluded. The increased, though manageable toxicity, precludes its use in routine practice. Our results strongly support anti-infective prophylaxis with aciclovir and cotrimoxazole for all patients receiving R-CHOP.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Murawski, N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pfreundschuh, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zeynalova, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Poeschel, V.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haenel, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Held, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmitz, N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Viardot, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmidt, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallek, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Witzens-Harig, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Truemper, L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rixecker, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zwick, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-429861
DOI: 10.1093/annonc/mdu208
Journal or Publication Title: Ann. Oncol.
Volume: 25
Number: 9
Page Range: S. 1800 - 1807
Date: 2014
Publisher: OXFORD UNIV PRESS
Place of Publication: OXFORD
ISSN: 1569-8041
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
B-CELL LYMPHOMA; CHEMOTHERAPY PLUS RITUXIMAB; RANDOMIZED CONTROLLED-TRIAL; ELDERLY-PATIENTS; CHOP CHEMOTHERAPY; 3-WEEKLY CHOPMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/42986

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