Universität zu Köln

Pfreundschuh, Michael, Poeschel, Viola, Zeynalova, Samira, Haenel, Mathias, Held, Gerhard, Schmitz, Norbert, Viardot, Andreas, Dreyling, Martin H., Hallek, Michael, Mueller, Carsten, Wiesen, Martin H. J., Witzens-Harig, Mathias ORCID: 0000-0002-2799-4661, Truemper, Lorenz, Keller, Ulrich, Rixecker, Tanja, Zwick, Carsten and Murawski, Niels (2014). Optimization of Rituximab for the Treatment of Diffuse Large B-Cell Lymphoma (II): Extended Rituximab Exposure Time in the SMARTE-R-CHOP-14 Trial of the German High-Grade Non-Hodgkin Lymphoma Study Group. J. Clin. Oncol., 32 (36). S. 4127 - 4135. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

Full text not available from this repository.

Abstract

Purpose To study pharmacokinetics, toxicity, and efficacy of prolonged rituximab exposure in elderly patients with diffuse large B-cell lymphoma (DLBCL). Patients and Methods In the SMARTE-R-CHOP-14 trial, rituximab 375 mg/m(2) was administered, together with six cycles of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone on a 14-day schedule (6xR-CHOP-14), on days -4, 0, 10, 29, 57, 99, 155, and 239. Pharmacokinetics and outcome were to be compared with those of patients who had received 6xR-CHOP-14 in combination with eight 2-week applications of rituximab in the RICOVER-60 (Rituximab With CHOP Over Age 60 Years) trial. Results The complete response (CR)/unconfirmed CR rate was 85% in 189 evaluable patients, 90% for 90 good-prognosis patients (International Prognostic Index [IPI], 1 or 2), and 81% for 99 poor-prognosis patients (IPI, 3 to 5); 3-year event-free survival (EFS) was 71%, 75%, and 67%, respectively; and 3-year overall survival (OS) was 84%, 88%, and 80%, respectively, with no differences between men and women. The preplanned historical comparison with 306 RICOVER-60 patients (good prognosis, n = 183; poor prognosis, n = 123) revealed no outcome differences for all and good-prognosis patients; however, the longer exposure time in SMARTE-R-CHOP-14 compared with RICOVER-60 was associated with better 3-year EFS (67% v 54%) and OS (80% v 67%) in poor-prognosis patients. Conclusion Extended rituximab exposure compared with eight 2-week applications in combination with 6xR-CHOP-14 significantly improved outcome of elderly poor-prognosis patients without increasing toxicity. To our knowledge, results obtained with the SMARTE-R-CHOP-14 rituximab schedule are the best reported for elderly patients with DLBCL to date. In the subgroup of poor-prognosis patients treated with extended rituximab exposure, the outcome seemed superior to that of a similar historical cohort of patients treated with 6xR-CHOP-14 plus 2-week rituximab, with similar toxicity. A randomized comparison of the two schedules is warranted. (C) 2014 by American Society of Clinical Oncology

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Pfreundschuh, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Poeschel, Viola UNSPECIFIED UNSPECIFIED UNSPECIFIED Zeynalova, Samira UNSPECIFIED UNSPECIFIED UNSPECIFIED Haenel, Mathias UNSPECIFIED UNSPECIFIED UNSPECIFIED Held, Gerhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmitz, Norbert UNSPECIFIED UNSPECIFIED UNSPECIFIED Viardot, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Dreyling, Martin H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hallek, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, Carsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Wiesen, Martin H. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Witzens-Harig, Mathias UNSPECIFIED orcid.org/0000-0002-2799-4661 UNSPECIFIED Truemper, Lorenz UNSPECIFIED UNSPECIFIED UNSPECIFIED Keller, Ulrich UNSPECIFIED UNSPECIFIED UNSPECIFIED Rixecker, Tanja UNSPECIFIED UNSPECIFIED UNSPECIFIED Zwick, Carsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Murawski, Niels UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-420086
DOI:	10.1200/JCO.2013.54.6861
Journal or Publication Title:	J. Clin. Oncol.
Volume:	32
Number:	36
Page Range:	S. 4127 - 4135
Date:	2014
Publisher:	AMER SOC CLINICAL ONCOLOGY
Place of Publication:	ALEXANDRIA
ISSN:	1527-7755
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CHEMOTHERAPY PLUS RITUXIMAB; RANDOMIZED CONTROLLED-TRIAL; DOSE-DENSE RITUXIMAB; ELDERLY-PATIENTS; CHOP CHEMOTHERAPY Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/42008