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

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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:
CreatorsEmailORCIDORCID Put Code
Pfreundschuh, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Poeschel, ViolaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zeynalova, SamiraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haenel, MathiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Held, GerhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmitz, NorbertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Viardot, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dreyling, Martin H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallek, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, CarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wiesen, Martin H. J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Witzens-Harig, MathiasUNSPECIFIEDorcid.org/0000-0002-2799-4661UNSPECIFIED
Truemper, LorenzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Keller, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rixecker, TanjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zwick, CarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Murawski, NielsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
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:
KeywordsLanguage
CHEMOTHERAPY PLUS RITUXIMAB; RANDOMIZED CONTROLLED-TRIAL; DOSE-DENSE RITUXIMAB; ELDERLY-PATIENTS; CHOP CHEMOTHERAPYMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/42008

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