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
2014 | journal article. A publication with affiliation to the University of Göttingen.
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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
Pfreundschuh, M.; Poeschel, V.; Zeynalova, S.; Haenel, M.; Held, G.; Schmitz, N. & Viardot, A. et al. (2014)
Journal of Clinical Oncology, 32(36) pp. 4127-U354. DOI: https://doi.org/10.1200/JCO.2013.54.6861
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Details
- Authors
- 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; Truemper, Lorenz H.; Keller, Ulrich; Rixecker, Tanja; Zwick, Carsten; Murawski, Niels
- 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
- Issue Date
- 2014
- Status
- published
- Publisher
- Amer Soc Clinical Oncology
- Journal
- Journal of Clinical Oncology
- ISSN
- 1527-7755; 0732-183X
- Sponsor
- Deutsche Krebshilfe; Roche