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Title: Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma
Authors: Tadeusz Robak
Huiqiang Huang
Jie Jin
Jun Zhu
Ting Liu
Olga Samoilova
Halyna Pylypenko
Gregor Verhoef
Noppadol Siritanaratkul
Evgenii Osmanov
Julia Alexeeva
Juliana Pereira
Johannes Drach
Jiri Mayer
Xiaonan Hong
Rumiko Okamoto
Lixia Pei
Brendan Rooney
Helgi Van De Velde
Franco Cavalli
Medical University of Lodz
Sun Yat-Sen University Cancer Center
Zhejiang University School of Medicine
Beijing Cancer Hospital
West China Hospital of Sichuan University
Fudan University Shanghai Cancer Center
Nizhny Novgorod Regional Hospital
N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences
Federal Center of Heart
Cherkassy Regional Oncology Center
KU Leuven– University Hospital Leuven
Janssen Research and Development
Mahidol University
Universidade de Sao Paulo - USP
Medizinische Universitat Wien
Fakultni Nemocnice Brno
Tokyo Metropolitan Komagome Hospital
Janssen Research and Development
Ospedale San Giovanni
Keywords: Medicine
Issue Date: 5-Mar-2015
Citation: New England Journal of Medicine. Vol.372, No.10 (2015), 944-953
Abstract: Copyright © 2015 Massachusetts Medical Society. Background The proteasome inhibitor bortezomib was initially approved for the treatment of relapsed mantle-cell lymphoma. We investigated whether substituting bortezomib for vincristine in frontline therapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) could improve outcomes in patients with newly diagnosed mantle-cell lymphoma. Methods In this phase 3 trial, we randomly assigned 487 adults with newly diagnosed mantlecell lymphoma who were ineligible or not considered for stem-cell transplantation to receive six to eight 21-day cycles of R-CHOP intravenously on day 1 (with prednisone administered orally on days 1 to 5) or VR-CAP (R-CHOP regimen, but replacing vincristine with bortezomib at a dose of 1.3 mg per square meter of body-surface area on days 1, 4, 8, and 11). The primary end point was progression-free survival. Results After a median follow-up of 40 months, median progression-free survival (according to independent radiologic review) was 14.4 months in the R-CHOP group versus 24.7 months in the VR-CAP group (hazard ratio favoring the VR-CAP group, 0.63; P<0.001), a relative improvement of 59%. On the basis of investigator assessment, the median durations of progression-free survival were 16.1 months and 30.7 months, respectively (hazard ratio, 0.51; P<0.001), a relative improvement of 96%. Secondary end points were consistently improved in the VR-CAP group, including the complete response rate (42% vs. 53%), the median duration of complete response (18.0 months vs. 42.1 months), the median treatment-free interval (20.5 months vs. 40.6 months), and the 4-year overall survival rate (54% vs. 64%). Rates of neutropenia and thrombocytopenia were higher in the VR-CAP group. Conclusions VR-CAP was more effective than R-CHOP in patients with newly diagnosed mantlecell lymphoma but at the cost of increased hematologic toxicity.
ISSN: 15334406
Appears in Collections:Scopus 2011-2015

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