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Title: Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma
Author: Robak, Tadeusz
Huang, Huiqiang
Jin, Jie
Zhu, Jun
Liu, Ting
Samoilova, Olga
Pylypenko, Halyna
Verhoef, Gregor
Siritanaratkul, Noppadol
Osmanov, Evgenii
Alexeeva, Julia
Pereira, Juliana
Drach, Johannes
Mayer, Jiří
Hong, Xiaonan
Okamoto, Rumiko
Pei, Lixia
Rooney, Brendan
Van de Velde, Helgi
Cavalli, Franco
González Barca, Eva
LYM-3002 Investigators
Keywords: Medicaments antineoplàstics
Ús terapèutic
Antineoplastic agents
Therapeutic use
Issue Date: 5-Mar-2015
Publisher: Massachusetts Medical Society
Abstract: 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 mantle-cell 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 mantle-cell lymphoma but at the cost of increased hematologic toxicity. (Funded by Janssen Research and Development and Millennium Pharmaceuticals; LYM-3002 number, NCT00722137).
Note: Reproducció del document publicat a:
It is part of: New England Journal of Medicine, 2015, vol. 372, num. 10, p. 944-953
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ISSN: 0028-4793
Appears in Collections:Articles publicats en revistes (Ciències Clíniques)

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