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2015-03-05

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Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/178533

Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma

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https://doi.org/10.1056/NEJMoa1412096

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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 ClinicalTrials.gov number, NCT00722137).

Matèries

Medicaments antineoplàstics, Limfomes, Ús terapèutic

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Antineoplastic agents, Lymphomas, Therapeutic use

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Articles publicats en revistes (Ciències Clíniques)

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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. Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma. _New England Journal of Medicine_. 2015. Vol. 372, núm. 10, pàgs. 944-953. [consulta: 23 de gener de 2026]. ISSN: 0028-4793. [Disponible a: https://hdl.handle.net/2445/178533]

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