Další formáty:
BibTeX
LaTeX
RIS
@article{1306999,
author = {Robak, Tadeusz and Huang, Huiqiang and Jin, Jie and Zhu, Jun and Liu, Ting and Samoilova, Olga and Pylypenko, Halyna and Verhoef, Gregor and Siritanaratkul, Noppadol and Osmanov, Evgenii and Alexeeva, Julia and Pereira, Juliana and Drach, Johannes and Mayer, Jiří and Hong, Xiaonan and Okamoto, Rumiko and Pei, Lixia and Rooney, Brendan and Velde, Helgi van de and Cavalli, Franco},
article_location = {USA},
article_number = {10},
doi = {http://dx.doi.org/10.1056/NEJMoa1412096},
keywords = {RELAPSED MULTIPLE-MYELOMA; EUROPEAN-MCL-NETWORK; PERIPHERAL NEUROPATHY; RANDOMIZED-TRIALS; PHASE-2 PINNACLE; PROGNOSTIC INDEX; FREE SURVIVAL; RITUXIMAB; VINCRISTINE; CYCLOPHOSPHAMIDE},
language = {eng},
issn = {0028-4793},
journal = {New England Journal of Medicine},
title = {Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma},
volume = {372},
year = {2015}
}
TY - JOUR
ID - 1306999
AU - 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 - Velde, Helgi van de - Cavalli, Franco
PY - 2015
TI - Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma
JF - New England Journal of Medicine
VL - 372
IS - 10
SP - 944-953
EP - 944-953
PB - MASSACHUSETTS MEDICAL SOC
SN - 00284793
KW - RELAPSED MULTIPLE-MYELOMA
KW - EUROPEAN-MCL-NETWORK
KW - PERIPHERAL NEUROPATHY
KW - RANDOMIZED-TRIALS
KW - PHASE-2 PINNACLE
KW - PROGNOSTIC INDEX
KW - FREE SURVIVAL
KW - RITUXIMAB
KW - VINCRISTINE
KW - CYCLOPHOSPHAMIDE
N2 - 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.)
ER -
ROBAK, Tadeusz, Huiqiang HUANG, Jie JIN, Jun ZHU, Ting LIU, Olga SAMOILOVA, Halyna PYLYPENKO, Gregor VERHOEF, Noppadol SIRITANARATKUL, Evgenii OSMANOV, Julia ALEXEEVA, Juliana PEREIRA, Johannes DRACH, Jiří MAYER, Xiaonan HONG, Rumiko OKAMOTO, Lixia PEI, Brendan ROONEY, Helgi van de VELDE a Franco CAVALLI. Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma. \textit{New England Journal of Medicine}. USA: MASSACHUSETTS MEDICAL SOC, 2015, roč.~372, č.~10, s.~944-953. ISSN~0028-4793. Dostupné z: https://dx.doi.org/10.1056/NEJMoa1412096.
|
