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@article{1399044,
author = {AvetandLoiseau, H. and Bahlis, N.J. and Chng, W.J. and Masszi, T. and Viterbo, L. and Pour, Luděk and Ganly, P. and Palumbo, A. and Cavo, M. and Langer, C. and Pluta, A. and Nagler, A. and Kumar, S. and BenandYehuda, D. and Rajkumar, S.V. and SanandMiguel, J. and Berg, D. and Lin, J.C. and Velde, H. van de and Esseltine, D.L. and Bacco, A. di and Moreau, P. and Richardson, P.G.},
article_location = {Washington DC, USA},
article_number = {24},
doi = {http://dx.doi.org/10.1182/blood-2017-06-791228},
keywords = {Ixazomib},
language = {eng},
issn = {0006-4971},
journal = {Blood},
title = {Ixazomib significantly prolongs progression-free survival in high-risk relapsed/refractory myeloma patients},
url = {http://dx.doi.org/10.1182/blood-2017-06-791228},
volume = {130},
year = {2017}
}
TY - JOUR
ID - 1399044
AU - Avet-Loiseau, H. - Bahlis, N.J. - Chng, W.J. - Masszi, T. - Viterbo, L. - Pour, Luděk - Ganly, P. - Palumbo, A. - Cavo, M. - Langer, C. - Pluta, A. - Nagler, A. - Kumar, S. - Ben-Yehuda, D. - Rajkumar, S.V. - San-Miguel, J. - Berg, D. - Lin, J.C. - Velde, H. van de - Esseltine, D.L. - Bacco, A. di - Moreau, P. - Richardson, P.G.
PY - 2017
TI - Ixazomib significantly prolongs progression-free survival in high-risk relapsed/refractory myeloma patients
JF - Blood
VL - 130
IS - 24
SP - 2610-2618
EP - 2610-2618
PB - American Society of Hematology
SN - 00064971
KW - Ixazomib
UR - http://dx.doi.org/10.1182/blood-2017-06-791228
L2 - http://dx.doi.org/10.1182/blood-2017-06-791228
N2 - Certain cytogenetic abnormalities are known to adversely impact outcomes in patients with multiple myeloma (MM). The phase 3 TOURMALINE-MM1 study demonstrated a significant improvement in progression-free survival (PFS) with ixazomib-lenalidomide-dexamethasone (IRd) compared with placebo-lenalidomide-dexamethasone (placebo-Rd). This preplanned analysis assessed the efficacy and safety of IRd vs placebo-Rd according to cytogenetic risk, as assessed using fluorescence in situ hybridization. High-risk cytogenetic abnormalities were defined as del(17p), t(4;14), and/or t(14;16); additionally, patients were assessed for 1q21 amplification. Of 722 randomized patients, 552 had cytogenetic results; 137 (25%) had high-risk cytogenetic abnormalities and 172 (32%) had 1q21 amplification alone. PFS was improved with IRd vs placebo-Rd in both high-risk and standard-risk cytogenetics subgroups: in high-risk patients, the hazard ratio (HR) was 0.543 (95% confidence interval [CI], 0.321-0.918; P = .021), with median PFS of 21.4 vs 9.7 months; in standard-risk patients, HR was 0.640 (95% CI, 0.462-0.888; P = .007), with median PFS of 20.6 vs 15.6 months. This PFS benefit was consistent across subgroups with individual high-risk cytogenetic abnormalities, including patients with del(17p) (HR, 0.596; 95% CI, 0.286-1.243). PFS was also longer with IRd vs placebo-Rd in patients with 1q21 amplification (HR, 0.781; 95% CI, 0.492-1.240), and in the "expanded high-risk" group, defined as those with high-risk cytogenetic abnormalities and/or 1q21 amplification (HR, 0.664; 95% CI, 0.474-0.928). IRd demonstrated substantial benefit compared with placebo-Rd in relapsed and/or refractory MM (RRMM) patients with high-risk and standard-risk cytogenetics, and improves the poor PFS associated with high-risk cytogenetic abnormalities.
ER -
AVET-LOISEAU, H., N.J. BAHLIS, W.J. CHNG, T. MASSZI, L. VITERBO, Luděk POUR, P. GANLY, A. PALUMBO, M. CAVO, C. LANGER, A. PLUTA, A. NAGLER, S. KUMAR, D. BEN-YEHUDA, S.V. RAJKUMAR, J. SAN-MIGUEL, D. BERG, J.C. LIN, H. van de VELDE, D.L. ESSELTINE, A. di BACCO, P. MOREAU a P.G. RICHARDSON. Ixazomib significantly prolongs progression-free survival in high-risk relapsed/refractory myeloma patients. Online. \textit{Blood}. Washington DC, USA: American Society of Hematology, 2017, roč.~130, č.~24, s.~2610-2618. ISSN~0006-4971. Dostupné z: https://dx.doi.org/10.1182/blood-2017-06-791228. [citováno 2024-04-23]
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