J 2017

Ixazomib significantly prolongs progression-free survival in high-risk relapsed/refractory myeloma patients

AVET-LOISEAU, H., N.J. BAHLIS, W.J. CHNG, T. MASSZI, L. VITERBO et. al.

Basic information

Original name

Ixazomib significantly prolongs progression-free survival in high-risk relapsed/refractory myeloma patients

Authors

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 and P.G. RICHARDSON

Edition

Blood, Washington DC, USA, American Society of Hematology, 2017, 0006-4971

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

Impact factor

Impact factor: 15.132

Organization unit

Faculty of Medicine

UT WoS

000417919800010

Keywords in English

Ixazomib

Tags

Tags

International impact, Reviewed
Změněno: 12/4/2018 19:02, Soňa Böhmová

Abstract

V originále

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.