Survival benefit of ixazomib, lenalidomide and dexamethasone
(IRD) over lenalidomide and dexamethasone (Rd) in relapsed and
refractory multiple myeloma patients in routine clinical
practice

J 2021

Survival benefit of ixazomib, lenalidomide and dexamethasone (IRD) over lenalidomide and dexamethasone (Rd) in relapsed and refractory multiple myeloma patients in routine clinical practice

MINARIK, J., T. PIKA, J. RADOCHA, A. JUNGOVA, J. STRAUB et. al.

Basic information

Original name

Survival benefit of ixazomib, lenalidomide and dexamethasone (IRD) over lenalidomide and dexamethasone (Rd) in relapsed and refractory multiple myeloma patients in routine clinical practice

Authors

MINARIK, J. (203 Czech Republic, guarantor), T. PIKA (203 Czech Republic), J. RADOCHA (203 Czech Republic), A. JUNGOVA (203 Czech Republic), J. STRAUB (203 Czech Republic), T. JELINEK (203 Czech Republic), Luděk POUR (203 Czech Republic, belonging to the institution), P. PAVLICEK (203 Czech Republic), M. MISTRIK (203 Czech Republic), Lucie BROŽOVÁ (203 Czech Republic), P. KRHOVSKA (203 Czech Republic), K. MACHALKOVA (203 Czech Republic), P. JINDRA (203 Czech Republic), I. SPICKA (203 Czech Republic), H. PLONKOVA (203 Czech Republic), Martin ŠTORK (203 Czech Republic, belonging to the institution), J. BACOVSKY (203 Czech Republic), L. CAPKOVA (203 Czech Republic), M. SYKORA (203 Czech Republic), P. KESSLER (203 Czech Republic), L. STEJSKAL (203 Czech Republic), A. HEINDORFER (203 Czech Republic), J. ULLRYCHOVA (203 Czech Republic), T. SKACEL (203 Czech Republic), V. MAISNAR (203 Czech Republic) and R. HAJEK (203 Czech Republic)

Edition

BMC Cancer, LONDON, BMC, 2021, 1471-2407

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30204 Oncology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 4.638

RIV identification code

RIV/00216224:14110/21:00120101

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1186/s12885-020-07732-1

UT WoS

000610557500001

Keywords in English

Multiple myeloma; Ixazomib; Lenalidomide; Dexamethasone; Clinical trial; Patient registry

Abstract

V originále

Background We have performed a head to head comparison of all-oral triplet combination of ixazomib, lenalidomide and dexamethasone (IRD) versus lenalidomide and dexamethasone (RD) in patients with relapsed and refractory multiple myeloma (RRMM) in the routine clinical practice. Methods A total of 344 patients treated with IRD (N = 127) or RD (N = 217) were selected for analysis from the Czech Registry of Monoclonal Gammopathies (RMG). Descriptive statistics were used to assess patient's characteristics associated with the respective therapy. The primary endpoint was progression free survival (PFS), secondary end points included response rates and overall survival (OS). Survival endpoints were plotted using Kaplan-Meier methodology at 95% Greenwood confidence interval. Univariable and multivariable Cox proportional hazards models were used to evaluate the effect of treatment regimens and the significance of uneven variables. Statistical tests were performed at significance level 0.05. Results In the whole cohort, median PFS for IRD was 17.5 and for RD was 11.5 months favoring the all-oral triplet, p = 0.005; in patients within relapse 1-3, the median PFS was 23.1 vs 11.6 months, p = 0.001. The hazard ratio for PFS was 0.67 (95% confidence interval [CI] 0.51-0.89, p = 0.006). The PFS advantage translated into improved OS for patients treated with IRD, median 36.6 months vs 26.0 months (p = 0.008). The overall response rate (ORR) was 73.0% in the IRD group vs 66.2% in the RD group with a complete response rate (CR) of 11.1% vs 8.8%, and very good partial response (VGPR) 22.2% vs 13.9%, IRD vs RD respectively. The IRD regimen was most beneficial in patients <= 75 years with ISS I, II, and in the first and second relapse. Patients with the presence of extramedullary disease did not benefit from IRD treatment (median PFS 6.5 months). Both regimens were well tolerated, and the incidence of total as well as grade 3/4 toxicities was comparable. Conclusions Our analysis confirms the results of the TOURMALINE-MM1 study and shows benefit of all-oral triplet IRD treatment versus RD doublet. It demonstrates that the addition of ixazomib to RD improves key survival endpoints in patients with RRMM in a routine clinical setting.

Links

NV17-29343A, research and development project

Name: Analýza mikroprostředí kostní dřeně u extramedulárního relapsu mnohočetného myelomu

Citovat

MINARIK, J., T. PIKA, J. RADOCHA, A. JUNGOVA, J. STRAUB, T. JELINEK, Luděk POUR, P. PAVLICEK, M. MISTRIK, Lucie BROŽOVÁ, P. KRHOVSKA, K. MACHALKOVA, P. JINDRA, I. SPICKA, H. PLONKOVA, Martin ŠTORK, J. BACOVSKY, L. CAPKOVA, M. SYKORA, P. KESSLER, L. STEJSKAL, A. HEINDORFER, J. ULLRYCHOVA, T. SKACEL, V. MAISNAR and R. HAJEK. Survival benefit of ixazomib, lenalidomide and dexamethasone (IRD) over lenalidomide and dexamethasone (Rd) in relapsed and refractory multiple myeloma patients in routine clinical practice. BMC Cancer. LONDON: BMC, 2021, vol. 21, No 1, p. 1-13. ISSN 1471-2407. Available from: https://dx.doi.org/10.1186/s12885-020-07732-1.

@article{1773340,
   author = {Minarik, J. and Pika, T. and Radocha, J. and Jungova, A. and Straub, J. and Jelinek, T. and Pour, Luděk and Pavlicek, P. and Mistrik, M. and Brožová, Lucie and Krhovska, P. and Machalkova, K. and Jindra, P. and Spicka, I. and Plonkova, H. and Štork, Martin and Bacovsky, J. and Capkova, L. and Sykora, M. and Kessler, P. and Stejskal, L. and Heindorfer, A. and Ullrychova, J. and Skacel, T. and Maisnar, V. and Hajek, R.},
   article_location = {LONDON},
   article_number = {1},
   doi = {http://dx.doi.org/10.1186/s12885-020-07732-1},
   keywords = {Multiple myeloma; Ixazomib; Lenalidomide; Dexamethasone; Clinical trial; Patient registry},
   language = {eng},
   issn = {1471-2407},
   journal = {BMC Cancer},
   title = {Survival benefit of ixazomib, lenalidomide and dexamethasone (IRD) over lenalidomide and dexamethasone (Rd) in relapsed and refractory multiple myeloma patients in routine clinical practice},
   url = {https://bmccancer.biomedcentral.com/track/pdf/10.1186/s12885-020-07732-1.pdf},
   volume = {21},
   year = {2021}
}

TY  - JOUR
ID  - 1773340
AU  - Minarik, J. - Pika, T. - Radocha, J. - Jungova, A. - Straub, J. - Jelinek, T. - Pour, Luděk - Pavlicek, P. - Mistrik, M. - Brožová, Lucie - Krhovska, P. - Machalkova, K. - Jindra, P. - Spicka, I. - Plonkova, H. - Štork, Martin - Bacovsky, J. - Capkova, L. - Sykora, M. - Kessler, P. - Stejskal, L. - Heindorfer, A. - Ullrychova, J. - Skacel, T. - Maisnar, V. - Hajek, R.
PY  - 2021
TI  - Survival benefit of ixazomib, lenalidomide and dexamethasone (IRD) over lenalidomide and dexamethasone (Rd) in relapsed and refractory multiple myeloma patients in routine clinical practice
JF  - BMC Cancer
VL  - 21
IS  - 1
SP  - 1-13
EP  - 1-13
PB  - BMC
SN  - 14712407
KW  - Multiple myeloma
KW  - Ixazomib
KW  - Lenalidomide
KW  - Dexamethasone
KW  - Clinical trial
KW  - Patient registry
UR  - https://bmccancer.biomedcentral.com/track/pdf/10.1186/s12885-020-07732-1.pdf
N2  - Background We have performed a head to head comparison of all-oral triplet combination of ixazomib, lenalidomide and dexamethasone (IRD) versus lenalidomide and dexamethasone (RD) in patients with relapsed and refractory multiple myeloma (RRMM) in the routine clinical practice. Methods A total of 344 patients treated with IRD (N = 127) or RD (N = 217) were selected for analysis from the Czech Registry of Monoclonal Gammopathies (RMG). Descriptive statistics were used to assess patient's characteristics associated with the respective therapy. The primary endpoint was progression free survival (PFS), secondary end points included response rates and overall survival (OS). Survival endpoints were plotted using Kaplan-Meier methodology at 95% Greenwood confidence interval. Univariable and multivariable Cox proportional hazards models were used to evaluate the effect of treatment regimens and the significance of uneven variables. Statistical tests were performed at significance level 0.05. Results In the whole cohort, median PFS for IRD was 17.5 and for RD was 11.5 months favoring the all-oral triplet, p = 0.005; in patients within relapse 1-3, the median PFS was 23.1 vs 11.6 months, p = 0.001. The hazard ratio for PFS was 0.67 (95% confidence interval [CI] 0.51-0.89, p = 0.006). The PFS advantage translated into improved OS for patients treated with IRD, median 36.6 months vs 26.0 months (p = 0.008). The overall response rate (ORR) was 73.0% in the IRD group vs 66.2% in the RD group with a complete response rate (CR) of 11.1% vs 8.8%, and very good partial response (VGPR) 22.2% vs 13.9%, IRD vs RD respectively. The IRD regimen was most beneficial in patients <= 75 years with ISS I, II, and in the first and second relapse. Patients with the presence of extramedullary disease did not benefit from IRD treatment (median PFS 6.5 months). Both regimens were well tolerated, and the incidence of total as well as grade 3/4 toxicities was comparable. Conclusions Our analysis confirms the results of the TOURMALINE-MM1 study and shows benefit of all-oral triplet IRD treatment versus RD doublet. It demonstrates that the addition of ixazomib to RD improves key survival endpoints in patients with RRMM in a routine clinical setting.
ER  -

MINARIK, J., T. PIKA, J. RADOCHA, A. JUNGOVA, J. STRAUB, T. JELINEK, Luděk POUR, P. PAVLICEK, M. MISTRIK, Lucie BROŽOVÁ, P. KRHOVSKA, K. MACHALKOVA, P. JINDRA, I. SPICKA, H. PLONKOVA, Martin ŠTORK, J. BACOVSKY, L. CAPKOVA, M. SYKORA, P. KESSLER, L. STEJSKAL, A. HEINDORFER, J. ULLRYCHOVA, T. SKACEL, V. MAISNAR and R. HAJEK. Survival benefit of ixazomib, lenalidomide and dexamethasone (IRD) over lenalidomide and dexamethasone (Rd) in relapsed and refractory multiple myeloma patients in routine clinical practice. \textit{BMC Cancer}. LONDON: BMC, 2021, vol.~21, No~1, p.~1-13. ISSN~1471-2407. Available from: https://dx.doi.org/10.1186/s12885-020-07732-1.

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