Adjusted comparison of daratumumab monotherapy versus
real-world historical control data from the Czech Republic in
heavily pretreated and highly refractory multiple myeloma
patients

J 2018

Adjusted comparison of daratumumab monotherapy versus real-world historical control data from the Czech Republic in heavily pretreated and highly refractory multiple myeloma patients

JELINEK, T., V. MAISNAR, Luděk POUR, I. SPICKA, J. MINARIK et. al.

Basic information

Original name

Adjusted comparison of daratumumab monotherapy versus real-world historical control data from the Czech Republic in heavily pretreated and highly refractory multiple myeloma patients

Authors

JELINEK, T. (203 Czech Republic), V. MAISNAR (203 Czech Republic), Luděk POUR (203 Czech Republic, belonging to the institution), I. SPICKA (203 Czech Republic), J. MINARIK (203 Czech Republic), E. GREGORA (203 Czech Republic), P. KESSLER (203 Czech Republic), M. SYKORA (203 Czech Republic), H. FRANKOVA (203 Czech Republic), D. ADAMOVA (203 Czech Republic), M. WROBEL (203 Czech Republic), P. MIKULA (203 Czech Republic), Jiří JARKOVSKÝ (203 Czech Republic, belonging to the institution), J. DIELS (56 Belgium), X. GATOPOULOU (300 Greece), S. VESELA (203 Czech Republic), H. BESSON (56 Belgium), Lucie BROŽOVÁ (203 Czech Republic, belonging to the institution), T. ITO (826 United Kingdom of Great Britain and Northern Ireland) and R. HAJEK (203 Czech Republic, guarantor)

Edition

Current medical research and opinion, Oxon, Taylor & Francis, 2018, 0300-7995

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30218 General and internal medicine

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

Impact factor

Impact factor: 2.345

RIV identification code

RIV/00216224:14110/18:00103214

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1080/03007995.2017.1410121

UT WoS

000430209400003

Keywords in English

Czech Republic; multiple myeloma; daratumumab; matching adjusted indirect comparison; treatment outcomes

Abstract

V originále

Objectives: We conducted an adjusted comparison of progression-free survival (PFS) and overall survival (OS) for daratumumab monotherapy versus standard of care, as observed in a real-world historical cohort of heavily pretreated multiple myeloma patients from Czech Republic. Methods: Using longitudinal chart data from the Registry of Monoclonal Gammopathies (RMG) of the Czech Myeloma Group, patient-level data from the RMG was pooled with pivotal daratumumab monotherapy studies (GEN501 and SIRIUS; 16mg/kg). Results: From the RMG database, we identified 972 treatment lines in 463 patients previously treated with both a proteasome inhibitor and an immunomodulatory drug. Treatment initiation dates for RMG patients were between March 2006 and March 2015. The most frequently used treatment regimens were lenalidomide-based regimens (33.4%), chemotherapy (18.1%), bortezomib-based regimens (13.6%), thalidomide-based regimens (8.0%), and bortezomib plus thalidomide (5.3%). Few patients were treated with carfilzomib-based regimens (2.5%) and pomalidomide-based regimens (2.4%). Median observed PFS for daratumumab and the RMG cohort was 4.0 and 5.8 months (unadjusted hazard ratio [HR], 1.14; 95% confidence interval [CI], 0.94-1.39), respectively, and unadjusted median OS was 20.1 and 11.9 months (unadjusted HR, 0.61; 95% CI, 0.48-0.78), respectively. Statistical adjustments for differences in baseline characteristics were made using patient-level data. The adjusted HRs (95% CI) for PFS and OS for daratumumab versus the RMG cohort were 0.79 (0.56-1.12; p=.192) and 0.33 (0.21-0.52; p<.001), respectively. Conclusions: Adjusted comparisons between trial data and historical cohorts can provide useful insights to clinicians and reimbursement decision makers on relative treatment efficacies in the absence of head-to-head comparison studies for daratumumab monotherapy.

Citovat

JELINEK, T., V. MAISNAR, Luděk POUR, I. SPICKA, J. MINARIK, E. GREGORA, P. KESSLER, M. SYKORA, H. FRANKOVA, D. ADAMOVA, M. WROBEL, P. MIKULA, Jiří JARKOVSKÝ, J. DIELS, X. GATOPOULOU, S. VESELA, H. BESSON, Lucie BROŽOVÁ, T. ITO and R. HAJEK. Adjusted comparison of daratumumab monotherapy versus real-world historical control data from the Czech Republic in heavily pretreated and highly refractory multiple myeloma patients. Current medical research and opinion. Oxon: Taylor & Francis, 2018, vol. 34, No 5, p. 775-783. ISSN 0300-7995. Available from: https://dx.doi.org/10.1080/03007995.2017.1410121.

@article{1423208,
   author = {Jelinek, T. and Maisnar, V. and Pour, Luděk and Spicka, I. and Minarik, J. and Gregora, E. and Kessler, P. and Sykora, M. and Frankova, H. and Adamova, D. and Wrobel, M. and Mikula, P. and Jarkovský, Jiří and Diels, J. and Gatopoulou, X. and Vesela, S. and Besson, H. and Brožová, Lucie and Ito, T. and Hajek, R.},
   article_location = {Oxon},
   article_number = {5},
   doi = {http://dx.doi.org/10.1080/03007995.2017.1410121},
   keywords = {Czech Republic; multiple myeloma; daratumumab; matching adjusted indirect comparison; treatment outcomes},
   language = {eng},
   issn = {0300-7995},
   journal = {Current medical research and opinion},
   title = {Adjusted comparison of daratumumab monotherapy versus real-world historical control data from the Czech Republic in heavily pretreated and highly refractory multiple myeloma patients},
   volume = {34},
   year = {2018}
}

TY  - JOUR
ID  - 1423208
AU  - Jelinek, T. - Maisnar, V. - Pour, Luděk - Spicka, I. - Minarik, J. - Gregora, E. - Kessler, P. - Sykora, M. - Frankova, H. - Adamova, D. - Wrobel, M. - Mikula, P. - Jarkovský, Jiří - Diels, J. - Gatopoulou, X. - Vesela, S. - Besson, H. - Brožová, Lucie - Ito, T. - Hajek, R.
PY  - 2018
TI  - Adjusted comparison of daratumumab monotherapy versus real-world historical control data from the Czech Republic in heavily pretreated and highly refractory multiple myeloma patients
JF  - Current medical research and opinion
VL  - 34
IS  - 5
SP  - 775-783
EP  - 775-783
PB  - Taylor & Francis
SN  - 03007995
KW  - Czech Republic
KW  - multiple myeloma
KW  - daratumumab
KW  - matching adjusted indirect comparison
KW  - treatment outcomes
N2  - Objectives: We conducted an adjusted comparison of progression-free survival (PFS) and overall survival (OS) for daratumumab monotherapy versus standard of care, as observed in a real-world historical cohort of heavily pretreated multiple myeloma patients from Czech Republic. Methods: Using longitudinal chart data from the Registry of Monoclonal Gammopathies (RMG) of the Czech Myeloma Group, patient-level data from the RMG was pooled with pivotal daratumumab monotherapy studies (GEN501 and SIRIUS; 16mg/kg). Results: From the RMG database, we identified 972 treatment lines in 463 patients previously treated with both a proteasome inhibitor and an immunomodulatory drug. Treatment initiation dates for RMG patients were between March 2006 and March 2015. The most frequently used treatment regimens were lenalidomide-based regimens (33.4%), chemotherapy (18.1%), bortezomib-based regimens (13.6%), thalidomide-based regimens (8.0%), and bortezomib plus thalidomide (5.3%). Few patients were treated with carfilzomib-based regimens (2.5%) and pomalidomide-based regimens (2.4%). Median observed PFS for daratumumab and the RMG cohort was 4.0 and 5.8 months (unadjusted hazard ratio [HR], 1.14; 95% confidence interval [CI], 0.94-1.39), respectively, and unadjusted median OS was 20.1 and 11.9 months (unadjusted HR, 0.61; 95% CI, 0.48-0.78), respectively. Statistical adjustments for differences in baseline characteristics were made using patient-level data. The adjusted HRs (95% CI) for PFS and OS for daratumumab versus the RMG cohort were 0.79 (0.56-1.12; p=.192) and 0.33 (0.21-0.52; p<.001), respectively. Conclusions: Adjusted comparisons between trial data and historical cohorts can provide useful insights to clinicians and reimbursement decision makers on relative treatment efficacies in the absence of head-to-head comparison studies for daratumumab monotherapy.
ER  -

JELINEK, T., V. MAISNAR, Luděk POUR, I. SPICKA, J. MINARIK, E. GREGORA, P. KESSLER, M. SYKORA, H. FRANKOVA, D. ADAMOVA, M. WROBEL, P. MIKULA, Jiří JARKOVSKÝ, J. DIELS, X. GATOPOULOU, S. VESELA, H. BESSON, Lucie BROŽOVÁ, T. ITO and R. HAJEK. Adjusted comparison of daratumumab monotherapy versus real-world historical control data from the Czech Republic in heavily pretreated and highly refractory multiple myeloma patients. \textit{Current medical research and opinion}. Oxon: Taylor \&{} Francis, 2018, vol.~34, No~5, p.~775-783. ISSN~0300-7995. Available from: https://dx.doi.org/10.1080/03007995.2017.1410121.

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