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

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F18%3A73591250" target="_blank" >RIV/61989592:15110/18:73591250 - isvavai.cz</a>

Result on the web

<a href="http://dx.doi.org/10.1080/03007995.2017.1410121" target="_blank" >http://dx.doi.org/10.1080/03007995.2017.1410121</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1080/03007995.2017.1410121" target="_blank" >10.1080/03007995.2017.1410121</a>

Result language

angličtina

Original language name

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

Original language description

Abstract 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; 16 mg/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 &lt; .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.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30205 - Hematology

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2018

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

CURRENT MEDICAL RESEARCH AND OPINION

ISSN

0300-7995

e-ISSN

—

Volume of the periodical

34

Issue of the periodical within the volume

5

Country of publishing house

GB - UNITED KINGDOM

Number of pages

9

Pages from-to

775-783

UT code for WoS article

000430209400003

EID of the result in the Scopus database

2-s2.0-85042106038