Safety profile of lenalidomide in patients with lower-risk myelodysplastic syndromes without del(5q): results of a phase 3 trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F18%3A10378720" target="_blank" >RIV/00216208:11110/18:10378720 - isvavai.cz</a>
Alternative codes found
RIV/00064165:_____/18:10378720
Result on the web
<a href="https://doi.org/10.1080/10428194.2017.1421758" target="_blank" >https://doi.org/10.1080/10428194.2017.1421758</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1080/10428194.2017.1421758" target="_blank" >10.1080/10428194.2017.1421758</a>
Alternative languages
Result language
angličtina
Original language name
Safety profile of lenalidomide in patients with lower-risk myelodysplastic syndromes without del(5q): results of a phase 3 trial
Original language description
The safety profile of lenalidomide use in lower-risk myelodysplastic syndromes (MDS) patients with del(5q) is well-established, but less is known in non-del(5q) patients. We provide safety data from a randomized, phase 3 trial evaluating lenalidomide in 239 patients with lower-risk non-del(5q) MDS ineligible/refractory to erythropoiesis-stimulating agents (ESAs). Compared with placebo, lenalidomide was associated with a higher incidence of grade 3-4 treatment-emergent adverse events (TEAEs; 86% vs. 44%), but not risk of infection (p=.817) or hemorrhagic events (p=1.000). Grade 3-4 non-hematologic TEAEs were rare (the incidence of grade 3-4 pneumonia, e.g. was 5.6% in the lenalidomide group and 2.5% in the placebo group). Common grade 1-2 non-hematologic TEAEs did not require dose modifications or treatment discontinuation. Acute myeloid leukemia and second primary malignancies incidence was similar across treatment groups. Lenalidomide had a predictable and manageable safety profile in lower-risk non-del(5q) MDS patients ineligible/refractory to ESAs. Guidance on managing lenalidomide-related TEAEs is provided to help maintain patients on therapy to achieve maximum clinical benefit.TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01029262.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - 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
Result continuities
Project
—
Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2018
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Leukemia & Lymphoma
ISSN
1042-8194
e-ISSN
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Volume of the periodical
59
Issue of the periodical within the volume
9
Country of publishing house
GB - UNITED KINGDOM
Number of pages
9
Pages from-to
2135-2143
UT code for WoS article
000441265300014
EID of the result in the Scopus database
2-s2.0-85040990408