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A randomized phase ...
A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with del5q
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Fenaux, P (author)
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Giagounidis, A (author)
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Selleslag, D (author)
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Beyne-Rauzy, O (author)
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Mufti, G (author)
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Mittelman, M (author)
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Muus, P (author)
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Boekhorst, PT (author)
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Sanz, G (author)
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del Canizo, C (author)
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Guerci-Bresler, A (author)
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- Nilsson, Lars (author)
- Lund University,Lunds universitet,Stamcellscentrum (SCC),Avdelningen för stamcellsforskning,Institutionen för laboratoriemedicin,Medicinska fakulteten,Stem Cell Center,Division of stem cell research,Department of Laboratory Medicine,Faculty of Medicine
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Platzbecker, U (author)
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Lubbert, M (author)
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Quesnel, B (author)
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Cazzola, M (author)
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Ganser, A (author)
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Bowen, D (author)
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Schlegelberger, B (author)
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Aul, C (author)
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Knight, R (author)
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Francis, J (author)
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Fu, T (author)
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- Hellstrom-Lindberg, E (author)
- Karolinska Institutet
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(creator_code:org_t)
- American Society of Hematology, 2011
- 2011
- English.
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In: Blood. - : American Society of Hematology. - 1528-0020 .- 0006-4971. ; 118:14, s. 3765-3776
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http://dx.doi.org/10...
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http://kipublication...
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https://doi.org/10.1...
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Abstract
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- This phase 3, randomized, double-blind study assessed the efficacy and safety of lenalidomide in 205 red blood cell (RBC) transfusion-dependent patients with International Prognostic Scoring System Low-/Intermediate-1-risk del5q31 myelodysplastic syndromes. Patients received lenalidomide 10 mg/day on days 1-21 (n = 69) or 5 mg/day on days 1-28 (n = 69) of 28-day cycles; or placebo (n = 67). Crossover to lenalidomide or higher dose was allowed after 16 weeks. More patients in the lenalidomide 10- and 5-mg groups achieved RBC-transfusion independence (TI) for ≥ 26 weeks (primary endpoint) versus placebo (56.1% and 42.6% vs 5.9%; both P < .001). Median duration of RBC-TI was not reached (median follow-up, 1.55 years), with 60% to 67% of responses ongoing in patients without progression to acute myeloid leukemia (AML). Cytogenetic response rates were 50.0% (10 mg) versus 25.0% (5 mg; P = .066). For the lenalidomide groups combined, 3-year overall survival and AML risk were 56.5% and 25.1%, respectively. RBC-TI for ≥ 8 weeks was associated with 47% and 42% reductions in the relative risks of death and AML progression or death, respectively (P = .021 and .048). The safety profile was consistent with previous reports. Lenalidomide is beneficial and has an acceptable safety profile in transfusion-dependent patients with Low-/Intermediate-1-risk del5q myelodysplastic syndrome. This trial was registered at www.clinicaltrials.gov as #NCT00179621.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
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- ref (subject category)
- art (subject category)
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Blood
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- By the author/editor
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Fenaux, P
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Giagounidis, A
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Selleslag, D
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Beyne-Rauzy, O
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Mufti, G
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Mittelman, M
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show more...
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Muus, P
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Boekhorst, PT
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Sanz, G
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del Canizo, C
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Guerci-Bresler, ...
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Nilsson, Lars
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Platzbecker, U
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Lubbert, M
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Quesnel, B
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Cazzola, M
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Ganser, A
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Bowen, D
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Schlegelberger, ...
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Aul, C
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Knight, R
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Francis, J
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Fu, T
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Hellstrom-Lindbe ...
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Hematology
- Articles in the publication
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Blood
- By the university
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Karolinska Institutet
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Lund University