Safety of thalidomide in newly diagnosed elderly myeloma patients: a meta-analysis of data from individual patients in six randomized trials

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Safety of thalidomide in newly diagnosed elderly myeloma patients: a meta-analysis of data from individual patients in six randomized trials

Palumbo, Antonio (author)

Waage, Anders (author)

Hulin, Cyrille (author)

Beksac, Meral (author)

Zweegman, Sonja (author)

Gay, Francesca (author)

Gimsing, Peter (author)

Leleu, Xavier (author)

Wijermans, Pierre (author)

Sucak, Gulsan (author)

Pezzatti, Sara (author)

Juliusson, Gunnar (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

Pegourie, Brigitte (author)

Schaafsma, Martijn (author)

Galli, Monica (author)

Turesson, Ingemar (author)

Kolb, Brigitte (author)

van der Holt, Bronno (author)

Baldi, Ileana (author)

Rolke, Jurgen (author)

Ciccone, Giovannino (author)

Wetterwald, Marc (author)

Lokhorst, Henk (author)

Boccadoro, Mario (author)

Rodon, Philippe (author)

Sonneveld, Pieter (author)

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(creator_code:org_t)

2012-08-08
2013
English.
In: Haematologica. - : Ferrata Storti Foundation (Haematologica). - 1592-8721 .- 0390-6078. ; 98:1, s. 87-94

Related links:: http://www.ncbi.nlm.... (free); show more...; http://dx.doi.org/10... (free); https://doi.org/10.3...; https://lup.lub.lu.s...; https://doi.org/10.3...; show less...

Journal article (peer-reviewed)

Abstract Subject headings

Treatment with melphalan-prednisone-thalidomide improves the outcome of patients with multiple myeloma and is now considered a standard of care for patients not eligible for transplantation. However, this treatment is a major source of morbidity. A meta-analysis of data from individual patients (n=1680) in six randomized trials was performed, comparing the effects of melphalan-prednisone-thalidomide versus melphalan-prednisone. The main objective was to estimate the risk of serious adverse events and their impact on outcome. The primary endpoints were the 2-year cumulative incidence of grade 3-4 hematologic and non-hematologic toxicities. At least 75% of the grade 3-4 toxicities occurred during the first 6 months of treatment in both treatment groups. The cumulative incidence of grade 3-4 hematologic toxicities was higher in the melphalan-prednisone-thalidomide group than in the melphalan-prednisone group (28% versus 22%; HR 1.32, 95% CI 1.05-1.66) as was the cumulative incidence of non-hematologic toxicities (39% versus 17%, HR 2.78, 95% CI 2.21-3.50). Grade 3-4 non-hematologic toxicities were significantly increased in patients with poor Performance Status. Occurrence of grade 3-4 non-hematologic toxicities had a negative impact on both progression-free survival (HR 1.24, 95% CI 1.07-1.45) and overall survival, (HR 1.23, 95% CI 1.03-1.47). Besides toxicities, progression-free and overall survival were also negatively affected by advanced International Staging System stage, high creatinine levels and poor Performance Status. Age had a negative impact on survival as well. Although melphalan-prednisone-thalidomide improved outcome, it increased toxicities, especially non-hematologic ones. Serious non-hematologic toxicities, older age, poor Performance Status, and high creatinine levels negatively affected survival. (C) 2013 Ferrata Storti Foundation. This is an open-access paper. doi: 10.3324/haematol.2012.067058

Subject headings

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Hematology

Articles in the publication: Haematologica

By the university: Lund University

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