Safety of thalidomide in newly diagnosed elderly myeloma patients: a meta-analysis of data from individual patients in six randomized trials
dc.contributor.author | Palumbo, Antonio | |
dc.contributor.author | Waage, Anders | |
dc.contributor.author | Hulin, Cyrille | |
dc.contributor.author | Beksac, M | |
dc.contributor.author | Zweegman, Sonja | |
dc.contributor.author | Gay, Francesca | |
dc.contributor.author | Gimsing, Peter | |
dc.contributor.author | Leleu, X | |
dc.contributor.author | Wijermans, P | |
dc.contributor.author | Sucak, G | |
dc.contributor.author | Pezzatti, S | |
dc.contributor.author | Juliusson, Gunnar | |
dc.contributor.author | Pegourie, B | |
dc.contributor.author | Schaafsma, Marije | |
dc.contributor.author | Galli, M | |
dc.contributor.author | Turesson, Ingemar | |
dc.contributor.author | Kolb, B | |
dc.contributor.author | van der Holt, B | |
dc.contributor.author | Baldi, I | |
dc.contributor.author | Rolke, Jürgen | |
dc.contributor.author | Ciccone, G | |
dc.contributor.author | Wetterwald, M | |
dc.contributor.author | Lokhorst, H | |
dc.contributor.author | Boccadoro, Mario | |
dc.contributor.author | Rodon, P | |
dc.contributor.author | Sonneveld, Pieter | |
dc.date.accessioned | 2019-10-25T11:01:55Z | |
dc.date.available | 2019-10-25T11:01:55Z | |
dc.date.created | 2013-05-07T11:02:23Z | |
dc.date.issued | 2013 | |
dc.identifier.citation | Haematologica. 2013, 98 (1), 87-94. | nb_NO |
dc.identifier.issn | 0390-6078 | |
dc.identifier.uri | http://hdl.handle.net/11250/2624434 | |
dc.description.abstract | 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. | nb_NO |
dc.language.iso | eng | nb_NO |
dc.publisher | Ferrata Storti Foundation | nb_NO |
dc.title | Safety of thalidomide in newly diagnosed elderly myeloma patients: a meta-analysis of data from individual patients in six randomized trials | nb_NO |
dc.type | Journal article | nb_NO |
dc.type | Peer reviewed | nb_NO |
dc.description.version | publishedVersion | nb_NO |
dc.source.pagenumber | 87-94 | nb_NO |
dc.source.volume | 98 | nb_NO |
dc.source.journal | Haematologica | nb_NO |
dc.source.issue | 1 | nb_NO |
dc.identifier.doi | 10.3324/haematol.2012.067058 | |
dc.identifier.cristin | 1027400 | |
dc.description.localcode | ©2013 Ferrata Storti Foundation | nb_NO |
cristin.unitcode | 194,65,15,0 | |
cristin.unitcode | 1920,15,0,0 | |
cristin.unitname | Institutt for klinisk og molekylær medisin | |
cristin.unitname | Medisinsk klinikk | |
cristin.ispublished | true | |
cristin.fulltext | original | |
cristin.qualitycode | 1 |