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

dc.contributor.authorBeksac, Meral
dc.contributor.departmentFen Fakültesitr_TR
dc.date.accessioned2020-02-19T14:20:52Z
dc.date.available2020-02-19T14:20:52Z
dc.date.issued2013
dc.description.abstractTreatment 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. © 2013 Ferrata Storti Foundation.tr_TR
dc.description.indexWos
dc.description.indexScopus
dc.identifier.endpage94tr_TR
dc.identifier.issn/e-issn0390-6078
dc.identifier.issn/e-issn1592-8721
dc.identifier.issue1tr_TR
dc.identifier.startpage87tr_TR
dc.identifier.urihttps://doi.org/ https://doi.org/tr_TR
dc.identifier.urihttp://hdl.handle.net/20.500.12575/69854
dc.identifier.volume98tr_TR
dc.language.isoentr_TR
dc.relation.isversionofhttps://doi.org/tr_TR
dc.relation.journalHaematologicatr_TR
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıtr_TR
dc.rightsCC0 1.0 Universal*
dc.rights.urihttp://creativecommons.org/publicdomain/zero/1.0/*
dc.titleSafety of thalidomide in newly diagnosed elderly myeloma patients: A meta-analysis of data from individual patients in six randomized trialstr_TR
dc.typeArticletr_TR

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