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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@article{eea1918b30014205a6479dbbfa85f6e7,
title = "Safety of thalidomide in newly diagnosed elderly myeloma patients: a meta-analysis of data from individual patients in six randomized trials",
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. (C) 2013 Ferrata Storti Foundation. This is an open-access paper. doi: 10.3324/haematol.2012.067058",
author = "Antonio Palumbo and Anders Waage and Cyrille Hulin and Meral Beksac and Sonja Zweegman and Francesca Gay and Peter Gimsing and Xavier Leleu and Pierre Wijermans and Gulsan Sucak and Sara Pezzatti and Gunnar Juliusson and Brigitte Pegourie and Martijn Schaafsma and Monica Galli and Ingemar Turesson and Brigitte Kolb and {van der Holt}, Bronno and Ileana Baldi and Jurgen Rolke and Giovannino Ciccone and Marc Wetterwald and Henk Lokhorst and Mario Boccadoro and Philippe Rodon and Pieter Sonneveld",
year = "2013",
doi = "10.3324/haematol.2012.067058",
language = "English",
volume = "98",
pages = "87--94",
journal = "Haematologica-The Hematology Journal",
issn = "1592-8721",
publisher = "Ferrata Storti Foundation",
number = "1",

}