☆ 4.4 Article

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

HAEMATOLOGICA (2013)

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HAEMATOLOGICA

卷 98, 期 1, 页码 87-94

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FERRATA STORTI FOUNDATION

DOI: 10.3324/haematol.2012.067058

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Hematology

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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

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Dose/schedule-adjusted Rd-R vs continuous Rd for elderly, intermediate-fit patients with newly diagnosed multiple myeloma

Alessandra Larocca, Francesca Bonello, Gianluca Gaidano, Mattia D'Agostino, Massimo Offidani, Nicola Cascavilla, Andrea Capra, Giulia Benevolo, Patrizia Tosi, Monica Galli, Roberto Marasca, Nicola Giuliani, Annalisa Bernardini, Elisabetta Antonioli, Delia Rota-Scalabrini, Claudia Cellini, Alessandra Pompa, Federico Monaco, Francesca Patriarca, Tommaso Caravita di Toritto, Paolo Corradini, Paola Tacchetti, Mario Boccadoro, Sara Bringhen

Summary: In elderly patients with multiple myeloma, dose/schedule-adjusted lenalidomide-dexamethasone (Rd-R) showed superior event-free survival (EFS), progression-free survival, and 3-year overall survival compared to continuous Rd treatment. However, the rate of >= 1 nonhematologic grade >= 3 adverse events showed no significant difference between the two groups. Switching to reduced-dose lenalidomide maintenance without dexamethasone after 9 cycles of Rd was feasible and yielded similar outcomes to standard continuous Rd in intermediate-fit patients.

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