Efficacy and safety of once-weekly bortezomib in multiple myeloma patients

Sara Bringhen, Alessandra Larocca, Davide Rossi, Maide Cavalli, Mariella Genuardi, Roberto Ria, Silvia Gentili, Francesca Patriarca, Chiara Nozzoli, Anna Levi, Tommasina Guglielmelli, Giulia Benevolo, Vincenzo Callea, Vincenzo Rizzo, Clotilde Cangialosi, Pellegrino Musto, Luca De Rosa, Anna Marina Liberati, Mariella Grasso, Antonietta P. FalconeAndrea Evangelista, Michele Cavo, Gianluca Gaidano, Mario Boccadoro, Antonio Palumbo

Research output: Contribution to journalArticlepeer-review

Abstract

In a recent phase 3 trial, bortezomibmelphalan-prednisone-thalidomide followed by maintenance treatment with bortezomib-thalidomide demonstrated superior efficacy compared with bortezomib-melphalan-prednisone. To decrease neurologic toxicities, the protocol was amended and patients in both arms received once-weekly instead of the initial twice-weekly bortezomib infusions: 372 patients received once-weekly and 139 twice-weekly bortezomib. In this posthoc analysis we assessed the impact of the schedule change on clinical outcomes and safety. Long-term outcomes appeared similar: 3-year progression-free survival rate was 50% in the once-weekly and 47% in the twice-weekly group (P > .999), and 3-year overall survival rate was 88% and 89%, respectively (P = .54). The complete response rate was 30% in the onceweekly and 35% in the twice-weekly group (P = .27). Nonhematologic grade 3/4 adverse events were reported in 35% of once-weekly patients and 51% of twice-weekly patients (P = .003). The incidence of grade 3/4 peripheral neuropathy was 8% in the once-weekly and 28% in the twice-weekly group (P <.001); 5% of patients in the once-weekly and 15% in the twice-weekly group discontinued therapy because of peripheral neuropathy (P <.001). This improvement in safety did not appear to affect efficacy. This study is registered at http://www.clinicaltrials.gov as NCT01063179.

Original languageEnglish
Pages (from-to)4745-4753
Number of pages9
JournalBlood
Volume116
Issue number23
DOIs
Publication statusPublished - Dec 2 2010

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology

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