In a recent phase 3 trial, bortezomib-melphalan-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 once-weekly 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. (Blood. 2010; 116(23): 4745-4753)

Bringhen, S., Larocca, A., Rossi, D., Cavalli, M., Genuardi, M., Ria, R., Gentili, S., Patriarca, F., Nozzoli, C., Levi, A., Guglielmelli, T., Benevolo, G., Callea, V., Rizzo, V., Cangialosi, C., Musto, P., De Rosa, L., Liberati, A., Grasso, M., Falcone, A., Evangelista, A., Cavo, M., Gaidano, G., Boccadoro, M., Palumbo, A., Efficacy and safety of once-weekly bortezomib in multiple myeloma patients, <<BLOOD>>, 2010; 116 (23): 4745-4753. [doi:10.1182/blood-2010-07-294983] [http://hdl.handle.net/10807/57636]

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

Genuardi, Maurizio;
2010

Abstract

In a recent phase 3 trial, bortezomib-melphalan-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 once-weekly 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. (Blood. 2010; 116(23): 4745-4753)
2010
Inglese
Bringhen, S., Larocca, A., Rossi, D., Cavalli, M., Genuardi, M., Ria, R., Gentili, S., Patriarca, F., Nozzoli, C., Levi, A., Guglielmelli, T., Benevolo, G., Callea, V., Rizzo, V., Cangialosi, C., Musto, P., De Rosa, L., Liberati, A., Grasso, M., Falcone, A., Evangelista, A., Cavo, M., Gaidano, G., Boccadoro, M., Palumbo, A., Efficacy and safety of once-weekly bortezomib in multiple myeloma patients, <<BLOOD>>, 2010; 116 (23): 4745-4753. [doi:10.1182/blood-2010-07-294983] [http://hdl.handle.net/10807/57636]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/57636
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