The Weekly Infusion of Bortezomib Reduces Peripheral Neuropathy

• Published in: Blood 2009-11, Vol.114 (22), p.3887-3887
• Main Authors: Gay, Francesca, Bringhen, Sara, Genuardi, Mariella, Rossi, Davide, Ria, Roberto, Romano, Alessandra, Ferrara, Felicetto, Renzo, Nicola Di, Dominietto, Alida, Andriani, Alessandro, Rizzi, Rita, Vallone, Roberto, Mele, Giuseppe, Storti, Sergio, Podda, Luigi, Aitoro, Gabriele, Mettivier, Vincenzo, Annibali, Ombretta, Rossini, Fausto, Gentilini, Patrizia, Pavone, Vincenzo, Giuliani, Nicola, Rauco, Anna Maria, Baraldi, Anna, Capaldi, Antonio, Gherlinzoni, Filippo, Gaidano, Gianluca, Boccadoro, Mario, Palumbo, Antonio
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V114.22.3887.3887

Abstract 3887 Poster Board III-823 Peripheral neuropathy (PN) is a non-hematologic side effect frequently reported in elderly patients treated with bortezomib-melphalan-prednisone (VMP). To address this issue, both bortezomib-melphalan-prednisone-thalidomide (VMPT) and VMP dosing regimens were changed; and bortezomib schedule was modified from twice weekly to weekly administration. To determine incidence and risk factors of bortezomib-associated PN in twice weekly or weekly bortezomib infusion schedules. Patients (N=511) older than 65 years were randomly assigned to receive VMPT followed by maintenance with bortezomib and thalidomide or VMP. Initially, patients were treated with nine 6-week cycles of VMPT (induction: bortezomib 1.3 mg/m2 days 1,4,8,11,22,25,29,32 in cycles 1-4 and days 1,8,22,29 in cycles 5-9; melphalan 9 mg/m2 days 1-4; prednisone 60 mg/m2 days 1-4 and thalidomide 50 mg days 1-42; maintenance: bortezomib 1.3 mg/m2 every 15 days and thalidomide 50 mg/day as maintenance) or VMP (bortezomib, melphalan and prednisone at the same doses and schedules previously described without maintenance). In March 2007, the protocol was amended: both VMPT and VMP induction schedules were changed to nine 5-week cycles and bortezomib schedule was modified to weekly administration (1.3 mg/m2 days 1,8,15,22 in cycles 1-9). Baseline grade ≥ 2 PN was an exclusion criteria. 254 VMPT patients and 257 VMP patients were evaluated in intention-to-treat: 141 patients received twice weekly infusion of bortezomib and 370 once weekly. The overall incidence of PN was 37% in the VMPT patients and 27% in the VMP patients (p=0.01) while the grade ≥ 3 was quite similar (8% and 5%. p=0.19). When VMPT and VMP groups were combined, the incidence of PN was significantly higher in patients who received twice weekly infusion of bortezomib: the incidence of all grade PN was 45% in the twice weekly group and 27% in the once weekly group (p=0.0002), including a grade ≥ 3 PN incidence of 16% and 3% (p