TY - JOUR
T1 - A phase 2 study of three low-dose intensity subcutaneous bortezomib regimens in elderly frail patients with untreated multiple myeloma
AU - Larocca, A
AU - Bringhen, S
AU - Petrucci, MT
AU - Oliva, S
AU - Falcone, AP
AU - Caravita, T
AU - Villani, O
AU - Benevolo, G
AU - Liberati, AM
AU - Morabito, F
AU - Montefusco, V
AU - Passera, R
AU - De Rosa, L
AU - Omede, P
AU - Vincelli, ID
AU - Spada, S
AU - Carella, AM
AU - Ponticelli, E
AU - Derudas, D
AU - Genuardi, M
AU - Guglielmelli, T
AU - Nozzoli, C
AU - Aghemo, E
AU - De Paoli, L
AU - Conticello, C
AU - Musolino, C
AU - Offidani, M
AU - Boccadoro, M
AU - Sonneveld, Pieter
AU - Palumbo, A
PY - 2016
Y1 - 2016
N2 - This phase 2 trial evaluated three low-dose intensity subcutaneous bortezomib-based treatments in patients. 75 years with newly diagnosed multiple myeloma (MM). Patients received subcutaneous bortezomib plus oral prednisone (VP, N=51) or VP plus cyclophosphamide (VCP, N=51) or VP plus melphalan (VMP, N=50), followed by bortezomib maintenance, and half of the patients were frail. Response rate was 64% with VP, 67% with VCP and 86% with VMP, and very good partial response rate or better was 26%, 28.5% and 49%, respectively. Median progression-free survival was 14.0, 15.2 and 17.1 months, and 2-year OS was 60%, 70% and 76% in VP, VCP, VMP, respectively. At least one drug-related grade. 3 non-hematologic adverse event (AE) occurred in 22% of VP, 37% of VCP and 33% of VMP patients; the discontinuation rate for AEs was 12%, 14% and 20%, and the 6-month rate of toxicityrelated deaths was 4%, 4% and 8%, respectively. The most common grade. 3 AEs included infections (8-20%), and constitutional (10-14%) and cardiovascular events (4-12%); peripheral neuropathy was limited (4-6%). Bortezomib maintenance was effective and feasible. VP, VCP and VMP regimens demonstrated no substantial difference. Yet, toxicity was higher with VMP, suggesting that a two-drug combination followed by maintenance should be preferred in frail patients.
AB - This phase 2 trial evaluated three low-dose intensity subcutaneous bortezomib-based treatments in patients. 75 years with newly diagnosed multiple myeloma (MM). Patients received subcutaneous bortezomib plus oral prednisone (VP, N=51) or VP plus cyclophosphamide (VCP, N=51) or VP plus melphalan (VMP, N=50), followed by bortezomib maintenance, and half of the patients were frail. Response rate was 64% with VP, 67% with VCP and 86% with VMP, and very good partial response rate or better was 26%, 28.5% and 49%, respectively. Median progression-free survival was 14.0, 15.2 and 17.1 months, and 2-year OS was 60%, 70% and 76% in VP, VCP, VMP, respectively. At least one drug-related grade. 3 non-hematologic adverse event (AE) occurred in 22% of VP, 37% of VCP and 33% of VMP patients; the discontinuation rate for AEs was 12%, 14% and 20%, and the 6-month rate of toxicityrelated deaths was 4%, 4% and 8%, respectively. The most common grade. 3 AEs included infections (8-20%), and constitutional (10-14%) and cardiovascular events (4-12%); peripheral neuropathy was limited (4-6%). Bortezomib maintenance was effective and feasible. VP, VCP and VMP regimens demonstrated no substantial difference. Yet, toxicity was higher with VMP, suggesting that a two-drug combination followed by maintenance should be preferred in frail patients.
U2 - 10.1038/leu.2016.36
DO - 10.1038/leu.2016.36
M3 - Article
C2 - 26898189
SN - 0887-6924
VL - 30
SP - 1320
EP - 1326
JO - Leukemia
JF - Leukemia
IS - 6
ER -