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, Alessandra
AU - Bringhen, S.
AU - Petrucci, Maria T.
AU - Oliva, Stefania
AU - Falcone, Antonietta Pia
AU - Caravita, T.
AU - Villani, Oreste
AU - Benevolo, Giulia
AU - Liberati, Am
AU - Morabito, F.
AU - Montefusco, Vittorio
AU - Passera, R.
AU - de Rosa, L.
AU - Omedè, P.
AU - Vincelli, Iolanda
AU - Spada, S.
AU - Carella, Angelo Michele
AU - Ponticelli, E.
AU - Derudas, Daniele
AU - Genuardi, M.
AU - Guglielmelli, Tommasina
AU - Nozzoli, C.
AU - Aghemo, E.
AU - De Paoli, Lorenzo
AU - Conticello, C.
AU - Musolino, Caterina
AU - Offidani, Massimo
AU - Boccadoro, M.
AU - Sonneveld, P.
AU - Palumbo, A.
PY - 2016/2/22
Y1 - 2016/2/22
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 toxicity-related 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.Leukemia advance online publication, 8 March 2016; doi:10.1038/leu.2016.36.
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 toxicity-related 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.Leukemia advance online publication, 8 March 2016; doi:10.1038/leu.2016.36.
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U2 - 10.1038/leu.2016.36
DO - 10.1038/leu.2016.36
M3 - Article
SN - 0887-6924
JO - Leukemia
JF - Leukemia
ER -