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EnglishThis 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 .
| Titolo: | A phase 2 study of three low-dose intensity subcutaneous bortezomib regimens in elderly frail patients with untreated multiple myeloma |
| Autori Riconosciuti: | |
| Autori: | Larocca, A.; Bringhen, S.; Petrucci, M.T.; Oliva, S.; Falcone, A.P.; Caravita, T.; Villani, O.; Benevolo, G.; Liberati, A.M.; Morabito, F.; Montefusco, V.; Passera, R.; De Rosa, L.; Omedé, P.; Vincelli, I.D.; Spada, S.; Carella, A.M.; Ponticelli, E.; Derudas, D.; Genuardi, M.; Guglielmelli, T.; Nozzoli, C.; Aghemo, E.; De Paoli, L.; Conticello, C.; Musolino, C.; Offidani, M.; Boccadoro, M.; Sonneveld, P.; Palumbo, A |
| Data di pubblicazione: | 2016 |
| Abstract: | 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 . |
| Volume: | 30 |
| Fascicolo: | 6 |
| Pagina iniziale: | 1320 |
| Pagina finale: | 1326 |
| Digital Object Identifier (DOI): | 10.1038/leu.2016.36 |
| URL: | http://www.nature.com/leu/index.html |
| Parole Chiave: | Hematology; Cancer Research; Anesthesiology and Pain Medicine |
| Rivista: | LEUKEMIA |
| Appare nelle tipologie: | 03A-Articolo su Rivista |
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