A phase 2 study of three low-dose intensity subcutaneous bortezomib regimens in elderly frail patients with untreated multiple myeloma
| Autor: | Mario Boccadoro, Pieter Sonneveld, Tommasina Guglielmelli, Elena Ponticelli, Mariella Genuardi, Antonietta Falcone, Giulia Benevolo, Chiara Nozzoli, Anna Marina Liberati, Oreste Villani, Roberto Passera, Concetta Conticello, Maria Teresa Petrucci, Elena Aghemo, Iolanda Vincelli, Fortunato Morabito, Daniele Derudas, Sara Bringhen, L De Paoli, Paola Omedè, L. De Rosa, Tommaso Caravita, Caterina Musolino, Salvatore Oliva, Alessandra Larocca, Vittorio Montefusco, Stefano Spada, A. M. Carella, Massimo Offidani, Antonio Palumbo |
|---|---|
| Přispěvatelé: | Hematology |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Melphalan
Male Cancer Research MELPHALAN-PREDNISONE INITIAL TREATMENT PLUS THALIDOMIDE CLINICAL-TRIALS SURVIVAL DEXAMETHASONE LENALIDOMIDE METAANALYSIS MAINTENANCE THERAPY Phases of clinical research Gastroenterology Bortezomib 0302 clinical medicine Hematology Anesthesiology and Pain Medicine Prednisone Antineoplastic Combined Chemotherapy Protocols Multiple myeloma Aged 80 and over Survival Rate Oncology 030220 oncology & carcinogenesis Female Multiple Myeloma medicine.drug medicine.medical_specialty Cyclophosphamide Disease-Free Survival 03 medical and health sciences Internal medicine medicine Humans Adverse effect Aged business.industry medicine.disease Surgery Hematology cancer research anesthesiology and pain medicine business 030215 immunology |
| Zdroj: | Leukemia, 30(6), 1320-1326. Nature Publishing Group |
| ISSN: | 0887-6924 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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