Multiple myeloma (MM) typically follows a relapsing course with many patients requiring multiple therapies. This single-arm phase 2 study prospectively evaluated the efficacy and safety of bortezomib retreatment in MM patients who had relapsed after achieving at least a partial response (≥ PR) to prior bortezomib-based therapy. Patients aged ≥ 18 years, with measurable, secretory MM, who relapsed ≥ 6 months after prior bortezomib treatment were eligible. Patients received up to eight cycles of bortezomib (± dexamethasone). The primary endpoint was best confirmed response at retreatment; secondary endpoints included duration of response (DOR), time to progression (TTP), and safety. Adverse events (AEs) were graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. A total of 130 patients (median of two prior lines of therapy) were enrolled and received retreatment. At retreatment, 28% and 72% of patients received bortezomib and bortezomib-dexamethasone, respectively. Overall response rate was 40%. In patients who achieved ≥ PR, median DOR and TTP were 6.5 and 8.4 months, respectively. Thrombocytopenia was the most common grade ≥ 3 AE (35%). Forty percent of patients experienced neuropathy events, which improved and resolved in a median of 1.5 and 8.9 months, respectively. In conclusion, bortezomib retreatment was effective and tolerable in relapsed MM patients, with no evidence of cumulative toxicities.
A prospective, international phase 2 study of bortezomib retreatment in patients with relapsed multiple myeloma / M.T. Petrucci, P. Giraldo, P. Corradini, A. Teixeira, M.A. Dimopoulos, I.W. Blau, J. Drach, R. Angermund, N. Allietta, E. Broer, V. Mitchell, J. Bladé. - In: BRITISH JOURNAL OF HAEMATOLOGY. - ISSN 0007-1048. - 160:5(2013 Mar), pp. 649-659.
|Titolo:||A prospective, international phase 2 study of bortezomib retreatment in patients with relapsed multiple myeloma|
|Parole Chiave:||Salvage Therapy ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents ; Antineoplastic Combined Chemotherapy Protocols ; Boronic Acids ; Combined Modality Therapy ; Dexamethasone ; Disease-Free Survival ; Drug Resistance, Neoplasm ; Europe ; Female ; Gastrointestinal Diseases ; Hematopoietic Stem Cell Transplantation ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Multiple Myeloma ; Peripheral Nervous System Diseases ; Prospective Studies ; Protease Inhibitors ; Pyrazines ; Recurrence ; Thalidomide ; Thrombocytopenia ; Treatment Outcome|
|Settore Scientifico Disciplinare:||Settore MED/15 - Malattie del Sangue|
|Data di pubblicazione:||mar-2013|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1111/bjh.12198|
|Appare nelle tipologie:||01 - Articolo su periodico|