title: Safety and efficacy of bortezomib-based regimens for multiple myeloma patients with renal impairment: a retrospective study of Italian Myeloma Network GIMEMA.
abstract: Renal impairment (RI) is a severe complication throughout the course of multiple myeloma (MM). Bortezomib has been shown to be highly active in MM patients with RI. We designed this retrospective analysis to investigate the safety and efficacy of bortezomib-based therapy in 117 MM patients with RI, 14 cases required dialysis. A total of 603 cycles of bortezomib were administered (median number, five cycles/patient). Ten patients required early discontinuation of bortezomib because of WHO grade IV toxicity. The rate of bortezomib discontinuation in cases with severe, moderate and mild RI was 11%, 5% and 0%, respectively (P = NS). Overall, 91 episodes of WHO grade III/IV toxicity were observed. At least a partial response was documented in 83/113 evaluable patients (73%), including complete response (19%) and near complete response (8%). The overall response rate was similar across RI subgroups. Reversal of RI was documented in 41% of patients after a median of 2.3 months (range 0.4-7.9). In three of 14 patients on dialysis, renal replacement therapy was discontinued after 1, 1 and 4 months. The 2-yr estimate of response duration and overall survival was 70% and 51%, respectively. In conclusion, bortezomib-based regimens are safe and effective and should be considered as appropriate treatment options for MM patients with any degree of RI.
authors.affiliation: Unità Operativa di Ematologia, Azienda Ospedaliera dell'Annunziata, 87100 Cosenza, Italy. fortunato_morabito@tin.it
authors.forename: Fortunato
authors.initials: F
authors.lastname: Morabito
authors.forename: Massimo
authors.initials: M
authors.lastname: Gentile
authors.forename: Stefania
authors.initials: S
authors.lastname: Ciolli
authors.forename: Maria T
authors.initials: MT
authors.lastname: Petrucci
authors.forename: Sara
authors.initials: S
authors.lastname: Galimberti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Mele
authors.forename: Antonio F
authors.initials: AF
authors.lastname: Casulli
authors.forename: Donato
authors.initials: D
authors.lastname: Mannina
authors.forename: Eugenio
authors.initials: E
authors.lastname: Piro
authors.forename: Graziella
authors.initials: G
authors.lastname: Pinotti
authors.forename: Salvatore
authors.initials: S
authors.lastname: Palmieri
authors.forename: Lucio
authors.initials: L
authors.lastname: Catalano
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Callea
authors.forename: Massimo
authors.initials: M
authors.lastname: Offidani
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
authors.forename: Sara
authors.initials: S
authors.lastname: Bringhen
authors.forename: Luca
authors.initials: L
authors.lastname: Baldini
authors.forename: Patrizia
authors.initials: P
authors.lastname: Tosi
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Raimondo
authors.forename: Mario
authors.initials: M
authors.lastname: Boccadoro
authors.forename: Antonio
authors.initials: A
authors.lastname: Palumbo
authors.forename: Michele
authors.initials: M
authors.lastname: Cavo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage / Q000009:adverse effects; D000069286:Bortezomib; D002318:Cardiovascular Diseases / Q000139:chemically induced; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D003520:Cyclophosphamide / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage / Q000627:therapeutic use; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D005919:Glomerular Filtration Rate; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007558:Italy / Q000453:epidemiology; D007674:Kidney Diseases / Q000150:complications*; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D009363:Neoplasm Proteins / Q000037:antagonists & inhibitors; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D011480:Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D061988:Proteasome Inhibitors; D011719:Pyrazines / Q000008:administration & dosage / Q000009:adverse effects; D012189:Retrospective Studies; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage
chemical_list: D001897:Boronic Acids; D009363:Neoplasm Proteins; D011480:Protease Inhibitors; D061988:Proteasome Inhibitors; D011719:Pyrazines; D013792:Thalidomide; D000069286:Bortezomib; D003907:Dexamethasone; D004317:Doxorubicin; D003520:Cyclophosphamide; D008558:Melphalan