title: Pegylated liposomal doxorubicin plus bortezomib in relapsed or refractory multiple myeloma: efficacy and safety in patients with renal function impairment.
abstract: A retrospective analysis was undertaken of patients (n = 193) with renal insufficiency (creatinine clearance [CrCl] < 60 mL/min) from a phase III trial comparing bortezomib +/- pegylated liposomal doxorubicin (PLD) in relapsed/refractory myeloma (n = 646). The response rate (49% vs. 42%) and median time to disease progression (331 days vs. 199 days) were comparable or slightly better for patients with renal insufficiency treated with PLD/bortezomib compared with patients treated with bortezomib alone. There was a steady, clinically meaningful improvement in renal function for patients with renal insufficiency in both treatment arms. However, patients with impaired renal function were at a slightly increased risk of a drug-related serious adverse event (28% vs. 19% for CrCl < 60 and > or = 60 mL/min, respectively).
authors.affiliation: Hematology Department, Universitat de Barcelona Hospital Clinic, IDIBAPS Villaroel 170, Barcelona, Spain. jblade@clinic.ub.es
authors.forename: Joan
authors.initials: J
authors.lastname: Bladé
authors.forename: Pieter
authors.initials: P
authors.lastname: Sonneveld
authors.forename: Jesús F
authors.initials: JF
authors.lastname: San Miguel
authors.forename: Heather J
authors.initials: HJ
authors.lastname: Sutherland
authors.forename: Roman
authors.initials: R
authors.lastname: Hajek
authors.forename: Arnon
authors.initials: A
authors.lastname: Nagler
authors.forename: Andrew
authors.initials: A
authors.lastname: Spencer
authors.forename: Tadeusz
authors.initials: T
authors.lastname: Robak
authors.forename: M Teresa
authors.initials: MT
authors.lastname: Cibeira
authors.forename: Sen H
authors.initials: SH
authors.lastname: Zhuang
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Harousseau
authors.forename: Robert Z
authors.initials: RZ
authors.lastname: Orlowski
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage*; D000069286:Bortezomib; D003404:Creatinine / Q000652:urine; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D019008:Drug Resistance, Neoplasm; D006801:Humans; D009101:Multiple Myeloma / Q000150:complications* / Q000188:drug therapy*; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011719:Pyrazines / Q000008:administration & dosage*; D012008:Recurrence; D051437:Renal Insufficiency / Q000150:complications* / Q000503:physiopathology; D012189:Retrospective Studies
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D000069286:Bortezomib; D004317:Doxorubicin; D003404:Creatinine