title: Liposomal daunorubicin in the treatment of relapsed or refractory non-Hodgkin's lymphoma.
abstract: OBJECTIVE
  To assess the efficacy and toxicity of liposomal daunorubicin administered as a two-hour intravenous infusion to patients with relapsed or refractory non-Hodgkin's lymphoma (NHL).
  
  
  METHODS
  Eligible patients had relapsed or refractory NHL with measurable or evaluable disease, and low grade, select intermediate grade, or mantle cell pathologic types. Prior exposure to an anthracycline or anthracenedione was allowed. Liposomal daunorubicin at a dose of 100 mg/m2 was given intravenously over a minimum of 120 minutes every 3 weeks. as a single agent.
  
  
  RESULTS
  Thirty-three patients were accrued: twenty-three (70%) had low-grade histologies; six (18%) had intermediate-grade histologies (follicular large-cell and diffuse small cleaved); and four (12%) patients had mantle-cell lymphoma. Eighteen (55%) had received two or more prior regimens; fourteen (42%) received a prior anthracycline. A median of six cycles of liposomal daunorubicin were administered (range 1-15). Of 31 patients evaluable for response, 2 complete and 10 partial remissions were documented for a major response rate of 39% (95% confidence interval (CI): 22%-58%). The median duration of response was 19.5 months (range 4.3-41.1+). Six responders (50%) had received a prior anthracycline; one responder had mantle-cell histology. The major toxicities were grade 3 or 4 neutropenia in 26 patients (79%), mild to moderate nausea in 22 (67%), and fatigue in 16 (48%).
  
  
  CONCLUSIONS
  Liposomal daunorubicin at 100 mg/m2 every three weeks has activity in patients with relapsed or refractory NHL, including patients with prior exposure to an anthracycline. Further studies of liposomal daunorubicin in combination with other agents are warranted.
authors.affiliation: University of Southern California Schools of Medicine and Pathology, Los Angeles, USA. tulpule@hsc.usc.edu
authors.forename: A
authors.initials: A
authors.lastname: Tulpule
authors.forename: M U
authors.initials: MU
authors.lastname: Rarick
authors.forename: J
authors.initials: J
authors.lastname: Kolitz
authors.forename: J
authors.initials: J
authors.lastname: Bernstein
authors.forename: A
authors.initials: A
authors.lastname: Myers
authors.forename: L A
authors.initials: LA
authors.lastname: Buchanan
authors.forename: B M
authors.initials: BM
authors.lastname: Espina
authors.forename: A
authors.initials: A
authors.lastname: Traynor
authors.forename: J
authors.initials: J
authors.lastname: Letzer
authors.forename: G R
authors.initials: GR
authors.lastname: Justice
authors.forename: D
authors.initials: D
authors.lastname: McDonald
authors.forename: L
authors.initials: L
authors.lastname: Roberts
authors.forename: W
authors.initials: W
authors.lastname: Boswell
authors.forename: B
authors.initials: B
authors.lastname: Nathwani
authors.forename: A M
authors.initials: AM
authors.lastname: Levine
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D003630:Daunorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008081:Liposomes; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced
chemical_list: D000903:Antibiotics, Antineoplastic; D008081:Liposomes; D003630:Daunorubicin