title: A dose- and schedule-finding study of darbepoetin alpha for the treatment of chronic anaemia of cancer.
abstract: A multicentre study evaluated the efficacy and safety of darbepoetin alpha administered weekly (QW), every 3 weeks (Q3W), and every 4 weeks (Q4W) to anaemic patients with cancer not concurrently receiving chemotherapy or radiotherapy. The QW portion (n=102) was an open-label, sequential, dose-escalation design; cohorts received darbepoetin alpha QW by subcutaneous (s.c.) injection at 0.5, 1.0, 2.25, or 4.5 micro g kg(-1) week(-1) for 12 weeks. The 12-week placebo-controlled, double-blind Q3W (6.75 micro g kg(-1)) and Q4W (6.75 or 10.0 micro g kg(-1)) schedules (n=86), which enrolled different patients, took place after the QW schedule and were followed by a 12-week, open-label phase. Patients were evaluated for change in haemoglobin end points and red blood cell transfusions, serum darbepoetin alpha concentration, and safety. Selected domains of health-related quality of life (HRQOL) were measured. With QW dosing, at least 70% of each cohort had a haemoglobin increase from baseline of > or =2 g dl(-1) or a concentration > or =12 g dl(-1) (haematopoietic response). In the 4.5 micro g kg(-1) QW cohort, all patients achieved a haematopoietic response (100%; 95% confidence interval (CI)=100, 100). In the Q3W and Q4W schedules, all cohorts had at least 60% of patients who achieved a haematopoietic response. Darbepoetin alpha effectively increases haemoglobin concentration when given QW, Q3W, or Q4W. Less-frequent administration may benefit patients with chronic anaemia of cancer and their caregivers alike.
authors.affiliation: South Carolina Oncology Associates, 1301 Taylor, Suite 1A, Columbia, SC 29201, USA. rsmith@sconcology.net
authors.forename: R E
authors.initials: RE
authors.lastname: Smith
authors.forename: N S
authors.initials: NS
authors.lastname: Tchekmedyian
authors.forename: D
authors.initials: D
authors.lastname: Chan
authors.forename: L A
authors.initials: LA
authors.lastname: Meza
authors.forename: D W
authors.initials: DW
authors.lastname: Northfelt
authors.forename: R
authors.initials: R
authors.lastname: Patel
authors.forename: M
authors.initials: M
authors.lastname: Austin
authors.forename: A B
authors.initials: AB
authors.lastname: Colowick
authors.forename: G
authors.initials: G
authors.lastname: Rossi
authors.forename: J
authors.initials: J
authors.lastname: Glaspy
mesh_terms: D000368:Aged; D000740:Anemia / Q000150:complications / Q000188:drug therapy*; D002908:Chronic Disease; D000068256:Darbepoetin alfa; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D016896:Treatment Outcome
chemical_list: D004921:Erythropoietin; D000068256:Darbepoetin alfa