A dose- and schedule-finding study of darbepoetin alpha for the treatment of chronic anaemia of cancer

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 μg kg^-1 week^-1 for 12 weeks. The 12-week placebo-controlled, double- blind Q3W (6.75 μg kg^-1) and Q4W (6.75 or 10.0 μg 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 > 2 gdl^-1 or a concentration > 12g dl^-1 (haematopoietic response). In the 4.5 μg kg^-1 QW cohort, all patients achieved a haematopoietic response (100%; 95% confidence interval (Cl)= 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.