Darbepoetin alfa given every 1 or 2 weeks alleviates anaemia associated with cancer chemotherapy

Abstract

In part A of this study, patients were randomised to cohorts receiving darbepoetin alfa at doses of 0.5 to 8.0 m.c.g x kg(-1) x wk(-1) or to a control group receiving epoetin alfa at an initial dose of 150 U x kg(-1) three times weekly. In part B, the cohorts were darbepoetin alfa 3.0 to 9.0 m.c.g x kg(-1) every 2 weeks or epoetin alfa, initial dose 40 000 U x wk(-1). Safety was assessed by adverse events, changes in blood pressure, and formation of antibodies to darbepoetin alfa. Efficacy was assessed by several haematologic endpoints, including change in haemoglobin from baseline. The adverse event profile of darbepoetin alfa was similar to that of epoetin alfa. No relationship between the rapidity of haemoglobin response and any adverse event was observed. No antibodies to darbepoetin alfa were detected. Higher doses of darbepoetin alfa increased the proportion of patients with a haemoglobin response and decreased the median time to response. The overall dose of darbepoetin alfa required to produce a mean increase in haemoglobin does not increase when the dosing interval is increased from 1 to 2 weeks. Therapy with darbepoetin alfa is safe and effective in producing a dose-related increase in haemoglobin levels in patients with cancer receiving chemotherapy.

Copyright 2002 Cancer Research UK

Figures

Figure 1

Study design and treatment schema. See text for information concerning dose adjustments for patients receiving epoetin alfa. In part A (A), darbepoetin alfa was administered once every week; in part B (B), it was administered once every 2 weeks.

Figure 2

Comparison of adverse events that occurred with ⩾10% incidence in patients receiving darbepoetin alfa and epoetin alfa. Bars represent 95% confidence limits of the odds ratio.

Figure 3

Cumulative proportion of patients achieving a haemoglobin response (defined as a ⩾2.0 g dl−1 increase over baseline). Patients who did not manifest a haemoglobin response to epoetin alfa had their dose increased at week 8 in part A and week 6 in part B. In part A (A), darbepoetin alfa was administered once every week; in part B (B), it was administered once every 2 weeks.

Figure 4

Mean change from baseline in haemoglobin at weeks 4 and 13. In part A, darbepoetin alfa was administered once every week; in part B, it was administered once every 2 weeks. Bars represent standard error of the mean.

Figure 5

Plot of Kaplan–Meier proportion of patients with haematopoietic response during the treatment phase. Part A, darbepoetin alfa was administered once every week; Part B, darbepoetin alfa was administered once every 2 weeks. Bars represent 95% confidence limits.