BOSTONDarbepoetin alfa (Ara-nesp), the new long-lasting erythropoietic
agent, is safe and effective for treatment of chemotherapy-induced anemia in
older patients, Lodovico Balducci, MD, of the H. Lee Moffitt Cancer Center &
Research Institute, Tampa, Florida, told ONI at the third meeting of
the International Society of Geriatric Oncology (SIOG abstract P-12).
Dr. Balducci and his colleagues pooled data from three similarly designed
studies. All 305 patients in the analysis received an average dose of 1.5 to
2.25 µg/kg of darbepoetin alfa or placebo every 1 or 2 weeks during 12 weeks
of chemotherapy. In one analysis, 138 patients aged 65 and older were matched
against 167 patients under age 65. In another, 35 patients aged 75 and older
were compared with 270 patients under age 75.
In both analyses, similar results were reported for older and younger
cohorts. Mean hemoglobin increases for patients receiving darbepoetin were
1.4, 1.3, 1.4, and 1.1 g/dL for patients under 65, age 65 and over, under 75,
and 75 and over, respectively. At all ages, mean hemoglobin levels decreased
in the placebo group.
At week 5, for the darbepoetin patients, red blood cell transfusions were
required in 33%, 25%, 29%, and 30% of those under 65, age 65 and over, under
75, and 75 and over, respectively. Half or more of the patients given placebo
required transfusions, with the proportion reaching 70% among those 75 and
By studies’ end, about 65% of patients under and over age 65 had a
hemoglobin increase of 2 g/dL or more, or maintained their hemoglobin levels
at 12 g/dL or higher. There were no significant differences in adverse
events, which were typical of chemotherapy.