Darbepoetin Alfa Safe, Effective for Elderly Chemo Patients

BOSTON—Darbepoetin 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 older.

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.