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Investigative Drug Aranesp (Darbepoetin) Effective for Chemotherapy-Induced Anemia: Presented at ASH

By Bruce Sylvester

ATLANTA, GA -- December 14, 2005 -- Treatment of chemotherapy-induced anemia with the investigative agent darbepoetin (Aranesp) administered every 3 weeks is well tolerated and effective, according to phase 3 data presented here at the 47^th Annual Meeting of the American Society of Hematology (ASH).

"For the majority of patients in our study, we got them into a desirable hemoglobin range," said lead investigator Kerry Taylor, MD, hematologist, Mater Hospital, Brisbane, Australia, in his presentation on December 12^th. "They feel better, and it was an easy schedule, which is adaptable to most chemotherapy regimens."

Dr. Taylor and coinvestigators enrolled subjects who were 18 years older and had hemoglobin (Hb) levels lower than 11 g/ dL and a nonmyeloid malignancy with 12 weeks or more of planned chemotherapy.

Subjects were randomized in a 1:1 ratio; 193 received darbepoetin 300 mcg and 193 received placebo every 3 weeks for 15 weeks.

The investigators assessed treatment efficacy by measuring incidence of red blood cell (RBC) transfusions and achievement of a target Hb level of 11 g/dL or higher (not exceeding 13 g/dL).

They treated 386 subjects for up to 16 weeks.

Results show that 77% of the darbepoetin group achieved the target hemoglobin level compared with 55% in the placebo group.

From week 5 to the end of treatment, the incidence of red blood cell transfusions was significantly lower in the darbepoetin group (24%) than in the placebo group (41%).

"In addition, there was very little toxicity." Dr. Taylor noted.

The study was supported by Amgen.


[Presentation title: Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin alfa Every 3 Weeks for the Treatment of Chemotherapy-Induced Anemia. Abstract 3556]

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