Researchers involved in a multi-center trial have reported that Aranesp® (darbepoetin alfa) administered every 2 or 3 weeks is as effective as a weekly schedule for correction of chemotherapy induced anemia. The details of this interim analysis were reported at the 2007 Gastrointestinal Cancer Symposium sponsored by the American Society of Clinical Oncology.

Aranesp is indicated for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies with an original dosing schedule of once per week. One year ago an every 3 week schedule was approved by the FDA which makes administration more convenient and can be timed more easily with chemotherapy administration.

The current study is an open label phase II study which randomly allocates patients to receive weekly, every 2 week or every 3 week Aranesp to correct chemotherapy induced anemia in patients with cancer. The expected accrual to this study is 750 patients. The current study was an interim analysis of 487 patients, 111 of whom had gastrointestinal tumors. Data on the administration of Aranesp every 2 or 3 weeks were combined and compared to the weekly dosing. The mean increase in hemoglobin was 0.9-1.1 for all groups. Approximately 65-70% of patients achieved a target hemoglobin level of 11 grams with no difference between groups. Treatment related adverse events were similar for all groups. There were not major differences in results between gastrointestinal tumors and non-gastrointestinal tumors. These authors concluded that Aranesp could be given on a 2 or 3 week basis to coincide with the administration of chemotherapy.

Comments: These data further support the use of an extended dose schedule of Aranesp.

Reference: Silberstein PT, Rearden T, Lee L, et al. The efficacy of extended dose schedule (EDS) administration of darbepoetin Alfa in patients (pts) with cancer and chemotherapy induced anemia (CIA): Interim results from a phase II, randomized, open-label study. American Society of Clinical Oncology, 2007 Gastrointestinal Symposium, Abstract 322.

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