This study, the first of its kind to evaluate an extended initiation dose of epoetin alfa in this patient population, is expected to be published in the June issue of Current Medical Research and Opinion.

The randomized, open-label, multicenter study compared the response of study patients to 80,000 units once every two weeks with 40,000 units once weekly. The primary endpoint was comparison of baseline-to-final hemoglobin levels between the treatment groups. Secondary endpoints included assessment of hemoglobin response, time to hemoglobin response, transfusion requirements, and safety.

"PROCRIT (Epoetin alfa) dosed once weekly is proven and widely accepted for the management of chemotherapy-related anemia," explained the study's lead investigator, David H. Henry, MD, Clinical Professor of Medicine at the Joan Karnell Cancer Center, Pennsylvania Hospital, Philadelphia, PA. "These findings suggest dosing PROCRIT every two weeks produces similar hemoglobin changes and safety results as once weekly administration. The possibility of administering PROCRIT at a two week dosing interval merits further investigation."

A total of 310 patients with non-myeloid malignancy were enrolled in the study. At entry, patients had hemoglobin levels less than or equal to 11 grams per deciliter (g/dL) blood and were scheduled to undergo chemotherapy for a minimum of 12 weeks. Patients were randomized to one of the two dosing regimens subcutaneously for up to 12 weeks, with dose modifications allowable to maintain hemoglobin levels at approximately 12 g/dL blood.

Breast, lung and colorectal cancer were the most common tumor types at study entry. Almost 50 percent of patients in each group received platinum-containing chemotherapeutic agents.
The average change in hemoglobin levels from the start to the end of the study in the group dosed with 80,000 units every two weeks was 1.6 g/dL blood. This was statistically comparable with the increase of 1.8 g/dL blood achieved with 40,000 units weekly.
Additionally, of the patients dosed once every two weeks, 9.6 percent required a transfusion between Day 29 and the end of the study compared with 11.1 percent in the patients dosed weekly.

Seventeen patients in each treatment group were withdrawn from the study due to an adverse event, most of which were related to the patient's underlying cancer or chemotherapy. Adverse events were generally consistent with those expected for a population of patients with cancer undergoing chemotherapy.

Clinically relevant thrombotic vascular events occurred in 8 percent of patients in each group.