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Darbepoetin Alfa Extends Benefits of Erythropoietic Therapy to Patients With Chronic Anemia

Darbepoetin Alfa Extends Benefits of Erythropoietic Therapy to Patients With Chronic Anemia

COLUMBIA, South Carolina—A dose escalation trial of darbepoetin alfa
(Aranesp) found the new erythropoietic agent can boost hemoglobin rates in
most cancer patients with chronic anemia, a group not usually treated with
erythropoietic therapy (ASCO abstract 1465).

The multicenter investigation led by Robert E. Smith, MD, president of
South Carolina Oncology Associates in Columbia, focused on patients who were
not receiving concomitant chemotherapy or radiation. The sole erythropoietic
agent approved for treating anemia in cancer patients, epoetin alfa
(Procrit), is indicated for patients undergoing chemotherapy for nonmyeloid
malignancies.

Yet anemia is common in patients who are not receiving chemotherapy or
radiation treatments, according to Dr. Smith and his co-investigators.
Previous studies suggest anemia could be the result of reduced red blood
cell survival, relative deficiency of endogenous erythropoietin, or blunted
erythropoietic response.

Dose Escalation

All 188 patients in the pilot study had hemoglobin levels of 11 g/dL or
less at the outset. Their cancers included breast, prostate,
gastrointestinal, lung, gynecologic, and other primary tumors. None of the
patients had received chemotherapy or been treated with erythropoietic
therapy in the 8 weeks prior to the trial, but patients may have had up to
two red blood cell transfusions within 4 weeks of enrollment. Participants
also could not expect to receive chemotherapy or external beam radiotherapy
within 16 weeks of enrollment.

The first 102 patients were injected weekly with darbepoetin alfa in
sequential doses of 0.5, 1.0, 2.25, or 4.5 µg/kg for the 12 weeks of the
study. Hematopoietic response was defined as an increase in hemoglobin of 2
g/dL or greater or reaching a hemoglobin level of 12 g/dL or more. The
hematopoietic response rate hovered around 70% for the 1.0 and 2.25 µg/kg
doses, and reached 100% at the top dose (see Table 1). "I don’t think
anything has shown a 100% response rate," Dr. Smith said, referring to
previous studies.

Frequency of Administration

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