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Randomized phase 2 dose-finding study of weekly administration of darbepoetin alpha in anemic patients with lung or ovarian cancer receiving multicycle platinum-containing chemotherapy.

OBJECTIVE
This is the first clinical trial for Japanese to evaluate the dose-response and determine the clinically effective dose of darbepoetin alpha by weekly subcutaneously administration in anemic patients with lung cancer or ovarian cancer receiving chemotherapy.


METHODS
Eligible patients were required to have anemia (hemoglobin level of <or=11.0 g/dl). Patients were randomized in a 1:1:1 ratio to receive darbepoetin alpha (1.0, 2.25 or 4.5 microg/kg) subcutaneously once a week for up to 12 weeks. The study drug was withheld from patients who had a hemoglobin level >15.0 g/dl (for men) or 14.0 g/dl (for women), and reinstated at 50% of the previous weekly dose when the hemoglobin level decreased to <or=13.0 g/dl. Quality-of-life assessments were conducted using the Japanese version of the Functional Assessment of Cancer Therapy-anemia (FACT-an) questionnaire.


RESULTS
Hemoglobin response rate was 31.6%, 55.6% and 70.3% in 1.0, 2.25 and 4.5 microg/kg groups, respectively. The dosages of 2.25 and 4.5 microg/kg thus met the clinically effective dose criterion of at least 50% of patients achieving a hemoglobin response. The FACT-fatigue subscale had a high internal consistency with Cronbach's alpha score. Although no improvement in FACT-fatigue subscale score from baseline to the end of the treatment phase was confirmed for any dose group, there was a correlation between FACT-fatigue subscale score and hemoglobin concentration. Darbepoetin alpha appears to be well tolerated in this setting and no dose-dependent adverse events were observed.


CONCLUSIONS
Darbepoetin alpha alleviated anemia caused by platinum-based chemotherapy, and the dosage of 2.25 microg/kg was the lowest dose that met the clinically effective dose criteria when administered once weekly.