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Dose Response of Darbepoetin Alfa Is Similar in Anemic Patients with Solid Tumors or Lymphoproliferative Malignancies.
Reviewer: William Levin, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: December 9, 2001
Presenter: Michael Hedenus
Presenter's Affiliation: Sundsvall, Sweden
Type of Session: Poster
BackgroundOne of the most problematic side-effects of chemotherapy is anemia, or a decreased red blood cell count. Not only can anemia cause shortness of breath and fatigue, but it can also cause delays in cancer treatment.
There is a substance, erythropoieten, produced by the kidneys that activates red blood cell production, and this substance has been isolated by scientists and formulated to treat patients with low blood counts.
More recently, a long acting form of erthropoietin has been produced, and can be given a once every 2 weeks instead of once a week.
Investigators are continuing to determine the optimal dose and time schedule for this drug, darbepoetin alpha (DA).
Materials and MethodsThe goal of this current study is determine if the effects of darbepoetin alpha (increasing hemeglobin levels) are dependent on dose increases.
Another question being investigated is if DA works equally well for patients with solid tumors and those wth lymphoproliferative malignancies (LM), such as lymphoma.
The safty of DA is also under investigation.
124 patients with solid tumors and 55 with LM were enrolled.
Patients had to be receiving cyclic chemotherapy for at lest 12 weeks.
Patients had to have normal liver and kidney function, and they could not be iron deficient.
DA was given subcutaneously once weeky for 12 weeks at 3 different doses, 1.0, 2.25, and 4.5 mcg/kg (3 separate groups of patients).
Dosing was witheld once hemeglobin levels reached 14 g/dl for women and 15 g/dl for men.
ResultsA dose response trend was observed in both solid tumor and LM groups at each dose of DA.
Greater than 50% of patients in the 2.25 and 4.5 mcg/kg having a greater or equal to 2g/dl increase in hemeglobin from baseline.
The side-effect profile was similar between all groups, with the most common adverse events being fatigue, nausea, fever, and abdomenal pain.
Author's ConclusionsDarbepoetin alpha is safe and effective in reversing chemotherapy-induced anemia for patients with solid tumors and lymphoproliferative malignancies alike.
There is a dose-response relationship for DA.
There was no difference in response between patients with solid tumors or LM in regards to transfusion requirements
Clinical/Scientific ImplicationsThis drug is currently only approved for the treatment of anemia in patients with kidney failure.
Further testing will be needed to determine optimal dosing of DA in cancer patients.
As with any new medication, long term saftey information on DA will not be known for some time.
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