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

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Presenter: Michael Hedenus
Presenter's Affiliation: Sundsvall, Sweden
Type of Session: Poster

Background

  • One 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 Methods

  • The 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.

    Results

  • A 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 Conclusions

  • Darbepoetin 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 Implications

  • This 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.

    Oncolink's ASH Coverage made possible by an unrestricted Educational Grant from Amgen.