Darbepoetin Alfa Administered Every 1 or 2 Weeks Alleviates Anemia in Patients With Solid Tumors

Reviewer: William Levin, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: December 9, 2001

Presenter: John Glaspy
Presenter's Affiliation: UCLA
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.

In the current study, investigators compare the safety and efficacy of this drug, darbepoetin alpha (DA)when given subcutaneously either once a week (QW) or once every 2 weeks (Q2W) at varying doses. Each subgroup was also matched with a comparison group were patients received recombinant human erythropoietin (rHuEPO) instead of DA.

Materials and Methods

Patients with solid tumors, who were receiving chemotherapy and had hemeglobin levels less than or equal to 11 g/dl were included.

Patients could not have received recombinant human erythropoietin within 8 weeks of randomization.

In part one of the study, 228 patients were randomized to 3 dose groups of DA (1.0, 2.25, or 4.5 mcg/kg).

In the second part of the study 141 patients were randomized to DA at roughly twice the doses given in the first part of the study.

In both parts of the study, groups were further subdivided to receive DA either once weekly or once every 2 weeks.

Hematopoietic response was defined as greater or equal to 2 g/dl increase in hemeglobin level.

Results

There were no differences in the types of side-effects experienced by the DA patients and those receiving rHuEPO in any of the subgroups.

Most common side-effects were nausea, vomiting, diarrhea and shortness of breath.

Higher doses of DA resulted in higher hematopoietic response rates with a faster time to response.

There were no differences in response rates between the once a week and once every 2 week groups.

All subgroups had at least a 1.6 g/dl increase in hemeglobin.

Author's Conclusions

Darbepoetin alpha given once every 2 weeks is as effective as weekly dosing in treatment of chemotherapy-related anemia.

DA is well tolerated and has a similar safety profile as rHuEPO.

Clinical/Scientific Implications

Darbepoetin Alpha appears to be a safe and effective treatment for chemotherapy-related anemia.

Once every two week dosing offers the advantage of reducing the number of needle sticks for patients, which may increase compliance and thus reduce the complications associated with anemia.

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