EPREX (Epoetin Alfa) Versus ARANESP (Darbepoetin Alfa): Looking at Outcome of Anemia Treatment and Comparing Cost-effectiveness (EVALUATE).
Anemia has been identified as a common complication and a widespread problem in the cancer
population. Anemia is a condition in which a patient has below normal levels of
hemoglobin, the substance in red blood cells that carries oxygen to all parts of the body.
People with severe anemia may experience fatigue and shortness of breath with activity.
Therefore, this condition can have a negative influence on a person's quality of life.
Epoetin alfa and darbepoetin alfa, used to treat anemia in cancer patients, are genetically
engineered proteins that stimulate red blood cell production. This study investigates
treatment of anemia using either epoetin alfa or darbepoetin alfa during chemotherapy in
adult patients with cancer. The study is intended to collect information on normal medical
practice and routine anemia management performed at the participating centers. This is an
observational, non-randomized, prospective, comparative, parallel-group survey performed in
The Netherlands. Patients with various severities of disease may enter the survey as soon as
either their epoetin alfa or their darbepoetin alfa treatment starts and will be followed
until the end of their epoetin alfa/darbepoetin alfa treatment. Patient data are collected,
on average, once monthly (depending on the treatment being received) and this continues
until 4 weeks after the end of treatment with epoetin alfa or darbepoetin alfa. An
assessment of cost-effectiveness will be made for both treatments. The assessment of
cost-effectiveness will be based on the following: cancer type and status, chemotherapy and
other anti-cancer treatment, hemoglobin levels, use of either epoetin alfa or darbepoetin
alfa, use of blood transfusions, and serum iron levels and iron supplementation. Safety
evaluations include the incidence of serious and non-serious adverse events. Because the
study involves only collection of information, no treatment will be required by the Sponsor
and no medication will be supplied by the Sponsor. Epoetin alpha and darbepoetin alpha are
administered according to routine clinical practice.
Time Perspective: Prospective
Cost-effectiveness based on: cancer type and status, chemotherapy and other anti-cancer treatment, hemoglobin levels, use of either epoetin alfa or darbepoetin alfa, use of blood transfusions, serum iron levels and iron supplementation.
4 weeks, 8 weeks and end of treatment
Janssen-Cilag B.V. Clinical Trial
Netherlands: Netherlands Medicines Evaluation Board