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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results
  • Posted: 04/21/2008

IV Iron Effective in Treating Chemotherapy-Induced Anemia

Adapted from the NCI Cancer Bulletin 1.

Two studies in the April 1, 2008, Journal of Clinical Oncology (JCO) found that intravenous (IV) iron significantly improves hemoglobin levels in patients taking erythropoietin-stimulating agents (ESAs) for chemotherapy-induced anemia compared with ESAs alone or ESAs plus oral iron.

Anemia occurs in up to 75 percent of cancer patients who undergo chemotherapy or radiation treatment in clinical trials, and ESA therapy has been found to correct the blood condition in only 50 to 70 percent of patients.

In the first JCO study, (see the journal abstract 2), 86 percent of patients receiving the ESA darbepoetin alpha (AranespĀ®) plus IV iron achieved either a hemoglobin level of at least 12 g/dL or an increase of at least 2 g/dL over their baseline hemoglobin level, compared with 73 percent of patients who received the ESA alone or ESAs with oral iron. Patients receiving IV iron responded more quickly to ESA therapy, achieving target hemoglobin levels in a median of 50 days compared with 64 days for patients not receiving IV iron.

In the second study, (see the journal abstract 3), 76.7 percent of patients receiving darbepoetin alpha with IV iron achieved target hemoglobin levels, compared with 61.8 percent of patients receiving ESA therapy alone.

Last month, the U.S. Food and Drug Administration's Oncologic Drug Advisory Committee recommended substantially limiting the use of ESAs 4 to treat anemia in cancer patients after clinical trials showed an increased mortality risk in patients using ESAs to achieve hemoglobin levels of 12 g/dL or higher.

However, in an editorial accompanying the JCO articles, Dr. Michael Auerbach of Georgetown University writes: "These two studies add unique and useful information to a rapidly growing body of data supporting the routine use of IV iron as an adjunct to ESA therapy in appropriately selected oncology patients."

Related Pages



Glossary Terms

anemia (uh-NEE-mee-uh)
A condition in which the number of red blood cells is below normal.
clinical trial (KLIH-nih-kul TRY-ul)
A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.
erythropoietin (eh-RITH-roh-POY-eh-tin)
A substance that is naturally produced by the kidneys, and that stimulates the bone marrow to make red blood cells. When erythropoietin is made in the laboratory, it is called epoetin alfa or epoetin beta.
hemoglobin (HEE-moh-GLOH-bin)
The substance inside red blood cells that binds to oxygen in the lungs and carries it to the tissues.
intravenous (IN-truh-VEE-nus)
Into or within a vein. Intravenous usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein. Also called IV.
median (MEE-dee-un)
A statistics term. The middle value in a set of measurements.

Table of Links

1http://www.cancer.gov/ncicancerbulletin
2http://www.ncbi.nlm.nih.gov/pubmed/18375890
3http://www.ncbi.nlm.nih.gov/pubmed/18375891
4http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_031808/page14
5http://www.cancer.gov/clinicaltrials/search
6http://www.cancer.gov/cancertopics/coping