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Using Erythropoietin-Stimulating Agents in Patients with Breast Cancer

Using Erythropoietin-Stimulating Agents in Patients with Breast Cancer

The rate of breast cancer has declined over the past few years but still, one in eight women will develop it sometime in their life. The best treatment option for these patients is chemotherapy either on its own or in adjunct with surgery, in spite of its many adverse effects.

Many patients survive for an extended period of time after their initial diagnosis, but relapses and treatment failures are not uncommon. So, to maintain the patient’s quality of life (QOL), managing the complications of breast cancer and its treatment is quite important.


The group of diseases characterized by a decrease in either hemoglobin or the volume of red blood cells (RBCs), which ultimately results in a reduction of oxygen-carrying capacity in the blood, is called anemia. A hemoglobin concentration of <13 g/dL in men or a hemoglobin concentration of <12 g/dL in women is how anemia is defined by the WHO (World Health Organization). Blood loss, underlying pathologies, deficiencies of iron, vitamin B12, or folic acid may be the cause of anemia. Anemia may be associated with the type and stage of malignancy or the chemotherapy used in treatment, and it is a common hematologic complication in cancer.


Fatigue, the most common sign of anemia, is the most frequently reported symptom in patients who are undergoing chemotherapy. The presence and severity of fatigue are directly associated with the levels of hemoglobin in anemic patients with cancer.


The only treatment option for chemotherapy-induced and cancer-related anemia was RBC transfusion before the introduction of erythropoietin-stimulating agents (ESAs). Since the introduction of ESAs, RBC transfusions have largely been replaced as the standard of care (SOC), but RBC transfusions are still the preferred treatment option for acute management of severe anemia. The safety and efficacy of ESAs in cancer patients have been documented by several large clinical trials, including improvements in patients’ QOL, significant increases in hemoglobin and hematocrit levels, and decreased transfusion requirements. For the treatment of anemia in patients with chronic renal failure, HIV, or cancer, ESAs have been currently approved for marketing by the FDA. However, only when other specific treatable causes of the anemia have been ruled out should these agents be considered for the treatment of cancer-related anemias.


ESAs are now considered first-line treatment for many forms of anemia, and their use in multiple disease states has been well established. This article will describe the clinical efficacy, conflicting new safety data, and recent label changes of epoetin alfa for cancer-related anemia in patients with breast cancer.


The most recent updated safety information for both epoetn alfa and darbepoetin alfa was released in August 2008 by the FDA, in collaboration with Amgen and Ortho Biotech. The black-box warning carried by both these products acknowledges that in patients with advanced breast cancer who are given ESAs to achieve a target hemoglobin concentration of ≥12 g/dL, the ESAs have shortened overall survival and time to disease progression.


Also cited in the new safety information were results from similar trials studying nonsmall cell lung, neck and head, lymphoid and cervical cancers. The warning says that when the anticipated outcome is cure, ESAs aren’t indicated for patients receiving myelosuppressive therapy. If these patients are indicated, to prevent RBC transfusions, they should be given only the lowest possible dose of ESAs. For cancer patients, the dosing and administration recommendations advise that once hemoglobin concentrations reach the level needed to avoid transfusion (this level is determined by hospital protocol or individualized on a case-by-case basis), or increase by more than 1 g/dL in any two-week period, the doses should be reduced by 25%. In case the hemoglobin concentration is above 12 g/dL, doses should be withheld. ESA treatment should be restarted at a dose about 25% below the previous one once hemoglobin levels start to decrease.


During chemotherapy treatment, improvement of patient QOL has become an important goal. The most commonly reported symptom of chemotherapy is fatigue. Evidence has shown that when hemoglobin concentrations are 11-12 g/dL, which includes the upper limit of the new FDA guidelines for target treatment levels, is when the greatest improvements in QOL are seen. However, the hemoglobin response to epoetin alfa is unpredictable according to clinical practice experience and previous studies.


Chang et al. reported that because of elevated hemoglobin levels, 28% of the patients enrolled in their study required reductions in their epoetin alfa dose. While Leyland-Jones et al. reported that a hemoglobin concentration of >14 g/dL has been found in 77% of patients receiving epoetin alfa. Change in hemoglobin levels or reticulocyte count, ferritin elvels and serum erythropoietin levels are included in the evaluations of possible indicators of response to these agents in the first four weeks of therapy, but across the board, they demonstrated weak associations. When treating cancer-related anemia for all types of cancer, the meta-analysis most recently conducted by Bennett et al. suggested that there may be increased survival risk, as well as a considerable risk of VTEs. Currently, it is recommended that increases in hemoglobin levels be monitored carefully, and if hemoglobin concentrations increase any faster than 1 g/dL in two weeks or reach levels high enough to avoid RBC transfusion, the doses are recommended to be reduced. FDA has also left health care providers to determine which patient populations would be considered curable and which patients are at greater risk for relapse, which is an uncharacteristically subjective warning. The attention required when administering ESAs is now comparable to that needed for more classic drugs with well-known toxicities, such as the aminoglycoides and warfarin. To clearly define the pathogenic pathway in which epoetin alfa decreases survival in breast cancer as well as all other cancer patients, further research would have to be conducted, but clinically, it is apparent that in this patient population, ESAs should be avoided when possible.


ESAs should only be given at the lowest possible dose to prevent RBC transfusions when being used in patients with cancer-induced anemia. The hemoglobin levels should be monitored closely during treatment, and doses of ESA need to be adjusted accordingly.


Prepared By: Dr. Mehyar Al-Khashroum
Edited By: Miss  Araz Kahvedjian

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