The Remember Me feature is an automatic login process which creates a cookie on the hard drive of your computer containing a unique identifier which ASCO.org will utilize to remember you by, thereby avoiding the need to enter username and password upon subsequent visits to ASCO.org. DO NOT select this option if you share this computer with others since transactional, personal, or member only information will be accessible by other users.

To activate the Remember Me option, click the empty check box when signing in to the site. The Remember Me functionality is deactivated at the logout.

For additional information please review our Privacy Policy.

Use of Epoetin and Darbepoetin in Patients With Cancer: 2007 American Society of Clinical Oncology-American Society of Hematology Clinical Practice Guideline Update


J. Douglas Rizzo, Mark R. Somerfield, Karen L. Hagerty, Jerome Seidenfeld, Julia Bohlius, Charles L. Bennett, David F. Cella, Benjamin Djulbegovic, Matthew J. Goode, Ann A. Jakubowski, Mark U. Rarick, David H. Regan, and Alan E. Lichtin

Special Annoucement (Updated August 5, 2008): Effective July 31, 2008, the Food and Drug Administration (FDA) mandated the following changes to the labels for the erythropoiesis stimulating agents, epoetin alfa and darbepoetin:

  • ESAs are no longer indicated for patients receiving myelosuppressive chemotherapy if the anticipated treatment outcome is cure. They remain indicated when myelosuppressive chemotherapy is intended for palliation.

  • ESAs should not be initiated if the patient's hemoglobin is above 10 g/dL. Further, the label change
    • specifies that ESA treatment should target the lowest hemoglobin concentration that will avoid transfusion,
    • removes "...or exceeds 12 g/dL" as an upper range for ESA use, and
    • removes language that allowed earlier initiation of ESAs, or treatment to higher hemoglobin targets, if the patient cannot tolerate anemia due to a co-morbid condition

The labels' boxed Warnings now read: "ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers." The warning is no longer focused on studies with hemoglobin targets at or above 12 g/dL.


Purpose: To update the American Society of Clinical Oncology/American Society of Hematology (ASCO/ASH) recommendations for the use of epoetin. The guideline was expanded to address use of darbepoetin and thromboembolic risk associated with these agents.

Methods: An Update Committee ("Committee") reviewed and analyzed data published since 2002 through July 2007. MEDLINE and the Cochrane Collaboration Library databases were searched.

Recommendations: For patients with chemotherapy-associated anemia, the Committee continues to recommend initiating an erythropoiesis-stimulating agent (ESA) as hemoglobin (Hb) approaches, or falls below, 10 g/dL, to increase Hb and decrease transfusions. ESA treatment continues to be recommended for patients with low-risk myelodysplasia for similar reasons. There is no evidence showing increased survival as a result of ESA treatment. Conclusive evidence is lacking that, absent clinical circumstances necessitating earlier treatment, initiating ESAs at Hb levels greater than 10 g/dL either spares more patients from transfusion or substantially improves their quality of life. Starting doses and dose modifications based on response or lack thereof should follow the package insert. Continuing ESAs beyond 6 to 8 weeks in the absence of response, assuming appropriate dose increase has been attempted in nonresponders as per US Food and Drug Administration guidelines, does not seem to be beneficial, and ESA therapy should be discontinued. The Committee recommends monitoring iron stores and supplementing iron intake for ESA-treated patients. ESAs should be used cautiously with chemotherapy, or in clinical states, associated with elevated risk for thromoembolic complications. The Committee also cautions against ESA use for patients with cancer who are not receiving chemotherapy, since recent trials report increased thromboembolic risks and decreased survival under these circumstances.



ASCO’s practice guidelines and technology assessments reflect expert consensus based on clinical evidence and literature available at the time they are written, and are intended to assist physicians in clinical decision-making and identify questions and settings for further research.  Due to the rapid flow of scientific information in oncology, new evidence may have emerged since the time a guideline or assessment was submitted for publication.  Guidelines and assessments are not continually updated and may not reflect the most recent evidence.  Guidelines and assessments cannot account for individual variation among patients, and cannot be considered inclusive of all proper methods of care or exclusive of other treatments.  It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine the best course of treatment for the patient.  Accordingly, adherence to any guideline or assessment is voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances.  ASCO guidelines and assessments describe the use of procedures and therapies in clinical practice and cannot be assumed to apply to the use of these interventions in the context of clinical trials. ASCO and ASH assume no responsibility for any injury or damage to persons or property arising out of or related to any use of this guideline, or to any errors or omissions








 
2318 Mill Road, Suite 800, Alexandria, VA 22314   |   phone: (571) 483-1300
© 2005-2009 American Society of Clinical Oncology (ASCO).  All rights reserved worldwide.