Use of Epoetin and Darbepoetin in Patients With Cancer: 2007 American Society of Clinical
Oncology/American Society of Hematology Clinical Practice Guideline Update
J Clin Oncol Rizzo et al. 26:132
Addendum
This notice serves to update the Special Announcement published in the January 1, 2008, special
article by Rizzo et al entitled, "Use of Epoetin and Darbepoetin in Patients With Cancer: 2007
American Society of Clinical Oncology/American Society of Hematology Clinical Practice
Guideline Update" (J Clin Oncol 26:132-149).
Special Announcement (Updated September 3, 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 as follows: "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.
Special Announcement (Updated May 1, 2008): The US Food and Drug Administration (FDA) announced
revisions to erythropoiesis-stimulating agent (ESA) product labels on November 8, 2007, when
this guideline was in press. These revisions warn that data are not sufficient to exclude the
possibility of shortened survival and tumor progression in cancer patients when ESAs are dosed
to reach a hemoglobin (Hb) level between 10 and 12 g/dL. Clinicians are advised to consider
this warning, as discussed in the guideline.
On March 12, 2008, the FDA posted the following information to its Web site: "Amgen and FDA
notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased
Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update
information describing the results of two additional studies showing increased mortality and
more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of
these studies, the prescribing information has been revised as follows: ESAs shortened overall
survival and/or time to tumor progression in clinical studies in patients with breast,
non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a
hemoglobin of ≥ 12 g/dL."
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