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## Complete Summary

#### GUIDELINE TITLE

Use of epoetin and darbepoetin in patients with cancer: 2007 American
Society of Clinical Oncology/American Society of Hematology clinical
practice guideline update.

#### BIBLIOGRAPHIC SOURCE(S)

Rizzo JD, Somerfield MR, Hagerty KL, Seidenfeld J, Bohlius J, Bennett
CL, Cella DF, Djulbegovic B, Goode MJ, Jakubowski AA, Rarick MU, Regan
DH, Lichtin AE. Use of epoetin and darbepoetin in patients with cancer:
2007 American Society of Clinical Oncology/American Society of
Hematology 2007 clinical practice guideline update. J Clin Oncol 2008
Jan 1;26(1):132-49. \[39 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17954713)

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Rizzo JD, Lichtin AE, Woolf
SH, Seidenfeld J, Bennett CL, Cella D, Djulbegovic B, Goode MJ,
Jakubowski AA, Lee SJ, Miller CB, Rarick MU, Regan DH, Browman GP,
Gordon MS; American Society of Clinical Oncology; American Society of
Hematology. Blood 2002 Oct 1;100(7):2303-20.
[PubMed](http://www.ncbi.nlm.nih.gov/pubmed/12239138?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum)

Rizzo JD, Lichtin AE, Woolf SH, Seidenfeld J, Bennett CL, Cella D,
Djulbegovic B, Goode MJ, Jakubowski AA, Lee SJ, Miller CB, Rarick MU,
Regan DH, Browman GP, Gordon MS; American Society of Clinical Oncology.
American Society of Hematology. J Clin Oncol 2002 Oct 1;20(19):4083-107.
[PubMed](http://www.ncbi.nlm.nih.gov/pubmed/12351606?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum)

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [July 31, 2008, Erythropoiesis Stimulating Agents
    (ESAs)](http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA2):
    Amgen and the U.S. Food and Drug Administration (FDA) informed
    healthcare professionals of modifications to certain sections of the
    Boxed Warnings, Indications and Usage, and Dosage and Administration
    sections of prescribing information for Erythropoiesis Stimulating
    Agents (ESAs). The changes clarify the FDA-approved conditions for
    use of ESAs in patients with cancer and revise directions for dosing
    to state the hemoglobin level at which treatment with an ESA should
    be initiated.

-   [November 8, 2007 and January 3, 2008 Update, Erythropoiesis
    Stimulating Agents
    (ESAs)](http://www.fda.gov/medwatch/safety/2007/safety07.htm#ESA2):
    The U.S. Food and Drug Administration (FDA) notified healthcare
    professionals of revised boxed warnings and other safety-related
    product labeling changes for erythropoiesis-stimulating agents
    (ESAs) stating serious adverse events, such as tumor growth and
    shortened survival in patients with advanced cancer and chronic
    kidney failure.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

-   Chemotherapy-associated anemia

-   Anemia associated with low-risk myelodysplastic syndrome (MDS)

#### GUIDELINE CATEGORY

Assessment of Therapeutic Effectiveness\
Evaluation\
Management\
Treatment

#### CLINICAL SPECIALTY

Hematology\
Oncology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

-   To update the 2002 American Society of Clinical Oncology/American
    Society of Hematology (ASCO/ASH) recommendations for the use of
    epoetin

-   To expand the guideline to include recommendations for the use of
    darbepoetin alfa

-   To address thromboembolic risk associated with epoetin and
    darbepoetin

#### TARGET POPULATION

Patients with chemotherapy-associated anemia or anemia associated with
low-risk myelodysplastic syndrome (MDS)

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  History and physical to identify causes of anemia, including drug
    exposure history; peripheral blood smear; iron, folate, and B~12~
    deficiency; assessment for occult blood loss and renal
    insufficiency; Coomb\'s testing; and endogenous erythropoietin
    levels

2.  Erythropoiesis-stimulating agents (ESAs): epoetin or darbepoetin
    treatment

3.  Monitoring of hemoglobin levels

4.  Red blood cell transfusion alone or as supplement to epoetin or
    darbepoetin treatment

5.  Baseline and periodic monitoring of iron, total iron-binding
    capacity, transferrin saturation, or ferritin levels

6.  Assessment of thromboembolic risk in patients prescribed epoetin or
    darbepoetin

#### MAJOR OUTCOMES CONSIDERED

-   Hematologic response rates

-   Transfusion rates

-   Thromboembolic event rates

-   Survival

-   Quality of life

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

For the 2007 update, the American Society of Clinical Oncology/American
Society of Hematology (ASCO/ASH) Update Committee completed a review and
analysis of data published since 2002. The Update Committee\'s
literature review focused attention on available systematic reviews and
meta-analyses of published clinical trials. Computerized literature
searches of MEDLINE and the Cochrane Collaboration Library were
performed. Searches of the English-language literature from 2002 to July
2007 were conducted to address each of the original guideline questions
and two new questions concerning, respectively, the comparative
effectiveness of epoetin and darbepoetin, and thrombosis risk of
erythropoietin stimulating agents (ESAs). Relevant practice guidelines
from other oncology and national organizations were identified through a
search of Medline and of the National Guideline Clearinghouse Web site.

**Literature Search**

Five comprehensive systematic reviews and meta-analyses of randomized
controlled trials served as the primary evidentiary basis for this
update. Supplementary searches of the Medline database (National Library
of Medicine, Bethesda, MD) were conducted to identify relevant
information (2003 to 2007) from additional published randomized clinical
trials, systematic reviews, meta-analyses, and practice guidelines for
this update. A series of searches was conducted using the medical
subject headings or text words \"erythropoietin, recombinant,\"
\"epoetin alfa,\" \"epoetin beta,\" \"darbepoetin alfa,\" and
\"neoplasms,\" and variants thereof. (Details of the searches can be
obtained from guidelines@asco.org on request.) Search results were
limited to human studies and English-language articles. Editorials,
letters, and commentaries were excluded from consideration, as were
systematic reviews and meta-analyses that were limited to single agents
given the U.S. Food and Drug Administration\'s position that available
ESAs are members of the same pharmacologic class. The Cochrane Library
was searched for available systematic reviews and meta-analyses with the
phrases, \"erythropoietin,\" \"epoetin,\" \"darbepoetin,\" \"cancer,\"
and \"malignancies.\" Directed searches based on the bibliographies of
primary articles were also performed. Finally, Update Committee members
and ASCO staff contributed articles from their personal collections.

#### NUMBER OF SOURCE DOCUMENTS

Five systematic reviews served as the primary evidence base for the
guideline update.

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus (Committee)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The Update Committee had a single face-to-face meeting to consider the
evidence for each of the 2007 recommendations. Additional meetings were
held via teleconference.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The guideline was circulated in draft form to the Update Committee, the
American Society of Clinical Oncology\'s (ASCO\'s) Health Services
Committee, the American Society of Hematology\'s (ASH\'s) Committee on
Practice, ASH\'s Subcommittee on Quality of Care, and the ASCO Board of
Directors and the ASH Executive Committee for review and approval. The
ASCO Board of Directors approved this guideline on August 15, 2007, and
the Executive Committee of ASH approved it on August 14, 2007.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Note: Differences between the 2002 and 2007 guideline recommendations
appear in italicized text.

**I. General Recommendation**

*2007 Recommendation*

As in any medical situation, it is essential to consider other
correctable causes of anemia before initiating therapy with stimulants
of erythropoiesis. Therefore, it is advisable to conduct an appropriate
history and physical, and to consider relevant diagnostic testing aimed
at identifying causes of anemia aside from chemotherapy or underlying
hematopoietic malignancy. At a minimum, one should take a thorough drug
exposure history, carefully review the peripheral blood smear (and in
some cases, the bone marrow), consider iron, folate, and B~12~
deficiency where indicated, and assess for occult blood loss *and renal
insufficiency*. Coomb\'s testing may be appropriate for patients with
chronic lymphocytic leukemia, *non-Hodgkin\'s lymphoma*, *and for those
with a history of autoimmune disease*; endogenous erythropoietin levels
may predict response in patients with myelodysplasia. *Consideration
should be given to minimize use of erythropoiesis-stimulating agents
(ESAs) in patients with high risk of thromboembolic events, as further
discussed in Recommendation IV (below)*.

**II. Special Commentary on the Comparative Effectiveness of Epoetin and
Darbepoetin (Note: This Topic in New to the Guideline)**

*2007 Update Committee Statement*

Based on a comprehensive systematic review comparing outcomes of epoetin
and darbepoetin in patients with chemotherapy induced anemia; and on
identical cancer-related indications, warnings, and cautions in the
relevant U.S. Food and Drug Administration--approved package inserts,
the Update Committee considers these agents to be equivalent with
respect to effectiveness and safety.

**IIIa. Chemotherapy-Induced Anemia: Threshold for Initiating ESA
Therapy (Hemoglobin \[Hb\] Concentration Approaching or \<10 g/dL)**

*2007 Recommendation*

The use of epoetin *or darbepoetin* is recommended as a treatment option
for patients with chemotherapy-associated anemia and a Hb concentration
*that is approaching, or has fallen below,* 10 g/dL, *to increase Hb and
decrease transfusions*. Red blood cell (RBC) transfusion is also an
option depending on the severity of the anemia or clinical
circumstances.

**IIIb. Chemotherapy-Induced Anemia: Initiation Threshold \>10 g/dL BUT
\< 12 g/dL**

*2007 Recommendation*

For patients with declining Hb levels but less severe anemia (those with
Hb concentration \<12 g/dL, but who have never fallen *near* 10 g/dL),
the decision of whether to use epoetin *or darbepoetin* immediately or
to wait until the Hb levels fall closer to 10 g/dL should be determined
by clinical circumstances (*including but not limited to elderly
individuals with limited cardiopulmonary reserve, those with underlying
coronary artery disease or symptomatic angina, or substantially reduced
exercise capacity, energy, or ability to carry out activities of daily
living \[ADLs*\]). RBC transfusion is also an option when warranted by
clinical conditions.

**IV. Thromboembolic Risk (Note. This Topic is New to the Guideline)**

*2007 Recommendation*

Clinicians should carefully weigh the risks of thromboembolism in
patients for whom epoetin or darbepoetin is prescribed. Randomized
clinical trials and systematic reviews of available randomized clinical
trials demonstrate an increased risk of thromboembolism in patients
receiving epoetin or darbepoetin. Specific risk factors for
thromboembolism have not been defined in these trials; therefore,
clinicians should use caution and clinical judgment when considering use
of these agents. Established, general risk factors for thromboembolic
events include previous history of thromboses, surgery, and prolonged
periods of immobilization or limited activity. Multiple myeloma patients
who are being treated with thalidomide or lenalidomide and doxorubicin
or corticosteroids are at increased risk (Bennett et al., 2006). There
are no data regarding concomitant use of anticoagulants or aspirin to
modulate this risk.

**V. Starting and Escalating Doses**

*2007 Recommendation*

The U.S. Food and Drug Administration-approved starting dose of epoetin
is 150 U/kg *three times per week or 40,000 U weekly subcutaneously. The
U.S. Food and Drug Administration--approved starting dose of darbepoetin
is 2.25 micrograms/kg weekly or 500 micrograms every 3 weeks
subcutaneously. Alternative starting doses or dosing schedules have
shown no consistent difference in effectiveness on outcomes including
transfusion and Hb response, although they may be considered to improve
convenience. Dose escalation should follow U.S. Food and Drug
Administration--approved labeling (see table below); no convincing
evidence exists to suggest that differences in dose escalation schedules
are associated with different effectiveness*.

  --------------------------------------------------------------------------------------------
  **Table.                                                                        
  Erythropoiesis-Stimulating                                                      
  Agent (ESA) Dosing**                                                            
  ---------------------------- -------------- ------------------- --------------- ------------
  **Dose and Modifications**   **Epoetin                          **Darbepoetin   
                               Alfa**                             Alfa**          

  Initial dose                 150 U/kg SC    40,000 U SC weekly  2.25            500
                               TIW                                micrograms/ kg  micrograms
                                                                  SC weekly       SC Q3W

  Dose increase                Increase dose  Increase dose to    Increase dose   \-\--
                               to 300 U/kg    60,000 U SC weekly  to 4.5          
                               TIW if no      if no increase in   micrograms/ kg  
                               reduction in   Hb by               if there is \<1 
                               transfusion    [\>]{.underline}1   g/dL increase   
                               requirements   g/dL after 4 wk of  in Hb after 6   
                               or rise in Hb  therapy, in the     wk              
                               after 8 wk     absence of a RBC                    
                                              transfusion                         

  Dose reductions              Decrease dose                      Decrease dose   
                               by 25% when Hb                     by 40% of       
                               reaches a                          previous dose   
                               level needed                       when Hb reaches 
                               to avoid                           a level needed  
                               transfusion or                     to avoid        
                               Hb increases                       transfusion or  
                               \>1 g/dL in 2                      Hb increases    
                               wk                                 \>1 g/dL in 2   
                                                                  wk              

  Dose withholding             If Hb exceeds                      If Hb exceeds   
                               12 g/dL,                           12 g/dL,        
                               withhold dose                      withhold dose   
                               until Hb                           until Hb        
                               approaches a                       approaches a    
                               level where                        level where     
                               transfusions                       transfusions    
                               may be                             may be          
                               required;                          required;       
                               restart dose                       restart dose at 
                               at 25% below                       40% below       
                               previous dose                      previous dose   

  **Abbreviations**: ESA,                                                         
  erythropoiesis-stimulating                                                      
  agent; SC, subcutaneous;                                                        
  TIW, three times per week;                                                      
  Q3W, every 3 weeks; Hb,                                                         
  hemoglobin; wk, week; RBC,                                                      
  red blood cell                                                                  
  --------------------------------------------------------------------------------------------

**VI. Discontinuing Therapy for No Response**

*2007 Recommendation*

Continuing epoetin or darbepoetin treatment beyond 6 to 8 weeks in the
absence of response (e.g., \<1-2 g/dL rise in Hb or *no diminution of
transfusion requirements*), assuming appropriate dose increase has been
attempted in nonresponders *as per the U.S. Food and Drug
Administration--approved label*, does not appear to be beneficial, *and
ESA therapy should be discontinued*. Patients who do not respond should
be investigated for underlying tumor progression, iron deficiency, *or
other etiologies for anemia*.

**VII. Hb Target**

*2007 Recommendation*

Hb can be raised to (or near) a concentration of 12 g/dL, at which time
the dosage of epoetin or darbepoetin should be titrated to maintain that
level. *Dose and dose modification recommendations recorded in the
package insert as of March 2007 and approved by the U.S. Food and Drug
Administration (also based on the November 8, 2007, FDA label
announcement) can be found in the table above. Dose reductions are also
recommended when Hb rise exceeds 1 g/dL in any 2 week period or when the
Hb exceeds 11 g d/L. Risk of venous thromboembolism should also be
considered when determining dose reduction schedules*.

**VIII. Iron Monitoring and Supplementation**

*2007 Recommendation*

Baseline and periodic monitoring of iron, total iron-binding capacity,
transferrin saturation, or ferritin levels and instituting iron
repletion when indicated, may be valuable in limiting the need for
epoetin or darbepoetin, maximizing symptomatic improvement for patients,
and determining the reason for failure to respond adequately to ESA
therapy. There is inadequate evidence to specify the timing,
periodicity, or testing regimen for such monitoring. There is no change
to the recommendation from the 2002 guideline.

**IX. Anemia in Patients Not Receiving Concurrent Chemotherapy**

*2007 Recommendation*

There is evidence that supports the use of epoetin or *darbepoetin* in
patients with anemia associated with low-risk myelodysplasia. There are
no published high-quality studies to support its *exclusive* use in
anemic myeloma, non-Hodgkin\'s lymphoma, or chronic lymphocytic leukemia
patients in the absence of concurrent chemotherapy. *Analyses of primary
data from Study 20010103 (as yet unpublished) submitted to the U.S. Food
and Drug Administration in March 2007, support a stronger recommendation
against the use of ESAs to treat anemia associated with malignancy, or
the anemia of cancer, among patients with either solid or nonmyeloid
hematological malignancies who are not receiving concurrent
chemotherapy. This recommendation is consistent with the black-box
warning that was added to the prescribing information for both epoetin
alfa and darbepoetin in March 2007, as follows: \"Use of ESAs increased
the risk of death when administered to a target Hb of 12 g/dL in
patients with active malignant disease receiving neither chemotherapy
nor radiation therapy. ESAs are not indicated in this population*.\"

**X. Treatment of Anemia in Patients with Nonmyeloid Hematological
Malignancies Who Are Receiving Concurrent Chemotherapy**

*2007 Recommendation*

Physicians caring for patients with myeloma, non-Hodgkin\'s lymphoma, or
chronic lymphocytic leukemia are advised to begin treatment with
chemotherapy and/or corticosteroids and observe the hematologic outcomes
achieved solely through tumor reduction before considering epoetin. If a
rise in Hb is not observed following chemotherapy, treatment with
epoetin *or darbepoetin for myeloma, non-Hodgkin\'s lymphoma, or chronic
lymphocytic leukemia patients experiencing chemotherapy-associated
anemia should follow the recommendations outlined previously. Particular
caution should be exercised in the use of epoetin or darbepoetin
concomitant with chemotherapeutic agents and diseases where risk of
thromboembolic complications is increased. (Refer to Recommendation
IV.)* Blood transfusion is also a therapeutic option. This
recommendation is essentially unchanged from the 2002 guideline. Slight
modifications to the recommendation appear in italics.

#### CLINICAL ALGORITHM(S)

An algorithm for the use of epoetin and darbepoetin in patients with
cancer is provided as a companion document (see \"Availability of
Companion Documents\" field in this summary).

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=11742)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The updated recommendations are supported primarily by five
comprehensive systematic reviews and meta-analyses of randomized
clinical trials.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Appropriate use of epoetin and darbepoetin in cancer patients with
    chemotherapy-associated anemia and patients with anemia associated
    with low-risk myelodysplasia

-   Increased hemoglobin (Hb) levels

-   Decreased transfusions

#### POTENTIAL HARMS

**Adverse Events Associated with Treatment**

-   Randomized clinical trials and systematic reviews of available
    randomized clinical trials demonstrate an increased risk of
    thromboembolism in patients receiving epoetin or darbepoetin.
    Specific risk factors for thromboembolism have not been defined in
    these trials; therefore, clinicians should use caution and clinical
    judgment when considering use of these agents. Established, general
    risk factors for thromboembolic events include previous history of
    thromboses, surgery, and prolonged periods of immobilization or
    limited activity. Multiple myeloma patients who are being treated
    with thalidomide or lenalidomide and doxorubicin or corticosteroids
    are at increased risk. There are no data regarding concomitant use
    of anticoagulants or aspirin to modulate this risk.

-   The U.S. Food and Drug Administration (FDA) announced revisions to
    erythropoiesis-stimulating agent (ESA) product labels on November
    8, 2007. 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 sections IIIB and XI of the Major
    Recommendations Field.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

It is important to emphasize that guidelines and technology assessments
cannot always account for individual variation among patients. They are
not intended to supplant physician judgment with respect to particular
patients or special clinical situations, and cannot be considered
inclusive of all proper methods of care or exclusive of other treatments
reasonably directed at obtaining the same result. Accordingly, the
American Society of Clinical Oncology (ASCO) and the American Society of
Hematology (ASH) consider adherence to this guideline to be voluntary,
with the ultimate determination regarding its application to be made by
the physician in light of each patient\'s individual circumstances. In
addition, this guideline describes the use of procedures and therapies
in clinical practice; it cannot be assumed to apply to the use of these
interventions performed in the context of clinical trials, given that
clinical studies are designed to evaluate or validate innovative
approaches in a condition for which improved staging and treatment is
needed.

**Special Commentary on Erythropoiesis-Stimulating Agents (ESAS),
Survival, and Tumor Response**

Since publication of the 2002 guideline, a number of published studies
on ESAs in cancer patients have raised safety concerns. Additional
studies have completed accrual or were terminated prematurely and do not
have complete data available. Much of the non--peer-reviewed data in the
public domain comes from briefing documents made available in
conjunction with U.S. Food and Drug Administration Oncologic Drug
Advisory Committee (ODAC) meetings in 2004 and 2007.Those studies, both
published and unpublished, that showed a detrimental effect on survival
or tumor response are discussed further in the original guideline
document.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Chart Documentation/Checklists/Forms\
Clinical Algorithm\
Patient Resources\
Personal Digital Assistant (PDA) Downloads\
Quick Reference Guides/Physician Guides\
Slide Presentation

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness\
Safety

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Rizzo JD, Somerfield MR, Hagerty KL, Seidenfeld J, Bohlius J, Bennett
CL, Cella DF, Djulbegovic B, Goode MJ, Jakubowski AA, Rarick MU, Regan
DH, Lichtin AE. Use of epoetin and darbepoetin in patients with cancer:
2007 American Society of Clinical Oncology/American Society of
Hematology 2007 clinical practice guideline update. J Clin Oncol 2008
Jan 1;26(1):132-49. \[39 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17954713)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2002 Apr 18 (revised 2008 Jan 1)

#### GUIDELINE DEVELOPER(S)

American Society of Clinical Oncology - Medical Specialty Society\
American Society of Hematology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

American Society of Clinical Oncology\
American Society of Hematology

#### GUIDELINE COMMITTEE

2007 ASCO/ASH Epoetin and Darbepoetin Update Panel

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Authors*: 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; Alan E. Lichtin

*Panel Members*: Alan E. Lichtin, MD (Co-Chair), Cleveland Clinic
Foundation; J. Douglas Rizzo, MD (Co-Chair), Medical College of
Wisconsin; Charles L. Bennett, MD, PhD, Northwestern University; Julia
Bohlius, MD, University Hospital of Cologne; David F. Cella, PhD,
Evanston Northwestern Healthcare; Benjamin Djulbegovic, MD, PhD, H. Lee
Moffitt Cancer Center; Matthew Goode, Patient Representative; Ann A.
Jakubowski, MD, PhD, Memorial Sloan-Kettering Cancer Center; Mark U.
Rarick, MD, NW Kaiser Permanent; David H. Regan, MD, US Oncology

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Note: Although all authors completed the disclosure declaration, the
following author(s) indicated a financial or other interest that is
relevant to the subject matter under consideration in this article.
Certain relationships marked with a \"U\" are those for which no
compensation was received; those relationships marked with a \"C\" were
compensated. For a detailed description of the disclosure categories, or
for more information about ASCO\'s conflict of interest policy, please
refer to the Author Disclosure Declaration and the Disclosures of
Potential Conflicts of Interest section in Information for Contributors
in the original journal of publication.

**Employment or Leadership Position**: None **Consultant or Advisory
Role**: Charles L. Bennett, Amgen (C); Benjamin Djulbegovic, Amgen (C);
Alan E. Lichtin, Amgen (Advisory Board Meeting) (U) **Stock Ownership**:
None **Honoraria**: Julia Bohlius, Amgen; Charles L. Bennett, Amgen
**Research Funding**: Charles L. Bennett, Amgen; David F. Cella, Amgen,
Johnson and Johnson; Benjamin Djulbegovic, Johnson and Johnson; Alan E.
Lichtin, Amgen **Expert Testimony**: None **Other Remuneration**: Julia
Bohlius, Amgen

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Rizzo JD, Lichtin AE, Woolf
SH, Seidenfeld J, Bennett CL, Cella D, Djulbegovic B, Goode MJ,
Jakubowski AA, Lee SJ, Miller CB, Rarick MU, Regan DH, Browman GP,
Gordon MS; American Society of Clinical Oncology; American Society of
Hematology. Blood 2002 Oct 1;100(7):2303-20.
[PubMed](http://www.ncbi.nlm.nih.gov/pubmed/12239138?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum)

Rizzo JD, Lichtin AE, Woolf SH, Seidenfeld J, Bennett CL, Cella D,
Djulbegovic B, Goode MJ, Jakubowski AA, Lee SJ, Miller CB, Rarick MU,
Regan DH, Browman GP, Gordon MS; American Society of Clinical Oncology.
American Society of Hematology. J Clin Oncol 2002 Oct 1;20(19):4083-107.
[PubMed](http://www.ncbi.nlm.nih.gov/pubmed/12351606?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum)

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [American Society of Clinical
Oncology](http://jco.ascopubs.org/cgi/content/full/26/1/132) and the
[American Society of Hematology (ASH) Web
site](http://bloodjournal.hematologylibrary.org/cgi/content/short/blood-2007-08-109488v2).

Print copies: Available from American Society of Clinical Oncology
(ASCO), Cancer Policy and Clinical Affairs, 1900 Duke Street, Suite 200,
Alexandria, VA 22314.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Erythropoiesis stimulating agent order and flow sheet. 1 p.
    Available in Portable Document Format (PDF) from the [American
    Society of Clinical Oncology (ASCO) Web
    site](http://www.asco.org/ASCO/Downloads/Cancer Policy and Clinical Affairs/Clinical Affairs (derivative products)/ESAs/ESA Flow Sheet-Order Form 4.pdf).

-   ASCO/ASH 2007 clinical practice guideline update on the use of
    epoetin and darbepoetin. Algorithm. 1 p. Available in Portable
    Document Format (PDF) from the [American Society of Clinical
    Oncology (ASCO) Web
    site](http://www.asco.org/ASCO/Downloads/Cancer Policy and Clinical Affairs/Clinical Affairs (derivative products)/ESAs/ESA Update Algorithm Final 3.pdf).

-   2007 update table of the ASCO/ASH guideline on the use of epoetin
    and darbepoetin. 2007. 4 p. Electronic copies: Available in Portable
    Document Format (PDF) from the American Society of Clinical Oncology
    (ASCO) Web site.

-   2007 clinical practice guideline update on the use of epoetin and
    darbepoetin. Slide set. 2007. 27 p. Electronic copies: Available in
    [Portable Document Format
    (PDF)](http://www.asco.org/ASCO/Downloads/Cancer Policy and Clinical Affairs/Clinical Affairs (derivative products)/ESAs/ESA 2007 Update slides 3 (pdf).pdf)
    and [Power
    Point](http://www.asco.org/ASCO/Downloads/Cancer Policy and Clinical Affairs/Clinical Affairs (derivative products)/ESAs/ESA 2007 Update slides 3-unmodifiable (ppt).ppt)
    from the American Society of Clinical Oncology (ASCO) Web site.

-   2007 clinical practice guideline update on the use of epoetin and
    darbepoetin. Guideline summary. Electronic copies: Available in
    Portable Document Format (PDF) from the [American Society of
    Clinical Oncology (ASCO) Web
    site](http://jop.ascopubs.org/cgi/content/full/4/1/48).

-   2007 clinical practice guideline update on the use of epoetin and
    darbepoetin. Quick reference guide. 2007 Dec. 2 p. Electronic
    copies: Available in Portable Document Format (PDF) from the
    [American Society of Hematology Web
    site](http://www.hematology.org/policy/resources/guidelines/EPO_Quick_Reference.pdf).

Guidelines are available for Personal Digital Assistant (PDA) download
from the [ASCO Web
site](http://www.asco.org/ASCO/Downloads+%26+Technology/PDA+Services).

#### PATIENT RESOURCES

The following is available:

-   ASCO patient guide: epoetin and darbepoetin treatment. 2007 Oct.
    3 p. Available from the [Cancer.Net Web
    site](http://www.cancer.net/portal/site/patient/menuitem.169f5d85214941ccfd748f68ee37a01d/?vgnextoid=add041eca8daa010VgnVCM100000ed730ad1RCRD).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI on May 16, 2003. The information
was verified by the guideline developer on June 25, 2003. This summary
was updated by ECRI on January 29, 2007, following the U.S. Food and
Drug Administration advisory on erythropoiesis stimulating agents. This
summary was updated by ECRI Institute on July 9, 2007, following the FDA
advisory on erythropoiesis stimulating agents. This NGC summary was
updated by ECRI Institute on February 19, 2008. The updated information
was verified by the guideline developer on February 20, 2008. This
summary was updated by ECRI Institute on August 15, 2008 following the
U.S. Food and Drug Administration advisory on Erythropoiesis Stimulating
Agents (ESAs).

#### COPYRIGHT STATEMENT

This summary is based on the original guideline, which is subject to the
American Society of Clinical Oncology\'s copyright restrictions.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced
under the auspices of medical specialty societies, relevant professional
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Guidelines represented on the NGC Web site are submitted by guideline
developers, and are screened solely to determine that they meet the NGC
Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

NGC, AHRQ, and its contractor ECRI Institute make no warranties
concerning the content or clinical efficacy or effectiveness of the
clinical practice guidelines and related materials represented on this
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contact the guideline developer.

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008