(NCCN Guidelines®) Cancer- and Chemotherapy- Induced Anemia

43 Pages·2014·1.09 MB·English

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
Cancer- and
Chemotherapy-
Induced Anemia
Version 3.2014
NCCN.org
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Version 3.2014, 02/11/14 © National Comprehensive Cancer Network, Inc. 2014, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines Version 3.2014 Panel Members NCCN Guidelines Index
Anemia Table of Contents
Cancer- and Chemotherapy-Induced Anemia
Discussion
*George M. Rodgers, III, MD, PhD/Chair ‡ Benjamin Djulbegovic, MD, PhD † ‡ x Joseph Rosenthal, MD ‡ €
Huntsman Cancer Institute Moffitt Cancer Center City of Hope Comprehensive Cancer Center
at the University of Utah
Eric H. Kraut, MD ‡ Satish Shanbhag, MBBS, MPH † ‡
*Jeffrey A. Gilreath, PharmD/Vice Chair σ The Ohio State University Comprehensive The Sidney Kimmel Comprehensive
Huntsman Cancer Institute Cancer Center - James Cancer Hospital Cancer Center at Johns Hopkins
at the University of Utah and Solove Research Institute
Gerald Soff, MD ‡
Morey Blinder, MD ‡ Marisa B. Marques, MD ≠ Memorial Sloan-Kettering Cancer Center
Siteman Cancer Center at Barnes- University of Alabama at Birmingham
Jewish Hospital and Washington Comprehensive Cancer Center Richard S. Stein, MD ‡ x
University School of Medicine Vanderbilt-Ingram Cancer Center
Ursula Matulonis, MD †
David Cella, PhD q Dana-Farber/Brigham and Women’s Gordana Vlahovic, MD †
Robert H. Lurie Comprehensive Cancer Cancer Center Duke Cancer Institute
Center of Northwestern University
Michael Millenson, MD ‡ Þ Alva B. Weir III, MD ‡
Charles Cleeland, PhD q Fox Chase Cancer Center St. Jude Children`s Research Hospital
The University of Texas The University of Tennessee Health Science
MD Anderson Cancer Center Denise Reinke, MS, NP # Center
University of Michigan
Peter F. Coccia, MD ‡ € Comprehensive Cancer Center
NCCN
Fred & Pamela Buffett Cancer Center at
Jennifer Burns
The Nebraska Medical Center
Mary Dwyer, MS
Maria Ho, PhD
x Bone marrow transplantation
‡ Hematology/Hematology oncology
Þ Internal medicine
NCCN Guidelines Panel Disclosures
† Medical oncology
# Nursing
≠ Pathology
Continue € Pediatric oncology
σ Pharmacotherapy
q Psychiatry/Psychology
* Writing Committee Member
Version 3.2014, 02/11/14 © National Comprehensive Cancer Network, Inc. 2014, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines Version 3.2014 Table of Contents NCCN Guidelines Index
Anemia Table of Contents
Cancer- and Chemotherapy-Induced Anemia
Discussion
NCCN Cancer- and Chemotherapy-Induced Anemia Panel Members
Clinical Trials: NCCN believes that
Summary of the Guidelines Updates the best management for any cancer
patient is in a clinical trial.
Participation in clinical trials is
especially encouraged.
Evaluation of Anemia (ANEM-1)
To find clinical trials online at NCCN
Risk Assessment and Indications for Initial Transfusion in Acute Setting (ANEM-2)
member institutions, click here:
Comparison of Risks and Benefits of ESA Use Versus Red Blood Cell Transfusion nccn.org/clinical_trials/physician.html.
(ANEM-3)
NCCN Categories of Evidence and
Special Categories in Considering ESA Use (ANEM-4) Consensus: All recommendations
Evaluation of Iron Deficiency (ANEM-5) are Category 2A unless otherwise
specified.
See NCCN Categories of Evidence
and Consensus.
Indications for Red Blood Cell Transfusion in Cancer Patients (ANEM-A)
Erythropoietic Therapy - Dosing, Titration, and Adverse Effects (ANEM-B)
REMS: Risk Evaluation and Mitigation Strategy for Erythropoiesis Stimulating
Agents (ESAs) (ANEM-C)
Parenteral Iron Preparations (ANEM-D)
The NCCN Guidelines® are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment.
Any clinician seeking to apply or consult the NCCN Guidelines is expected to use independent medical judgment in the context of individual clinical
circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network® (NCCN®) makes no representations or
warranties of any kind regarding their content, use or application and disclaims any responsibility for their application or use in any way. The NCCN
Guidelines are copyrighted by National Comprehensive Cancer Network®. All rights reserved. The NCCN Guidelines and the illustrations herein may
not be reproduced in any form without the express written permission of NCCN. ©2014.
Version 3.2014, 02/11/14 © National Comprehensive Cancer Network, Inc. 2014, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.
Printed by Eliot Williams on 6/11/2014 11:15:21 AM. For personal use only. Not approved for distribution. Copyright © 2014 National Comprehensive Cancer Network, Inc., All Rights Reserved.
NCCN Guidelines Version 3.2014 Updates NCCN Guidelines Index
Anemia Table of Contents
Cancer- and Chemotherapy-Induced Anemia
Discussion
Updates in the 3.2014 Version of the NCCN Guidelines for Cancer- and Chemotherapy-Induced Anemia from the 2.2014 Version include:
ANEM-C
• This page was significantly revised to reflect recent modifications to the ESA APPRISE Oncology Program.
ANEM-D 2 of 3
• Footnote "*" was revised: "Dose (mL) = 0.0442 (Desired Hgb - Observed Hgb) X LBW + (0.26 X LBW); Dose (mg) = Dose (mL) x 50 mg/mL. LBW = Lean Body
Weight (kg); Hgb= Hemoglobin (g/dL). If dose exceeds 1000 mg, remaining dose may be given after 4 wks if inadequate hemoglobin response."
Updates in the 2.2014 Version of the NCCN Guidelines for Cancer- and Chemotherapy-Induced Anemia from the 1.2014 Version include:
MS-1
• The discussion section was updated to reflect the changes in the algorithm.
Updates in the 1.2014 Version of the NCCN Guidelines for Cancer- and Chemotherapy-Induced Anemia from the 1.2013 Version include:
ANEM-1 ANEM-5 (continued)
• Evaluation of anemia • Iron status
Hemolysis was modified by adding “LDH” as a test for hemolysis. A new iron status was added: “Absolute iron deficiency (ferritin <30 ng/mL AND
After “no cause identified,” the statement was clarified: “Consider TSAT <20%).”
anemia of chronic inflammation or anemia due to myelosuppressive Functional iron deficiency status was clarified by adding “in patients
chemotherapy.” Also for ANEM-2. receiving ESAs” and revising the parameters from “ferritin ≤800 ng/mL AND
A link to “Evaluation of Iron Deficiency” was added. TSAT <50%” to “ferritin 30-800 ng/mL AND TSAT 20%-50%.”
• Footnote No iron deficiency status, the TSAT parameter was revised from “≥20” to
Footnote “c” was revised by removing: “If absolute iron deficiency is “≥50%.”
present (ferritin <30 ng/mL and transferrin saturation <15%), consider • Footnotes
IV or oral iron supplementation.” and “If Hb increases after 4 wks then Footnote “n” was added: “If the ferritin and TSAT are discordant, the low
observe with periodic re-evaluation for symptoms and risk factors, ferritin value should take precedence in determining whether IV iron will be of
if Hb does not increase after 4 wks, see functional iron deficiency benefit.”
pathway (See ANEM-5).” Footnote “o” was added: “In clinical trials using IV iron plus an ESA, a higher
ANEM-3 response rate is seen when iron is used for patients with a TSAT <20%. For
• ESA in the cancer setting patients who received IV iron that had baseline TSATs >20%, the response
Risks, 2nd bullet was modified: “Possible decreased survival.” rate to IV iron is both diminished and prolonged as the TSAT increased from
• Red blood cell transfusion 20% to 50%; therefore, the decision to offer IV iron to this subset of patients
Risks, 7th bullet was modified: “Possible decreased survival.” should be reserved for those in whom the benefits are likely to outweigh the
ANEM-4 risks.”
• For the categories, “Patient undergoing palliative treatment” and ANEM-A
“Remainder of patients with anemia on myelosuppressive chemotherapy • Footnote “a” was modified by updating the publication information of the
without other identifiable cause of anemia” the treatments to consider reference.
were clarified by adding text to indicate that the options should be • Footnote “b” was added: “If there is a regimen (research or standard protocol)
considered equal by the physician and patient. The revised text reads: for which a higher hemoglobin is required for full dose treatment, it would be
“Consider based on patient preference and values:” acceptable to be more aggressive with the hemoglobin target.”
ANEM-5 ANEM-D 2 OF 3
• Title of page was changed from “Management of functional iron • Iron dextran, reference 14 was added: “Gilreath JA, Stenehjem DD, Rodgers
deficiency in patients receiving ESAs” to “Evaluation of Iron Deficiency.” GM. Total dose iron dextran infusion in cancer patients: is it SaFe2+? J Natl
Compr Canc Netw 2012;10:669-676.”
Version 3.2014, 02/11/14 © National Comprehensive Cancer Network, Inc. 2014, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. UPDATES
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NCCN Guidelines Version 3.2014 NCCN Guidelines Index
Anemia Table of Contents
Cancer- and Chemotherapy-Induced Anemia
Discussion
HEMOGLOBIN EVALUATION OF ANEMIAa,b
CONCENTRATION
TO PROMPT AN
Evaluate anemia for possible cause as
EVALUATION OF
indicated (see MS-3):
ANEMIA
• First check
Reticulocyte count and MCV
Treat as indicated
• Then consider
Hemorrhage (stool guaiac, endoscopy)
Hemoglobin Hemolysis (Coombs test, DIC panel,
• CBC with indices
(Hb) ≤11 g/dL haptoglobin, LDH)
• Blood smear
or ≥2 g/dL Nutritional (iron, total iron binding
below baseline morphology capacity, ferritin,c B , folate)
12 Consider anemia
Inherited (prior history, family history)
of chronic
Renal dysfunction See
No cause inflammation or
(GFR <60 mL/min/1.73 m2, low Epo)
identified anemia due to ANEM-2
Radiation-induced myelosuppression
myelosuppressive
• See Evaluation of Iron Deficiency
chemotherapy
(ANEM-5)
Myelodysplastic syndromes See NCCN Guidelines for Myelodysplastic Syndromes
Myeloid malignancies or Treat underlying disease per NCCN Guideline
Acute lymphoblastic leukemia See NCCN Guidelines Table of Contents
aThe NCCN Guidelines for Cancer- and Chemotherapy-Induced Anemia were formulated in reference to adult patients.
bThis is a basic evaluation for possible causes of anemia.
cThe ferritin value indicating iron deficiency is laboratory-specific. In general, the lower the level of ferritin, the higher the probability that the patient has true iron
deficiency anemia. However, in the cancer setting, be aware of a chronic inflammatory state, which may falsely elevate the serum ferritin.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 3.2014, 02/11/14 © National Comprehensive Cancer Network, Inc. 2014, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. ANEM-1
Printed by Eliot Williams on 6/11/2014 11:15:21 AM. For personal use only. Not approved for distribution. Copyright © 2014 National Comprehensive Cancer Network, Inc., All Rights Reserved.
NCCN Guidelines Version 3.2014 NCCN Guidelines Index
Anemia Table of Contents
Cancer- and Chemotherapy-Induced Anemia
Discussion
RISK ASSESSMENT AND INDICATIONS FOR INITIAL TRANSFUSION IN ACUTE SETTING
Asymptomatic without significant comorbiditiesd Observe Periodic re-evaluation
Asymptomatic with comorbiditiesd or high risk
• Comorbidities:
Anemia of chronic
Cardiac including congestive heart failure
inflammation or anemia
and coronary heart disease Consider red blood cell transfusion per guidelinesf
due to myelosuppressive
Chronic pulmonary disease See Indications for Red Blood Cell Transfusion in
chemotherapy for
Cerebral vascular disease Cancer Patients (ANEM-A)
lymphoid malignancies
• High risk:
and solid tumors
Progressive decline in Hb with recent
intensive chemotherapy or radiation
Symptomatic
• Physiologic:
Red blood cell transfusion per guidelinesf
Sustained tachycardia, tachypnea, chest
See Indications for Red Blood Cell
pain, dyspnea on exertion, lightheadedness,
Transfusion in Cancer Patients (ANEM-A)
syncope, severe fatiguee preventing work,
and usual activity
See Comparison of Risks and Benefits of ESA Use
Versus Red Blood Cell Transfusion (ANEM-3)
See Special Categories in Considering ESA Use (ANEM-4)
dDegree of severity of comorbidities in combination with the degree of severity of anemia should be taken into consideration when initiating red blood cell transfusion.
eFatigue (FACT-F) and Anemia (FACT-An) subscales of the Functional Assessment of Cancer Therapy (FACT) and Brief Fatigue Inventory (BFI) are examples of
standardized measures for assessing patient-reported fatigue.
fSee Discussion for further details on treating patients who may refuse blood transfusion (eg, Jehovah's Witnesses).
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 3.2014, 02/11/14 © National Comprehensive Cancer Network, Inc. 2014, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. ANEM-2
Printed by Eliot Williams on 6/11/2014 11:15:21 AM. For personal use only. Not approved for distribution. Copyright © 2014 National Comprehensive Cancer Network, Inc., All Rights Reserved.
NCCN Guidelines Version 3.2014 NCCN Guidelines Index
Anemia Table of Contents
Cancer- and Chemotherapy-Induced Anemia
Discussion
COMPARISON OF RISKS AND BENEFITS OF ESA USE VERSUS RED BLOOD CELL TRANSFUSIONg
If anemia is not due to absolute or functional iron deficiency, there are currently only two proven methods of
improving Hb - ESAs and red blood cell transfusion. Listed below are risks and benefits of each method.
ESA in the Cancer Setting Red Blood Cell Transfusion
Risks • Increased thrombotic events • Transfusion reactions (eg, hemolytic,
• Possible decreased survival febrile, non-hemolytic, lung injury)
• Time to tumor progression shortened • Congestive heart failure
• Virus transmission (eg, hepatitis, HIV)
• Bacterial contamination
• Iron overload
• Increased thrombotic events
• Possible decreased survival
Benefits • Transfusion avoidance • Rapid increase of Hb and
• Gradual improvement in fatigue hematocrit levels
• Rapid improvement in fatigue
See REMS: Risk Evaluation and Mitigation Strategy for
Erythropoiesis Stimulating Agents (ESAs) (ANEM-C)
gSee Discussion for detailed information regarding the risks and benefits of ESA use and red blood cell transfusion.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 3.2014, 02/11/14 © National Comprehensive Cancer Network, Inc. 2014, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. ANEM-3
Printed by Eliot Williams on 6/11/2014 11:15:21 AM. For personal use only. Not approved for distribution. Copyright © 2014 National Comprehensive Cancer Network, Inc., All Rights Reserved.
NCCN Guidelines Version 3.2014 NCCN Guidelines Index
Anemia Table of Contents
Cancer- and Chemotherapy-Induced Anemia
Discussion
SPECIAL CATEGORIES IN CONSIDERING ESA USE
Consider ESAs by FDA indications/dosing/dosing See Evaluation of
• Cancer and chronic kidney disease
adjustments for chronic kidney disease, under REMS Iron Deficiency
(moderate to severe)
guidelines, with informed consent of patientj,k,l,m (ANEM-5)
• Myelosuppressive chemotherapy with
curative intenth
Examples of cancers for which there is therapy
with curative intent: ESAs not recommended
early-stage breast cancer, Hodgkin lymphoma,
non-Hodgkin’s lymphoma, testicular cancer,
early-stage non-small cell lung cancer, etc.
• Consider based on patient preference and values:
• ESAs by FDA indications/dosing/dosing adjustments,
under REMS guidelines, with informed consent of
• Patient undergoing palliative treatmenti
patientj,k,l
or See Evaluation of
• Red blood cell transfusion per guidelines (See ANEM-A) Iron Deficiency
(ANEM-5)
Consider based on patient preference and values:
• ESAs by FDA indications/dosing/dosing adjustments,
• Remainder of patients with under REMS guidelines, with informed consent of
anemia on myelosuppressive patientj,k,l
chemotherapy without other or
identifiable cause of anemiai • Red blood cell transfusion per guidelines (See ANEM-A)
or
• Clinical trial
hA few studies suggest patients with small cell lung cancer on
myelosuppressive chemotherapy may not have an increase in
mortality when receiving ESAs. Oncologic Drugs Advisory Committee
March 2008; Pirker et al. J Clin Oncol 2008; 26:2342-3249; Grote et al. J Clin lPatients with previous risk factors for thrombosis may be at higher risk for thrombosis
Oncol 2005;23:9377-9386. with the use of ESAs. If considering use of ESAs, evaluate the risk factors for
iSee Comparison of Risks and Benefits of ESA Use Versus Red Blood Cell thrombosis: history of thromboembolism, heritable mutation, hypercoagulability,
Transfusion (ANEM-3). elevated pre-chemotherapy platelet counts, hypertension, steroids, prolonged
jSee Erythropoietic Therapy - Dosing, Titration, and Adverse Effects (ANEM-B). immobilization, recent surgery, certain therapies for multiple myeloma, hormonal
kHealth care providers prescribing ESAs need to enroll in the ESA APPRISE agents, etc. (See NCCN Guidelines for Venous Thromboembolic Disease).
program. See REMS: Risk Evaluation and Mitigation Strategy for mThe hemoglobin threshold for treatment and dosing with ESAs is different for
Erythropoiesis Stimulating Agents (ESAs) (ANEM-C). chemotherapy-induced anemia and chronic kidney disease.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 3.2014, 02/11/14 © National Comprehensive Cancer Network, Inc. 2014, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. ANEM-4
Printed by Eliot Williams on 6/11/2014 11:15:21 AM. For personal use only. Not approved for distribution. Copyright © 2014 National Comprehensive Cancer Network, Inc., All Rights Reserved.
NCCN Guidelines Version 3.2014 NCCN Guidelines Index
Anemia Table of Contents
Cancer- and Chemotherapy-Induced Anemia
Discussion
EVALUATION OF IRON DEFICIENCY
EVALUATION IRON STATUS MANAGEMENT
Hb increases Periodic evaluation
after 4 wks (repeat ferritin and TSAT)
Absolute iron deficiencyn
Consider IV or oral
(ferritin <30 ng/mL AND
iron supplementation
TSAT <20%) Hb does not
See Functional iron
increase after
deficiency pathway below
4 wks
Iron studies: Functional iron deficiency
Iron panel (serum iron, in patients receiving ESAso Consider IV iron supplementationq,r,s
total iron binding capacity, (ferritin 30-800 ng/mL AND with erythropoietic therapy
serum ferritin)c TSAT 20%-50%p)
No iron deficiency
(ferritin >800 ng/mL OR IV or oral iron supplementation is not needed
TSAT ≥50%)
See Parenteral Iron Preparations (ANEM-D)
cThe ferritin value indicating iron deficiency is laboratory-specific. In general, pOnly 1 of 6 studies (Henry DH, Dahl NV, Auerbach M, et al. Oncologist
the lower the level of ferritin, the higher the probability that the patient has true 2007;12:231-242) of IV iron therapy in cancer patients provided a TSAT guideline
iron deficiency anemia. However, in the cancer setting, be aware of a chronic for monitoring.
inflammatory state, which may falsely elevate the serum ferritin. qIV iron has superior efficacy and should be considered for supplementation. Oral
nIf the ferritin and TSAT are discordant, the low ferritin value should take iron has been more commonly used but is less effective.
precedence in determining whether IV iron will be of benefit. See Parenteral Iron Preparations (ANEM-D).
oIn clinical trials using IV iron plus an ESA, a higher response rate is seen when rAlthough all combinations of serum ferritin and TSAT could be found in at least
iron is used for patients with a TSAT <20%. For patients who received IV iron that one of six randomized controlled trials evaluating the use of IV iron with an ESA,
had baseline TSATs >20%, the response rate to IV iron is both diminished and eligibility criteria testing for serum ferritin and TSAT generally ranged from >10 to
prolonged as the TSAT increased from 20% to 50%; therefore, the decision to <900 ng/mL, and >15% to <60%, respectively.
offer IV iron to this subset of patients should be reserved for those in whom the sThere are insufficient data to routinely recommend IV iron as monotherapy
benefits are likely to outweigh the risks. without an ESA for the treatment of functional iron deficiency anemia.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 3.2014, 02/11/14 © National Comprehensive Cancer Network, Inc. 2014, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. ANEM-5
Printed by Eliot Williams on 6/11/2014 11:15:21 AM. For personal use only. Not approved for distribution. Copyright © 2014 National Comprehensive Cancer Network, Inc., All Rights Reserved.
NCCN Guidelines Version 3.2014 NCCN Guidelines Index
Anemia Table of Contents
Cancer- and Chemotherapy-Induced Anemia
Discussion
INDICATIONS FOR RED BLOOD CELL TRANSFUSION IN CANCER PATIENTSa,b
Goal: Prevent or treat deficit of oxygen-carrying capacity
Asymptomatic Anemia
• Hemodynamically stable chronic anemia without acute coronary syndrome:
Transfusion goal to maintain Hb 7-9 g/dL
Symptomatic Anemia
• Acute hemorrhage with evidence of hemodynamic instability or inadequate oxygen delivery:
Transfuse to correct hemodynamic instability and maintain adequate oxygen delivery
• Symptomatic (including tachycardia, tachypnea, postural hypotension) anemia (Hb <10 g/dL):
Transfusion goal to maintain Hb 8-10 g/dL as needed for prevention of symptoms
• Anemia in setting of acute coronary syndromes or acute myocardial infarction:
Transfusion goal to maintain Hb ≥10 g/dL
aThe AABB has also made recommendations regarding appropriate levels for red blood cell transfusion. See Discussion for details. Carson JL, Grossman BJ,
Kleinman S, et al.; for the Clinical Transfusion Medicine Committee of the AABB. Red Blood Cell Transfusion: A Clinical Practice Guideline from the AABB. Ann
Intern Med 2012;157:49-58.
bIf there is a regimen (either research or standard protocol) for which a higher hemoglobin is required for full dose treatment, it would be acceptable to be more
aggressive with the hemoglobin target.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 3.2014, 02/11/14 © National Comprehensive Cancer Network, Inc. 2014, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. ANEM-A