Practice Guidelines in Oncology free pdf ebook was written by The National Comprehensive Cancer Network on September 05, 2001 consist of 31 page(s). The pdf file is provided by www.leukemia-web.org and available on pdfpedia since April 08, 2011.
the new who classification defines acute leukemia as. 20% blasts in the marrow or blood. in newly diagnosed pml/raralpha-positive...
Clinical Practice Guidelines in Oncology – v.1.2006
Acute Myeloid
Leukemia
Version 1.2006
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NCCN
®
Practice Guidelines
in Oncology – v.1.2006
Acute Myeloid Leukemia
Guidelines Index
AML Table of Contents
MS, References
NCCN Acute Myeloid Leukemia Panel Members
*
Margaret R. O’Donnell, MD/Chair ‡
x
City of Hope Cancer Center
Frederick R. Appelbaum, MD † Þ
Fred Hutchinson Cancer Research
Center/Seattle Cancer Care Alliance
Eli Estey, MD ‡
The University of Texas M. D. Anderson
Cancer Center
James Foran, MD †
University of Alabama at Birmingham
Comprehensive Cancer Center
Jeffrey Lancet, MD ‡ † Þ
H. Lee Moffitt Cancer Center and
Research Institute at the University of
South Florida
Lori J. Maness, MD ‡ Þ
UNMC Eppley Cancer Center at The
Nebraska Medical Center
Peter G. Maslak, MD ‡ † Þ
x
Memorial Sloan-Kettering Cancer Center
Michael Millenson, MD ‡ Þ
Fox Chase Cancer Center
Joseph O. Moore, MD †
Duke Comprehensive Cancer Center
Donna Przepiorka, MD, PhD ‡
St. Jude Children's Research
Hospital/University of Tennessee Cancer
Institute
Paul Shami, MD ‡
Huntsman Cancer Institute at the
University of Utah
B. Douglas Smith, MD † Þ
The Sidney Kimmel Comprehensive
Cancer Center at Johns Hopkins
Richard M. Stone, MD ‡
Dana-Farber/Partners CancerCare
*
Maria R. Baer, MD ‡
Roswell Park Cancer Institute
John C. Byrd, MD ‡
Arthur G. James Cancer Hospital and
Richard J. Solove Research Institute
at The Ohio State University
Steven E. Coutre, MD ‡
Stanford Hospital and Clinics
Lloyd E. Damon, MD ‡
x
UCSF Comprehensive Cancer Center
Harry P. Erba, MD, PhD † ‡
University of Michigan
Comprehensive Cancer Center
*
Martin S. Tallman, MD ‡
Robert H. Lurie Comprehensive Cancer
Center of Northwestern University
‡ Hematology/Hematology oncology
† Medical Oncology
Þ Internal medicine
x
Bone Marrow Transplantation
Continue
*
Writing Committee Member
Version 1.2006, 09/22/05 © 2005 National Comprehensive Cancer Network, Inc. All rights reserved.
These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
NCCN
®
Practice Guidelines
in Oncology – v.1.2006
Acute Myeloid Leukemia
Guidelines Index
AML Table of Contents
MS, References
Table of Contents
NCCN Acute Myeloid Leukemia Panel Members
Workup and Classification (AML-1)
APL, Treatment Induction and Response (AML-2)
AML, Treatment Induction (AML-4)
AML, Post-Induction Therapy (Standard-dose cytarabine) (AML-5)
AML, Post-Induction Therapy (High-dose cytarabine) (AML-6)
AML, Surveillance (AML-8)
AML, Relapse (AML-8)
Evaluation and Treatment of CNS Leukemia (AML-A)
Supportive Care (AML-B)
Response Criteria for Acute Myeloid Leukemia (AML-C)
Monitoring During Therapy (AML-D)
Clinical Trials:
The
NCCN
believes that the best management
for any cancer patient is in a clinical
trial. Participation in clinical trials is
especially encouraged.
To find clinical trials online at NCCN
member institutions,
click here:
nccn.org/clinical_trials/physician.html
NCCN
Categories of Consensus:
For help using these
documents, please click here
Manuscript
References
All recommendations are Category
2A unless otherwise specified.
See
NCCN
Categories of Consensus
Guidelines Index
Print the Acute Myeloid Leukemia Guideline
Summary of Guidelines Updates
These guidelines are a statement of consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician
seeking to apply or consult these 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 makes no representations nor warranties of any kind
whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. These guidelines are
copyrighted by National Comprehensive Cancer Network. All rights reserved. These guidelines and the illustrations herein may not be reproduced in
any form without the express written permission of NCCN. ©2005.
Version 1.2006, 09/22/05 © 2005 National Comprehensive Cancer Network, Inc. All rights reserved.
These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
NCCN
DIAGNOSIS
®
Practice Guidelines
in Oncology – v.1.2006
WORKUP
Acute Myeloid Leukemia
CLASSIFICATION/STAIN ANALYSIS
Immunophenotyping (+) for
³
2 myeloid markers and (+) for
typically < 2 lymphoid markers
h
or
Myeloperoxidase (+)
or
Nonspecific esterase (+)
or
Butyrate (+)
Myeloperoxidase (–)
Nonspecific Esterase (–)
TdT (+)
or
Immunophenotyping (+) for
³
2 lymphoid markers and
(+) for < 2 myeloid markers
h
TdT (+)
Guidelines Index
AML Table of Contents
MS, References
Acute
leukemia
a,b,c
·
H&P
·
CBC, platelets, differential, chemistry profile
·
PT, PTT, fibrinogen
·
Bone marrow with cytogenetics (mandatory)
·
Immunophenotyping or cytochemistry
d
·
HLA typing (in patients considered potential
HSCT candidates)
e
·
Cardiac scan if prior cardiac history or prior
anthracycline use or clinical scenario which
would raise concern about cardiac function
·
Central venous access of choice
·
FLT3 mutation evaluation is recommended
f
If clinically indicated:
·
Begin alternative donor search if patient has
secondary AML, an antecedent hematologic
disorder, or known poor-risk cytogenetics
and there is no sibling donor
·
Lumbar puncture (LP), if symptomatic
g
(category 2B for asymptomatic)
Acute promyelocytic
leukemia (APL)
See Treatment
Induction (AML-2)
Acute myeloid
leukemia (AML)
See Treatment
Induction (AML-4)
Appropriate
therapy for acute
lymphoblastic
leukemia (ALL)
new WHO classification defines Acute Leukemia as
³
20% blasts in the marrow or blood. Ongoing clinical trials for both AML and high-risk MDS may still continue
to use FAB criteria at least until completion of those trials. AML evolving from MDS (AML-MDS) is often more resistant to cytotoxic chemotherapy than AML which
arises without antecedent hematologic disorder and may have a more indolent course. Some clinical trials designed for high-grade MDS may allow enrollment of
patients with AML-MDS.
b
Young adults may be eligible for pediatric trials with more intensive induction regimens and transplant options.
c
Rare patients who present with extramedullary disease should be treated with systemic therapy. Local therapy (surgery/RT) may be used for residual disease.
d
Samples for both techniques should be taken at the time of initial sampling. Prioritization of these two complementary diagnostic procedures will be left to the discretion
of the pathology departments of the individual institutions. The role of immunophenotyping in detecting minimal residual disease remains to be validated.
e
HLA typing for transfusion is left to the discretion of individual institutions. HSCT = hematopoietic stem cell transplantation.
f
Testing for FLT3 mutations currently is not widely available in the community. One should consider sending marrow sample at diagnosis to a reference lab for younger
patients without antecedent MDS or secondary AML.
g
For patients with major neurologic signs or symptoms at diagnosis, appropriate imaging studies should be performed to detect meningeal disease, chloromas, or CNS
bleeding. LP should be performed if no mass/lesion detected on imaging study. If patient thrombocytopenic prior to LP, give platelet transfusion. Screening LP should
be considered at first remission for patients with M5 or M4 morphology or WBC > 100,000/mcL at diagnosis.
See Evaluation and Treatment of CNS leukemia (AML-A).
h
When presented with rare cases not fitting this algorithm, consultation with an experienced hematopathologist is recommended.
a
The
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 1.2006, 09/22/05 © 2005 National Comprehensive Cancer Network, Inc. All rights reserved.
These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
AML-1
NCCN
CLASSIFICATION
®
Practice Guidelines
in Oncology – v.1.2006
Acute Myeloid Leukemia
Guidelines Index
AML Table of Contents
MS, References
TREATMENT INDUCTION
CONSOLIDATION THERAPY
Consolidate with at least 2
cycles of anthracycline-
based (idarubicin or
daunorubicin)
chemotherapy (category 1)
After consolidation:
·
document molecular
remission
l,m
·
maintenance therapy
x 1-2 y
n
with ATRA ±
6-mercaptopurine +
methotrexate
o
(category 1)
or
Clinical trial
Clinical trial
or
Arsenic trioxide
or
Matched sibling HSCT
or
Alternative donor HSCT
APL
M3 morphology
and (+) for t(15;17)
by either
cytogenetics or
molecular testing;
consider
possibility of M3
variant
All-trans-retinoic acid
(ATRA) and
anthracycline-based
(idarubicin or
daunorubicin)
chemotherapy
(category 1)
i
If t(15;17) not
confirmed,
discontinue ATRA and
treat as other AML
Complete
response
k
First relapse
See
Postremission
Therapy
(AML-3)
Assess marrow
morphology 5-6
wks from start
of induction
j
Induction
failure
k
i
Observe
j
Earlier
for APL differentiation syndrome,
see Supportive Care (AML-B).
assessment may be misleading. Patients are often still molecularly positive at the end of induction.
k
See Response Criteria for Acute Myeloid Leukemia (AML-C).
l
Polymerase chain reaction (PCR) should be routinely used to monitor minimal residual disease. At the current level of resolution, a change from PCR negative to
positive should be confirmed in a reliable laboratory 4 wks later and if molecular relapse is confirmed by a second positive test, intervention should be strongly
considered (eg, arsenic trioxide). If the second test was negative, frequent monitoring (every 3 mo for 1-2 y) is strongly suggested to confirm that the patient remains
negative.
m
If patient molecularly positive,
treat as relapse (AML-3).
n
Data suggest patients presenting with WBC > 10,000/mcL or platelets < 40,000/mcL are at a higher risk for relapse. A risk classification system is available that may
influence treatment decisions.
Sanz MA, Martin G, Rayon C, et al. A modified AIDA protocol with anthracycline-based consolidation results in high antileukemic efficacy
and reduced toxicity in newly diagnosed PML/RARalpha-positive acute promyelocytic leukemia. PETHEMA group. Blood 1999;94:3015-3021.
o
There are data that ATRA ± 6-mercaptopurine + methotrexate improve disease-free survival, but confirmatory studies are still in progress.
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 1.2006, 09/22/05 © 2005 National Comprehensive Cancer Network, Inc. All rights reserved.
These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
AML-2
NCCN
®
Practice Guidelines
in Oncology – v.1.2006
POSTREMISSION THERAPY
Acute Myeloid Leukemia
ADDITIONAL THERAPY
Guidelines Index
AML Table of Contents
MS, References
Second
remission
(morphologic)
r
First
relapse
p
Arsenic
trioxide
q
Autologous HSCT (if PCR negative)
or
Allogeneic HSCT
or
Clinical trial
No remission
Clinical trial
or
Allogeneic HSCT
or
Gemtuzumab ozogamicin
p
See
q
At
Supportive Care (AML-B).
the end of 2 cycles, if patient is not in molecular remission, consider allogeneic HSCT or clinical trial.
r
Patients unable to proceed to HSCT, maintenance arsenic for up to 4 cycles is an option.
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.
Back to AML
Table of Contents
Version 1.2006, 09/22/05 © 2005 National Comprehensive Cancer Network, Inc. All rights reserved.
These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
AML-3
NCCN
CLASSIFICATION
®
Practice Guidelines
in Oncology – v.1.2006
Acute Myeloid Leukemia
TREATMENT INDUCTION
b,p,v
High-dose cytarabine (HiDAC)
w
with either
anthracycline (idarubicin or daunorubicin) or
mitoxantrone (1 cycle) (category 2B)
or
Standard-dose cytarabine (100 mg/m
2
continuous
infusion (CI) x 7 days) with anthracycline (idarubicin
or daunorubicin) or mitoxantrone (7+3)
(may require 2 cycles) (category 2B)
Clinical trial (preferred)
or
Standard-dose cytarabine (100 mg/m
2
CI x 7 days)
with anthracycline (idarubicin or daunorubicin) or
mitoxantrone (7+3) (may require 2 cycles) (category 1)
Clinical trial (incorporating either chemotherapy
or low-intensity therapy)
or
Allogeneic HSCT
x
Low-intensity clinical trial
or
Best supportive care
u
Rare
Guidelines Index
AML Table of Contents
MS, References
Age < 60, no
antecedent
hematologic
disease
See Post-
induction
Therapy (AML-6)
See Post-
induction
Therapy (AML-5)
AML
s
Cytogenetics
unknown at
induction
Age
³
60,
good KPS
See Post-
induction
Therapy (AML-5)
Age < 60, antecedent
hematologic disease
t
or treatment-related
secondary AML
u
At any age, significant
comorbidities which
cause organ
dysfunction not directly
related to leukemia
b
Young
adults may be eligible for pediatric trials with more intensive induction
regimens and transplant options.
p
See Supportive Care (AML-B).
s
Patients with blast counts > 50,000/mcL are at risk for tumor lysis and organ
dysfunction secondary to leukostasis. Measures to rapidly reduce the white count
include apheresis or hydroxyurea to lower the white count to < 50,000/mcL.
Moreover, rapid institution of definitive therapy is essential.
t
Patients known to have recognized poor-prognosis cytogenetic abnormalities prior
to treatment may be treated like patients with an antecedent hematologic
disorder.
patients with favorable karyotypes [inversion 16, t(8;21), t(16;16)] may be
candidates for standard induction therapy, or APL therapy for t(15;17).
v
See Monitoring During Therapy (AML-D).
w
The use of high-dose cytarabine outside the setting of a clinical trial is still
controversial. While the remission rates are the same for standard- and high-dose
cytarabine, two studies have shown a disease-free survival advantage for patients
£
age 50 who received the high-dose therapy (category 2B).
x
The benefit of induction chemotherapy prior to allogeneic HSCT versus immediate
HSCT is unclear in patients with high grade MDS and low blast count AML evolving
from MDS. If donor is available, patient may proceed directly to
HSCT
.
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 1.2006, 09/22/05 © 2005 National Comprehensive Cancer Network, Inc. All rights reserved.
These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
AML-4
NCCN
®
Practice Guidelines
in Oncology – v.1.2006
Acute Myeloid Leukemia
Guidelines Index
AML Table of Contents
MS, References
AML POST-INDUCTION THERAPY
p,v
AFTER STANDARD-DOSE CYTARABINE
Age < 60
POSTREMISSION THERAPY
See Postremission
Therapy (AML-7)
Significant
residual
blasts
y
Follow-up
bone
marrow
v
Significant
cyto-
reduction
without
hypoplasia
Hypoplasia
z
k
S
ee
p
See
Response Criteria for Acute Myeloid Leukemia (AML-C).
Supportive Care (AML-B).
v
See Monitoring During Therapy (AML-D).
y
Begin matched unrelated donor search if no appropriate sibling donor is available and patient is a candidate for an allogeneic HSCT.
z
Hypoplasia is defined as cellularity < 10-20% and residual blasts < 5-10%.
aa
Patients in remission may be screened with LP if initial WBC > 100,000/mcL
or monocytic histology.
S
ee Evaluation and Treatment of CNS leuke
m
ia (AML-A).
bb
May include a reduced-intensity nonmyeloablative allogeneic HSCT.
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 1.2006, 09/22/05 © 2005 National Comprehensive Cancer Network, Inc. All rights reserved.
These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Standard-dose
cytarabine with
Clinical trial
bb
anthracycline
or
Complete
(idarubicin or
Standard-dose cytarabine
response
k,aa
daunorubicin) or
(100 mg/m
2
/day x 5-7 d x 1-2
mitoxantrone
cycles) ± anthracycline
or
(idarubicin or daunorubicin)
See
High-dose cytarabine
Age
³
60
Surveillance
or
or
(AML-8)
Consider cytarabine
See treatment for
Marrow to
1-1.5 g/m
2
/day x 4-6 doses x
Induction failure
document
1-2 cycles for patients with
remission
good performance status,
Standard-dose
status upon
normal renal function,
cytarabine with
hematologic
normal or good karyotype.
anthracycline
recovery
(idarubicin or
Clinical trial
daunorubicin)
or
or mitoxantrone
Matched sibling HSCT or alternative donor HSCT
or
Induction
High dose cytarabine ± anthracycline
failure
k
(daunorubicin or idarubicin), if clinical trial not
available while awaiting identification of a donor
or
Await recovery
Best Supportive Care
AML-5
NCCN
®
Practice Guidelines
in Oncology – v.1.2006
Acute Myeloid Leukemia
Guidelines Index
AML Table of Contents
MS, References
AML POST-INDUCTION THERAPY
p,v
AFTER HIGH-DOSE CYTARABINE
Significant
residual
blasts
y
See treatment
for Induction
failure
Complete
response
k,aa
Significant
cyto-
reduction
without
hypoplasia
Age < 60
POSTREMISSION THERAPY
See Postremission
Therapy (AML-7)
Clinical trial
bb
or
Standard-dose cytarabine
(100 mg/m
2
/day x 5-7 d x 1-2
cycles) ± anthracycline
(idarubicin or daunorubicin)
or
Consider cytarabine
1-1.5 g/m
2
/day x 4-6 doses x
1-2 cycles for patients with
good performance status,
normal renal function,
normal or good karyotype.
Follow-up
bone
marrow
v
Await
recovery
y
Age
³
60
Marrow to
document
remission
status upon
hematologic
recovery
See
Surveillance
(AML-8)
Hypoplasia
z
Await
recovery
Induction
failure
k
Clinical trial
or
Matched sibling HSCT or alternative donor HSCT
or
Best supportive care
k
S
ee
Response Criteria for Acute Myeloid Leukemia (AML-C).
Supportive Care (AML-B).
v
See Monitoring During Therapy (AML-D).
y
Begin matched unrelated donor search if no appropriate sibling donor is available and patient is a candidate for an allogeneic HSCT.
z
Hypoplasia is defined as cellularity < 10-20% and residual blasts < 5-10%.
aa
Patients in remission may be screened with LP if initial WBC > 100,000/mcL
or monocytic histology.
S
ee Evaluation and Treatment of CNS leuke
m
ia (AML-A).
bb
May include a reduced-intensity nonmyeloablative allogeneic HSCT.
p
See
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 1.2006, 09/22/05 © 2005 National Comprehensive Cancer Network, Inc. All rights reserved.
These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
AML-6
NCCN
®
Practice Guidelines
in Oncology – v.1.2006
Acute Myeloid Leukemia
POSTREMISSION THERAPY
High-dose cytarabine,
dd
3 g/m
2
over 3h q12 h
on days 1, 3, 5,
´
4 courses
ee
(category 1)
or
One cycle of high-dose cytarabine-based
consolidation followed by autologous HSCT
ff
(category 2B)
or
Clinical trial
Clinical trial
gg
or
Matched sibling
hh
or autologous HSCT
or
High-dose cytarabine,
dd
3 g/m
2
over 3h q 12 h on days 1, 3, 5, x 4 courses
ee
Clinical trial
gg
or
Matched sibling HSCT
or
Alternative donor HSCT
Guidelines Index
AML Table of Contents
MS, References
Better-risk cytogenetics
[inversion 16, t(8;21), t(16;16)]
cc
Age < 60
Intermediate-risk cytogenetics
[normal, +8 only, t(9;11), or
other abnormalities not listed
above or below]
See
Surveillance
(AML-8)
Antecedent hematologic disease,
Treatment-related disease or Poor-risk
cytogenetics
y
[complex (
³
3
abnormalities), -7, -5, 7q-, 5q-,
abnormalities of 11q23, excluding
t(9;11), t(9;22), inversion 3, t(3;3), t(6;9)]
y
Begin
cc
Other
matched unrelated donor search if no appropriate sibling donor is available and patient is a candidate for an allogeneic HSCT.
abnormalities in addition to these findings do not alter better risk status.
dd
Alternative regimens incorporating intermediate doses are acceptable.
ee
While the original study design incorporated maintenance chemotherapy following a planned 4 cycles of consolidation, only a small fraction of the patients who
received HiDAC, also received maintenance therapy.
ff
While both options- (1) multiple cycles of dose-intensive consolidation and (2) one cycle of dose-intensive consolidation followed by autologous HSCT- can produce
good survival for patients with favorable cytogenetics, there are significant differences in toxicity. Patient age, comorbid conditions, and issues such as fertility and
salvage options should be considered when choosing consolidation.
gg
Clinical trials when available are strongly recommended in the treatment of patients with poor prognostic features (eg, high WBC, CD56+, FLT3 mutation or two cycles
of induction needed to achieve CR).
hh
“Matched sibling” refers to a complete match or one antigen mismatch.
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 1.2006, 09/22/05 © 2005 National Comprehensive Cancer Network, Inc. All rights reserved.
These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
AML-7
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