Practice Guidelines in Oncology

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...

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Practice Guidelines in Oncology pdf




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Practice Guidelines in Oncology - page 1
Clinical Practice Guidelines in Oncology – v.1.2006 Acute Myeloid Leukemia Version 1.2006 Continue
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Practice Guidelines in Oncology - page 2
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.
Practice Guidelines in Oncology - page 3
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.
Practice Guidelines in Oncology - page 4
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
Practice Guidelines in Oncology - page 5
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
Practice Guidelines in Oncology - page 6
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
Practice Guidelines in Oncology - page 7
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
Practice Guidelines in Oncology - page 8
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
Practice Guidelines in Oncology - page 9
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
Practice Guidelines in Oncology - page 10
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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