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2010NCCN恶性黑色素瘤治疗指南

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2010NCCN恶性黑色素瘤治疗指南 Continue NCCN Clinical Practice Guidelines in Oncology™ Melanoma V.2.2010 www.nccn.org Version 2.2010, 03/17/10 © 2010 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form w...
2010NCCN恶性黑色素瘤治疗指南
Continue NCCN Clinical Practice Guidelines in Oncology™ Melanoma V.2.2010 www.nccn.org Version 2.2010, 03/17/10 © 2010 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 – v.2.2010 Melanoma Guidelines Index Melanoma Table of Contents Staging, Discussion, ReferencesNCCN ® Continue NCCN Melanoma Panel Members Daniel G. Coit, MD/Chair Memorial Sloan-Kettering Cancer Center William E. Carson, III, MD The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute Raza A. Dilawari, MD St. Jude Children’s Research Hospital/ University of Tennessee Cancer Institute Dominick DiMaio, MD Allan C. Halpern, MD Memorial Sloan-Kettering Cancer Center ¶ ¶ ¶ ¶ ¥ Þ Robert Andtbacka, MD Huntsman Cancer Institute at the University of Utah Christopher K. Bichakjian, MD University of Michigan Comprehensive Cancer Center UNMC Eppley Cancer Center at The Nebraska Medical Center Valerie Guild Aim at Melanoma � � � Merrick I. Ross, MD The University of Texas M. D. Anderson Cancer Center Susan M. Swetter, MD Stanford Comprehensive Cancer Center Kenneth K. Tanabe, MD Massachusetts General Hospital Cancer Center John A. Thompson, MD Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Vijay Trisal, MD City of Hope Comprehensive Cancer Center Marshall M. Urist, MD University of Alabama at Birmingham Comprehensive Cancer Center Jeffrey Weber, MD, PhD H. Lee Moffitt Cancer Center & Research Institute Michael K. Wong, MD, PhD Roswell Park Cancer Institute ¶ ¶ ‡ ¶ ¶ † † � † ¶ , ¶ † ¶ F. Stephen Hodi, Jr. MD Dana-Farber/Brigham and Women’s Cancer Center Mohammed Kashani-Sabet, MD UCSF Helen Diller Family Comprehensive Cancer Center Mark C. Kelley, MD Vanderbilt-Ingram Cancer Center Julie R. Lange, MD ScM The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Anne Lind, MD Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine Lainie Martin, MD Fox Chase Cancer Center Mary C. Martini, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern University Scott K. Pruitt, MD, PhD Duke Comprehensive Cancer Center � � � † Medical oncology Þ Internal medicine ¶ Surgery/Surgical oncology ‡ Hematology/Hematology oncology * Writing Committee member � � Dermatology Pathology ¥ Patient Advocacy * * NCCN Guidelines Panel Disclosures Version 2.2010, 03/17/10 © 2010 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 – v.2.2010 Melanoma Guidelines Index Melanoma Table of Contents Staging, Discussion, ReferencesNCCN ® Table of Contents NCCN Melanoma Panel Members Clinical Presentation and Preliminary Workup (ME-1) Stage 0 (in situ), Stage I-II (ME-2) Stage III (ME-3) Stage IV (ME-4) Follow-up (ME-5) Persistent disease or True local scar recurrence, In-transit recurrence (ME-6) Nodal recurrence (ME-7) Distant metastatic disease (ME-8) Principles of Biopsy (ME-A) (ME-B) Principles of Complete Lymph Node Dissection (ME-C) Systemic Therapy Options for Advanced or Metastatic Melanoma (ME-D) Guidelines Index Print the Melanoma Guideline Summary of Guidelines Updates Principles of Surgical Margins for Wide Excision of Primary Melanoma These 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 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. ©2010. Clinical Trials: Categories of Evidence and Consensus: NCCN The 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, All recommendations are Category 2A unless otherwise specified. See NCCN click here: nccn.org/clinical_trials/physician.html NCCN Categories of Evidence and Consensus For help using these documents, please click here Staging Discussion References Version 2.2010, 03/17/10 © 2010 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 – v.2.2010 Melanoma Guidelines Index Melanoma Table of Contents Staging, Discussion, ReferencesNCCN ® Summary of changes in the 2.2010 version of the Melanoma guidelines from the 1.2010 version include: Summary of the Guidelines Updates UPDATES 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. ( ) ( ) ( ) ME-1 ME-2 ME-3 ( ) ( ) ME-4 ME-5 � � � � � Pathology Report: “Mitotic rate” changed from category 2B to category 2A. Stage IB, Stage II, N0 pathway: Workup: The recommendations were revised for clarity. “Encourage sentinel node biopsy” changed to “ sentinel node biopsy”. Stage III in-transit pathway; Primary Treatment: “Consider sentinel node biopsy” changed to “Consider sentinel node biopsy .” � � Discuss and offer for resectable in-transit disease Stage IV Metastatic; Workup: “Chest x-ray and/or chest CT” was removed. The Workup recommendations for all stages were revised extensively. ( ) ( ): ( ): ( ): ME-8 ME-A ME-B ME-D � � � � � � � Distant metastatic disease; Workup: “Chest x-ray, and/or chest CT” was removed. Disseminated; Without brain metastases: The pathways for First/Second line therapy and performance scores were removed (this information is now on page ) and replaced with “Systemic therapy”. “With brain metastases” pathway: “Clinical trial” was removed. Principles of Biopsy Sixth Bullet: “Satellitosis, if present....” changed to “Microsatellitosis, if present...” Principles of Surgical Margins for Wide Excision of Primary Melanoma Footnote 2: The panel revised the footnote to read, “Clinical margins do not need to correlate with final histologic margins.” Systemic Therapy Options for Advanced or Metastatic Melanoma Dacarbazine, Temozolomide, and High-dose interleukin-2 changed from “category 2B” to “category 2A”. Footnotes “1” and “3” are new to the page. ME-D Summary of changes in the 1.2010 version of the Melanoma guidelines from the 2.2009 version include: Global Changes: � � � � � The Melanoma Discussion section was updated correspondent to the changes in the algorithm . The Staging tables were updated to reflect the 7th edition (2010) of the AJCC Staging Manual . Clinical Stage: For Stage IA, IB, and II “Clark level” was removed and “Mitotic rate” was added. Footnote “d”: “ and 0.75 mm thick” and “younger age” were added as adverse features. “Mitotic rate 1 per mm ” was removed. Adjuvant Treatment for Stage III (Clinically positive node(s)): “Consider RT to nodal basin if Stage IIIC...” changed from category 2B to category 2A. � � 2 ( ) ( ( ) MS-1 ME-1 ST-1) ST-2) ME-3 ( ( ) Version 2.2010, 03/17/10 © 2010 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 – v.2.2010 Melanoma Guidelines Index Melanoma Table of Contents Staging, Discussion, ReferencesNCCN ® 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. Breslow thickness + Ulceration status + Assess deep and peripheral margin status + Satellitosis, if present, should be reported + Mitotic rate + Clark level (for lesions 1 mm)� Suspicious pigmented lesion Biopsya Inadequateb Melanoma confirmedb Rebiopsy � � � H&P with attention to locoregional area, draining lymph nodes Complete skin exam Assessment of melanoma related risk factorsc a . If diagnostic biopsy is inadequate for treatment decisions, rebiopsy may be appropriate. Risk factors for melanoma include family history of melanoma, prior primary melanoma, and other factors such as atypical moles/dysplastic nevi. b c dAdverse features include 0.75 mm thick, positive deep margins, lymphovascular invasion (LVI), or younger age.� See Principles of Biopsy (ME-A) Stage IB, Stage II ( 1 mm thick with ulceration or mitotic rate or > 1 mm thick, any characteristic), N0 (ME-2) � � 1 per mm2 Stage IV Metastatic (ME-4) ME-1 CLINICAL PRESENTATION PATHOLOGY REPORT PRELIMINARY WORKUP Stage III (ME-3) CLINICAL STAGE Stage 0 in situ or Stage IA ( 1 mm thick, mitotic rate < 1 per mm ) with no adverse features (ME-2) � 2 d Stage IA ( 1 mm thick, mitotic rate < 1 per mm ) with adverse features (ME-2) � 2 d Version 2.2010, 03/17/10 © 2010 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 – v.2.2010 Melanoma Guidelines Index Melanoma Table of Contents Staging, Discussion, ReferencesNCCN ® 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. d e i Adverse features include 0.75 mm thick, positive deep margins, lymphovascular invasion (LVI), or younger age. Decision not to perform SLNB may be based on significant patient comorbidities, patient preference or other factors. . Sentinel lymph nodes should be evaluated with multiple sectioning and immunohistochemistry. IFN has been associated with improved DFS, however, its impact on overall survival is unclear. � g h fSentinel node biopsy is an important staging tool, but the impact of SLNB on overall survival is unclear. See Principles of Surgical Margins for Wide Excision of Primary Melanoma (ME-B) ME-2 Wide excision (category 1) with sentinel node biopsy g h Sentinel node negative Sentinel node positive See Stage III Workup and Primary Treatment (ME-3) Wide excisiong Wide excision (category 1) g Wide excision (category 1) with sentinel node biopsy g h WORKUP PRIMARY TREATMENT � � � H&P Stage IB, IIA: No further workup required Stage IIB-IIC: Chest x-ray (optional); routine imaging not recommended Further imaging as clinically indicated � � � (CT scan, PET, MRI) See Stage III Workup and Primary Treatment (ME-3) Sentinel node negative Sentinel node positive ADJUVANT TREATMENT Discuss and offer sentinel node biopsye,f See Follow-Up (ME-5) If Stage IB, IIA: Clinical trial or Observation If Stage IIB, IIC: Clinical trial or Interferon alfa (category 2B) Observation or i CLINICAL STAGE H&P Imaging only (CT scan, PET, MRI) to evaluate specific signs or symptoms Consider sentinel node biopsye See Follow-Up (ME-5) Wide excision (category 1) g Stage 0 in situ or Stage IA ( 1 mm thick, mitotic rate < 1 per mm ) with no adverse features � 2 d Stage IA ( 1 mm thick, mitotic rate < 1 per mm ) with adverse features � 2 d Stage IB, Stage II ( 1 mm thick with ulceration or mitotic rate or > 1 mm thick, any characteristic), N0 � � 1 per mm2 Version 2.2010, 03/17/10 © 2010 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 – v.2.2010 Melanoma Guidelines Index Melanoma Table of Contents Staging, Discussion, ReferencesNCCN ® Complete surgical excision to clear margins, if feasible (category 2B) Consider sentinel node biopsy for resectable in-transit disease preferred, (category 2B) or h Hyperthermic perfusion/infusion with melphalan (category 2B) or Clinical trial or Intralesional injection (BCG, IFN) (category 2B) or Local ablation therapy (category 2B) or RT (category 2B) or Systemic therapy or Topical imiquimod (category 2B) l 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. Stage III (Clinically positive node(s)) Clinical trial or or Observation ( ) Interferon alfa category 2B i Clinical trial or and/or Consider RT to nodal basin if Stage IIIC (category 2A) with multiple nodes involved or extranodal extension or Observation ( )Interferon alfa category 2Bi Stage III in-transit If free of disease (See Follow-up ME-5) g i k l hSentinel lymph nodes should be evaluated with multiple sectioning and immunohistochemistry. IFN has been associated with improved DFS, however, its impact on overall survival is unclear. Clinical trials assessing alternatives to complete lymph node dissection, such as careful observation. j See Principles of Surgical Margins for Wide Excision of Primary Melanoma (ME-B) See Systemic Therapy Options for Advanced or Metastatic Melanoma (ME-D) . . . See Principles of Complete Lymph Node Dissection (ME-C) � � � FNA preferred, if feasible, or lymph node biopsy Consider baseline imaging for staging and to evaluate specific signs or symptoms (category 2B) (Chest x-ray, CT ± PET, MRI) Pelvic CT if inguinofemoral nodes positive � � FNA preferred, if feasible, or biopsy Consider baseline imaging for staging and to evaluate specific signs or symptoms (category 2B) (Chest x-ray, CT ± PET, MRI) ME-3 CLINICAL/ PATHOLOGIC STAGE WORKUP PRIMARY TREATMENT ADJUVANT TREATMENT Stage III (Sentinel node positive) Consider baseline imaging for staging and to evaluate specific signs or symptoms (category 2B) (Chest x-ray, CT ± PET, MRI) Lymph node dissection or Clinical trial j k Clinical trial or Observation or Interferon alfa ( )i category 2B Wide excision of primary tumor (category 1) + complete lymph node dissection g j Version 2.2010, 03/17/10 © 2010 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 – v.2.2010 Melanoma Guidelines Index Melanoma Table of Contents Staging, Discussion, ReferencesNCCN ® Stage IV Metastatic See Treatment for Limited (Resectable) or Disseminated Disease (Unresectable) ME-8) � � � FNA preferred, if feasible or biopsy LDH Encourage chest/abdominal/pelvic CT, MRI brain, and/or PET as clinically indicated (category 2B) CLINICAL/ PATHOLOGIC STAGE WORKUP 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. ME-4 Version 2.2010, 03/17/10 © 2010 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 – v.2.2010 Melanoma Guidelines Index Melanoma Table of Contents Staging, Discussion, ReferencesNCCN ® 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. RECURRENCEo Stage IIB - IV NED FOLLOW-UPm Distant recurrencep Persistent disease or true local scar recurrencen,o,p Local, satellitosis, and/or in-transit recurrenceo,p Nodal recurrencep (See ME-6) (See ME-6) (See ME-7) (See ME-8) nPersistent disease or true local scar recurrence is defined by presence of in situ and/or radial growth phase. o p Local recurrence without in situ or radial growth phase, with deep dermal or subcutaneous fat recurrence within the melanoma scar or satellite metastasis adjacent to the melanoma scar. Initial clinical recurrence should be confirmed pathologically whenever possible. Stage 0 in situ � � H&P (with emphasis on nodes and skin) every 3-12 mo for 5 y, then annually as clinically indicated Routine lab testing/radiologic imaging to screen for asymptomatic recurrent/metastatic disease is not recommended � � � � � H&P (with emphasis on nodes and skin) every 3-6 mo for 2 y, then every 3-12 mo for 3 y, then annually as clinically indicated Consider chest x-ray, CT and/or PET-CT scans to screen for recurrent/metastatic disease (category 2B) Consider brain MRI annually (category 2B) Routine lab testing/radiologic imaging to screen for asymptomatic recurrent/metastatic disease is not recommended after 5 y � � � � CLINICAL/ PATHOLOGIC STAGE Stage IA - IIA NED ME-5 mCommon Follow-up Recommendations For All Patients: Follow-up schedule influenced by risk of recurrence, prior primary melanoma, and family history of melanoma, and includes other factors, such as atypical moles/dysplastic nevi, and patient anxiety. � � � At least annual skin exam for life Educate patient in monthly self skin exam (and monthly self lymph node exam for Stage IA - IV NED) Lab tests and/or imaging are indicated to investigate for specific signs and symptoms See Common Follow-up Recommendations For All Patients. (Below) Version 2.2010, 03/17/10 © 2010 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 – v.2.2010 Melanoma Guidelines Index Melanoma Table of Contents Staging, Discussion, ReferencesNCCN ® 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. TREATMENT OF RECURRENCEp Local, satellitosis, and/or in-transit recurrenceo,p Re-excise tumor site to appropriate margins. (See ME-B) Consider lymphatic mapping/SLNB according to thickness Clinical trial, or Observation or ( ) Interferon alfa category 2B i � � Biopsy to confirm Workup appropriate to stage a,p ( )See ME-2 � � FNA (preferred) or biopsy Consider baseline imaging for staging and to evaluate specific signs or symptoms (category 2B) (Chest x-ray, CT ± PET, MRI) p a i l n o p IFN has been associated with improved DFS, however, its impact on overall survival is unclear. Persistent disease or true local scar recurrence is defined by presence of in situ and/or radial growth phase. Local recurrence without in situ or radial growth phase, with
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