NCCN黑色素瘤临床实践指南2011

Version 1.2011, 10/13/10 © National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®. NCCN Guidelines Index Melanoma Table of Contents Discussion NCCN.org Continue NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) Melanoma Version 1.2011 NCCN Guidelines for Patients™ available at www.nccn.com Version 1.2011, 10/13/10 © National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®. NCCN Guidelines Index Melanoma Table of Contents Discussion NCCN Maria Ho, PhD Nicole McMillian, MS Continue NCCN Guidelines™ Version 1.2011 Panel Members Melanoma Daniel G. Coit, MD/Chair Memorial Sloan-Kettering Cancer Center Huntsman Cancer Institute at the University of Utah Huntsman Cancer Institute at the University of Utah William E. Carson, III, MD The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute Adil Daud, MD UCSF Helen Diller Family Comprehensive Cancer Center Raza A. Dilawari, MD St. Jude Children’s Research Hospital/ University of Tennessee Cancer Institute ¶ ¶ § ¶ †Þ ¶ Robert Andtbacka, MD Christopher J. Anker, MD Christopher K. Bichakjian, MD University of Michigan Comprehensive Cancer Center � Anthony J. Olszanski, MD Fox Chase Cancer Center Scott K. Pruitt, MD, PhD Duke Comprehensive Cancer Center 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 † ¶ ¶ ¶ ‡ ¶ ¶ � ¥ Þ † ¶ , ¶ Dominick DiMaio, MD UNMC Eppley Cancer Center at The Nebraska Medical Center Valerie Guild Aim at Melanoma Allan C. Halpern, MD Memorial Sloan-Kettering Cancer Center F. Stephen Hodi, Jr. MD Dana-Farber/Brigham and Women’s 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 Mary C. Martini, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern University � � � � Nikhil I. Khushalani, MD Roswell Park Cancer Institute † † Medical oncology Þ Internal medicine ¶ Surgery/Surgical oncology ‡ Hematology/Hematology oncology * Writing Committee member � � Dermatology Pathology ¥ Patient Advocacy § Radiotherapy/Radiation oncology * * NCCN Guidelines Panel Disclosures Printed by z z on 1/10/2011 2:16:45 AM. For personal use only. Not approved for distribution. Copyright © 2011 National Comprehensive Cancer Network, Inc., All Rights Reserved. Version 1.2011, 10/13/10 © National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®. NCCN Guidelines Index Melanoma Table of Contents Discussion NCCN Guidelines Name Panel Members Summary of the Guidelines Updates Clinical Presentation and Preliminary Workup (ME-1) Stage 0 (in situ), Stage I-II (ME-2) Stage III (ME-3) Stage III in-transit (ME-4) Stage IV (ME-5) Follow-up (ME-6) Persistent disease or True local scar recurrence, In-transit recurrence (ME-7) Nodal recurrence (ME-8) Distant metastatic disease (ME-9) Principles of Biopsy and Pathology (ME-A) Principles of Surgical Margins for Wide Excision of Primary Melanoma (ME-B) Principles of Complete Lymph Node Dissection (ME-C) Principles of Radiation Therapy (ME-D) Systemic Therapy Options for Advanced or Metastatic Melanoma (ME-E) Staging (ST-1) Clinical Trials: Categories of Evidence and Consensus: NCCN All recommendations are Category 2A unless otherwise specified. The believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. NCCN To find clinical trials online at NCCN member institutions, click here: nccn.org/clinical_trials/physician.html See NCCN Categories of Evidence and Consensus 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. ©2010. NCCN Guidelines™ Version 1.2011 Table of Contents Melanoma NCCN Guidelines for Patients™ available at www.nccn.com Printed by z z on 1/10/2011 2:16:45 AM. For personal use only. Not approved for distribution. Copyright © 2011 National Comprehensive Cancer Network, Inc., All Rights Reserved. Version 1.2011, 10/13/10 © National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®. NCCN Guidelines Index Melanoma Table of Contents Discussion UPDATES (1 of 2) NCCN Guidelines™ Version 1.2011 Updates Melanoma Updates in Version 1.2011 of the NCCN Guidelines from Version 1.2010 include:Melanoma ME-1 ME-2 ME-3 � � � � � � � Pathology report: “Mitotic rate” changed to “Dermal mitotic rate”. “Satellitosis, if present...” changed to “ satellitosis, if present...” “Pure desmoplasia if present” was added. Footnote “d”: “Clark level IV” was added as an adverse feature. “younger age” was removed as an adverse feature. Clinical Stage: Stage 0 in situ or Stage IA: “no ulceration” was added. (Also for Stage IA) Stage IA: Clarified as “Stage IA with adverse features”. Workup: Under Stage IA: The statement, “Imaging only to evaluate specific signs or symptoms” was removed from the algorithm and became footnote “e”. Footnote “h”: “ Footnote “k” was clarified as “ interferon has been associated with improved DFS, but its impact on overall survival is unclear”. Workup for all stages: “Consider baseline imaging for staging...” changed from category 2B to category 2A. � � � � � � Micro one or more Adjuvant For lower risk patients, such as IA and IB lesions 0.5mm thick and mitotic rate < 2 per mm , SLNB should generally not be recommended, unless there are specific clinical indications (category 2B),” is new to the algorithm. Stage II (clinically positive nodes): The recommendation changed to “Consider RT to nodal basin if Stage IIIC with multiple nodes involved or extranodal extension”. Footnote “l” was revised. � � � 2 macroscopic ME-5 ME-6 ME-9 � � � � � Workup: Third bullet regarding imaging changed from “Encourage chest/abdominal/pelvic CT, MRI brain, and/or PET as clinically indicated (category 2B)” to “Encourage chest/abdominal/pelvic CT, MRI brain, and/or PET ”. Footnote “p” that states, “Obtain tissue for genetic analysis if relevant to eligibility for participation in a clinical trial” is new to the algorithm. Stage IIB-IV, NED; Third bullet: Changed to “Consider chest x-ray, CT and/or PET-CT scans to screen...” Routine “lab testing/radiologic imaging...” changed to “Routine radiologic imaging...” Footnote “q” was revised and the following statement was added, “Routine blood tests are not recommended.” Workup; Third bullet: “as clinically indicated” changed to “...for baseline imaging and to evaluate specific signs or symptoms” Limited; Resect pathway: “Interferon alfa (category 2B)” was removed as an option. Disseminated; With brain metastases pathway: Recommendations changed to “ for baseline imaging and to evaluate specific signs and symptoms every 6-12 mo � � � Consider resection /or radiation for asymptomatic patients or Consider palliative resection /or radiation for symptomatic patients Best supportive care”. and and or Global Changes: Principles of Radiation Therapy i� s a new page that provides specific recommendations and dosing for radiation therapy throughout the Melanoma Guidelines .(ME-D) Printed by z z on 1/10/2011 2:16:45 AM. For personal use only. Not approved for distribution. Copyright © 2011 National Comprehensive Cancer Network, Inc., All Rights Reserved. Version 1.2011, 10/13/10 © National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®. NCCN Guidelines Index Melanoma Table of Contents Discussion UPDATES (2 of 2) NCCN Guidelines™ Version 1.2011 Updates Melanoma Updates in Version 1.2011 of the Melanoma NCCN Guidelines from Version 1.2010 include: ME-A ME-B ME-E Principles of Biopsy and Pathology Page title changed to Principles of Biopsy . Principles of Pathology section Second bullet: After Clark level “(encouraged for lesions 1 mm, optional for lesions > 1 mm)” was added. “After peripheral and deep margin status”, “positive or negative)” was added. Principles of Surgical Margins for Wide Excision of Primary Melanoma � � � � � � � and Pathology � � � � � � Fourth bullet: “Pure desmoplasia, if present (specify pure vs. mixed)” was added. New bullet was added “Consider use of fluorescent in situ hybridization (FISH) for histologically equivocol lesions” Footnote “3” that states, “Mitotic rate should be determined using the “hot spot” technique and expressed as number of mitoses per square millimeter” is new to the page. Footnote “1”: The following sentence was added “For selected patients with positive margins after optimal surgery, consider topical imiquimod or RT (category 2B)”. Footnote “2”: “Clinical margins do not need to correlate with final histologic margins” changed to “Excision recommendations are based on clinical margins taken at the time of surgery and not gross or histologic margins, as measured by the pathologist (category 1)”. Systemic Therapy Options for Advanced or Metastatic Melanoma Footnote “2” was revised to read “High-dose Interleukin-2 should not be used for patients with untreated or active brain metastases. ”. Footnote “3” was revised to read: “ multiagent regimens and associated with significant toxicities. Therapy should be restricted to an institution with medical staff experienced in the administration and management of regimens. inadequate organ reserve, poor performance status, or For patients with small brain metastases and without significant peritumoral edema, IL-2 therapy may be considered (category 2B) Administration of and high-dose interleukin-2 is complex these Printed by z z on 1/10/2011 2:16:45 AM. For personal use only. Not approved for distribution. Copyright © 2011 National Comprehensive Cancer Network, Inc., All Rights Reserved. Version 1.2011, 10/13/10 © National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®. NCCN Guidelines Index Melanoma Table of Contents Discussion 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 NCCN Guidelines™ Version 1.2011 Melanoma Breslow thickness + Ulceration status + Assess deep and peripheral margin status + Microsatellitosis, if present, should be reported + Dermal mitotic rate + Clark level (for lesions 1 mm) + Pure desmoplasia if present � a 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 b c 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. dAdverse features include 0.75 mm thick, positive deep margins, lymphovascular invasion (LVI), or Clark level IV.� See Principles of Biopsy and Pathology (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-5) CLINICAL PRESENTATION PATHOLOGY REPORT PRELIMINARY WORKUP Stage III (ME-3) and (ME-4) CLINICAL STAGE Stage 0 in situ or Stage IA ( 1 mm thick, no ulceration, mitotic rate < 1 per mm ) with no adverse features (ME-2) � 2 d Stage IA ( 1 mm thick, no ulceration, mitotic rate < 1 per mm ) with one or more adverse features (ME-2) � 2 d Printed by z z on 1/10/2011 2:16:45 AM. For personal use only. Not approved for distribution. Copyright © 2011 National Comprehensive Cancer Network, Inc., All Rights Reserved. Version 1.2011, 10/13/10 © National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®. NCCN Guidelines Index Melanoma Table of Contents Discussion 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-2 NCCN Guidelines™ Version 1.2011 Melanoma d f Adverse features include 0.75 mm thick, positive deep margins, lymphovascular invasion (LVI), or Clark Level IV. Imaging only to evaluate specific signs or symptoms (CT scan, PET, MRI). Decision not to perform SLNB may be based on significant patient comorbidities, patient preference or other factors. � e gSentinel node biopsy is an important staging tool, but the impact of SLNB on overall survival is unclear. Wide excision (category 1) with sentinel node biopsy i j Sentinel node negative Sentinel node positive See Stage III Workup and Primary Treatment (ME-3) Wide excisioni Wide excision (category 1) i Wide excision (category 1) with sentinel node biopsy i j WORKUP PRIMARY TREATMENT � � � H&P Stage IB, IIA: Routine imaging not recommended Stage IIB-IIC: Chest x-ray (optional); routine imaging not recommended Further imaging as clinically indicated � � � e (CT scan, PET, MRI) only See Stage III Workup and Primary Treatment (ME-3) Sentinel node negative Sentinel node positive ADJUVANT TREATMENT Discuss and offer sentinel node biopsyf,g,h See Follow-Up (ME-6) If Stage IB, IIA: Clinical trial or Observation If Stage IIB, IIC: Clinical trial or Interferon alfa (category 2B) Observation or k CLINICAL STAGE H&P Routine imaging not recommendede Consider sentinel node biopsyf,g,h See Follow-Up (ME-6) Wide excision (category 1) i Stage 0 in situ or Stage IA ( 1 mm thick, no ulceration, mitotic rate < 1 per mm ) with no adverse features � 2 d Stage IA ( 1 mm thick, no ulceration, mitotic rate < 1 per mm ) with one or more 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 h 2 k For lower risk patients, such as IA and IB lesions 0.5mm thick and mitotic rate < 2 per mm , SLNB should generally not be recommended, unless there are specific clinical indications. (category 2B). . Sentinel lymph nodes should be evaluated with multiple sectioning and immunohistochemistry. Adjuvant interferon has been associated with improved DFS, but its impact on overall survival is unclear. � i j See Principles of Surgical Margins for Wide Excision of Primary Melanoma (ME-B) Printed by z z on 1/10/2011 2:16:45 AM. For personal use only. Not approved for distribution. Copyright © 2011 National Comprehensive Cancer Network, Inc., All Rights Reserved. Version 1.2011, 10/13/10 © National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®. NCCN Guidelines Index Melanoma Table of Contents Discussion 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-3 NCCN Guidelines™ Version 1.2011 Melanoma Stage III (Clinically positive node(s)) Clinical trial or and/or Consider RT to nodal basin if Stage IIIC with multiple nodes involved or macroscopic extranodal extension or Observation ( )Interferon alfa category 2Bk n (See Follow-up ME-6) i k l n jSentinel lymph nodes should be evaluated with multiple sectioning and immunohistochemistry. Adjuvant interferon has been associated with improved DFS, but its impact on overall survival is unclear. Clinical trials assessing alternatives to complete lymph node dissection, such as careful observation with nodal basin ultrasound. m See Principles of Surgical Margins for Wide Excision of Primary Melanoma (ME-B) See Principles of Radiation Therapy (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 (Chest x-ray, CT ± PET, MRI) Pelvic CT if inguinofemoral nodes positive 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 (Chest x-ray, CT ± PET, MRI) Clinical trial or k mLymph node dissection Clinical trial or Observation or Interferon alfa ( )k category 2B Wide excision of primary tumor (category 1) + complete lymph node dissection i h Printed by z z on 1/10/2011 2:16:45 AM. For personal use only. Not approved for distribution. Copyright © 2011 National Comprehensive Cancer Network, Inc., All Rights Reserved. Version 1.2011, 10/13/10 © National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®. NCCN Guidelines Index Melanoma Table of Contents Discussion 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 NCCN Guidelines™ Version 1.2011 Melanoma Complete surgical excision to clear margins, if feasible (category 2B) Consider sentinel node biopsy for resectable in-transit disease preferred, (category 2B) or j 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 (