2010NCCN肛管癌治疗指南

Continue NCCN Clinical Practice Guidelines in Oncology™ Anal Carcinoma V.1.2010 www.nccn.org Version 1.2010, 10/20/09 © 2009 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.1.2010 Guidelines Index Anal Carcinoma Table of Contents Staging, Discussion, ReferencesNCCN ® NCCN Anal Carcinoma Panel Members Continue Anal Carcinoma † Medical Oncology ¶ Surgery/Surgical oncology Pathology ‡ Hematology/Hematology Oncology Þ Internal medicine § Radiotherapy/Radiation oncology *Writing Committee Member � ¤ Gastroenterology ф Diagnostic/Interventional Radiology * David P. Ryan, MD ¤ Massachusetts General Hospital Cancer Center Leonard Saltz, MD † ‡ Þ Memorial Sloan-Kettering Cancer Center David Shibata, MD ¶ H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida The University of Texas M. D. Anderson Cancer Center William Small, Jr., MD § Robert H. Lurie Comprehensive Cancer Center of Northwestern University Constantinos Sofocleous, MD, PhD Memorial Sloan-Kettering Cancer Center James Thomas, MD ‡ Arthur G. James Cancer Hospital & Richard J. Solove Research Institute at The Ohio State University UCSF Helen Diller Family Comprehensive Cancer Center Christopher Willett, MD § Duke Comprehensive Cancer Center John M. Skibber, MD ¶ Alan P. Venook, MD † ‡ ф Peter C. Enzinger, MD † Dana-Farber/Brigham and Women’s Cancer Center Marwan G. Fakih, MD † Roswell Park Cancer Institute James Fleshman, Jr., MD ¶ Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine Charles Fuchs, MD † Dana-Farber/Brigham and Women's Cancer Center Jean L. Grem, MD † UNMC Eppley Cancer Center at The Nebraska Medical Center James A. Knol, MD ¶ University of Michigan Comprehensive Cancer Center Lucille A. Leong, MD † City of Hope Comprehensive Cancer Center Edward Lin, MD † Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Mary F. Mulcahy, MD ‡ Robert H. Lurie Comprehensive Cancer Center of Northwestern University Eric Rohren, MD, PhD ф The University of Texas M. D. Anderson Cancer Center Paul F. Engstrom, MD/Chair † Fox Chase Cancer Center ¶ † † † UCSF Helen Diller Family Comprehensive Cancer Center Yi-Jen Chen, MD, PhD § City of Hope Comprehensive Cancer Center ¶ Comprehensive Cancer Center at ¶ Dayna S. Early, MD ¤ Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine Juan Pablo Arnoletti, MD University of Alabama at Birmingham Comprehensive Cancer Center Al B. Benson, III, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern University Jordan D. Berlin, MD Vanderbilt-Ingram Cancer Center J. Michael Berry, MD Michael A. Choti, MD The Sidney Kimmel Johns Hopkins Harry S. Cooper, MD Fox Chase Cancer Center Raza A. Dilawari, MD St. Jude Children's Research Hospital/University of Tennessee Cancer Institute � * NCCN Guidelines Panel Disclosures * Version 1.2010, 10/20/09 © 2009 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.1.2010 Guidelines Index Anal Carcinoma Table of Contents Staging, Discussion, ReferencesNCCN ® 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. ©2009. Table of Contents NCCN Anal Carcinoma Panel Members Summary of the Guidelines Updates Workup and Treatment - Anal canal cancer (ANAL-1) Workup and Treatment - Anal margin lesions (ANAL-2) Follow-up Therapy and Surveillance (ANAL-3) Principles of Chemotherapy (ANAL-A) Principles of Radiation Therapy (ANAL-B) Print the Anal Carcinoma Guideline Guidelines Index 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 Anal Carcinoma Version 1.2010, 10/20/09 © 2009 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.1.2010 Guidelines Index Anal Carcinoma Table of Contents Staging, Discussion, ReferencesNCCN ® Summary of the Guidelines updates UPDATES Summary of changes in the 1.2010 version of the Anal Carcinoma Guidelines from the 2.2009 version include: The recommendation for PET-CT scan was changed to “consider” in the workup section. Footnote “b” is new to the page: “PET-CT scan does not replace a diagnostic CT. The routine use of a PET-CT scan for staging or treatment planning has not been validated.” Metastatic disease was added with suggested treatment recommendations.� � ANAL-1 ANAL-2 � � Metastatic disease was added with suggested treatment recommendations. Principles of Radiation Therapy is a new page. ANAL-B Anal Carcinoma Version 1.2010, 10/20/09 © 2009 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.1.2010 Guidelines Index Anal Carcinoma 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. Anal canal cancer Biopsy: squamous cell carcinomaa � � � � � � � � Digital rectal examination (DRE) Inguinal lymph node evaluation Biopsy or FNA if suspicious nodes Anoscopy Abdominal/pelvic CT or MRI Consider HIV testing + CD4 level if indicated Gynecological exam for women, including screening for cervical cancer Consider PET-CT scan � Chest x-ray or Chest CT b WORKUP CLINICAL STAGE PRIMARY TREATMENT a c d For melanoma histology, see the , for adenocarcinoma, see the PET-CT scan does not replace a diagnostic CT. The routine use of a PET-CT scan for staging or treatment planning has not been validated. Ajani JA, Winter KA, Gunderson LL, et al. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. In a randomized trial, the strategy of using neoadjuvant therapy with 5-FU + cisplatin followed by concurrent therapy with 5-FU + cisplatin + RT was not superior to 5-FU + mitomycin + RT. Re-evaluate at 45 Gy, if persistent disease, consider increasing to 55-59 Gy. Include bilateral inguinal/low pelvic nodal regions based upon estimated risk of inguinal involvement. . b e f gPatients with anal cancer as the first manifestation of HIV/AIDS, may be treated with the same regimen as non-HIV patient. Patients with active HIV/AIDS-related complications or a history of complications (eg, malignancies, opportunistic infections) may not tolerate full-dose therapy or may not tolerate mitomycin and require dosage adjustment or treatment without mitomycin. Cisplatin/5-fluorouracil recommended for metastatic disease. If this regimen fails, no other regimens have shown to be effective.h NCCN Melanoma Guidelines NCCN Rectal Cancer Guidelines See Principles of Radiation Therapy ANAL-B. See Principles of Chemotherapy ANAL-A. See Principles of Chemotherapy ANAL-A. T1-2, N0 Mitomycin/5-FU +c RT (45 -59 Gy)d e See Follow-up Therapy and Surveillance (ANAL-3) T3-T4, N0 or Any T, N+ Mitomycin/5-FU + RT (55-59 Gy) c d f,g CLINICAL PRESENTATION ANAL-1 See Follow-up Therapy and Surveillance (ANAL-3) Anal Canal Cancer Metastatic disease Cisplatin-based chemotherapyh Version 1.2010, 10/20/09 © 2009 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.1.2010 Guidelines Index Anal Carcinoma Table of Contents Staging, Discussion, ReferencesNCCN ® ANAL-2 WORKUP CLINICAL STAGE PRIMARY TREATMENT Re-excision (preferred) or Consider local RT ± 5-FU-based chemotherapy d c Local excision CLINICAL PRESENTATION Adequate margins Observe Inadequate margins Anal margin lesion � � � � � � � Digital rectal examination (DRE) Inguinal lymph node evaluation Biopsy or FNA if suspicious nodes Chest x-ray or Chest CT Anoscopy Abdominal/pelvic CT or MRI Consider HIV testing + CD4 level if indicated Gynecological exam for women, including screening for cervical cancer � 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. T1, N0 Well differentiated T2-T4, N0 or Any T, N+ a c d h For melanoma histology, see the , for adenocarcinoma, see the Ajani JA, Winter KA, Gunderson LL, et al. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. JAMA 2008;299:1914. The strategy of using neoadjuvant therapy with 5-FU + cisplatin followed by concurrent therapy with 5-FU + cisplatin + RT was not superior to 5-FU + mitomycin + RT. Re-evaluate at 45 Gy, if persistent disease, consider increasing to 55-59 Gy. Include bilateral inguinal/low pelvic nodal regions based upon estimated risk of inguinal involvement. Patients with anal cancer as the first manifestation of HIV/AIDS, may be treated with the same regimen as non-HIV patient. Patients with active HIV/AIDS-related complications or a history of complications (eg, malignancies, opportunistic infections) may not tolerate full-dose therapy or may not tolerate mitomycin and require dosage adjustment or treatment without mitomycin. Cisplatin/5-fluorouracil recommended for metastatic disease. If this regimen fails, no other regimens have shown to be effective. . e f g NCCN Melanoma Guidelines NCCN Rectal Cancer Guidelines See Principles of Chemotherapy ANAL-A. See Principles of Radiation Therapy ANAL-B. See Principles of Chemotherapy ANAL-A. Mitomycin/5-FU + RT (55-59 Gy) c d f,g See Follow-up Therapy and Surveillance (ANAL-3) Biopsy: squamous cell carcinomaa Anal Margin Cancer Metastatic disease Cisplatin-based chemotherapyh Version 1.2010, 10/20/09 © 2009 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.1.2010 Guidelines Index Anal Carcinoma 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. SURVEILLANCE LOCALLY RECURRENT/METASTATIC DISEASE Complete remission Biopsy proven persistent disease Evaluate in 8-12 weeks with exam + DRE Biopsy only if clinical evidence of persistent disease after serial exams i FOLLOW-UP hCisplatin/5-fluorouracil recommended for metastatic disease. If this regimen fails, no other regimens have shown to be effective. i k If patient with an initially tethered tumor returns 6 weeks postop RT with a mobile but suspicious mass, consider biopsy. Consider muscle flap reconstruction. There is no evidence supporting resection of metastatic disease. j See Principles of Chemotherapy ANAL-A. APR + groin dissection, if positive inguinal nodes jLocal recurrence Distant metastasisk Cisplatin-based chemotherapy or Clinical trial h Every 3-6 mo for 5 y DRE Anoscopy Inguinal node palpation T3-T4 or inguinal node positive - consider chest x-ray, pelvic CT annually for 3 y � � � Progressive disease Biopsy proven Abdominoperineal resection (APR)j Reevaluate in 4 wks Serial exams No regression Progression � � Regression on serial exams Continue observation and reevaluate in 3 mo ANAL-3 Inguinal node recurrence � � Groin dissection Consider RT, if no prior RT to groin ± chemo Every 3-6 mo for 5 y Inguinal node palpation CT scan annually � � Every 3-6 mo for 5 y Inguinal node palpation CT scan annually � � Restage Anal Carcinoma Locally recurrent Metastatic disease 5-FU/Cisplatinh Version 1.2010, 10/20/09 © 2009 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.1.2010 Guidelines Index Anal Carcinoma Table of Contents Staging, Discussion, ReferencesNCCN ® ANAL-A Anal Carcinoma 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. PRINCIPLES OF CHEMOTHERAPY Localized cancer Metastatic Cancer 5-FU + Mitomycin + RT 5-FU 1000 mg/m /d IV days 1-4 and 29-32 Mitomycin 10 mg/m IV bolus days 1 and 29 Concurrent radiotherapy 1.8 Gy/d for 5 weeks to 45 Gy 5-FU + Cisplatin 5-FU 1000 mg/m /d IV days 1-5 Cisplatin 100 mg/m IV day 2 Repeat every 4 weeks 1,2 3 2 2 2 2 1 2 Ajani JA, Winter KA, Gunderson LL, et al. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. JAMA 2008;299:1914-1921. Flam M, John M, Pajak TF, et al. Role of mitomycin in combination with fluorouracil and radiotherapy, and of salvage chemoradiation in the definitive nonsurgical treatment of epidermoid carcinoma of the anal canal: results of a phase III randomized intergroup study. J Clin Oncol 1996;14:2527 3Faivre C, Rougier P, Ducreux M, et al. 5-fluorouracil and cisplatin combination chemotherapy for metastatic squamous-cell anal cancer. Bull Cancer 1999;86:861-5. Version 1.2010, 10/20/09 © 2009 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.1.2010 Guidelines Index Anal Carcinoma Table of Contents Staging, Discussion, ReferencesNCCN ® ANAL-B 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. PRINCIPLES OF RADIATION THERAPY1 Anal Carcinoma � � � � � � � All patients should receive a minimum dose of 45 Gy in 25 fractions of 1.8 Gy over 5 weeks to the primary cancer with supervoltage radiation (photon energy of > 6 mV) using anteroposterior-posteroanterior (AP-PA) or multifield techniques. Initial radiation fields include the pelvis, anus, perineum, and inguinal nodes, with the superior field border at L5-S1 and the inferior border to include the anus with a minimum margin of 2.5 cm. around the anus and tumor. The lateral border of AP fields includes the lateral inguinal nodes as determined from bony landmarks or imaging (computed tomography), but lateral inguinal nodes are not routinely included in the PA fields to allow adequate sparing of the femoral heads. After a dose of 30.6 Gy in 17 fractions, the superior field extent is reduced to the bottom of the sacroiliac joints and an additional 14.4 Gy is given in 8 fractions (total dose of 45 Gy in 25 fractions/5weeks), with additional field reduction off node- negative inguinal nodes after 36 Gy. For patients treated with an AP-PA rather than 4-field technique, an anterior electron boost (matched to the PA exit field) is used to bring the lateral inguinal region to the minimum dose of 30.6 Gy. For patients with T3, T4, node-positive disease or patients with T2 residual disease after 45 Gy, the intent is usually to deliver an additional boost of 9 to 14 Gy in 1.8 to 2 Gy fractions (total dose of 54-59 Gy in 30-32 fractions over 6.0-7.5 weeks). The target volume for boost field 2 is the original primary tumor volume/node plus a 2- to 2.5 cm. margin. Treatment field options include a multifield photon approach (AP-PA plus paired laterals, PA + laterals, or other) or a direct perineal boost with electrons or photons with the patient in lithotomy position. Intensity modulated radiation therapy in addition to three dimensional conformal radiation therapy may be used in the treatment of patients with anal cancer. 1Ajani JA, Winter KA, Gunderson LL, et al. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal. JAMA 2008;299:1914-1921. Version 1.2010, 10/20/09 © 2009 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.1.2010 Guidelines Index Anal Carcinoma Table of Contents Staging, Discussion, ReferencesNCCN ® Staging Anal Canal Cancer Table 1 2002 American Joint Committee on Cancer (AJCC) Staging System for Anal Canal Cancer*† Primary Tumor (T) TX T0 Tis T1 T2 T3 T4 Regional Lymph Nodes (N) NX N0 N1 N2 N3 Distant Metastasis (M) MX M0 M1 Stage Grouping Histologic Grade (G) GX G1 G2 G3 G4 Primary tumor cannot be assessed No evidence of primary tumor Carcinoma in situ Tumor 2 cm or less in greatest dimension Tumor more than 2 cm but not more than 5 cm in greatest dimension Tumor more than 5 cm in greatest dimension Tumor of any size invades adjacent organ(s), e.g., vagina, urethra, bladder Regional lymph nodes cannot be assessed No regional lymph node metastasis Metastasis in perirectal lymph node(s) Metastasis in unilateral internal iliac and/or inguinal lymph node(s) Metastasis in perirectal and inguinal lymph nodes and/or bilateral internal iliac and/or inguinal lymph nodes Distant metastasis cannot be assessed No distant metastasis Distant metastasis Stage 0 Tis N0 M0 Stage I T1 N0 M0 Stage II T2 N0 M0 T3 N0 M0 Stage IIIA T1 N1 M0 T2 N1 M0 T3 N1 M0 T4 N0 M0 Stage IIIB T4 N1 M0 Any T N2 M0 Any T N3 M0 Stage IV Any T Any N M1 Grade cannot be assessed Well differentiated Moderately differentiated Poorly differentiated Undifferentiated *Used with the permission of the American Joint Committee on Canc