2011食管癌nccn指南

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NCCN Guidelines Index Esophageal Table of Contents Discussion

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines )

Esophageal and Esophagogastric Junction Cancers(Excluding the proximal 5cm of the stomach)Version 2.2011 IMPORTANT NOTE REGARDING LEUCOVORIN SHORTAGE, PLEASE SEE MS-25

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Version 2.2011, 05/13/11© National Comprehensive Cancer Network, Inc. 2011, 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 Version 2.2011 Panel Members Esophageal and Esophagogastric Junction Cancers* Jaffer A. Ajani, MD/Chair ¤The University of Texas MD Anderson Cancer Center James S. Barthel, MD¤Þ H. Lee Moffitt Cancer Center& Research Institute David J. Bentrem, MD¶ Robert H. Lurie Comprehensive Cancer Center of Northwestern University Thomas A. D’Amico, MD¶ Duke Cancer Institute Prajnan Das, MD, MS, MPH§ The University of Texas MD Anderson Cancer Center Crystal Denlinger, MD Fox Chase Cancer Center Charles S. Fuchs, MD, MPH Dana-Farber/Brigham and Women’s Cancer Center Hans Gerdes, MD¤Þ Memorial Sloan-Kettering Cancer Center Robert E. Glasgow, MD¶ Huntsman Cancer Institute at the University of Utah James A. Hayman, MD, MBA§ University of Michigan Comprehensive Cancer CenterNCCN Lauren Gallagher, RPh, PhD Nicole McMillian, MS Hema Sundar, PhD

NCCN Guidelines Index Esophageal Table of Contents Discussion

Wayne L. Hofstetter, MD¶ The University of Texas MD Anderson Cancer Center David H. Ilson, MD, PhD Þ Memorial Sloan-Kettering Cancer Center Rajesh N. Keswani, MD¤ Robert H. Lurie Comprehensive Cancer Center of Northwestern University Lawrence R. Kleinberg, MD§ The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins W. Michael Korn, MD UCSF Helen Diller Family Comprehensive Cancer Center A. Craig Lockhart, MD, MHS Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine Mary F. Mulcahy, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern University Mark B. Orringer, MD¶ University of Michigan Comprehensive Cancer Center Raymond U. Osarogiagbon, MD Þ St. Jude Children’s Research Hospital/ University of Tennessee Cancer Institute

James A. Posey, MD University of Alabama at Birmingham Comprehensive Cancer Center Aaron R. Sasson, MD¶ UNMC Eppley Cancer Center at The Nebraska Medical Center Walter J. Scott, MD¶ Fox Chase Cancer Center Stephen Shibata, MD City of Hope Comprehensive Cancer Center Vivian E. M. Strong, MD¶ Memorial Sloan-Kettering Cancer Center Thomas K. Varghese, Jr, MD¶ Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Graham Warren, MD, PhD Roswell Park

Cancer Institute Mary Kay Washington, MD, PhD¹ Vanderbilt-Ingram Cancer Center Christopher Willett, MD§ Duke Cancer Institute Cameron D. Wright, MD¶ Massachusetts General Hospital Medical oncology¤ Gastroenterology¶ Surgery/Surgical oncologyÞ Internal medicine§ Radiotherapy/Radiation oncology Hematology/Hematology oncology¹ Pathology *Writing committee member

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NCCN Guidelines Version 2.2011 Sub-Committees Esophageal and Esophagogastric Junction CancersPrinciples of Systemic Therapy Mary F. Mulcahy, MD /Lead Robert H. Lurie Comprehensive Cancer Center of Northwestern University

NCCN Guidelines Index Esophageal Table of Contents Discussion

Principles of Surgery Thomas A. D’Amico, MD¶/Lead Duke Cancer Institute Robert E. Glasgow, MD¶ Huntsman Cancer Institute at the University of Utah Wayne L. Hofstetter, MD¶ The University of Texas MD Anderson Cancer Center Mark B. Orringer, MD¶ University of Michigan Comprehensive Cancer Center Walter J. Scott, MD¶ Fox Chase Cancer Center Thomas K. Varghese, Jr, MD¶ Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Cameron D. Wright, MD¶ Massachusetts General Hospital¤ Gastroenterology¶ Surgery/Surgical oncologyÞ Internal medicine§ Radiotherapy/Radiation oncology Hematology/Hematology oncology *Writing committee member

Principles of Radiation Therapy Lawrence R. Kleinberg, MD§/Lead The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Prajnan Das, MD, MS, MPH§ The University of Texas MD Anderson Cancer Center James A. Hayman, MD, MBA§ University of Michigan Comprehensive Cancer Center Christopher Willett, MD§ Duke Cancer InstitutePrinciples of Pathologic Review and HER2-neu Testing Mary Kay Washington, MD, PhD¹ Vanderbilt-Ingram Cancer Center

Jaffer A. Ajani, MD/Chair ¤ The University of Texas MD Anderson Cancer Center Crystal Denlinger, MD Fox Chase Cancer Center David H. Ilson, MD, PhD Þ Memorial Sloan-Kettering Cancer Center A. Craig Lockhart, MD, MHS Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine Raymond U. Osarogiagbon, MD Þ St. Jude Children’s Research Hospital/ University of Tennessee Cancer InstitutePrinciples of Endoscopic Staging and Therapy Hans Gerdes, MD¤Þ/Lead Memorial Sloan-Kettering Cancer Center

Principles of Best Supportive Care James S. Barthel, MD¤Þ/Lead H. Lee Moffitt Cancer Center& Research Institute Hans Gerdes, MD¤Þ Memorial Sloan-Kettering Cancer Cen

ter James A. Hayman, MD, MBA§ University of Michigan Comprehensive Cancer Center Rajesh N. Keswani, MD¤ Robert H. Lurie Comprehensive Cancer Center of Northwestern University Mary F. Mulcahy, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern University

James S. Barthel, MD¤Þ H. Lee Moffitt Cancer Center& Research Institute Rajesh N. Keswani, MD¤ Robert H. Lurie Comprehensive Cancer Center of Northwestern University

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NCCN Guidelines Panel Disclosures

NCCN Guidelines Index NCCN Guidelines Version 2.2011 Table of Contents Esophageal Table of Contents Esophageal and Esophagogastric Junction Cancers Discussion

NCCN Esophageal Cancers Panel Members NCCN Esophageal Cancers Sub-Committee Members Summary of the Guidelines Updates Workup and Evaluation (ESOPH-1) Medically fit and Resectable disease (ESOPH-2) and (ESOPH-3) Surgical Outcomes For Patients Who Have Not Received Preoperative Therapy (ESOPH-4) Surgical Outcomes For Patients Who Have Received Preoperative Therapy (ESOPH-5) Medically Unfit for Surgery or Surgery Not Elected (ESOPH-6) Follow-up, Recurrence and Palliative Therapy (ESOPH-7) Metastatic Cancer (ESOPH-8) Principles of Endoscopic Staging and Therapy (ESOPH-A) Principles of Pathologic Review and HER2-neu Testing (ESOPH-B) Principles of Multidisciplinary Team Approach (ESOPH-C) Principles of Surgery (ESOPH-D) Principles of Systemic Therapy (ESOPH-E) Principles of Radiation Therapy (ESOPH-F) Principles of Best Supportive Care (ESOPH-G) Staging (ST-1)

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: /clinical_trials/physician.htmlNCCN Categories of Evidence and

Consensus: All recommendations are Category 2A unless otherwise specified. See NCCN Categories of Evidence and Consensus

The NCCN Guidelines TM for Esophageal and Esophagogastric Junction Cancers do not include the proximal 5cm of the stomach.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 applic

ation 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.©2011.Version 2.2011, 05/13/11© National Comprehensive Cancer Network, Inc. 2011, 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 Version 2.2011 Updates Esophageal and Esophagogastric Junction Cancers

NCCN Guidelines Index Esophageal Table of Contents Discussion

Updates in version 2.2011 of the Esophageal and Esophagogastric Junction Cancers Guidelines from version 1.2010 include: ESOPH-1· Workup:“Pelvic CT as clinically indicated” was added. ESOPH-4· Postoperative Treatment (for patients who have not received preoperative therapy):“Taxane-based chemoradiation” was removed as an option for treatment. ESOPH-5· Postoperative Treatment (for patients who have received preoperative therapy):“Taxane-based chemoradiation” was removed as an option for treatment. ESOPH-B 3 of 4: Principles of Pathologic Review and HER-2 Neu Testing· Statement above table changed to“For patients with inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or esophagogastric junction for whom trastuzumab therapy is being considered, assessment for tumor HER2-neu overexpression should be performed using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) is recommended as a confirmation method for tumors with 2+ expression by IHC.” ESOPH-E: Principles of Systemic Therapy· 2 of 14: A new section on“Sequential Chemotherapy and Chemoradiation” was added. The corresponding dosing schedule was also added (5 of 14).· 2 of 14 and 3 of 14: Statement added to footnote directing the user to the discussion section for more information regarding the leucovorin shortage.· 4 of 14 through 11 of 14: This section was revised extensively including modification of some dose schedules. MS-1· The discussion section was updated to reflect the changes in the algorithm. Updates in version 1.2011 of the Esophageal and Esophagogastric Junction Cancers Guidelines from version 2.2010 include: Global changes:· The algorithms and staging tables were updated to reflect the 7th edition (2010) of the AJCC Staging Manual (ST-1) and (ST-2).· The title of the Esophageal Cancer Guidelines was changed to include Esophagogastric Junction cancers to be consistent with the new 7th edition AJCC Staging.· Principles of Endoscopic Staging and Therapy (ESOPH-A) is a new page that provides specific endoscopic

recommendations for diagnosis, staging, treatment, and post-treatment surveillance for esophageal and esophagogastric junction cancers.· Principles of Pathologic Review and HER2-neu Testing (ESOPH-B) is a new page that provides specific recommendations for analysis/interpretation/reporting of pathology results, assessment of treatment response, and assessment of overexpression of HER2-neu. UPDATES Continue 1 of 3

NCCN Guidelines Version 2.2011 Updates Esophageal and Esophagogastric Junction Cancers

NCCN Guidelines Index Esophageal Table of Contents Discussion

ESOPH-1:· Workup: Esophagogastroduodenoscopy changed to“Upper GI endoscopy and biopsy”.>“HER2-neu testing if metastatic disease is documented/suspected” and“Assess Siewert category” are new bullets. ESOPH-2:· Tumor Classification: Tis is now a separate pathway.· Primary treatment options for medically fit patients> Tis includes now includes the option of“Endoscopic mucosal resection (EMR) or Ablation”.· T1a now has the option of“EMR and Ablation”.· T1b, Any N: The recommendation“Esophagectomy (preferred for non cervical T1b disease)” changed to“Esophagectomy for noncervical disease; Chemoradiation for cervical disease.· Footnotes k,n,p,s,v are new to the algorithm. ESOPH-3:· Response Assessment: Upper GI endoscopy was clarified as“Upper GI endoscopy and biopsy”. For patients who receive preoperative chemoradiation or definitive radiation,“Upper GI endoscopy and biopsy” is now recommended. Previously Upper GI endoscopy was listed as“optional”.· Footnote x was revised to state“Assessment³ 5-6 weeks...” ESOPH-4:· This is a new algorithm that provides surgical outcomes after esophagectomy/clinical pathologic findings and recommendations for patients who have not received preoperative therapy”. ESOPH-5:· Postoperative Treatment:> Taxane-based chemoradiation was added as an option in addition to fluoropyrmidine-based chemoradiation.> ECF modifications was added as a treatment option following R0 resection. ESOPH-6:· Primary treatment for medically unfit patients:> For Tis and T1a patients,“EMR or chemoradiation” were previously recommended as treatment options. These options have changed to the following: 7 Tis:“EMR or Ablation” is now recommended. 7 T1a:“EMR and Ablation” is now recommended.> For patients other than Tis or T1a: Taxane-based chemoradiation was added as an option in addition to fluoropyrmidine-based chemoradiation. ESOPH-7:· Follow-up:> H&P changed from“every

3-6 mo for 1-3 y, every 6 mo for 3-5 y...” to“every 3-6 mo for 1-2 y, every 6-12 mo for 3-5 y...> Fourth bullet changed to“Upper GI endoscopy and biopsy”.>“Confirm that HER2-neu testing has been done if metastatic disease was present at diagnosis” is a new bullet.· Palliative/salvage therapy for locoregional recurrence following prior esophagectomy:> Taxane-based chemoradiation was added as option in addition to fluoropyrimidine-based chemoradiation. Continue UPDATES 2 of 3 Version 2.2011, 05/13/11© National Comprehensive Cancer Network, Inc. 2011, 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 Version 2.2011 Updates Esophageal and Esophagogastric Junction Cancers

NCCN Guidelines Index Esophageal Table of Contents Discussion

ESOPH-C: Principles of Multidisciplinary Team Approach· Second bullet: Clarified as“Optimally at each meeting...”.“Palliative care specialist” was added as a supporting discipline. ESOPH-D: Principles of Surgery· This page was revised to reflect the 7th edition (2010) of the AJCC Staging Manual. ESOPH-E: Principles of Systemic Therapy· This page was extensively revised (including the addition/deletion of regimens and the addition of dosing schedules). ESOPH-F: Principles of Radiation Therapy· Simulation and treatment planning:> The following bullets were added: Lung dose guidelines and Intensity modulated radiation therapy (IMRT).· Dose: The radiation dose range changed from“50-50.4 Gy” to“45-50.4 Gy”. ESOPH-G Principles of Best Supportive Care· This page was extensively revised.

UPDATES 3 of 3

NCCN Guidelines Version 2.2011 Esophageal and Esophagogastric Junction CancersWORKUP CLINICAL STAGE ADDITIONAL EVALUATION (as clinically indicated)

NCCN Guidelines Index Esophageal Table of Contents Discussion See Primary Treatment (ESOPH-2) and (ESOPH-3)

Medically fit, g and resectable disease h Medically unfit for surgery or Surgery not elected and patient medically able to tolerate chemoradiation or Unresectable T4, i Medically unfit for surgery and patient unable to tolerate chemoradiation

nodal involvement in cancers of the esophagogastric junction may still be considered for combined modality therapy. Principles of Endoscopic Staging and Therapy (ESOP

H-A). e Resectable T4: involvement of pericardium, pleura or diaphragm. T1-T3 tumors b See Principles of Pathologic Review and HER2-neu Testing (ESOPH-B). c Siewert JR. Carcinoma of the Cardia: Carcinoma of the gastroesophageal junction are resectable even with regional nodal metastases (N+). f classification, pathology, and extent of resection. Dis Esophagus 1996;9:173-182 See Principles of Multidisciplinary Team Approach (ESOPH-C). g Medically able to tolerate major abdominal and/or thoracic surgery. and Rudiger Siewert J, Feith M, Werner M, Stein HJ. Adenocarcinoma of the h See Principles of Surgery (ESOPH-D). esophagogastric junction: results of surgical therapy based on i Unresectable T4: Involvement of the heart, great vessels, trachea or adjacent anatomical/topographic classification in 1,002 consecutive patients. Ann Surg 2000;232:353-361. organs including liver, pancreas, lung, and spleen are unresectable.a SeeNote: 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 2.2011, 05/13/11© National Comprehensive Cancer Network, Inc. 2011, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN®.

· H&P· Upper GI endoscopy and biopsy a· Chest/abdominal CT with oral and IV contrast· Pelvic CT as clinically indicated· PET evaluation preferred if no evidence of M1 disease (PET-CT preferred over PET scan)· CBC and chemistry profile· Endoscopic ultrasound (EUS), if no evidence of M1 disease, with FNA if indicated· Bronchoscopy, if tumor is at or above the carina with no evidence of M1 disease· Laparoscopy (optional) if no evidence of M1 disease and tumor is at GE junction· Biopsy confirmation of suspected metastatic disease· HER2-neu testing if metastatic disease is documented/suspected b· Assess Siewert category c

Stage I–III d,e (locoregional disease)

· Multidisciplinary evaluation f· Nutritional assessment (for preoperative nutritional support, consider nasogastric or J-tube[PEG is not recommended])

See Primary Treatment (ESOPH-6)

See Primary Treatment (ESOPH-6) See Palliative Therapy (ESOPH-8)

Stage IV (metastatic disease)

d Celiac

ESOPH-1

NCCN Guidelines Version 2.2011 Esophageal and Esophagogastric Junction CancersTUMOR CLASSIFICATION j Tis k T1a l

NCCN Guidelines Index Esophageal Table of Contents Discussion

PRIMARY TREATMENT OPTIONS FOR MEDICALLY FIT PATIENTS Endoscopic mucosal resection Periodic endoscopic (EMR) o or Ablation p surveillance EMR o and ablation p See ESOPH-A (3 of 4) Esophagectomy h Esophagectomy h,q,r (for noncervical cancer)

s Chemoradiation t,u (for cervical cancer) Preoperative chemoradiation t,u,v (RT, 45-50.4 Gy+ concurrent chemotherapy) See Response Assessment (ESOPH-3) See Surgical Outcomes After Esophagectomy (ESOPH-4)

Medically resectable disease

fit, g and

T1b,m Any N Multidisciplinary evaluation preferred f

T2e

or higher, Any (regional) N n

Definitive chemoradiation t,u,w (Preferred for cervical cancer)

e Resectable

T4: involvement of pericardium, pleura or diaphragm. T1-T3 tumors are resectable even with regional nodal metastases (N+). f See Principles of Multidisciplinary Team Approach (ESOPH-C). g Medically able to tolerate major abdominal and/or thoracic surgery. h See Principles of Surgery (ESOPH-D). j See Staging (ST-1). k Tis: Defined as high-grade dysplasia or carcinoma in situ. l T1a: Defined as tumors involving the mucosa, but not invading the submucosa. m T1b: Tumors invading the submucosa. n Preclinical staging cannot establish the number of positive nodes. o May be applied to Tis or T1a, defined as tumor involving the mucosa, but not invading the submucosa. p Ablation may not be needed for squamous cell lesions that are completely excised. See Principles of Endoscopic Staging and Therapy (ESOPH-A)

Preoperative chemotherapy t for adenocarcinoma of distal esophagus or EGJ See Surgical Outcomes After Esophagectomy h Esophagectomy (ESOPH-4)

q Transhiatal r Feeding

or transthoracic, or minimally invasive; gastric reconstruction preferred. jejunostomy for postoperative nutritional support, generally preferred. s Surgery is preferred for noncervical cancer, but if the patient declines surgery See Primary Treatment for Patients Medically Unfit For Surgery pathway (ESOPH-6). t See Principles of Systemic Therapy (ESOPH-E). u See Principles of Radiation Therapy (ESOPH-F). v Preoperative chemoradiation (category 1) is preferred over preoperative chemotherapy for EGJ. (Gaast AV, van Hagen P, Hulshof M, et al. Effect of preoperative concurrent chemoradiotherapy on survival of patients with resectable esophageal or esophagogastric junction cancer: Results from a multicenter randomized phase III study. J Clin Oncol (Meeting Abstracts). 2010;28:4004-.) w Surgery is preferred for adenocarcinomas. Chemoradiation can be considered for squamous cell 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.Version 2.2011, 05/13/11© National Comprehensive Cancer Network, Inc. 2011, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN®.

ESOPH-2

NCCN Guidelines Version 2.2011 Esophageal an

d Esophagogastric Junction CancersPRIMARY TREATMENT FOR MEDICALLY FIT PATIENTS RESPONSE ASSESSMENT OUTCOME No evidence of disease· CT scan with contrast (not required if PET-CT is done)· PET-CT or PET x (category 2B)· Upper GI endoscopy and biopsy y

NCCN Guidelines Index Esophageal Table of Contents Discussion See Surgical Outcomes After Esophagectomy (ESOPH-5) See Surgical Outcomes After Esophagectomy (ESOPH-5)

ADJUVANT TREATMENT Esophagectomy h,q (preferred) or Observe (category 2B) Esophagectomy h,q (preferred) or Palliative treatment, including chemotherapy t See Palliative Therapy (ESOPH-8) Observe

Preoperative chemoradiation t,u,v (RT, 45-50.4 Gy+ concurrent chemotherapy)

Persistent local disease Unresectable or Metastatic disease

Definitive chemoradiation t,u,w (Preferred for cervical cancer) Preoperative chemotherapy t for adenocarcinoma of distal esophagus or EGJh See

· CT scan with contrast (not required if PET-CT is done)· PET-CT or PET x (category 2B)· Upper GI endoscopy and biopsyy

No evidence of disease Persistent local disease New metastatic disease

Follow-up (See ESOPH-7)Salvage esophagectomy h See Palliative Therapy (ESOPH-8) Esophagectomy h

See Surgical Outcomes After Esophagectomy (ESOPH-5)

Principles of Surgery (ESOPH-D). or transthoracic, or minimally invasive; gastric reconstruction preferred. t See Principles of Systemic Therapy (ESOPH-E). u See Principles of Radiation Therapy (ESOPH-F). w Surgery is preferred for adenocarcinomas. Chemoradiation can be considered for v Preoperative chemoradiation (category 1) is preferred over preoperative squamous cell carcinoma. chemotherapy for EGJ. (Gaast AV, van Hagen P, Hulshof M, et al. Effect of x Assessment³ 5-6 weeks after completion of preoperative therapy. preoperative concurrent chemoradiotherapy on survival of patients with resectable y See Post-Treatment Surveillance--Principles of Endoscopic Staging and Therapy esophageal or esophagogastric junction cancer: Results from a multicenter (ESOPH-A 3 of 4). randomized phase III study. J Clin Oncol (Meeting Abstracts). 2010;28:4004-.)q TranshiatalNote: 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 2.2011, 05/13/11© National Comprehensive Cancer Network, Inc. 2011, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN®.

Follow-up (See ESOPH-7) ESOPH-3

NCCN Guidelines Version 2.2011 Esophageal and Esophagogastric Junction CancersSURGICAL OUTCOMES AFTER ESOPHAGECTOMY/CLINICAL PATHOLOGIC FINDINGS (For Patients Who Have Not Received Preoper

ative Therapy) TUMOR CLASSIFICATION j Tis k T1, N0 Observe

NCCN Guidelines Index Esophageal Table of Contents Discussion

POSTOPERATIVE TREATMENT

AdenocarcinomaNode negative

T2, N0 Observe or Chemoradiation t,u (Fluoropyrimidine-based) Observe Observe or Chemoradiation (preferred) t,u (Fluoropyrimidine-based) Chemoradiation t,u (Fluoropyrimidine-based) Chemoradiation t,u (Fluoropyrimidine-based) Chemoradiation t,u (Fluoropyrimidine-based) or Palliative therapy (See ESOPH-8)

T3, N0 Squamous cell carcinoma

R0 resection z

Node positive

Adenocarcinoma of proximal or mid esophagus Adenocarcinoma of distal esophagus or EGJ

R1 resection z

R2 resection zj See

Staging (ST-1). Defined as high-grade dysplasia or carcinoma in situ. t See Principles of Systemic Therapy (ESOPH-E). u See Principles of Radiation Therapy (ESOPH-F). z R0= No cancer at resection margins, R1= Microscopic residual cancer, R2= Macroscopic residual cancer or M1B.k Tis: 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 2.2011, 05/13/11© National Comprehensive Cancer Network, Inc. 2011, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN®.

Follow-up (See ESOPH-7) ESOPH-4

NCCN Guidelines Version 2.2011 Esophageal and Esophagogastric Junction CancersSURGICAL OUTCOMES AFTER ESOPHAGECTOMY/CLINICAL PATHOLOGIC FINDINGS (For Patients Who Have Received Preoperative Therapy) TUMOR CLASSIFICATION j T2, N0

NCCN Guidelines Index Esophageal Table of Contents Discussion

POSTOPERATIVE TREATMENT Observe or ECF or its modifications if received preoperatively (category 1) Observe or Chemoradiation t,u,aa (Fluoropyrimidine-based) or ECF or its modifications if received preoperatively (category 1)

AdenocarcinomaNode negative T3, N0

R0 resection z

Squamous cell carcinoma Node positive

Observe Observe or Chemoradiation (preferred) t,u,aa (Fluoropyrimidine-based) Chemoradiation t,u,aa (Fluoropyrimidine-based) or ECF or its modifications if received preoperatively (category 1) Chemoradiation t,u,aa (Fluoropyrimidine-based) Chemoradiation t,u,aa (Fluoropyrimidine-based) or Palliative therapy (See ESOPH-8)

Adenocarcinoma of proximal or mid esophagus Adenocarcinoma of distal esophagus or EGJ

R1 resection z R2 resection z

j See

Staging (ST-1). Principles of Systemic Therapy (ESOPH-E). u See Principles of Radiation Therapy (ESOPH-F). z R0= No cancer at resection margins, R1= Microscopic residual cancer, R2= Macroscopic residual cancer or M1B. aa Postoperative chemoradiation only if not received preoperatively.t SeeNote

: 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 2.2011, 05/13/11© National Comprehensive Cancer Network, Inc. 2011, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN®.

Follow-up (See ESOPH-7) ESOPH-5

NCCN Guidelines Version 2.2011 Esophageal and Esophagogastric Junction CancersPRIMARY TREATMENT FOR MEDICALLY UNFIT PATIENTS Tis k T1a l EMR or Ablation a EMR and Ablation a

NCCN Guidelines Index Esophageal Table of Contents Discussion

Medically unfit for surgery or Surgery not elected and patient medically able to tolerate chemotherapy or Unresectable T4, i

45-50.4 Gy of RT+ concurrent chemotherapy (Fluoropyrimidine- or taxane-based) (preferred) t,u or Chemotherapy t or RT or Best supportive care bb

Medically unfit for surgery and patient unable to tolerate chemotherapy

Palliative RT u or Best supportive care bb

a See k Tis:

Principles of Endoscopic Staging and Therapy (ESOPH-A). Defined as high-grade dysplasia or carcinoma in situ. i Unresectable T4: Involvement of the heart, great vessels, trachea or adjacent organs including liver, pancreas, lung, and spleen are unresectable. l T1a: Defined as tumors involving the mucosa, but not invading the submucosa. t See Principles of Systemic Therapy (ESOPH-E). u See Principles of Radiation Therapy (ESOPH-F). bb See Principles of Best Supportive Care (ESOPH-G).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 2.2011, 05/13/11© National Comprehensive Cancer Network, Inc. 2011, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN®.

Follow-up (See ESOPH-7)

ESOPH-6

NCCN Guidelines Version 2.2011 Esophageal and Esophagogastric Junction CancersFOLLOW-UP RECURRENCE Concurrent chemoradiation t,u (Fluoropyrimidine- or taxane-based) preferred and/or Best supportive care bb or Surgery h or Chemotherapy t Esophagectomy h

NCCN Guidelines Index Esophageal Table of Contents Discussion

PALLIATIVE/SALVAGE THERAPY

· H&P> If asymptomatic: H&P every 3-6 mo for 1-2 y, every 6-12 mo for 3-5 y, then annually· Chemistry profile and CBC, as clinically indicated· Imaging

as clinically indicated· Upper GI endoscopy and biopsy as clinically indicated y· Dilatation for anastomotic stenosis· Nutritional counseling· Confirm that HER2-neu testing has been done if metastatic disease was present at diagnosis a

Local/regional only recurrence: Prior esophagectomy, no prior chemoradiation

Recurrence

See Palliative Therapy (ESOPH-8)

Resectable h and medically operable Local/regional only recurrence (Prior chemoradiation, no prior esophagectomy)

Recurrence

See Palliative Therapy (ESOPH-8)

Unresectable or Medically inoperable

See Palliative Therapy (ESOPH-8)

Metastatic diseasea Seeh See

Principles of Pathologic Review and HER2-neu Testing (ESOPH-B). Principles of Surgery (ESOPH-D). t See Principles of Systemic Therapy (ESOPH-E). u See Principles of Radiation Therapy (ESOPH-F). y See Post-Treatment Surveillance--Principles of Endoscopic Staging and Therapy (ESOPH-A 3 of 4). bb See Principles of Best Supportive Care (ESOPH-G).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 2.2011, 05/13/11© National Comprehensive Cancer Network, Inc. 2011, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN®.

ESOPH-7

NCCN Guidelines Version 2.2011 Esophageal and Esophagogastric Junction CancersPERFORMANCE STATUS

NCCN Guidelines Index Esophageal Table of Contents Discussion

PALLIATIVE THERAPY

Karnofsky performance score³ 60% or ECOG performance score£ 2

Chemotherapy t,cc and/or Best supportive care bb

Metastatic disease

Karnofsky performance score< 60% or ECOG performance score³ 3

Best supportive care bb

t See

Principles of Systemic Therapy (ESOPH-E). Principles of Best Supportive Care (ESOPH-G). cc Further treatment after two sequential regimens should be dependent upon performance status and availability of clinical trials.bb 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 2.2011, 05/13/11© National Comprehensive Cancer Network, Inc. 2011, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN®.

Back to Follow-up and Recurrence (ESOPH-7)

ESOPH-8

NCCN Guideline

s Version 2.2011 Esophageal and Esophagogastric Junction CancersPRINCIPLES OF ENDOSCOPIC STAGING AND THERAPY

NCCN Guidelines Index Esophageal Table of Contents Discussion

Endoscopy has become an important tool in the diagnosis, staging, treatment and surveillance of patients with esophageal cancer. Although some endoscopy procedures can be performed without anesthesia, most are performed with the aid of conscious sedation administered by the endoscopist or assisting nurse or deeper anesthesia (monitored anesthesia care) provided by the endoscopist, nurse, a nurse anesthetist, or an anesthesiologist. Some patients who are at risk of aspiration during endoscopy may require general anesthesia. DIAGNOSIS· Diagnostic and surveillance endoscopies are performed with the goal of determining the presence and location of esophageal cancer and to biopsy any suspicious lesions. Thus, an adequate endoscopic exam addresses both of these components.· The location of the tumor relative to the teeth and the esophago-gastric junction (EGJ), the length of the tumor, the extent of circumferential involvement, and degree of obstruction should be carefully recorded to assist with treatment planning. If present, the location, length and circumferential extent of Barrett's esophagus should be characterized in accordance with the Prague criteria, 1 and mucosal nodules should be carefully documented.· High-resolution endoscopic imaging and narrow-band imaging are presently available and may enhance visualization during endoscopy, with improved detection of lesions in Barrett's and non-Barrett's esophagus and stomach. 2· Multiple biopsies, six to eight, using standard size endoscopy forceps should be performed to provide sufficient material for histologic interpretation. Larger forceps are recommended during surveillance endoscopy of Barrett's esophagus for the detection of dysplasia. 3 Endoscopic mucosal resection (EMR) of focal nodules can be performed in the setting of early stage disease to provide accurate T-staging including degree of differentiation and vascular and or lymphatic invasion, with the potential of being therapeutic. 4· Cytologic brushings or washings are rarely adequate in the initial diagnosis, but can be useful in confirming persistent disease following treatment.

ContinueNote: 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 2.2011, 05/13/11© National Comprehensive Cancer Network, Inc. 2011, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN®.

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NCCN Guide

lines Version 2.2011 Esophageal and Esophagogastric Junction CancersPRINCIPLES OF ENDOSCOPIC STAGING AND THERAPY

NCCN Guidelines Index Esophageal Table of Contents Discussion

STAGING· Endoscopic ultrasound (EUS) performed prior to any treatment is important in the initial clinical staging of neoplastic disease. Careful attention to ultrasound images provides evidence of depth of tumor invasion (T-stage), presence of abnormal or enlarged lymph nodes likely to harbor cancer (N-stage), and occasionally signs of distant spread, such as lesions in surrounding organs (M-stage). 5· Hypoechoic (dark) expansion of the esophageal wall layers identifies the location of tumor, with gradual loss of the layered pattern of the normal esophageal wall corresponding with greater depths of tumor penetration, correlating with higher T-stages. A dark expansion of layers 1-3 correspond with infiltration of the superficial and deep mucosa plus the submucosal, T1 disease. A dark expansion of layers 1-4, correlates with penetration into the muscularis propria, T2 disease, and expansion beyond the smooth outer border of the muscularis propria correlates with invasion of the adventitia, T3 disease. Loss of a bright tissue plane between the area of tumor and surrounding structures such as the trachea, aorta, liver correlates with infiltration of tumor into surrounding organs (T4 disease).· Mediastinal and perigastric lymph nodes are readily seen by EUS, and the identification of enlarged, hypoechoic (dark), homogeneous, well circumscribed, rounded structures in these areas correlates with the presence of malignant or inflammatory lymph nodes. The accuracy of this diagnosis is significantly increased with the combination of features, but also confirmed with the use of fine needle aspiration (FNA) biopsy for cytology assessment. 6 FNA of suspicious lymph nodes should be performed if it can be performed without traversing an area of primary tumor or major blood vessels, and if it will impact on treatment decisions. The pre-procedure review of CT and PET scans, when available, prior to EGD/EUS, to become fully familiar with the nodal distribution for possible FNA is recommended.· Obstructing tumors may increase the risk of perforation while performing staging EUS exams. The use of wire guided EUS probes, or miniprobes, may permit EUS staging with a lower risk. In certain cases, dilating the malignant stricture to allow completion of staging may be appropriate but there is increased risk of perforation after dilation.

on of NCCN®.

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NCCN Guidelines Version 2.2011 Esophageal and Esophagogastric Junction CancersPRINCIPLES OF ENDOSCOPIC STAGING AND THERAPY

NCCN Guidelines Index Esophageal Table of Contents Discussion

TREATMENT:· The goal of EMR and/or ablation is the complete removal of all Barrett’s metaplasia in addition to eradication of early malignancy.· Early stage disease, Tis, also known as high grade dysplasia, needs to be fully characterized, including evaluating presence of nodularity, lateral spread and ruling out multifocal disease. This is important to permit decisions on endoscopic treatment with ablative methods such as radiofrequency ablation (RFA), cryoablation, photodynamic therapy (PDT) or EMR. 7-10 All focal nodules should be resected rather than ablated.· T1a disease, carcinoma limited to the lamina propria or muscularis mucosae, in the absence of evidence of lymph node metastases, lymphovascular invasion or poor differentiation grade can be treated with full EMR. EUS staging prior to proceeding with mucosal resection in the setting of carcinoma is recommended. Ablative therapy of residual flat Barrett's esophagus associated with Tis or T1a disease should be performed following mucosal resection.· Esophageal dilation can be performed with the use of dilating balloons or bougies to temporarily relieve obstruction from tumors, or treatment related strictures. Caution should be exercised to avoid overdilation, to minimize the risk of perforation.· Long-term palliation of dysphagia can be achieved with endoscopic tumor ablation by Nd:YAG Laser, PDT and cryotherapy, or endoscopic and radiographic assisted insertion of expandable metal or plastic stents. 11,12· Long-term palliation of anorexia, dysphagia or malnutrition may be achieved with endoscopic or radiographic assisted placement of feeding gastrostomy or jejunostomy. The placement of a gastrostomy in the preoperative setting may compromise the gastric vasculature, thereby interfering with the creation of the gastric conduit in the reconstruction during esophagectomy and should be avoided. POST-TREATMENT SURVEILLANCE:· Assessment with endoscopy with biopsy and brushings should be done³ 5-6 weeks after completion of preoperative therapy.· EUS exams performed after chemotherapy or radiation therapy have a reduced ability to accurately determine the present stage of disease. 13 Similarly, biopsies performed after chemotherapy or radiation therapy may not accurately diagnose the presence of residual disease. 14· Endoscopic surveillance following definitive treatment of esophageal cancer requires careful attention to detail for mucosal surface changes, and multiple biopsies of any visualized abnormalities. Strictures should be biopsied to rule-out neoplastic cause. EUS

performed in conjunction with endoscopy exams has a high sensitivity for recurrent disease. 15 EUS guided FNA should be performed if suspicious lymph nodes or areas of wall thickening are seen.· Endoscopic surveillance after ablative therapy or EMR of early esophageal malignancy should continue after completion of treatment. Biopsies should be taken of the neo-squamous mucosa even in the absence of mucosal abnormalities as dysplasia may occasionally be present beneath the squamous mucosa.· Endoscopic surveillance should also include a search for the presence of Barrett's esophagus, and four-quadrant biopsies to detect residual or recurrent dysplasia. The ablation of residual or recurrent high-grade and low-grade dysplasia using RFA or cryoablation should be considered. Ablation of non-dysplastic Barrett's esophagus is not recommended.· For follow-up, patients with Tis or T1a who undergo EMR should have endoscopic surveillance every 3 months for one year, then annually. ContinueNote: 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 2.2011, 05/13/11© National Comprehensive Cancer Network, Inc. 2011, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN®.

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NCCN Guidelines Version 2.2011 Esophageal and Esophagogastric Junction CancersPRINCIPLES OF ENDOSCOPIC STAGING AND THERAPY (REFERENCES)1 Sharma

NCCN Guidelines Index Esophageal Table of Contents Discussion

P, Dent J, Armstrong D, et al., The Development and Validation of an Endoscopic Grading System for Barrett's Esophagus: The Prague C& M Criteria Gastroenterology 2006;131;1392-1399. 2 Mannath J, Subramanian V, Hawkey CJ, Ragunath K. Narrow band imaging for characterization of high grade dysplasia and specialized intestinal metaplasia in Barrett's esophagus: a meta-analysis. Endoscopy 2010;42:351-359. 3 Komanduri S, Swanson G, Keefer L, Jakate S. Use of a new jumbo forceps improves tissue acquisition of Barrett's esophagus surveillance biopsies. Gastrointest Endosc 2009;70:1072-1078 e1071. 4 Thomas T, Singh R, Ragunath K. Trimodal imaging-assisted endoscopic mucosal resection of early Barrett's neoplasia. Surg Endosc 2009;23:1609-1613. 5 Barbour AP, Rizk NP, Gerdes H, et al. Endoscopic ultrasound predicts outcomes for patients with adenocarcinoma of the gastroesophageal junction. J Am Coll Surg 2007;205:593-601. 6 Keswani RN, Early DS, Edmundowicz SA, et al. Routine positron emission tomography does not alter nodal staging in patients undergoing EUS-guided FNA for esophageal cancer. Gastrointest Endosc 200

9;69:1210-1217. 7 Shaheen NJ, Sharma P, Overholt BF, et al. Radiofrequency ablation in Barrett's esophagus with dysplasia. N Engl J Med 2009;360:2277-2288. 8 Shaheen NJ, Greenwald BD, Peery AF, et al. Safety and efficacy of endoscopic spray cryotherapy for Barrett's esophagus with high-grade dysplasia. Gastrointest Endosc 2010;71:680-685. 9 Overholt BF, Wang KK, Burdick JS, et al. Five-year efficacy and safety of photodynamic therapy with Photofrin in Barrett's high-grade dysplasia. Gastrointest Endosc 2007;66:460-468. 10 Pech O, Behrens A, May A, et al. Long-term results and risk factor analysis for recurrence after curative endoscopic therapy in 349 patients with high-grade intraepithelial neoplasia and mucosal adenocarcinoma in Barrett's oesophagus. Gut 2008;57:1200-1206. 11 Lightdale CJ, Heier SK, Marcon NE, et al. Photodynamic therapy with porfimer sodium versus thermal ablation therapy with Nd:YAG laser for palliation of esophageal cancer: a multicenter randomized trial. Gastrointest Endosc 1995;42:507-512. 12 Vakil N, Morris AI, Marcon N, et al. A prospective, randomized, controlled trial of covered expandable metal stents in the palliation of malignant esophageal obstruction at the gastroesophageal junction. Am J Gastroenterol 2001;96:1791-1796. 13 Ribeiro A, Franceschi D, Parra J, et al. Endoscopic ultrasound restaging after neoadjuvant chemotherapy in esophageal cancer. Am J Gastroenterol 2006;101:1216-1221. 14 Sarkaria IS, Rizk NP, Bains MS, et al. Post-treatment endoscopic biopsy is a poor-predictor of pathologic response in patients undergoing chemoradiation therapy for esophageal cancer. Ann Surg 2009;249:764-767. 15 Lightdale CJ, Botet JF, Kelsen DP, et al. Diagnosis of recurrent upper gastrointestinal cancer at the surgical anastomosis by endoscopic ultrasound. Gastrointest Endosc 1989;35:407-412.

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NCCN Guidelines Version 2.2011 Esophageal and Esophagogastric Junction CancersTABLE 1 Specimen Type Biopsy PRINCIPLES OF PATHOLOGIC REVIEW AND HER2-NEU TESTING Analysis/Interpretation/Reporting a

NCCN Guidelines Index Esophageal Table of Contents Discussion

Include in pathology report:· Invasion, if present; high grade dysplasia in Barrett's esophagus is reported for staging purposes as“carcinoma in situ (Tis)” b,c,d· Histologic type e· Grade f· Presence or absence o

f Barrett's esophagus Include in pathology report:· Invasion, if present b,d· Histologic type e· Grade f· Depth of tumor invasion· Vascular invasion· Status of mucosal and deep margins For pathology report, include all elements as for endoscopic mucosal resection plus· Location of tumor midpoint in relationship to EGJ g· Whether tumor crosses EGJ· LN status and number of lymph nodes recovered· Tumor site should be thoroughly sampled, with submission of entire GEJ or ulcer bed for specimens s/p neoadjuvant therapy without grossly obvious residual tumor· For pathology report, include all elements as for resection without prior chemo/radiation plus assessment of treatment effect

Endoscopic mucosal resection

Esophagectomy, without prior chemoradiation

Esophagectomy, with prior chemoradiation

a Use of a standardized minimum data set such as the College of American Pathologists Cancer Protocols (available at ) for reporting pathologic findings is recommended. b For purposes of data reporting, Barrett's esophagus with high-grade dysplasia in an esophageal resection specimen is reported as“carcinoma in situ (Tis) .” The term“carcinoma in situ” is not widely applied to glandular neoplastic lesions in the gastrointestinal tract but is retained for tumor registry reporting purposes as specified by law in many states.1 c Biopsies showing Barrett's esophagus with suspected dysplasia should be reviewed by a second expert gastrointestinal pathologist for confirmation. 2 d Invasion of a thickened and duplicated muscularis mucosae should not be misinterpreted as invasion of the muscularis propria in Barrett's esophagus. 3 e A specific diagnosis of squamous cell carcinoma or adenocarcinoma should be established when possible for staging and treatment purposes. Mixed adenosquamous carcinomas and carcinomas not otherwise classified are staged using the TNM system for squamous cell carcinoma. 1 f Pathologic grade is needed for stage grouping in the AJCC TNM 7th edition. 1 g Tumors arising in the proximal stomach and crossing the EGJ are classified for purposes of staging as esophageal carcinomas. 1

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NCCN Guidelines Version 2.2011 Esophageal and Esophagogastric Junction CancersPRINCIPLES OF PATHOLOGIC REVIEW AND HER2-NEU TESTING

NCCN Guidelines Index

Esophageal Table of Contents Discussion

Assessment of treatment response Response of the primary tumor to previous chemotherapy or radiation therapy should be reported. Residual primary tumor in the resection specimen following neoadjuvant therapy is associated with shorter overall survival for both adenocarcinoma 4-6 and squamous cell carcinoma of the esophagus. 7 Although grading systems for tumor response in esophageal cancer have not been uniformly adopted, in general, three-category systems provide good reproducibility among pathologists. 6,8 The following system developed specifically for esophagus by Wu, et al 6 is reported to provide good interobserver agreement, but other systems such as the one 8 suggested by the CAP Cancer Protocol for Esophageal Carcinoma (available at ), may also be used. Sizable pools of acellular mucin may be present after chemoradiation but should not be interpreted as representing residual tumor. TABLE 2 Tumor Regression Grade 0 (Complete response) 1 (Moderate response) Wu et al Description No residual cancer cells 1% to 50% residual cancer; rare individual cancer cells or minute clusters of cancer cells More than 50% residual cancer cells, often grossly identifiable at primary site Ryan et al Description No cancer cells Single cells or small groups of cancer cells

2 (Minimal response)

Residual cancer cells outgrown by fibrosis Minimum or no treatment effect; extensive residual cancer

3 (Poor response)

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