1、NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)Rectal CancerVersion 1.2016ContinueNCCN.orgVersion 1.2016, 11/04/15 National Comprehensive Cancer Network, Inc. 2015, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express wr
2、itten permission of NCCNNCCN Guidelines IndexRectal Cancer Table of ContentsDiscussionVersion 1.2016, 11/04/15 National Comprehensive Cancer Network, Inc. 2015, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of
3、NCCN.NCCN Guidelines Version 1.2016 Panel MembersRectal CancerContinueNCCN Guidelines Panel DisclosuresNCCNDeborah Freedman-Cass, PhDKristina M. Gregory, RN, MSN, OCN Medical oncology Radiotherapy/Radiation oncology Surgery/Surgical oncology Pathology Hematology/Hematology oncology Internal medicine
4、 Diagnostic/Interventional radiology Gastroenterology Patient advocate*Discussion Section Writing CommitteeAl B. Benson, III, MD/Chair Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityAlan P. Venook, MD/Vice-Chair UCSF Helen Diller Family Comprehensive Cancer CenterTanios Bekaii
5、-Saab, MD The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research InstituteEmily Chan, MD, PhD Vanderbilt-Ingram Cancer CenterYi-Jen Chen, MD, PhD City of Hope Comprehensive Cancer CenterHarry S. Cooper, MD Fox Chase Cancer Center Paul F. Engstrom, MD Fox Ch
6、ase Cancer CenterPeter C. Enzinger, MD Dana-Farber/Brigham and Womens Cancer CenterMoon J. Fenton, MD, PhD St. Jude Childrens Research Hospital/University of Tenessee Health Science CenterCharles S. Fuchs, MD, MPH Dana-Farber/Brigham and Womens Cancer Center Jean L. Grem, MD Fred & Pamela Buffett Ca
7、ncer Center at The Nebraska Medical Center*Axel Grothey, MD Mayo Clinic Cancer CenterHoward S. Hochster, MDYale Cancer Center/Smilow Cancer HospitalSteven Hunt, MD Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineAhmed Kamel, MD University of Alabama at Bir
8、mingham Comprehensive Cancer CenterNatalie Kirilcuk, MD Stanford Cancer InstituteSmitha Krishnamurthi, MD Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute Lucille A. Leong, MD City of Hope Comprehensive Cancer CenterEdward Lin,
9、 MD Fred Hutchinson Cancer Research Center/ Seattle Cancer Care AllianceWells A. Messersmith, MD University of Colorado Cancer CenterMary F. Mulcahy, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityJames D. Murphy, MD, MS UC San Diego Moores Cancer CenterSteven Nurkin, MD, M
10、S Roswell Park Cancer InstituteDavid P. Ryan, MD Massachusetts General Hospital Cancer CenterLeonard Saltz, MD Memorial Sloan Kettering Cancer CenterSunil Sharma, MD Huntsman Cancer Institute at the University of UtahJohn M. Skibber, MD The University of Texas MD Anderson Cancer CenterConstantinos T
11、. Sofocleous, MD, PhD Memorial Sloan Kettering Cancer CenterElena M. Stoffel, MD, MPH University of Michigan Comprehensive Cancer Center Eden Stotsky-Himelfarb, BSN, RN The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsChristopher G. Willett, MD Duke Cancer Institute*Printed by Maria Che
12、n on 12/16/2015 3:59:23 AM. For personal use only. Not approved for distribution. Copyright 2015 National Comprehensive Cancer Network, Inc., All Rights RClinical Trials: NCCN believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especia
13、lly encouraged. To find clinical trials online at NCCN Member Institutions, click here:nccn.org/clinical_trials/physician.html.NCCN Categories of Evidence and Consensus: All recommendations are category 2A unless otherwise specified. See NCCN Categories of Evidence and Consensus.NCCN Rectal Cancer P
14、anel MembersSummary of the Guidelines UpdatesClinical Presentations and Primary Treatment: Pedunculated polyp (adenoma) with invasive cancer (REC-1) Sessile polyp (adenoma) with invasive cancer (REC-1) Rectal cancer appropriate for resection (REC-2)4cT1-2, N0: Primary and Adjuvant Treatment (REC-3)4
15、T3, N0 or T any, N1-2: Primary and Adjuvant Treatment (REC-4)4T4 and/or locally unresectable: Primary and Adjuvant Treatment (REC-4)4Medical Contraindication to Combined Modality Therapy (REC-5)4T any, N any, M1: Resectable Synchronous Metastases (REC-6) T any, N any, M1: Unresectable Synchronous Me
16、tastases or Medically Inoperable Treatment (REC-7) Surveillance (REC-8) Recurrence and Workup (REC-9) Serial CEA Elevation (REC-9)Principles of Pathologic Review (REC-A)Principles of Surgery (REC-B)Principles of Adjuvant Therapy (REC-C)Principles of Radiation Therapy (REC-D)Chemotherapy for Advanced
17、 or Metastatic Disease (REC-E)Principles of Survivorship (REC-F)Staging (ST-1)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
18、 use independent medical judgment in the context of individual clinical circumstances to determine any patients 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 respons
19、ibility 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. 2015.Version 1.2016,
20、11/04/15 National Comprehensive Cancer Network, Inc. 2015, 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 1.2016 Table of ContentsRectal CancerNCCN Guidelines IndexRectal Cancer T
21、able of ContentsDiscussionPrinted by Maria Chen on 12/16/2015 3:59:23 AM. For personal use only. Not approved for distribution. Copyright 2015 National Comprehensive Cancer Network, Inc., All Rights RNCCN Guidelines IndexRectal Cancer Table of ContentsDiscussionVersion 1.2016, 11/04/15 National Comp
22、rehensive Cancer Network, Inc. 2015, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.UPDATESNCCN Guidelines Version 1.2016 UpdatesRectal CancerUpdates in Version 1.2016 of the Guidelines for Rectal Cancer
23、 from Version 3.2015 include:REC-1 Footnote “b” added: For melanoma histology, see the NCCN Guidelines for Melanoma.REC-2 Footnote “b” added: For melanoma histology, see the NCCN Guidelines for Melanoma. Workup, bullet 4: “rigid” removed from proctoscopy.REC-3 T1,NX with high-risk features or T2,NX:
24、 the treatment option of Chemo/RT added followed by transabdominal resection. Chemo/RT options: Capecitabine/RT or infusional 5-FU/RT (preferred for both) or Bolus 5-FU/leucovorin/RT. Footnote “n” added: Bolus 5-FU/leucovorin/RT is an option for patients not able to tolerate capecitabine or infusion
25、al 5-FU. (also applies to REC-4, REC-5, REC-6, REC-7, and REC-9)REC-4 Neoadjuvant Therapy: Radiation therapy used in Chemo/RT clarified as “long-course” RT. Neoadjuvant Therapy: The option of Short-course RT added with the qualifier that it is not recommended for T4 tumors. Footnote “o” added: Evalu
26、ation for short-course RT should be in a multidisciplinary setting, with a discussion of the need for down-staging and the possibility of long-term toxicity.REC-6 The treatment option of “Staged or synchronous resection of metastases and rectal lesion” modified to “Staged or synchronous resection (p
27、referred) and/or local therapy for metastases and resection of rectal lesion” Footnote “v” modified: Determination of tumor gene status for RAS (KRAS and NRAS) and BRAF. Determination of tumor MMR or MSI status (if not previously done). See Principles of Pathologic Review (REC-A 5 of 6) - KRAS, NRAS
28、 and BRAF Mutation Testing and Microsatellite Instability (MSI) or Mismatch Repair (MMR) Testing. (also applies to REC-7 and REC-9) Footnote “z” added to the page: Resection is preferred over locally ablative procedures (eg, image-guided ablation or SBRT). However, these local techniques can be cons
29、idered for liver oligometastases (REC-B and REC-D).REC-8 Surveillance, bullet 3 modified: Chest/abdominal/pelvic CT annually for up to every 3-6 mo x 2 y, then every 6-12 mo or up to a total of 5 y for patients at high risk for recurrence Surveillance recommendations added for patients after transan
30、al excision only.4Proctoscopy (with EUS or MRI) every 3-6 mo for the first 2 years, then every 6 mo for a total of 5 years (for patients treated with transanal excision only).REC-10 The treatment option of “Resection” modified to “Resection (preferred) and/or Local therapy.” Footnote “z” added: Rese
31、ction is preferred over locally ablative procedures (eg, image-guided ablation or SBRT). However, these local techniques can be considered for liver oligometastases (REC-B and REC-D).REC-11 Footnote “jj” modified: Bevacizumab is the preferred anti-angiogenic agent based on toxicity and/or cost.Print
32、ed by Maria Chen on 12/16/2015 3:59:23 AM. For personal use only. Not approved for distribution. Copyright 2015 National Comprehensive Cancer Network, Inc., All Rights RNCCN Guidelines IndexRectal Cancer Table of ContentsDiscussionVersion 1.2016, 11/04/15 National Comprehensive Cancer Network, Inc.
33、2015, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.UPDATESNCCN Guidelines Version 1.2016 UpdatesRectal CancerUpdates in Version 1.2016 of the Guidelines for Rectal Cancer from Version 3.2015 include:RE
34、C-A 2 of 6 Pathologic Stage: The system used to grade tumor response as recommended by the AJCC Cancer Staging manual, 7th Edition and the CAP guidelines is that as modified from Ryan R, et al. Histopathology 2005;47:141-146. Sentence added: Other grading systems that are used are referenced. REC-A
35、5 of 6 KRAS, NRAS, and BRAF Mutation Testing, bullet 1 modified: All patients with metastatic colorectal cancer should have tumor tissue genotyped for RAS mutations (KRAS and NRAS) and BRAF mutations. Patients with any known KRAS mutation (exon 2 or non-exon 2) or NRAS mutation should not be treated
36、 with either cetuximab or panitumumab. Evidence increasingly suggests that BRAF V600E mutation makes response to panitumumab or cetuximab highly unlikely, as a single agent, or in combination with cytotoxic chemotherapy. KRAS, NRAS, and BRAF Mutation Testing, bullet 2 removed: Patients with a V600E
37、BRAF mutation appear to have a poorer prognosis. There are insufficient data to guide the use of anti-EGFR therapy in the first-line setting with active chemotherapy based on BRAF V600E mutation status. Limited available data suggest lack of antitumor activity from anti-EGFR monoclonal antibodies in
38、 the presence of a V600E mutation when used after a patient has progressed on first-line therapy. Microsatellite Instability (MSI) section modified: “.or Mismatch Repair (MMR) Testing” 4Bullet 1 modified: Lynch Syndrome tumors screening (ie, IHC for MMR or PCR for MSI) should be considered performed
39、 for all patients with colorectal cancer diagnosed at age 70 y and also those 70 y who meet the Bethesda guidelines. See NCCN Guidelines for Genetic/Familial High-Risk Assessment: Colorectal 4Bullet 2 added: The presence of a BRAF V600E mutation in the setting of MLH1 absence would preclude the diag
40、nosis of Lynch Syndrome4Bullet 3 added: MMR or MSI testing should also be performed for all patients with stage II disease, because stage II MSI-H patients may have a good prognosis and do not benefit from 5-FU adjuvant therapy. 4Bullet 4 added: MMR or MSI testing should also be performed for all pa
41、tients with metastatic disease.4Footnote “*”added: IHC for MMR and PCR for MSI are different assays measuring the same biological effect.REC-A 6 of 6 Reference 59 added.REC-B 1 of 3 The following bullet removed: Laparoscopic surgery is preferred in the setting of a clinical trial. The following text
42、 added: Some studies have shown that laparoscopy is associated with similar short- and long-term outcomes when compared to open surgery, whereas other studies have shown that laparoscopy is associated with higher rates of circumferential margin positivity and incomplete TME. Therefore, minimally inv
43、asive resection may be considered based on the following principles: The surgeon should have experience performing minimally invasive proctectomy with total mesorectal excision. It is not indicated for locally advanced disease with a threatened or high risk circumferential margin based on staging. F
44、or these high risk tumors, open surgery is preferred. It is not indicated for acute bowel obstruction or perforation from cancer. Thorough abdominal exploration is required.REC-B 3 of 3 References 2-5 added.Printed by Maria Chen on 12/16/2015 3:59:23 AM. For personal use only. Not approved for distr
45、ibution. Copyright 2015 National Comprehensive Cancer Network, Inc., All Rights RNCCN Guidelines IndexRectal Cancer Table of ContentsDiscussionNCCN Guidelines Version 1.2016 UpdatesRectal CancerVersion 1.2016, 11/04/15 National Comprehensive Cancer Network, Inc. 2015, All rights reserved. The NCCN G
46、uidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.UPDATESREC-C 1 of 2 Footnote “*” added: Oxaliplatin may be given either over 2 hours, or may be infused over a shorter time at a rate of 1 mg/m2/minute. Leucovorin infusion should match i
47、nfusion time of oxaliplatin. Cercek A, Park V, Yaeger RD, et al. Oxaliplatin can be safely infused at a rate of 1mg/m2/min. J Clin Oncol 33, 2015 (suppl; abstr e14665). Footnote “” added: Bolus 5-FU/leucovorin/RT is an option for patients not able to tolerate capecitabine or infusional 5-FUREC-D Bul
48、let 4 modified: Intensity-modulated radiation therapy (IMRT) should only be used in the setting of a clinical trial or in unique clinical situations including such as re-irradiation of previously treated patients with recurrent disease or unique anatomical situations. Bullet 6 added: Short course ra
49、diation therapy (25 Gy in 5 fractions) with surgery within 1 to 2 weeks of completion of therapy can also be considered for patients with ultrasound or pelvic MRI stage T3 rectal cancer. Reference added: Ngan SY, Burmeister B, Fisher RJ, et al. Randomized trial of short-course radiotherapy versus lo
50、ng-course chemoradiation comparing rates of local recurrence in patients with T3 rectal cancer: Trans-Tasman Radiation Oncology Group trial 01.04. J Clin Oncol 2012;30:3827-3833.REC-E 1 of 9 The regimen of trifluridine + tipiracil was added as a subsequent therapy option for patients with disease pr
