2010NCCN指南-肾癌

Continue NCCN Clinical Practice Guidelines in Oncology™ Kidney Cancer V.2.2010 www.nccn.org Version 2.2010, 10/30/09 © 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.2.2010 Guidelines Index Kidney Cancer Table of Contents Staging, Discussion, ReferencesKidney CancerNCCN ® NCCN Kidney Cancer Panel Members Robert J. Motzer, MD/Chair Memorial Sloan-Kettering Cancer Center Neeraj Agarwal, MD Huntsman Cancer Institute at the University of Utah Clair Beard, MD St. Jude Children’s Research Hospital/University of Tennessee Cancer Institute Michael A. Carducci, MD The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Sam S. Chang, MD Vanderbilt-Ingram Cancer Center Toni K. Choueiri, MD † Þ ‡ § † † £ † Þ † Þ Dana-Farber/Brigham and Women’s Cancer Center Sam Bhayani, MD Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine Graeme B. Bolger, MD University of Alabama at Birmingham Comprehensive Cancer Center Barry Boston, MD Dana-Farber/Brigham and Women’s Cancer Center � � Thomas Olencki, DO The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute Roberto Pili, MD Roswell Park Cancer Institute UCSF Helen Diller Family Comprehensive Cancer Center Memorial Sloan-Kettering Cancer Center UNMC Eppley Cancer Center at The Nebraska Medical Center ‡ † † † † Bruce G. Redman, DO University of Michigan Comprehensive Cancer Center Cary N. Robertson, MD Duke Comprehensive Cancer Center Charles J. Ryan, MD Lawrence H. Schwartz, MD Joel Sheinfeld, MD Memorial Sloan-Kettering Cancer Center Jue Wang, MD � � ф Robert A. Figlin, MD City of Hope Comprehensive Cancer Center Mayer Fishman, MD, PhD H. Lee Moffitt Cancer Center & Research Institute Steven L. Hancock, MD Stanford Comprehensive Cancer Center Gary R. Hudes, MD Fox Chase Cancer Center Eric Jonasch, MD The University of Texas M. D. Anderson Cancer Center Timothy M. Kuzel, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern University Paul H. Lange, MD Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Ellis G. Levine, MD Roswell Park Cancer Institute Kim A. Margolin, MD Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance M. Dror Michaelson, MD, PhD Massachusetts General Hospital Cancer Center † † ‡ Þ § Þ † ‡ † † ‡ † † ‡ † � * † Medical oncology ‡ Hematology/hematology oncology § Radiotherapy/Radiation oncology Diagnostic Radiology £ Supportive Care including Palliative, Pain Management, Pastoral care and Oncology social work Þ Internal medicine Urology * Writing committee member ф � Continue NCCN Guidelines Panel Disclosures Version 2.2010, 10/30/09 © 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.2.2010 Guidelines Index Kidney Cancer Table of Contents Staging, Discussion, ReferencesKidney CancerNCCN ® 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 or warranties of any kind, 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 Kidney Cancer Panel Members Workup, Primary Treatment, and Follow-up (KID-1 First-Line Therapy for Relapse and Stage IV Medically or Surgically Unresectable Disease (KID-2 Principles of Surgery (KID-A Predictors of Short Survival (KID-C Guidelines Index Print the Kidney Cancer Guideline Summary of Guidelines Updates ) ) ) ) Subsequent Therapy for (KID-3Predominant Clear Cell Histology Surveillance Protocol Based on UISS Risk (KID-B ) ) For help using these documents, please click here Staging Discussion References 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 Version 2.2010, 10/30/09 © 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.2.2010 Guidelines Index Kidney Cancer Table of Contents Staging, Discussion, ReferencesKidney CancerNCCN ® Summary of the Guidelines updates UPDATES Summary of changes in the 1.2010 version of the Kidney Cancer Guidelines from the 2.2009 version include: : : For predominant clear cell histology, subsequent therapy: “Preferred” was removed from clinical trial. “IFN, low dose IL-2 ± IFN, and high dose IL-2” regimens were modified as “IFN or IL-2” and is a category 2B recommendation. � : KID-1 KID-2 KID-A � � � � � � � For stage I-III, after primary treatment of surgical excision, “Consider adjuvant therapy in a clinical trial” was clarified as “clinical trial”. For stage I-III follow-up “Abdominal/renal ultrasound and chest x-ray” were added as an option for imaging. Footnote a, “Biopsy may be considered to confirm malignancy and guide surveillance strategies” was added to the page. Footnote d, “UCLA Integrated Staging System (UISS) surveillance protocol based on risk group stratification of high, intermediate, low, or nodal status has been published and may be considered as an alternate to the listed follow-up for patients with localized or locally advanced RCC. See Surveillance Protocol Based on UISS Risk (KID-B)” was added to the page. Footnote e, “No single follow-up plan is appropriate for all patients. Follow-up should be individualized based on patient and tumor characteristics.” : � � � � Principles of Surgery: Second bullet was modified by adding, “regional” to lymph node dissection is optional. Last bullet was modified by adding “Biopsy of small lesions may be considered to confirm diagnosis of malignancy and guide surveillance strategies.” An alternate surveillance protocol based on the UCLA Integrated Staging System (UISS) for patients following surgical resection for localized and locally advanced renal cell cancer is new to the guidelines. KID-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. Summary of changes in the 2.2010 version of the Kidney Cancer Guidelines from the 1.2010 version include: : For predominant clear cell histology, first-line therapy, “pazopanib” was added as an option with a category 1 designation. For non clear cell histology, first-line therapy, “pazopanib” was added as an option with a category 3 designation. Footnote f, “Category 1 recommendations are listed in order of FDA approval” is new to the page. : For predominant clear cell histology, subsequent therapy, “pazopanib” was added as an option with a category 1 designation following cytokine therapy and category 3 designation following tyrosine kinase inhibitor therapy. Footnote i, “Tyrosine kinase inhibitors with a category 1 designation are listed in order of FDA approval” is new to the page and footnote ‘j’ was modified by adding “or pazopanib.” � � � � � KID-2 KID-3 Version 2.2010, 10/30/09 © 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.2.2010 Guidelines Index Kidney Cancer Table of Contents Staging, Discussion, ReferencesKidney CancerNCCN ® 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. INITIAL WORKUP Suspicious mass PRIMARY TREATMENT Stage IV Potentially surgically resectable solitary metastatic site Potentially surgically resectable primary with multiple metastatic sites c Medically or surgically unresectablec Cytoreductive nephrectomy in select patients prior to systemic therapy See First-Line Therapy (KID-2) See First-Line Therapy (KID-2) Nephrectomy + surgical metastasectomye Relapse See First-Line Therapy (KID-2) � � � � � � � � � H&P CBC, comprehensive metabolic panel, LDH Urinalysis Abdominal/pelvic CT or a with or without contrast depending on renal Chest imaging Bone scan, if clinically indicated Brain MRI, if clinically indicated If urothelial carcinoma suspected (eg, central mass), consider urine cytology, ureteroscopy Consider needle biopsy, if clinically indicated bdominal MRI insufficiency a a d e Biopsy of small lesions may be considered to confirm diagnosis of malignancy and guide surveillance strategies. Patients are encouraged to participate in clinical trials. UCLA Integrated Staging System (UISS) surveillance protocol based on risk group stratification of high, intermediate, low, or nodal status has been published and may be considered as an alternate to the listed follow-up for patients with localized or locally advanced RCC. No single follow-up plan is appropriate for all patients. Follow-up should be individualized based on patient and tumor characteristics. b cIndividualized treatment based upon symptoms and extent of metastatic disease. See Surveillance Protocol Based on UISS Risk (KID-B) KID-1 Stage I, II, IIIb Surgical excision ( )See KID-A Relapse See First-Line Therapy (KID-2) FOLLOW-UPd,e (category 2B) Every 6 mo for 2 y, then annually for 5 y: H&P Comprehensive metabolic panel, LDH At 4-6 mo, then as indicated: Chest and abdominal CT or Abdominal/renal ultrasound and chest x-ray � � � � Observation or Clinical trial Version 2.2010, 10/30/09 © 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.2.2010 Guidelines Index Kidney Cancer Table of Contents Staging, Discussion, ReferencesKidney CancerNCCN ® 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. FIRST-LINE THERAPYf f g hCategory 1 recommendations are listed in order of FDA approval. Best supportive care can include palliative RT, metastasectomy, or bisphosphonates for bony metastases.Poor-prognosis patients, defined as those with 3 predictors of short survival.� .See Predictors of Short Survival (KID-C) Relapse or Stage IV and medically or surgically unresectable KID-2 See Subsequent Therapy (KID-3) Predominant clear cell histology Non clear cell histology Clinical trial or Sorafenib and Best supportive care: Bevacizumab + IFN (category 1) or Pazopanib (category 1) or High dose IL-2 for selected patients or for selected patients h Sunitinib (category 1) or Temsirolimus (category 1 for poor-prognosis patients, category 2B for selected patients of other risk groups) or g See NCCN Palliative Care Guidelines Clinical trial (preferred) or Pazopanib (category 3) or Chemotherapy (category 3): gemcitabine or capecitabine or floxuridine or 5-FU or doxorubicin (in sarcomatoid only) and Best supportive care: or Temsirolimus (category 1 for poor-prognosis patients, category 2A for other risk groups) or Sorafenib or Sunitinib g h See NCCN Palliative Care Guidelines Version 2.2010, 10/30/09 © 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.2.2010 Guidelines Index Kidney Cancer Table of Contents Staging, Discussion, ReferencesKidney CancerNCCN ® 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. h j Best supportive care can include palliative RT, metastasectomy, or bisphosphonates for bony metastases. For example, sorafenib, sunitinib, or pazopanib. iTyrosine kinase inhibitors with a category 1 designation are listed in order of FDA approval. KID-3 SUBSEQUENT THERAPYi Predominant clear cell histology Clinical trial or or or IFN or IL-2 (category 2B) Everolimus (category 1 following tyrosine kinase inhibitor ) or Sorafenib (category 1 following cytokine therapy and category 2A following other tyrosine kinase inhibitor ) or Sunitinib (category 1 following cytokine therapy and category 2A following other tyrosine kinase inhibitor ) or Pazopanib (category 1 following cytokine therapy and category 3 following other tyrosine kinase inhibitor ) or Temsirolimus (category 2A following cytokine therapy and category 2B following tyrosine kinase inhibitor ) Bevacizumab (category 2B) j j j j j and Best supportive care:h See NCCN Palliative Care Guidelines Version 2.2010, 10/30/09 © 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.2.2010 Guidelines Index Kidney Cancer Table of Contents Staging, Discussion, ReferencesKidney CancerNCCN ® 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 SURGERY � � � � � � Nephron-sparing surgery is appropriate in selected patients, for example: Multiple primaries Uninephric state Renal insufficiency Selected patients with small unilateral tumors Regional lymph node dissection is optional. Adrenal gland may be left if uninvolved and tumor is not high risk, on the basis of size and location. Special teams may be required for extensive inferior vena cava involvement. Observation or emerging energy ablative techniques (eg, cryosurgery or radiofrequency ablation) can be considered for patients who are not surgical candidates. Emerging energy ablative techniques (eg, cryosurgery or radiofrequency ablation) are currently considered an option by some experts for selected small tumors. Though a rigorous comparison with surgical resection (ie, total or partial nephrectomy by open or laparoscopic techniques) has not been done. Biopsy of small lesions may be considered to confirm diagnosis of malignancy and guide surveillance stragegies. � � � � KID-A Version 2.2010, 10/30/09 © 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.2.2010 Guidelines Index Kidney Cancer Table of Contents Staging, Discussion, ReferencesKidney CancerNCCN ® KID-B 1 of 2 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. UISS Risk Group Based Surveillance Protocol for Patients Following Surgical Resection for Localized and Locally Advanced Renal Cell Cancer Nodal disease: � � � � History and physical examination Laboratory studies* Chest CT† Abdominal CT * Includes complete blood count, serum chemistries and liver function tests. † A chest radiograph can be alternated with a chest CT after 3 years of follow-up. High risk: � � � � History and physical examination Laboratory studies* Chest CT† Abdominal CT Intermediate risk: � � � � History and physical examination Laboratory studies* Chest CT† Abdominal CT Low risk: � � � � History and physical examination Laboratory studies* Chest CT Abdominal CT 3 6 12 18 24 30 36 48 60 84 108 Months Follow-up ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● 1Lam J, Shvarts O, Leppert J, et al. Postoperative surveillance protocol for patients with localized and locally advanced renal cell carcinoma based on a validated prognostic nomogram and risk group stratification system. J Urol 2005;174:466-472. SURVEILLANCE PROTOCOL BASED ON UISS RISK (1 of 2)1 See Risk Group Stratification (KID-B 2 of 2) Version 2.2010, 10/30/09 © 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.2.2010 Guidelines Index Kidney Cancer Table of Contents Staging, Discussion, ReferencesKidney CancerNCCN ® 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. 1Lam J, Shvarts O, Leppert J, et al. Postoperative surveillance protocol for patients with localized and locally advanced renal cell carcinoma based on a validated prognostic nomogram and risk group stratification system. J Urol 2005;174:466-472. RISK GROUP STRATIFICATION N Stage T stage 0 Nodal disease 1 + T1 T2 T3 T4 Grade 1-2 Grade 3-4 Grade 1-4 Grade 1 Grade > 1 Grade 1-4 ECOG 0 ECOG > 0 ECOG 0 ECOG > 0 ECOG 0-3 ECOG 0-3 Low Risk Intermediate Risk High Risk Flow chart for determination of UISS risk group assignment of patients with localized or locally advanced RCC. Start from left to right using 1997 AJCC N stage and T stage, Fuhrman grade, and ECOG-PS. KID-B 2 of 2 SURVEILLANCE PROTOCOL BASED ON UISS RISK (2 of 2)1 Version 2.2010, 10/30/09 © 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.2.2010 Guidelines Index Kidney Cancer Table of Contents Staging, Discussion, ReferencesKidney CancerNCCN ® KID-C PREDICTORS OF SHORT SURVIVAL1 � � � � �