2010NCCN指南-前列腺癌

Continue NCCN Clinical Practice Guidelines in Oncology™ Prostate Cancer V.2.2009 www.nccn.org Continue Version 2.2009, 02/09/09 © 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. Prostate Cancer Guidelines Index Prostate Cancer TOC Staging, Discussion, References Practice Guidelines in Oncology – v.2.2009NCCN ® ContinueContinue NCCN Prostate Cancer Panel Members James Mohler, MD/Chair Roswell Park Cancer Institute Christopher Lee Amling, MD University of Alabama at Birmingham Comprehensive Cancer Center Arthur G. James Cancer Hospital & Richard J. Solove Research Institute at The Ohio State University Barry Boston, MD St. Jude Children’s Research Hospital/University of Tennessee Cancer Institute Anthony D’Amico, MD, PhD Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center James A. Eastham, MD Memorial Sloan-Kettering Cancer Center Charles A. Enke, MD UNMC Eppley Cancer Center at The Nebraska Medical Center Daniel George, MD Duke Comprehensive Cancer Center � � � � Robert R. Bahnson, MD † † £ § § Julio M. Pow-Sang, MD H. Lee Moffitt Cancer Center & Research Institute Mack Roach, III, MD UCSF Helen Diller Family Comprehensive Cancer Center Howard Sandler, MD University of Michigan Comprehensive Cancer Center Dennis C. Shrieve, MD, PhD Huntsman Cancer Institute at the University of Utah Matthew R. Smith, MD, PhD Massachusetts General Hospital Cancer Center Sandhya Srinivas, MD Stanford Comprehensive Cancer Center Przemyslaw Twardowski, MD City of Hope Patrick C. Walsh, MD The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins � � § § § † † † * Eric Mark Horwitz, MD Fox Chase Cancer Center Robert P. Huben, MD Roswell Park Cancer Institute Philip Kantoff, MD Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center Mark Kawachi, MD City of Hope Michael Kuettel, MD, MBA, PhD Roswell Park Cancer Institute Paul H. Lange, MD Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Christopher J. Logothetis, MD The University of Texas M.D. Anderson Cancer Center Gary MacVicar, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern Unviersity § § � � � � † † § Radiotherapy/Radiation oncology Urology Medical oncology £ Supportive Care including Palliative, Pain management, Pastoral care and Oncology social work ¥ Patient advocacy � † *Writing committee member * NCCN Guidelines Panel Disclosure * * Version 2.2009, 02/09/09 © 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. Prostate Cancer Guidelines Index Prostate Cancer TOC Staging, Discussion, References Practice Guidelines in Oncology – v.2.2009NCCN ® 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 Prostate Cancer Panel Members Summary of Guideline Updates Initial Prostate Cancer Diagnosis, Staging Workup, Recurrence Risk (PROS-1) Initial Therapy, Adjuvant Therapy (PROS-2) Surveillance (PROS-4) Salvage Workup: Post-Radical Prostatectomy (PROS-5) Salvage Workup: Post-RT (PROS-6) Disseminated Recurrence (PROS-7) Systemic Therapy, Systemic Salvage Therapy (PROS-7) Principles of Life Expectancy Estimation (PROS-A) Principles of Active Surveillance (PROS-B) Principles of Radiation Therapy (PROS-C) Principles of Surgery (PROS-D) Principles of Hormonal Therapy ( (PROS-E) Principles of Chemotherapy (PROS-F) Androgen Deprivation Therapy) For help using these documents, please click here Staging Discussion References Guidelines Index Print the Prostate Cancer Guideline 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 2.2009, 02/09/09 © 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. Prostate Cancer Guidelines Index Prostate Cancer TOC Staging, Discussion, References Practice Guidelines in Oncology – v.2.2009NCCN ® 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 the Guideline Updates Summary of changes in the 2009 version of the guidelines from the 1.2008 version include:Prostate Cancer Treatment UPDATES �Global Changes Expectant management was changed to active surveillance. 3D-CRT was changed to 3D-CRT/IMRT with IGRT. Androgen deprivation therapy (ADT) co-administered with 3D-CRT/IMRT with IGRT was changed to neoadjuvant/concomitant/adjuvant ADT. and : Post radical p recurrence Indication for adjuvant or salvage radiation therapy (RT) have been simplified to reflect the demonstration that the survival benefit has been demonstrated for both salvage and adjuvant RT and that previously accepted clinical criteria for treatment did not predict response. Post implant dosimetry is recommended to document quality. Frequency of adverse effects from ADT warrants a discussion among patient, oncologist and personal physicians, monitoring of osteoporosis, obesity, insulin resistance, alteration in lipids and appreciation for a greater risk of diabetes and cardiovascular disease. Osteoporosis risk should be assessed using guidelines for the general population from the National Osteoporosis Foundation. Zoledronic acid is recommended to prevent skeletal-related events in men with castration recurrent prostate cancer who have documented bone metastases and creatinine clearance > 30 mL/min. � � � � � � rostatectomy (RP) � � � � � PROS-5 PROS-C PROS-E PROS-F Summary of changes in the 2.2009 version of the guidelines from the 1.2009 version include the addition of the updated Discussion section. Prostate Cancer Treatment Version 2.2009, 02/09/09 © 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. Prostate Cancer Guidelines Index Prostate Cancer TOC Staging, Discussion, References Practice Guidelines in Oncology – v.2.2009NCCN ® 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. Preferred treatment for any therapy is approved clinical trial. INITIAL PROSTATE CANCER DIAGNOSIS INITIAL CLINICAL ASSESSMENT STAGING WORKUP (TNM staging refers to 2002 Classification) RECURRENCE RISK � � � DRE PSA Gleason primary and secondary grade Life expectancy 5 y and asymptomatic a � Life expectancy > 5 y or symptomatic a No further workup or treatment until symptoms except for high risk patientb Bone scan if T1-T2 and PSA > 20 ng/mL or Gleason score 8 or T3, T4 or symptomatic � Pelvic CT or MRI if T3, T4 or T1-T2 and nomogram indicated probability of lymph node involvement > 20% c Suspicious nodes Consider FNA Low: T1-T2a and Gleason score 2-6 and PSA < 10 ng/mL Intermediate: T2b-T2c or Gleason score 7 or PSA 10-20 ng/mL c High: T3a or Gleason score 8-10 or PSA > 20 ng/mL c Very high: T3b-T4 Any T, N1 Any T, Any N, M1 See Initial Therapy (PROS-2) See Initial Therapy (PROS-3) a bIn selected patients where complications such as hydronephrosis or metastasis can be expected within 5 y, androgen deprivation therapy (ADT) or radiation therapy (RT) may be considered. High risk factors include bulky T3-T4 disease or Gleason score 8-10. cPatients with multiple adverse factors may be shifted into the next higher risk group. See Principles of Life Expectancy (PROS-A). PROS-1 All others; no additional imaging Clinically Localized: Locally Advanced: Metastatic: Version 2.2009, 02/09/09 © 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. Prostate Cancer Guidelines Index Prostate Cancer TOC Staging, Discussion, References Practice Guidelines in Oncology – v.2.2009NCCN ® 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. RECURRENCE RISK Low: T1-T2a and Gleason score 2-6 and PSA < 10 ng/mL Intermediate: T2b-T2c or Gleason score 7 or PSA 10-20 ng/mL c EXPECTED PATIENT SURVIVALa < 10 y < 10 y � 10 yd � 10 y INITIAL THERAPY Active surveillance or RT (3D-CRT/IMRT with IGRT or brachytherapy) e f Active surveillance or RT (3D-CRT/IMRT with IGRT or brachytherapy) or Radical prostatectomy ± pelvic lymph node dissection if predicted probability of lymph node metastasis is 7% e f g � Active surveillance or RT 3D-CRT/IMRT with IGRT) ± short-term neoadjuvant/concomitant/adjuvant ADT (4-6 mo) ± brachytherapy) or Radical prostatectomy + pelvic lymph node dissection if predicted probability of lymph node metastasis is 7% e f g ( � Radical prostatectomy + pelvic lymph node dissection if predicted probability of lymph node metastasis is 7% or RT 3D-CRT/IMRT with IGRT ± short-term neoadjuvant/concomitant/adjuvant ADT (4-6 mo) ± brachytherapy) g f � ( If radical prostatectomy and positive margins, observe or RT If radical prostatectomy and lymph node metastasis, observe or androgen deprivation therapy f h See Surveillance (PROS-4) ADJUVANT THERAPY a cPatients with multiple adverse factors may be shifted into the next higher risk group. d e Active surveillance of intermediate and high risk clinically localized cancers is not recommended in patients with life expectancy > 10 years (category 1). Active surveillance involves actively monitoring the course of disease with the expectation to intervene if the cancer progresses. . See Principles of Life Expectancy (PROS-A). See Principles of Active Surveillance (PROS-B) PROS-2 Clinically Localized: f g h . . See Principles of Radiation Therapy (PROS-C See Principles of Surgery (PROS-D See Principles of Androgen Deprivation Therapy (PROS-E ) ) ). Version 2.2009, 02/09/09 © 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. Prostate Cancer Guidelines Index Prostate Cancer TOC Staging, Discussion, References Practice Guidelines in Oncology – v.2.2009NCCN ® High: T3a or Gleason score 8-10 or PSA > 20 ng/mL c Very high: T3b-T4 Any T, N1 Any T, Any N, M1 RECURRENCE RISK INITIAL THERAPY ADJUVANT THERAPY Long-term neoadjuvant/concomitant/adjuvant ADT (2-3 y) + RT (3D-CRT/IMRT with IGRT) (category 1) or RT (3D conformal/IMRT ± short-term neoadjuvant/concomitant/adjuvant ADT (4-6 mo) (selected patients with a single adverse high risk factor) or Radical prostatectomy (selected patients: low volume, no fixation + pelvic lymph node dissection) h f f h g RT (3D-CRT/IMRT with IGRT) + short-term neoadjuvant/concomitant/adjuvant ADT (4-6 mo) (category 1) or Long-term ADT (2-3 y) Radical prostatectomy (selected patients: low volume, no fixation + pelvic lymph node dissection) f h h g or Long-term ADT (2-3 y) or RT (3D-CRT/IMRT with IGRT) + short-term neoadjuvant/concomitant/adjuvant ADT (4-6 mo) h f h Long-term ADT (2-3 y)h Positive margins: Lymph node metastasis: � � � � Observation or RT ADT or Active surveillance f h e See Surveillance (PROS-4) Undetectable PSA Detectable PSA See Salvage Therapy (PROS-5) PROS-3 cPatients with multiple adverse factors may be shifted into the next higher risk group eActive surveillance involves monitoring the course of disease with the expectation to intervene if the cancer progresses. .See Principles of Active Surveillance (PROS-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. f g h . . See Principles of Radiation Therapy (PROS-C See Principles of Surgery (PROS-D See Principles of Androgen Deprivation Therapy (PROS-E ) ) ). Locally Advanced Metastatic: See Surveillance (PROS-4) See Surveillance (PROS-4) See Surveillance (PROS-4) Positive margins: Lymph node metastasis: � � � � Observation or RT ADT or Active surveillance f h e See Surveillance (PROS-4) Undetectable PSA Detectable PSA See Salvage Therapy (PROS-5) Version 2.2009, 02/09/09 © 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. Prostate Cancer Guidelines Index Prostate Cancer TOC Staging, Discussion, References Practice Guidelines in Oncology – v.2.2009NCCN ® 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 Initial-definitive therapy N1 or M1 PSA, DRE, prostate biopsy may be done less frequently � � � PSA as often as every 3 mo but at least every 6 mo DRE as often as every 6 mo but at least every 12 mo Repeat prostate biopsy as often as annually � � PSA every 6-12 mo for 5 y, then every year DRE every year Physical exam (including DRE) + PSA every 3-6 mo RECURRENCE Post-radical prostatectomy Post-RT Disseminated Failure of PSA to fall to undectable levels Detectable PSA that increases on 2 subsequent measurements Rising PSA or Positive DRE j Rising PSA and/or blastic bone metastases and/or other metastases j Visceral or lytic bone metastases and low PSA See Primary Salvage Therapy (PROS-5) See Systemic Therapy (PROS-7) Progressive diseasei See Initial Clinical Assessment (PROS-1)Active surveillancee Life expectancy < 10 y Life expectancy 10 y� e j Active surveillance involves actively monitoring the course of disease with the expectation to intervene if the cancer progresses or if symptoms become imminent. . Criteria for progression are not well defined and require physician judgement; however, a change in risk group strongly implies disease progression. RTOG-ASTRO Phoenix Consensus - (1) PSA rise by 2 ng/ml or more above the nadir PSA is the standard definition for biochemical failure after EBRT with or without HT; (2) the date of failure is determined "at call" (not backdated). They recommended that investigators be allowed to use the ASTRO Consensus Definition after EBRT alone (with no hormonal therapy) with strict adherence to guidelines as to "adequate follow-up" to avoid the artifacts resulting from short follow-up. For example, if the median follow-up is 5 years, control rates at 3 years should be cited. Retaining a strict version of the ASTRO definition allows comparison with a large existing body of literature. i (Radiation Therapy Oncology Group - American Society for Therapeutic Radiology and Oncology) See Principles of Active Surveillance (PROS-B) INITIAL MANAGEMENT OR PATHOLOGY See Primary Salvage Therapy (PROS-6) PROS-4 Version 2.2009, 02/09/09 © 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. Prostate Cancer Guidelines Index Prostate Cancer TOC Staging, Discussion, References Practice Guidelines in Oncology – v.2.2009NCCN ® 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. Failure of PSA to fall to undetectable PSA detectable and rising on 2 or more subsequent determinations SALVAGE WORKUP PRIMARY SALVAGE THERAPY ± Bone Scan ± Biopsy ± CT/MRI ± ProstaScint ± PSADT POST-RADICAL PROSTATECTOMY RECURRENCE f h . . See Principles of Radiation Therapy (PROS-C See Principles of Androgen Deprivation Therapy (PROS-E ) ) PROS-5 See Systemic Therapy (PROS-7) Distant metastases RT ADTf h± neoadjuvant/concomitant/adjuvant or ADT aloneh or Observation ADT or Observation h No evidence of distant metastases Version 2.2009, 02/09/09 © 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. Prostate Cancer Guidelines Index Prostate Cancer TOC Staging, Discussion, References Practice Guidelines in Oncology – v.2.2009NCCN ® 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. Radical prostatectomy or Cryosurgery or Brachytherapy g f Post RT rising PSA or Positive DRE j SALVAGE WORKUP PRIMARY SALVAGE THERAPY Biopsy Bone scan ± Abd/pelvic CT ± MRI ± ProstaScint See Systemic Therapy (PROS-7) Candidate for local therapy: Original clinical stage T1-T2, NX or N0 Life expectancy > 10 y PSA now < 10 ng/mL � � � Not a candidate for local therapy Observation or ADTh Biopsy positive, no metastases Positive studies for metastases ADT or Observation h f g h . . . RTOG-ASTRO Phoenix Consensus - (1) PSA rise by 2 ng/ml or more above the nadir PSA is the standard definition for biochemical failure after EBRT with or without HT; (2) the date of failure is determined "at call" (not backdated). They recommended that investigators be allowed to use the ASTRO Consensus Definition after EBRT alone (with no hormonal therapy) with strict adherence to guidelines as to "adequate follow-up" to avoid the artifacts resulting from short follow-up. For example, if the median follow-up is 5 years, control rates at 3 years should be cited. Retaining a strict version of the ASTRO definition allows comparison with a large existing body of literature. j (Radiation Therapy Oncology Group - American Society for Therapeutic Radiology and Oncology) See Principles of Radiation Therapy (PROS-C See Principles of Surgery (PROS-D See Principle