2009NCCN指南-止吐剂

Continue NCCN Clinical Practice Guidelines in Oncology™ Antiemesis V.4.2009 www.nccn.org Version 4.2009,10/15/09 © 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. Guidelines Index Antiemesis Table of Contents Discussion, ReferencesAntiemesis Practice Guidelines in Oncology – v.4.2009NCCN ® NCCN Antiemesis Panel Members Steve Kirkegaard, PharmD Huntsman Cancer Institute at the University of Utah Mark G. Kris, MD † Memorial Sloan-Kettering Cancer Center Dean Lim, MD † City of Hope Michael Anne Markiewicz, PharmD University of Alabama at Birmingham Comprehensive Cancer Center Lauren Boehnke Michaud, PharmD, BCOP The University of Texas M.D. Anderson Cancer Center Lida Nabati, MD £ Þ Dana-Farber/Brigham and Women's Cancer Center � � � Dwight D. Kloth, PharmD, FCCP, BCOP Fox Chase Cancer Center � Hope S. Rugo, MD † ‡ UCSF Helen Diller Family Comprehensive Cancer Center Steven M. Sorscher, MD † Barbara Todaro, PharmD Roswell Park Cancer Institute Susan Urba, MD † £ University of Michigan Comprehensive Cancer Center Siteman Cancer Center at Barnes- Jewish Hospital and Washington University School of Medicine Lisa Stucky-Marshall, RN, MS, AOCN # Robert H. Lurie Cancer Center of Northwestern University � ‡ Þ † # £ * Hematology/hematology oncology Internal medicine Medical Oncology Nurse Pharmacology Supportive Care including Palliative, Pain management, Pastoral care and Oncology social work Writing Committee member � *David S. Ettinger, MD/Chair † The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Debra K. Armstrong, RN # Vanderbilt-Ingram Cancer Center Duke Comprehensive Cancer Center Michael J. Berger, PharmD, BCOP Arthur G. James Cancer Hospital & Richard J. Solove Research Institute at The Ohio State University Sally Barbour, PharmD, BCOP Philip J. Bierman, MD † ‡ UNMC Eppley Cancer Center at The Nebraska Medical Center Bob Bradbury, BCPS H. Lee Moffitt Cancer Center & Research Institute Georgianna Ellis, MD † Fred Hutchinson Cancer Research Center/ Seattle Cancer Care Alliance � � � * * Continue Disclosure of Conflict of Interest Version 4.2009,10/15/09 © 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. Guidelines Index Antiemesis Table of Contents Discussion, ReferencesAntiemesis Practice Guidelines in Oncology – v.4.2009NCCN ® Table of Contents CHEMOTHERAPY INDUCED: RADIATION-INDUCED: ANTICIPATORY: NCCN Antiemesis Panel Members High Emetic Risk Chemotherapy - Emesis Prevention (AE-2) Moderate Emetic Risk Chemotherapy - Emesis Prevention (AE-3) Low and Minimal Emetic Risk Chemotherapy - Emesis Prevention (AE-4) Oral Chemotherapy - Emesis Prevention (AE-5) Breakthrough Treatment for Chemotherapy Induced Nausea and Vomiting (AE-6) Emetogenic Potential of Intravenous Antineoplastic Agents (AE-7) Emetogenic Potential of Oral Antineoplastic Agents (AE-9) Principles of Managing Multi-Day Emetogenic Chemotherapy Regimens (AE-A) Principles for Managing Breakthrough Emesis (AE-B) Radiation-Induced Nausea and Vomiting (AE-10) Anticipatory Nausea and Vomiting (AE-11) Summary of Guidelines Updates Priniciples of Emesis Control (AE-1) Guidelines Index Print the Antiemesis Guideline � � � � � � � � � � � These guidelines are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient's care or treatment. The National Comprehensive Cancer Network makes no representations nor warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. These guidelines are copyrighted by National Comprehensive Cancer Network. All rights reserved. These guidelines and the illustrations herein may not be reproduced in any form without the express written permission of NCCN. ©2009. 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 This discussion is being updated to correspond with the newly updated algorithm. For help using these documents, please click here Discussion References Version 4.2009,10/15/09 © 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. Guidelines Index Antiemesis Table of Contents Discussion, ReferencesAntiemesis Practice Guidelines in Oncology – v.4.2009NCCN ® Summary of the Guidelines updatesSummary of the Guidelines updates Summary of the major changes in the 4.2009 version of the NCCN Antiemesis Guidelines from the 3.2009 version are: Two new pages were added to the Guidelines: and . Clofarabine, Interferon alfa > 10 million IU/m , and temozolomide have been added to moderate emetic risk. Aldesleukin 12 million IU/m has been added to low emetic risk. Pegaspargase has been added to minimal emetic risk. Summary of the major changes in the 3.2009 version of the NCCN Antiemesis Guidelines from the 2.2009 version are: � � � � � 2 2 Added “preferred” to Palonosetron with a category 2B level of evidence and consensus for the “preferred designation.” Footnote “e”: In a randomized study, a larger dose of palonosetron was used without aprepitant. Saito M, Aogi K, Sekine I, et al. Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial. Lancet Oncol 2009;10:115-124. Oral Chemotherapy - Emesis Prevention (AE-5) Emetogenic Potential of Oral Antineoplastic Agents (AE-9) AE-7 AE-8 AE-2 UPDATES Version 4.2009,10/15/09 © 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. Guidelines Index Antiemesis Table of Contents Discussion, ReferencesAntiemesis Practice Guidelines in Oncology – v.4.2009NCCN ® PRINCIPLES OF EMESIS CONTROL IN THE CANCER PATIENT 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. AE-1 � � � � � � � Prevention of nausea/vomiting is the goal. The risk of nausea/vomiting for persons receiving chemotherapy of high and moderate emetic risk lasts for at least 4 days after the last dose of chemotherapy for high and 3 days for moderate. Patients need to be protected throughout the full period of risk. Oral and IV antiemetic formulations have equivalent efficacy. Consider the toxicity of the specific antiemetic(s). Choice of antiemetic(s) used should be based on the emetic risk of the therapy, prior experience with antiemetics, as well as patient factors. There are other potential causes of emesis in cancer patients. These may include: Partial or complete bowel obstruction Vestibular dysfunction Brain metastases Electrolyte imbalance: hypercalcemia, hyperglycemia, hyponatremia Uremia Concomitant drug treatments including opiates Gastroparesis: tumor or chemotherapy (vincristine etc) induced or other causes (eg diabetes). Psychophysiologic: Consider using an H2 blocker or proton pump inhibitor to prevent dyspepsia, which can mimic nausea. � � � � � � � � � � � Anxiety Anticipatory nausea and vomiting For use of antiemetics for nausea and vomiting that are not related to radiation and/or chemotherapy, For multidrug regimens, select antiemetic therapy based on drug with the highest emetic risk. � See NCCN Palliative Care Guidelines See Emetogenic Potential of Intravenous Antineoplastic Agents (AE-7) Version 4.2009,10/15/09 © 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. Guidelines Index Antiemesis Table of Contents Discussion, ReferencesAntiemesis Practice Guidelines in Oncology – v.4.2009NCCN ® 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. AE-2 HIGH EMETIC RISK INTRAVENOUS CHEMOTHERAPY - EMESIS PREVENTIONb,c Higha �Start before chemotherapy Aprepitant 125 mg PO day 1 or fosaprepitant 115 mg IV day 1 , 80 mg PO daily days 2-3 and Dexamethasone 12 mg PO or IV days 1 - 4 and Palonosetron 0.25 mg IV day 1 (preferred,category 2B) Dolasetron 100 mg PO or 1.8 mg/kg IV or 100 mg IV day 1 or Ondansetron 16-24 mg PO or 8-12 mg (maximum 32 mg) IV day 1 ± Lorazepam 0.5-2 mg PO or IV or sublingual either every 4 or every 6 h prn days 1 - 4 ± H blocker or proton pump inhibitor b,c 2 � � � � � d f e 5-HT3 antagonist: or Granisetron 2 mg PO or 1 mg PO bid or 0.01 mg/kg (maximum 1 mg) IV day 1 or transdermal patch containing 34.3 mg granisetron applied a minimum of 24 h prior to first dose of chemotherapy maximum duration of patch is 7 days or and a d Data for post-cisplatin ( 50 mg/m ) emesis prevention are category 1, others are category 2A. Fosaprepitant dimeglumine (115 mg) may be substituted for aprepitant (125 mg) 30 minutes prior to chemotherapy, on Day 1 only of the CINV regimen as an infusion administered over 15 minutes. In a randomized study, a larger dose of palonosetron was used without aprepitant. Saito M, Aogi K, Sekine I, et al. Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial. Lancet Oncol 2009;10:115-124. Order of listed antiemetics does not reflect preference. � 2 e f bAntiemetic regimens should be chosen based on the drug with the highest emetic risk as well as patient specific risk factors. cSee Principles for Managing Multi-day Emetogenic Chemotherapy Regimens (AE-A). See Principles of Emesis Control (AE-1) (category 1, for combined regimen) See Breakthrough Treatment (AE-6) Version 4.2009,10/15/09 © 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. Guidelines Index Antiemesis Table of Contents Discussion, ReferencesAntiemesis Practice Guidelines in Oncology – v.4.2009NCCN ® 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. MODERATE EMETIC RISK CHEMOTHERAPY - EMESIS PREVENTIONb,cINTRAVENOUS Day 1 Days 2-3 Moderateh � � � � � Aprepitant 80 mg PO days 2-3 if used on Day 1 Dexamethasone 12 mg PO or IV daily or Dexamethasone 12 mg PO or IV daily or 5-HT3 antagonist: Dolasetron 100 mg PO daily or 1.8 mg/kg IV Ondansetron 8 mg PO bid or 16 mg PO daily or 8 mg (maximum 32 mg/day) IV ± H blocker or proton pump inhibitor2 ± f or Granisetron 1-2 mg PO daily or 1 mg PO bid or 0.01 mg/kg (maximum 1 mg) IV or ± Lorazepam 0.5-2 mg PO or IV or sublingual either every 4 or every 6 h prn �Start before chemotherapy Aprepitant 125 mg PO or fosaprepitant 115 mg IV day 1 in select patients and Dexamethasone 12 mg PO or IV and 5-HT3 antagonist: Dolasetron 100 mg PO or 1.8 mg/kg or 100 mg IV (category 1) or Granisetron 1-2 mg PO or 1 mg PO bid (category 1) or 0.01 mg/kg (maximum 1 mg) IV or transdermal patch containing 34.3 mg granisetron applied 24-48 h prior to first dose of chemotherapy or Ondansetron 16-24 mg PO or 8-12 mg (maximum 32 mg/day) IV (category 1) Palonosetron 0.25 mg IV (category 1) ± Lorazepam 0.5-2 mg PO or IV or sublingual either every 4 or every 6 h prn ± H blocker or proton pump inhibitor b,c 2 � � � � � d g f or and g h 2 2 2 Aprepitant should be added (to dexamethasone and a 5-HT3 antagonist regimen) for select patients receiving other chemotherapies of moderate emetic risk (for example, carboplatin, cisplatin, doxorubicin, epirubicin, ifosfamide, irinotecan or methotrexate). Data for post-carboplatin 300 mg/m , cyclophosphamide 600-1000 mg/m , doxorubicin 50 mg/m emesis prevention are category 1. � � � AE-3 bAntiemetic regimens should be chosen based on the drug with the highest emetic risk as well as patient specific risk factors. Fosaprepitant dimeglumine (115 mg) may be substituted for aprepitant (125 mg) 30 minutes prior to chemotherapy, on Day 1 only of the CINV regimen as an infusion administered over 15 minutes. Order of listed antiemetics does not reflect preference. c d f See Principles for Managing Multi-day Emetogenic Chemotherapy Regimens (AE-A). See Breakthrough Treatment (AE-6) Version 4.2009,10/15/09 © 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. Guidelines Index Antiemesis Table of Contents Discussion, ReferencesAntiemesis Practice Guidelines in Oncology – v.4.2009NCCN ® 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. Low Minimal � � Start before chemotherapy Dexamethasone 12 mg PO or IV daily or b,c Repeat daily for fractionated doses of chemotherapy Metoclopramide 10-40 mg PO or IV prior to dose and then as needed either every 4 or every 6 h or Prochlorperazine 10 mg PO or IV prior to dose and then as needed every 4 or every 6 h ± Lorazepam, 0.5-2 mg PO or IV either every 4 or every 6 h prn ± H blocker or proton pump inhibitor � � � � � i i 2 AE-4 LOW AND MINIMAL EMETIC RISK INTRAVENOUS CHEMOTHERAPY - EMESIS PREVENTIONb,c b c Antiemetic regimens should be chosen based on the drug with the highest emetic risk as well as patient specific risk factors. Monitor for dystonic reactions; use diphenhydramine 25-50 mg PO or IV either every 4 or every 6 h for dystonic reactions.i See Principles for Managing Multi-day Emetogenic Chemotherapy Regimens (AE-A). See Principles of Emesis Control (AE-1) No routine prophylaxis Breakthrough Treatment For Chemotherapy Induced Nausea/vomiting (AE-6) Version 4.2009,10/15/09 © 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. Guidelines Index Antiemesis Table of Contents Discussion, ReferencesAntiemesis Practice Guidelines in Oncology – v.4.2009NCCN ® ORAL CHEMOTHERAPY - EMESIS PREVENTIONj Prophylaxis recommended PRN recommended � Start before chemotherapy 5-HT3 antagonist: or Granisetron 2 mg PO daily or 1 mg PO BID or � � Dolasetron 100 mg PO daily Ondansetron 16-24 mg PO daily ± Lorazepam 0.5-2 mg PO or sublingual every 4 or every 6 h as needed ± H blocker or proton pump inhibitor� 2 Nausea/emesis No routine prophylaxis � Start before chemotherapy Metoclopramide 10-40 mg PO prior to dose and then as needed every 4 or every 6 h or Prochlorperazine 10 mg PO prior to dose and then as needed every 4 or every 6 h ± Lorazepam, 0.5-2 mg PO every 4 or every 6 h prn ± H blocker or proton pump inhibitor � i � � � i 2 f i j Order of listed antiemetics does not reflect preference. Monitor for dystonic reactions; use diphenhydramine 25-50 mg PO or IV either every 4 or every 6 h for dystonic reactions. These recommendations apply to oral chemotherapy only. When combined with IV agents in a combination chemotherapy regimen, the recommendations for the IV agents given should be used for their period of emetogenic risk. If multiple oral agents are combined, emetic risk may be increased and require prophylaxis. 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. AE-5 Continued nausea/emesis, recommend any of the oral 5-HT3 antagonist above Breakthrough Treatment For Chemotherapy Induced Nausea/vomiting (AE-6) Version 4.2009,10/15/09 © 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. Guidelines Index Antiemesis Table of Contents Discussion, ReferencesAntiemesis Practice Guidelines in Oncology – v.4.2009NCCN ® 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. No nausea/ emesis Any nausea/ emesis No change in antiemetic regimen �General principle of breakthrough treatment is to give an additional agent from a different drug class prn Prochlorperazine 25 mg supp pr every 12 h or 10 mg PO or IV every 4 or every 6 h or Promethazine 12.5-25 mg PO or IV every 4 h or Metoclopramide 10-40 mg PO or IV either every 4 or every 6 h or Lorazepam 0.5-2 mg PO either every 4 or every 6 h or � � � � � � � � i i i or Haloperidol 1-2 mg PO every 4-6 h prn Dolasetron 100 mg PO daily or 1.8 mg/kg IV or 100 mg IV or Ondansetron 16 mg PO or 8 mg IV daily or Granisetron 1-2 mg PO daily or 1 mg PO bid or 0.01 mg/kg (maximum 1 mg) IV or transdermal patch containing 34.3 mg granisetron or Dronabinol 5-10 mg PO either every 3 or every 6 h or Nabilone 1-2 mg PO bid or Dexamethasone 12 mg PO or IV daily or Olanzapine 2.5-5 mg PO bid (category 2B) � � � � i l Continue breakthrough medications, on a schedule, not prn Consider changing antiemetic therapy to higher-level primary treatment SUBSEQUENT CYCLES RESPONSE TO BREAKTHROUGH ANTIEMETIC TREATMENT AE-6 See Principles of Emesis Control (AE-1) BREAKTHROUGH TREATMENT FOR CHEMOTHERAPY INDUCED NAUSEA/VOMITINGc,k Nausea and emesis controlled Nausea and/or emesis uncontrolled c iMonitor for dystonic reactions; use diphenhydramine 25-50 mg PO or IV either every 4 or every 6 h for dystonic reactions. k lSee blackbox warning/label indication regarding type II diabetes, hyperglycemia and death in elderly dementia patients. See Principles for Managing Multi-day Emetogenic Chemotherapy Regimens (AE-A). See Principles of Managing Breakthrough Treatment (AE-B). Version 4.2009,10/15/09 © 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. Guidelines Index Antiemesis Table of Contents Discussion, ReferencesAntiemesis Practice Guidelines in Oncology –