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NCCN Clinical Practice Guidelines in Oncology™

Antiemesis

V.2.2008

www.nccn.org



Version 2.2008, 01/11/08 © 2008 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

MS, ReferencesAntiemesisPractice Guidelinesin Oncology – v.2.2008

NCCN®

NCCN Antiemesis Panel Members

Steve Kirkegaard, PharmDHuntsman Cancer Institute at the Universityof Utah

Mark G. Kris, MD †Memorial Sloan-Kettering Cancer Center

Dean Lim, MD †City of Hope

Michael Anne Markiewicz, PharmDUniversity of Alabama at BirminghamComprehensive Cancer Center

Lida Nabati, MD £ ÞDana-Farber/Brigham and Women's Cancer Center | Massachusetts General HospitalCancer Center

Dwight D. Kloth, PharmD, FCCP, BCOPFox Chase Cancer Center

Carli Nesheiwat, PharmD, BCOPSt. Jude Children's ResearchHospital/University of TennesseeCancer Institute

Hope S. Rugo, MD † ‡UCSF Helen Diller Family

Comprehensive Cancer Center

Steven M. Sorscher, MD †

Barbara Todaro, PharmDRoswell Park Cancer Institute

Susan Urba, MD † £University of MichiganComprehensive Cancer Center

Siteman Cancer Center at Barnes-Jewish Hospital and WashingtonUniversity School of Medicine

‡

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

Duke Comprehensive Cancer Center

Michael J. Berger, PharmD, BCOPArthur G. James & 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, BCPSH. Lee Moffitt Cancer Center & ResearchInstitute at the University of South Florida

Georgianna Ellis, MD †Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance

*

*

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Guidelines Index


MS, ReferencesAntiemesisPractice Guidelinesin Oncology – v.2.2008

NCCN®

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)

Breakthrough Treatment for Chemotherapy Induced Nausea and Vomiting (AE-5)

Emetogenic Potential of Antineoplastic Agents (AE-6)

Principles of Managing Multi-Day Emetogenic Chemotherapy Regimens (AE-A)

Principles For Managing Breakthrough Emesis (AE-B)

Radiation-induced nausea and vomiting (AE-8)

Anticipatory nausea and vomiting (AE-9)

Summary Of Guidelines Updates

Priniciples Of Emesis Control (AE-1)

Guidelines IndexPrint the Antiemesis Guideline

Order the Patient Version of 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 clinicalcircumstances to determine any patient's care or treatment. The National Comprehensive Cancer Network makes no representations nor warrantiesof any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. Theseguidelines are copyrighted by National Comprehensive Cancer Network. All rights reserved. These guidelines and the illustrations herein may notbe reproduced in any form without the express written permission of NCCN. ©2008.

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Manuscript

References

Clinical Trials:

Categories of Evidence andConsensus:NCCN

Thebelieves that the best managementfor any cancer patient is in a clinicaltrial. Participation in clinical trials isespecially encouraged.

To find clinical trials online at NCCNmember institutions,

All recommendationsare Category 2A unless otherwisespecified.

See

NCCN

click here:nccn.org/clinical_trials/physician.html

NCCN Categories of Evidence

and Consensus



http://print/

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Guidelines Index


MS, ReferencesAntiemesisPractice Guidelinesin Oncology – v.2.2008NCCN

®

SUMMARY OF GUIDELINES UPDATES

Change in the 2.2008 version of the NCCN Antiemesis Guidelines from the 1.2008 version is the addition of the 2008 manuscript.

Deleted recommendation prochlorperazine for 15 mg Spansule PO every 8 or every 12 h throughout the guidelines.

Added Vorinostat to the list of agents with low emetic risk.

Added Cetuximab, Lapatinib, Panitumumab, and Temsirolimus to the list of agents with minimal emetic risk.

The general principle of breakthrough treatment is to give an additional agent from a different drug class. Added the following

statement: No one treatment is better than the other for managing breakthrough emesis.

Multiple concurrent agents, perhaps in alternating schedules or by alternating routes, may be necessary. Added the following

statement: Dopamine antagonists (eg, metoclopramide), haloperidol, corticosteroids and agents such as lorazepam may be required.

Summary of changes in the 1.2008 version of the NCCN Antiemesis Guidelines from the 1.2007 version include:

Added footnote g: "Monitor for dystonic reactions; use diphenhydramine for dystonic reactions."

General

AE-4

AE-7

AE-B Principles for Managing Breakthrough Emesis

UPDATES

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.






Guidelines Index



®

PRINCIPLES OF EMESIS CONTROL IN THE CANCER PATIENT



AE-1

Prevention of nausea/vomiting is the goal.

The risk of emesis and nausea for persons receiving chemotherapy of high

and moderate emetic risk lasts for at least 4 days. 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 dysfunctionBrain metastases

Electrolyte imbalance: hypercalcemia, hyperglycemia, hyponatremiaUremiaConcomitant drug treatments including opiatesGastroparesis, tumor or chemotherapy (vincristine etc) induced.Psychophysiologic:

AnxietyAnticipatory nausea and vomiting

For use of antiemetics for nausea and vomiting that is not related to

radiation and/or chemotherapy, See NCCN Palliative Care Guidelines


http://palliative.pdf/







Guidelines Index



®



AE-2

HIGH EMETIC RISK CHEMOTHERAPY - EMESIS PREVENTION b,c

Higha

Start before chemotherapyAprepitant 125 mg PO day 1, 80 mg PO daily days 2-3

andDexamethasone 12 mg PO or IV day 1, 8 mg PO or IV daily days 2-4

and

± Lorazepam 0.5-2 mg PO or IV or sublingual either every 4 or every 6 h days 1-4

b,c

5-HT3 antagonist:

Ondansetron 16-24 mg PO or 8-12 mg (maximum 32 mg) IV day 1

or

Granisetron 2 mg PO or 1 mg PO bid or 0.01 mg/kg (maximum 1 mg) IV day 1

or

Dolasetron 100 mg PO or 1.8 mg/kg IV or 100 mg IV day 1or

Palonosetron 0.25 mg IV day 1

and

d

a

d

Data for post-cisplatin ( 50 mg/m ) emesis prevention are category 1, others are category 2A.

Order of listed antiemetics does not reflect preference.

2

b Antiemetic regimens should be chosen based on emetogenic potential of the chemotherapy regimen 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)

SeeBreakthroughTreatment(AE-5)






Guidelines Index



®



MODERATE EMETIC RISK CHEMOTHERAPY - EMESIS PREVENTION b,c

Day 1 Days 2-3

Moderate e

Aprepitant 80 mg PO days 2-3 if used on Day 1Dexamethasone 8 mg PO or IV daily

or

Dexamethasone 8 mg PO or IV daily or 4 mg POor IV bidor 5-HT3 antagonist:

±

e

Ondansetron 8 mg PO bid or 16 mg PO daily or

8 mg (maximum 32 mg/day) IV

or

Granisetron 1-2 mg PO daily or 1 mg PO bid or

0.01 mg/kg (maximum 1 mg) IV

or

Dolasetron 100 mg PO daily or 1.8 mg/kg IV or ± Lorazepam 0.5-2 mg PO or IV or sublingual

either every 4 or every 6 h

Start before chemotherapyAprepitant 125 mg PO in select patientsDexamethasone 12 mg PO or IV

and

5-HT3 antagonist:Palonosetron 0.25 mg IV (category 1)

or

Ondansetron 16-24 mg PO or 8-12 mg

(maximum 32 mg/day) IV (category 1)

or

± Lorazepam 0.5-2 mg PO or IV or sublingual

either every 4 or every 6 h

b,c

f

d

Granisetron 1-2 mg PO or 1 mg PO bid

(category 1) or 0.01 mg/kg (maximum 1 mg) IV

or Dolasetron 100 mg PO or 1.8 mg/kg or

100 mg IV (category 1)

and

e 2 2

2

f

Data for post-carboplatin 300 mg/m , cyclophosphamide 600-1000 mg/m ,

doxorubicin 50 mg/m emesis prevention are category 1.

Aprepitant should be added (to dexamethasone and a 5-HT3 antagonist regimen)for patients receiving the combination of an anthracycline and cyclophosphamideand select patients receiving other chemotherapies of moderate emetic risk (for example, carboplatin, cisplatin, doxorubicin, epirubicin, ifosfamide, irinotecan or

methotrexate).

AE-3

b Antiemetic regimens should be chosen based on emetogenic potential of thechemotherapy regimen as well as patient specific risk factors.

Order of listed antiemetics does not reflect preference.

c

dSee Principles for Managing Multi-day Emetogenic Chemotherapy Regimens (AE-A).

SeeBreakthroughTreatment(AE-5)






Guidelines Index



®



Low

Minimal

Start before chemotherapy

Dexamethasone 12 mg PO or IV daily

or

b,c

Repeat daily for fractionated doses of chemotherapy

Prochlorperazine 10 mg PO or IV every 4 or every 6 h

or Metoclopramide 10-40 mg PO or IV either every 4 or every 6 h

± Diphenhydramine 25-50 mg PO or IV either every 4 or every 6 h± Lorazepam, 0.5-2 mg PO or IV either every 4 or every 6 h

g

Nausea/emesis

(0–24 h)

Consider using antiemetics listed under primaryprophylaxis as treatment for low emetogenic-potential drugs

AE-4

LOW AND MINIMAL EMETIC RISK CHEMOTHERAPY - EMESIS PREVENTION b,c

b

c Antiemetic regimens should be chosen based on emetogenic potential of the chemotherapy regimen as well as patient specific risk factors.

Monitor for dystonic reactions; use diphenhydramine for dystonic reactions.

gSee Principles for Managing Multi-day Emetogenic Chemotherapy Regimens (AE-A).


No routine

prophylaxis

Breakthrough Treatment For Chemotherapy InducedNausea/vomiting (AE-5)






Guidelines Index



®



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 prnProchlorperazine 25 mg supp pr every 12 h or 10 mg PO or IV

every 4 or every 6 h

or Metoclopramide 10-40 mg PO or IV either every 4 or every 6 h

± Diphenhydramine 25-50 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

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

Dolasetron 100 mg PO daily or 1.8 mg/kg IV or 100 mg IVor Haloperidol 1-2 mg PO every 4-6 h prn

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, if not previously givenor Olanzapine 2.5-5 mg PO bid (category 2B)

or Promethazine 12.5-25 mg PO or IV every 4 h

i

Continue breakthroughmedications, on aschedule, not prn

Consider changingantiemetic therapy tohigher-level primarytreatment

SUBSEQUENTCYCLES

RESPONSE TOBREAKTHROUGHANTIEMETIC TREATMENT

AE-5


BREAKTHROUGH TREATMENT FOR CHEMOTHERAPY INDUCED NAUSEA/VOMITINGc,h

Nausea andemesis controlled

Nausea and/or emesis uncontrolled

c

gMonitor for dystonic reactions; use diphenhydramine for dystonic reactions.h

i

See blackbox warning/label indication regarding type II diabetes and hyperglycemia.

See Principles for Managing Multi-day Emetogenic Chemotherapy Regimens (AE-A).

See Principles of Managing Breakthrough Treatment (AE-B).







Guidelines Index



®

EMETOGENIC POTENTIAL OF ANTINEOPLASTIC AGENTS

AC combination defined as either doxorubicin

or epirubicin with cyclophosphamide

Altretamine

Cyclophosphamide > 1,500 mg/m

Carmustine > 250 mg/m

Cisplatin 50 mg/m

2

2

2

AGENTLEVEL

j

kProportion of patients who experience emesis in the absence of effective antiemetic prophylaxis

Daily use of antiemetics is not recommended based on clinical experience.

Low emetic risk,level 2 (See AE-7)

Minimal emetic risk,

level 1 (See AE-7)

AE-6

Adapted with permission from:Hesketh PJ, et al. Proposal for classifying the acute emetogenicity of cancer chemotherapy. J. Clin Onc 15: 103-9, 1997.Grunberg SM, Osoba D, Hesketh PJ, et al. Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity---an update. Support Care Cancer 2005;13:80-84.

Epub 2004 Dec 14.



High emetic risk(> 90 % frequency of emesis) j

Moderate emetic risk

(30- 90 % frequency of emesis j

Dacarbazine

Mechlorethamine

Procarbazine (oral)

Streptozocin

Aldesleukin > 12-15 million units/mAmifostine > 300 mg/m

Arsenic trioxide

Azacitidine

Busulfan > 4 mg/d

Carboplatin

Carmustine 250 mg/m

Cisplatin < 50 mg/m

Cyclophosphamide 1,500 mg/mCyclophosphamide (oral)

Cytarabine > 1 g/m

Dactinomycin

Daunorubicin

Doxorubicin

2

2

2

2

2

2

EpirubicinEtoposide (oral)

Idarubicin

Ifosfamide

Imatinib (oral)

Irinotecan

Lomustine

Melphalan > 50 mg/m

Methotrexate 250 - > 1,000 mg/mOxaliplatin > 75 mg/m

Temozolomide (oral)

Vinorelbine (oral)

k

2

22

G id li I d








Guidelines Index



®



AE-7

EMETOGENIC POTENTIAL OF ANTINEOPLASTIC AGENTS

AGENTLEVEL

Low emetic risk(10-30 % frequency of emesis) j

Amifostine 300 mgBexarotene

Capecitabine

Cytarabine (low dose) 100-200 mg/m

Docetaxel

Doxorubicin (liposomal)

Etoposide

Fludarabine (oral)

5-Fluorouracil

2

GemcitabineMethotrexate > 50 mg/m < 250 mg/m

Mitomycin

Mitoxantrone

Paclitaxel

Paclitaxel-albumin

Pemetrexed

Topotecan

Vorinostat

2 2

Minimal emetic risk(< 10 % frequency of emesis) j

Lapatinib

Lenalidomide

Melphalan (oral low-dose)

Methotrexate 50 mg/m

Nelarabine

Panitumumab

Pentostatin

RituximabSorafenib

Sunitinib

Temsirolimus

Thalidomide

Thioguanine (oral)

Trastuzumab

Valrubicin

Vinblastine Vincristine

Vinorelbine

2

Alemtuzumab

Alpha Interferon

Asparaginase

Bevacizumab

Bleomycin

Bortezomib

Busulfan

CetuximabChlorambucil (oral)

Cladribine (2-chlorodeoxyadenosine)

Decitabine

Denileukin diftitox

Dasatinib

Dexrazoxane

Erlotinib

FludarabineGefitinib

Gemtuzumab ozogamicin

Hydroxyurea (oral)

jProportion of patients who experience emesis in the absence of effective antiemetic prophylaxis

Adapted with permission from:Hesketh PJ, et al. Proposal for classifying the acute emetogenicity of cancer chemotherapy. J. Clin Onc 15: 103-9, 1997.Grunberg SM, Osoba D, Hesketh PJ, et al. Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity---an update. Support Care Cancer 2005;13:80-84.

Epub 2004 Dec 14.

Guidelines Index








Guidelines Index



®

EMETOGENIC

POTENTIAL

TYPE OF RADIATION

THERAPYEMESIS PREVENTION BREAKTHROUGH TREATMENT

Radiation-inducednausea/vomiting

RT - upper abdomen

RT - Other sites

Chemotherapy and RT

Total body irradiation

None

Start pretreatment for each day of RT treatment:

Dexamethasone 4 mg PO daily

or

Granisetron 2 mg PO daily

Ondansetron 8 mg PO bid

±

Start pretreatment for each day of RTtreatment:

Granisetron 2 mg PO daily, or 3 mg IV

daily (category 2B)

± Dexamethasone 2 mg PO tid

Ondansetron 8 mg PO bid-tid

or See BreakthroughTreatment (AE-5)

Start pretreatment for each dayof RT treatment

Ondansetron, 8 mg PO bid-tid



AE-8


See emesis prevention for chemotherapy-induced nausea/vomiting

and(High AE-2, Moderate AE-3 Low AE-4)

Guidelines Index








Guidelines Index



®



ANTICIPATORY EMESIS PREVENTION/TREATMENT

Anticipatory

nausea/vomiting

Prevention:

Behavioral therapy:

Hypnosis/guided imagery

Music therapy

Acupuncture/acupressure

Alprazolam 0.5-2 mg PO tid beginning on the night before treatment

Lorazepam 0.5-2 mg PO on the night before and morning of treatment

Use optimal antiemetic therapy during every cycle of treatment

Relaxation/systematic desensitization

See primary and breakthrough treatments for chemotherapy-induced

nausea/vomiting (Antiemesis TOC)

AE-9







Antiemesis

Guidelines Index


MS, ReferencesPractice Guidelinesin Oncology – v 2 2008NCCN

®





Version 2.2008, 01/11/08 © 2008 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this i llustration may not be reproduced in any form w ithout the express writt en permission of NCCN. REF-7

Antiemesis ,in Oncology – v.2.2008 NCCN

108. Redd WH, Andrykowski MA. Behavioral intervention in cancertreatment: Controlling aversion reactions to chemotherapy. J ConsultClin Psychol 1982;50:1018-1029.

109. Razavi D, Delvaux N, Farvacques C, et al. Prevention ofadjustment disorders and anticipatory nausea secondary to adjuvantchemotherapy: A double-blind, placebo-controlled study of assessingthe usefulness of alprazolam. J Clin Oncol 1993;11:1384-1390.

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