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ANTIEMETIC GUIDELINES: MASCC/ESMO
ANTIEMETIC GUIDELINES: MASCC/ESMO
Open Issues for CINV
Do we reliably measure that? Do we control nausea optimally? Are guidelines useful for oral therapies related
nausea and vomiting? Breakthrough and refractory nausea and
vomiting: where we are? Are we missing something regarding
anticipatory nausea and vomiting?
ANTIEMETIC GUIDELINES: MASCC/ESMO
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AcuteNausea
AcuteVomiting
DelayedNausea
DelayedVomiting
Perc
ent o
f Pat
ient
s MD/RN predictionPatient experience
Physicians and nurses from 14 oncology practices in 6 countriesPatients [N=298] 75% women; 78% Mod emetic chemo; 50% breast cancer; 18% lung cancer
PERCEPTIONS AND REALITYUnderestimation of Emesis with Chemotherapy
Grunberg S et al., Cancer 2004; 100: 2261-8
ANTIEMETIC GUIDELINES: MASCC/ESMO
The ‘ANCHOR’ Study: Prediction vs Observed
MD/RD prediction (N=24)
Patients’ perception (N=231)
HEC MEC
Grunberg S et al., Cancer 2004; 100: 2261-8
ANTIEMETIC GUIDELINES: MASCC/ESMO
Di Maio M et al, JCO 2015
Perceptions and RealityAgreement between patient and physician reporting
Subjective toxicities are at high risk of under- reorting by phisicians, even when prospectively collected within randomized trials.
ANTIEMETIC GUIDELINES: MASCC/ESMO
Di Maio M et al, JCO 2015
Perceptions and RealityAgreement between patient and physician reporting
ANTIEMETIC GUIDELINES: MASCC/ESMO
Aapro M & Grunberg S, Educational ASCO 20122016 V.1.27
BUT WHAT IS NAUSEA?
Nausea is subjective; vomiting is objective.Therefore the accurate measuremnet of nausea is more of anobstacle
For patients nausea ( if they understand the word at all) oftenmeans << feeling bad>>
ANTIEMETIC GUIDELINES: MASCC/ESMO
2016 V.1.28
NAUSEA AND APPETITE
Several agents that have appetite stimuing properties also haveanti- nausea properties:CorticosteroidMegestrolOlanzapineDronabinol
Nausea/anorexia may be a more valid construct thennausea/vomiting
A low dose anti-nausea agent might complement anti-vomitingagents
Modified by Grunberg S & Clark-Snow, Educational ASCO 2012
ANTIEMETIC GUIDELINES: MASCC/ESMO
The MASCC/ESMO Antiemetics Guidelines Committee has discussed the presently available published data about olanzapine, which suggest that it is an effective antiemetic agent.
Olanzapine may be considered with a 5-HT3 receptor antagonist plus dexamethasone, particularly when nausea is an issue.(NOTE: Patient sedation may be a concern for the 10 mg dose.)
MASCC Level of Confidence : Low
MASCC Level of Consensus: Low
ESMO Level of Evidence: II
ESMO Grade of Recommendation: B
COMMITTEE II (5/5):
ANTIEMETIC GUIDELINES: MASCC/ESMO
2016 V.1.210
Are guidelines useful for oral therapiesrelated nausea and vomiting?
ANTIEMETIC GUIDELINES: MASCC/ESMO
HIGHHexamethylmelamineProcarbazine
MODERATEBosutinibCeritinib Crizotinib
CyclophosphamideImatinibTemozolomide
Vinorelbine
LOW
AfatinibAxatinibCapecitabineDabrafenibDasatinibEverolimusEtoposideFludarabine
IbrutinibIdelalisibLapatinibLenalidomideOlaparibNilotinibPazopanib
PonatinibRegorafenibSunitinibTegafur UracilThalidomideVandetanibVorinostat
MINIMAL
ChlorambucilErlotinibGefitinibHydroxyureaMelphalan
MethotrexateL-Phenylalanine mustardPomalidomideRuxolitinib
Sorafenib6-ThioguanineVemurafenibVismodegib
Committee I (5/5): Emetic Risk Groups – Adults – Single Oral Agents
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ANTIEMETIC GUIDELINES: MASCC/ESMO
Caveats:
Drug-drug interactions
Polipharmacotherapies
Adherence
Duration of antiemetic prophylaxis?
Rescue with antiemetic therapies?
Same guidelines of iv emetogenic therapies?
No recommendations for single oral agents-related nausea/vomiting
ANTIEMETIC GUIDELINES: MASCC/ESMO
Breakthrough Nausea and Vomiting
Breakthrough CINV is defined as nausea and/or vomiting attributable to antineoplasticchemotherapy that occurs during the acute or
delayed phase despite CINV prophylaxis.
ANTIEMETIC GUIDELINES: MASCC/ESMO
For example
Initial Presentation
Mary T. is a 56-year-old female had a mastectomy and auxiliary lymph node dissection.
Diagnosis – T3 (more than 5 cm) N0(0/6 lymph nodes) M0; poorly differentiated invasive ductal carcinoma of right breast, ER/PR positive and HER-2/neu negative.
ANTIEMETIC GUIDELINES: MASCC/ESMO
Medical history….
PAST MEDICAL HISTORY: Unremarkable.
SOCIAL HISTORY: School teacher, married, mother of two grown children, non smoker, occasional drink on the weekends.
MEDICATIONS: Ranitidine 150 mg b.i.d., Lorazepam 1 mg prn
Allergies : NKA (drugs, food, environmental allergens)
ANTIEMETIC GUIDELINES: MASCC/ESMO
First Cycle of Chemotherapy (FEC)
The patient is prescribed FEC (Fluorouracil, Epirubicin, Cyclophosphamide) – for 3 cycles followed by Taxotere for 3 cycles.
She was given Ondansetron 8 mg and Dexamethasone 8 mg prior to her first cycle of chemotherapy.
She was given a prescription for Ondansetron 8 mg and Dexamethasone 4 mg po b.i.d. x 2 days post chemotherapy as well as Metoclopramide 10 mg po q6hprn to be taken post chemotherapy.
ANTIEMETIC GUIDELINES: MASCC/ESMO
Breakthrough nausea Nausea and Vomiting post Cycle 1
When she returned for cycle two she informed that she had vomited on day 2 and that she had experienced nausea for days 2-5 post chemotherapy.
She rates this nausea as a 8/10 for days 2-4 and 6/10 for day 5, olanzapine 10 mg for three days was administered without results.
ANTIEMETIC GUIDELINES: MASCC/ESMO
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Guideline for Breakthrough Nausea and Vomiting
The available evidence for breakthrough nausea and vomiting suggests the use of 10 mg oral olanzapine, daily for 3 days.
(The mild to moderate sedation in this patient population,especially elderly patients, is a potential problem with olanzapine.)
MASCC Level of Confidence: ModerateMASCC Level of Consensus: ModerateESMO Level of Evidence: IIESMO Grade of Recommendation: B
NOTE: No guideline was felt to be appropriate for refractory nausea and vomiting.
COMMITTEE V (3/3):
ANTIEMETIC GUIDELINES: MASCC/ESMO
Olanzapine Breaktrough
ANTIEMETIC GUIDELINES: MASCC/ESMO
Refractory Nausea and Vomiting
Refrectory CINV is defined as nausea and/or vomitingattributable to antineoplastic chemotherapy whichoccurs during the acute or delayed phase despite
CINV prophylaxis in patients who have experiencedbrekthrough CINV in a previous chemotherapy cycle
ANTIEMETIC GUIDELINES: MASCC/ESMO
Second Cycle of Chemotherapy (FEC)
She was given Ondansetron 12 mg and Dexamethasone 12 mg prior to her second cycle of chemotherapy.
She was given a prescription for Ondansetron 8 mg po b.i.d. and Dexamethasone 4 mg po b.i.d. x 5 days post chemotherapy
ANTIEMETIC GUIDELINES: MASCC/ESMO
Refractory nausea Nausea and Vomiting post Cycle 2
When she returned for cycle three she informed that she had vomited on day 3-5 and that she had experienced nausea for days 3-7 post chemotherapy.
She rates this nausea as a 10/10 for days 3-4 and 6/10 for day 5-7
ANTIEMETIC GUIDELINES: MASCC/ESMOPractical Suggestions forrefractory nausea and vomiting
1) For patients receiving minimally, low emetogenicchemotherapy, upgrade or escalate the acute CINV prophylaxisto that recommended for chemotherapy of the next higherlevel of emetogenic risk.
2) For patients receiving moderately or highly emetogenicchemotherapy, we suggest that the 5-HT3 antagonist given for CINV prophylaxis be changed from ondansetron or granisetronto palonosetron or pass to NK1 antagonist
3) Stimulation of Nei Gaun (P6) by means of acupressure or electroacupuncture.
ANTIEMETIC GUIDELINES: MASCC/ESMO
MASCC/ESMO 2016 RECOMMENDATIONS
Refractory emesis
another 5-HT3 add benzodiazepines metopimazine NK1 antagonist
ANTIEMETIC GUIDELINES: MASCC/ESMO
Anticipatory nausea and vomiting
Anticipatory nausea and/or vomiting is the occurrence of nausea and/or vomiting before patients receive their chemotherapy treatment.
Challenge - Anticipatory nausea and/or vomiting occurs in 18% to 57% of chemotherapy patients.
Younger patients may be more susceptible as they generally receive more aggressive therapy and have poorer emesis control than older patients.
Adapted from: 1. Roscoe JA, et al. J Pain Symptom Manage 2000;20:113. 2. Morrow GR, et al. Support Care Cancer 1998;6:244.
ANTIEMETIC GUIDELINES: MASCC/ESMO
ANTIEMETIC GUIDELINES: MASCC/ESMO
Risk Factors
Kamen C et al, Eur J Pharmacol, 2014
ANTIEMETIC GUIDELINES: MASCC/ESMO
991 patients; perspective observational european study AN reported in 8.3-13.8% of patients Increase frequency and intensity over each cycle Key predictors of AN: pre-chemotherapy anxiety; AN and CINV
experience in previous cycle
ANTIEMETIC GUIDELINES: MASCC/ESMO
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Prevention of Anticipatory Nausea and Vomiting
The best approach for the prevention of anticipatory nausea and vomiting is the best possible control of acute and delayed nausea and vomiting.
MASCC Level of Confidence: High
MASCC Level of Consensus: High
ESMO Level of Evidence: III
ESMO Grade of Recommendation: A
COMMITTEE VI (1/2):
ANTIEMETIC GUIDELINES: MASCC/ESMO
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Prevention of Anticipatory Nausea and VomitingBehavioral therapies (progressive muscle relaxation training, in particular), systematic desensitization, and hypnosis may be used to treat anticipatory nausea and vomiting.
MASCC Level of Confidence: Moderate
MASCC Level of Consensus: Moderate
ESMO Level of Evidence: II
ESMO Grade of Recommendation: B
Benzodiazepines can reduce the occurrence of anticipatory nausea and vomiting.
MASCC Level of Confidence: Moderate
MASCC Level of Consensus: Moderate
ESMO Level of Evidence: II
ESMO Grade of Recommendation: A
COMMITTEE VI (2/2):
ANTIEMETIC GUIDELINES: MASCC/ESMO….and what about nausea between 5 to 21 days after chemotherapy?
2016 V.1.2
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ANTIEMETIC GUIDELINES: MASCC/ESMO
Grazie per la Vostra Attenzione
2016 V.1.2
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