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Mount Vernon Cancer Network GUIDELINES FOR THE MANAGEMENT OF NAUSEA AND VOMITING IN ADULT PATIENTS RECEIVING CHEMOTHERAPY AND/OR RADIOTHERAPY Applicable to Principal authors(s) Written / Updated Review Date Version number Approved by Signed (Chair) Date All staff involved in the care of patients receiving systemic anticancer therapy or radiotherapy within the Mount Vernon Cancer Network Reviewed by Ruk Parkar January 2013 January 2016 2.0 MVCN SACT Group 24 March 2014 1 GUIDELINES FOR THE MANAGEMENT OF NAUSEA AND VOMITING IN ADULT PATIENTS RECEIVING CHEMOTHERAPY AND/OR RADIOTHERAPY SCOPE The following guidelines have been designed for use within Mount Vernon Cancer Network for adult oncology and haemato-oncology patients receiving chemotherapy and/or radiotherapy. AIM To ensure appropriate prescription and administration of antiemetics for patients receiving chemotherapy and/or radiotherapy. To reduce the risk of emesis and minimise the side effects and complications of antiemetic drugs. RISK FACTORS Certain risk factors exist which predict those patients likely to be more susceptible to the emetogenic effects of chemotherapy or radiotherapy: Female gender Young (<30 years old) History of nausea and vomiting (e.g. sickness in pregnancy, motion sickness) Poor control of emesis with prior chemotherapy or radiotherapy Anxiety There should be a low threshold for increasing the level of antiemetic cover for patients with more than two of any of these risk factors. CHEMOTHERAPY Section 1: Notes on Use of Guidelines 1.1 Choice of antiemetics Consult section 2 for the antiemetic category of the relevant individual cytotoxic drugs or specific oncology/haemato-oncology chemotherapy regimen being prescribed. The categories represent minimal (category A), low (category B), moderate (category C) or high (category D) levels of emetogenicity. Choose and prescribe the appropriate pre and post chemotherapy antiemetic regimen from the relevant category listed in section 3. For combination chemotherapy regimens not specifically listed in section 2, choose the appropriate antiemetic regimen for the most emetogenic drug in the regimen. For multiple day chemotherapy regimens, prescribe the appropriate pre chemotherapy antiemetics for each day of the highest emetogenic drug and prescribe post chemotherapy antiemetics from the day after the final dose of the highest emetogenic drug. Many chemotherapy regimens for haemato-oncology patients incorporate corticosteroid treatment (commonly with prednisolone or dexamethasone). These patients should NOT receive dexamethasone as part of their antiemetic regimen even if the chemotherapy regimen falls into Category B, C or D in section 2. Generally no patient with acute leukaemia should receive dexamethasone as an antiemetic even if the drug/regimen falls into category B, C or D (although some of these regimen may include a corticosteroid as part of the anti-cancer treatment). Note: A chemotherapy regimen named in section 2 does not imply approval to prescribe, if that regimen contains a non-NICE approved high cost drug. 2 Domperidone – Although the benefits of domperidone continue to outweigh the risks, some epidemiology studies have shown that domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death. These risks may be higher in patients older than 60 years and in patients who receive daily oral doses of more than than 30mg. Domperidone should be used at the lowest effective dose, and patients should be advised to seek prompt medical attention if symptoms such as syncope or tachyarrhythmia appear during treatment. Domperidone should be avoided in patients who are taking concomitant medication know to cause QT prolongation (such as ketoconazole and erythromycin) 1.2 Anticipatory nausea and vomiting Prescribe lorazepam 1-2mg orally/sublingually at least 1 hour prior to chemotherapy, in addition to standard antiemetics. If severe, consider 1mg night before chemotherapy and 1mg on the morning of chemotherapy. 3 Section 2: Categorisation of Individual Chemotherapy Drugs and Specific Chemotherapy Regimens Notes: (a) This list is in alphabetical order based on the name of the drug or regimen. (b) Check comments column for any special instructions related to the antiemetic or chemotherapy regimen. (c) In the “tumour site” column, “various” denotes that the drug or regimen is used in more than two tumour sites. Drug / Regimen Tumour Site Antiemetic Category (refer to section 3) ABCM ABCM ABVD AC ACE ADE (AML 15) Alemtuzumab Amsacrine Asparaginase Axitinib Azacitidine BCG intravesical Bendamustine BEP Bevacizumab Bleomycin Haemato-onc Haemato-onc Haemato-onc Breast Germ cell Haemato-onc Haemato-onc Haemato-onc Haemato-onc Renal Haemato-onc Urology Haemato-onc Germ cell Lower GI Various C A D C D C A A A A A A A D A A Bortezomib Cabazitaxel Haemato-onc Prostate B B Capecitabine Carboplatin Lower GI Germ cell / gynaecology Lung Head & neck Haemato-onc / CNS Lung Haemato-onc Lower GI Haemato-onc Haemato-onc Haemato-onc Various Gynaecology Gynaecology A C Various Lung D D Haemato-onc Haemato-onc Breast Haemato-onc A B B C Carboplatin / Etoposide Carboplatin / 5-FU Carmustine CAV CDT Cetuximab Chlorambucil ChlVPP CHOP Cisplatin Cisplatin / Doxorubicin Cisplatin weekly/oral etoposide (Van Der Burg regimen) Cisplatin / 5-FU Cisplatin/ Pemetrexed Cladribine CMD CMF C-VAMP Comments or special instructions AB week only CM week only No dexamethasone as antiemetic Dexamethasone 8mg PO pre-medication to prevent reactions Dexamethasone not needed post chemo as on continuous prednisolone C C C C A A A A C D D D No Dexamethasone as antiemetic. All regimens Dexamethasone 4mg PO BD for 3 days starting day before pemetrexed + ondansetron/ domperidone/ aprepitant as per section 3. 2-CDA No Dexamethasone as antiemetic. No Dexamethasone as antiemetic. 4 CVP Cyclophosphamide Cyclophosphamide Haemato-onc Various Various Drug / Regimen Tumour Site Cyclophosphamide Cytarabine Haemato-onc Haemato-onc D B Cytarabine Haemato-onc C C-Z-DEX DA (AML 15/16) Dacarbazine Daunorubicin / Clofarabine (AML 16) Daunorubicin De Gramont (standard/modified) Deoxycoformycin Docetaxel Haemato-onc Haemato-onc Melanoma Haemato-onc C C D C Haemato-onc Lower GI C A Haemato-onc Breast A B Urology (prostate) B Docetaxel / Capecitabine Breast B Docetaxel / Carboplatin Lung / gynaecology C Lung D Head & Neck D Various C EC Breast C ECF Upper GI D ECX Upper GI D Germ cell / lung D Epi-CMF Breast C Epirubicin only Epi-CMF Breast B CMF only Epirubicin Eribulin Breast Breast C B Erlotinib Lung A ESHAP Haemato-onc D No Dexamethasone as antiemetic. Various A Oral only Docetaxel Docetaxel / Cisplatin Docetaxel/Cisplatin/5Fluorouracil Doxorubicin EP Etoposide C A C Antiemetic Category (refer to section 3) No Dexamethasone as antiemetic. Oral only IV doses <1500mg/m2 Comments or special instructions IV doses >1500mg/m2 IV doses <1000mg/m2 (No dexamethasone as antiemetic if AML) IV doses >1000mg/m2 (No dexamethasone as antiemetic if AML) No Dexamethasone as antiemetic. No dexamethasone as antiemetic No dexamethasone as antiemetic Pentostatin Dexamethasone 8mg PO BD for 3 days starting day before docetaxel + post chemo domperidone as per section 3. Given the concurrent use of prednisolone, the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel + domperidone as per section 3 Dexamethasone 8mg PO BD for 3 days starting day before docetaxel + domperidone as per section 3 Dexamethasone 8mg PO BD for 3 days starting day before docetaxel + ondansetron / domperidone as per section 3 Dexamethasone 8mg PO BD for 3 days starting day before docetaxel + ondansetron / domperidone/ aprepitant as per section 3 Docetaxel 8mg PO BD for 3 days starting day before docetaxel + ondansetron / domperidone/ aprepitant as per section 3 5 Etoposide Drug / Regimen Etoposide Everolimus Various Tumour Site B Antiemetic Category (refer to section 3) Germ cell Renal C A Lung B FAD Haemato-onc C FC (Fludarabine / Cyclophosphamide) FEC 60 FEC 75 FEC100 Haemato-onc C Breast Breast Breast C C D FLAG-Ida (AML 15) Fludarabine 5-Fluorouracil Haemato-onc Haemato-onc Various C A A FMD GCP Haemato-onc Germ cell B C Gefitinib Gemcitabine Gemcitabine / Carboplatin Gemcitabine / Cisplatin Gem-TIP Lung Various Lung Lung / Urology Germ cell A A C D D Gemtuzumab Ozogamicin Haemato-onc A Haemato-onc Haemato-onc Haemato-onc Various Sarcoma GIST / Haematoonc Renal Melanoma Lower GI A C C C C A EV Hydroxycarbamide Hyper-CVAD + Rituxumab Idarubicin Ifosfamide Ifosfamide / Doxorubicin Imatinib Interferon alfa Ipilimumab Irinotecan A A C Irinotecan / De Gramont (FOLFIRI) Irinotecan / Mitomycin C IVE Lapatinib Lower GI C Upper GI Haemato-onc Breast C C A Liposomal Doxorubicin Lomustine MACE (AML 15) Melphalan Gynaecology CNS Haemato-onc Haemato-onc B A B A Mercaptopurine Haemato-onc A IV only (except high dose etoposide for germ cell) Comments or special instructions High dose 1.6gm/m2 etoposide for germ cell If needed No Dexamethasone as antiemetic. All epirubicin doses In patients with high risk of N&V or experiencing grade 3 or 4 N&V during epirubicin doses, aprepitant may be considered. No dexamethasone as antiemetic Oral and IV Includes continuous infusional 5-FU and 5-FU + RT regimens. No Dexamethasone as antiemetic. Dexamethasone 20mg IV pre 3 weekly paclitaxel (instead of 8mg) plus other antiemetics as per section 3. Dexamethasone 20mg IV pre 3 weekly paclitaxel (instead of 8mg) plus other antiemetics as per section 3. Hydroxyurea No Dexamethasone as antiemetic. No dexamethasone as antiemetic if AML If needed No dexamethasone as antiemetic Including PO melphalan + prednisolone; IV melphalan + dexamethasone. No dexamethasone as antiemetic if ALL 6 Methotrexate Drug / Regimen Various Tumour Site A Antiemetic Category (refer to section 3) Oral and IV doses <300mg/m2 only. Comments or special instructions IV doses > 300mg/m2 (No dexamethasone as antiemetic if ALL) No dexamethasone as antiemetic Day 1 & 6 only Day 2 – 5 only Intravesical only For Mitomycin C weeks only All regimens. For Mitomycin C weeks only Methotrexate Haemato-onc C MidAC (AML 15) MiniBEAM MiniBEAM Mitomycin C Mitomycin C / Capecitabine Mitomycin C / 5-FU Mitoxantrone MM MMM MVC MVP Ofatumumab OMB Oral C-weekly Oxaliplatin Oxaliplatin / Capecitabine (XELOX) Oxaliplatin / De Gramont (FOLFOX) Paclitaxel (weekly) Haemato-onc Haemato-onc Haemato-onc Urology Lower GI Lower GI Various Breast Breast Urology Mesothelioma Haemato-onc Germ cell Haemato-onc Lower GI Lower GI C C B A B B B B B D D A C A C C Lower GI C Breast B (On paclitaxel weeks only if regimen in combination with other agents.) Paclitaxel (every 3 weeks) Gynae B Various B Paclitaxel / Carboplatin (every 3 weeks) Gynaecology / lung C PCV Pemetrexed CNS Lung / mesothelioma A B PMB PMitCEBO Gynaecology Haemato-onc D C PMitCEBO POMB Procarbazine Raltitrexed Haemato-onc Germ cell Haemato-onc Lower GI A D A B R-CHOP R-CVP Haemato-onc Haemato-onc C C No Dexamethasone as antiemetic. No Dexamethasone as antiemetic. R-ESHAP Haemato-onc D No Dexamethasone as antiemetic. R-FC Haemato-onc C Rituximab R-IVE Haemato-onc Haemato-onc A C R-MiniBEAM Haemato-onc C If needed Dexamethasone 8mg (or 6.6mg) IV pre weekly paclitaxel. Dexamathasone post chemotherapy may be omitted or given 4mg b.d.for 1 day only Dexamethasone 20mg (or 19.8mg) IV pre three weekly paclitaxel and other antiemetics as per section 3. Dexamethasone 20mg (or 19.8mg) IV pre three weekly paclitaxel plus other antiemetics as per section 3. Dexamethasone 4mg PO BD for 3 days starting day before pemetrexed + other antiemetics as per section 3. MitCE week only. No Dexamethasone as antiemetic. BO week only. Day 1 & 6 only 7 R-MiniBEAM Drug / Regimen Haemato-onc Tumour Site B Antiemetic Category (refer to section 3) R-PMitCEBO Haemato-onc C R-PMitCEBO Sorafenib Stanford V Haemato-onc Renal Haemato-onc A A C Stanford V Haemato-onc A Sunitinib Temozolamide Thalidomide Tioguanine TIP Renal CNS Haemato-onc Haemato-onc Germ cell A A A A D Topotecan Trastuzumab Trastuzumab / Docetaxel Gynaecology Breast Breast B A B Trastuzumab / Paclitaxel Breast B Trastuzumab / Vinorelbine VAD VAMP VAPEC-B Breast Haemato-onc Haemato-onc Haemato-onc A C C C VAPEC-B Vemurafenib Vinblastine Vincristine Vinorelbine Vinorelbine / Carboplatin Vinorelbine / Cisplatin VIP Z-DEX Haemato-onc Melanoma Various Various Breast / lung Lung Lung Germ cell Haemato-onc A A A A A C D D C Day 2 – 5 only Comments or special instructions MitCE week only. No Dexamethasone as antiemetic. BO week only. Week 1, 3, 5, 7, 9, 11 only. No Dexamethasone as antiemetic. Week 2, 4, 6, 8, 10, 12 only. Thioguanine Dexamethasone 20mg (19.8mg) IV pre 3 weekly paclitaxel (instead of 8mg) plus other antiemetics as per section 3. Dexamethasone 8mg PO BD for 3 days starting day before docetaxel + domperidone as per section 3. Dexamethasone 20mg (19.8mg) IV pre 3 weekly paclitaxel (instead of 8mg) plus other antiemetics as per section 3. No dexamethasone as antiemetic No dexamethasone as antiemetic Week 1 & 3 only. No Dexamethasone as antiemetic. Week 2 & 4 only No dexamethasone as antiemetic 8 Section 3: Antiemetic Regimen Categories (grouped according to emetogenic potential) Category A: MINIMAL EMETOGENIC POTENTIAL PRE CHEMOTHERAPY POST CHEMOTHERAPY No routine antiemetic indicated DOMPERIDONE 20mg PO QDS PRN Category B: LOW EMETOGENIC POTENTIAL PRE CHEMOTHERAPY POST CHEMOTHERAPY DEXAMETHASONE 8mg PO (IV only if nausea / vomiting / dysphagia) DEXAMETHASONE 4mg PO BD for 3 days And DOMPERIDONE 20mg PO QDS x 3 days, then PRN Category C: MODERATE EMETOGENIC CHEMOTHERAPY PRE CHEMOTHERAPY POST CHEMOTHERAPY ONDANSETRON 8mg PO (8mg IV if nausea/vomiting/dysphagia) and DEXAMETHASONE 8mg PO (6.6mg IV only if nausea / vomiting / dysphagia) DEXAMETHASONE 4mg PO BD for 3 day and ONDANSETRON 8mg PO BD x 1 days and DOMPERIDONE 20mg PO QDS x 5 days then PRN Category D: HIGH EMETOGENIC CHEMOTHERAPY PRE CHEMOTHERAPY POST CHEMOTHERAPY ANTIEMETIC FAILURE (see definition – section 1) Recommend Domperidone postchemotherapy to be taken regularly. Commence on first line antiemetics for breakthrough nausea and vomiting (Section 4). Treat on subsequent courses of chemotherapy as for low emetogenic (Category B). ANTIEMETIC FAILURE (see definition – section 1) Ensure took antiemetics regularly post chemotherapy (as prescribed). Commence on first line antiemetics for breakthrough nausea and vomiting (Section 4) or subsequent line if had before with no benefit. Treat on subsequent courses of chemotherapy as for moderate emetogenic (Category C). ANTIEMETIC FAILURE (see definition – section 1) Ensure took antiemetics regularly post chemotherapy (as prescribed). Commence on first line antiemetics for breakthrough nausea and vomiting (Section 4) or subsequent line if had before with no benefit. Treat on subsequent courses of chemotherapy as for high emetogenic (Category D). ANTIEMETIC FAILURE (see definition – section 1) 9 Ensure took antiemetics regularly post chemotherapy (as prescribed) and used suppositories if vomiting. Commence on first line antiemetics for breakthrough nausea and vomiting (Section 4) or subsequent line if had and before with no benefit. DOMPERIDONE Consider treating on subsequent 20mg PO QDS x 5 days then courses with: PRN Ondansetron 8mg PO BD for up to 5 Cisplatin >70mg / m2 Cisplatin >70mg / m2 days maximum As above but also: As above but also: and/or Regular antiemetic from APREPITANT 125mg PO APREPITANT 80mg PO OD Section 4 in addition to the post on days 2&3 post chemo (Fosaprepitant 150mg IVI) Day chemotherapy antiemetic regimen. 1 stat, only if nausea / vomiting / (not needed if given IV Consider aprepitant for patients with dysphagia) Fosaprepitant) grade 3 / 4 N&V if they are not already receiving it Note: TTA’s – For category D drugs/regimens, prescribe DOMPERIDONE suppositories 30mg PR QDS prn if vomiting) ONDANSETRON 8mg PO (8mg IV if nausea/vomiting/dysphagia) and DEXAMETHASONE 8mg PO (6.6mg IV only if nausea / vomiting / dysphagia) ONDANSETRON 8mg PO BD x 3 days and DEXAMETHASONE 4mg PO BD x 3 days Section 4: Breakthrough nausea and vomiting Antiemetic failure If prolonged /distressing nausea occurs, or 2 or more episodes of vomiting in 24 hours occur after a course of chemotherapy, move onto suggested antiemetic regimens for the next category level of emetogenicity. Ensure patient has taken post chemotherapy antiemetic drugs regularly as prescribed, otherwise add in drugs as below. 1st Line 2nd Line 3rd Line DRUG AND SCHEDULE COMMENTS Cyclizine Prescribe regularly in addition to 50mg PO TDS recommended post chemotherapy Or antiemetics Ondansetron 8mg BD for 3-5 days if not given already Prochlorperazine Prochlorperazine – replaces 5-10mg PO TDS or 25mg Domperidone as post chemotherapy PR TDS antiemetic or Metoclopramide Metoclopramide – replaces 10mg PO TDS or 30mg PR Domperidone as post chemotherapy QDS (max 5 days) antiemetic Lorazepam 1mg PO/SL upto TDS (2mg in patients > 100kg) 4th Line Levomepromazine 12.5mg PO nocte – BD Prescribe regularly in addition to recommended post chemotherapy antiemetics. Consider adding first line if anxiety component/anticipatory nausea Levomepromazine – replaces Metoclopramide as post chemotherapy antiemetic Consider instituting S/C infusion of Cyclizine 1st or 2nd line if severe or Cyclizine 100-150mg continuous 10 subcutaneous infusion over 24 hours vomiting occurs in inpatients. Aprepitant Only in patients who have failed the 125mg PO prior to category D antiemetic regimen and chemotherapy, followed by have CTC grade 3 / 4 Nausea and 80mg OD for 2 days after Vomiting. chemotherapy Subsequent cycles of chemotherapy: If a patient has experienced significant breakthrough nausea & vomiting on a category, then the category of antiemetic may be escalated e.g. breakthrough N&V on carboplatin (category C) may be escalated to category D antiemetics for future cycles. 5th Line RADIOTHERAPY GUIDELINES FOR PATIENTS AT MOUNT VERNON CANCER CENTRE Notes on Use of Guidelines Major determinants of emetic risk include treatment field, dose of radiotherapy administered per fraction, pattern of fractionation and previous chemotherapy. RISK AREA RECEIVING RT ANTIEMETIC REGIMEN Low Breast Head and Neck Extremities Pelvis – small field Thorax No routine antiemetics – treat symptomatically with Upper abdominal Abdominal Whole Pelvis Mantle Cranium Craniospinal Before each fraction: Dexamethasone 4-8mg PO and either: Domperidone 20mg PO or Ondansetron 4-8mg PO (or 4-8mg IV) Moderate Domperidone 20mg PO QDS prn (and Domperidone 20mg PO QDS prn after radiotherapy) High Hemibody Irradiation TBI Before each fraction Dexamethasone 8mg PO/IV and 11 Ondansetron 8mg PO (or 8mg IV) (and 8mg PO BD for one day after) Antiemetic failure: If patients suffer breakthrough nausea and vomiting while receiving the above recommended antiemetics, additional therapy should be commenced in accordance with the guidelines for breakthrough nausea and vomiting for adult chemotherapy patients in Section 4. Chemoradiation: Treat according to the highest emetogenic risk based on radiotherapy treatment field or cytotoxic drug(s)/regime. 12