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MASCC/ESMO Antiemetic Guideline 2013 Multinational Association of Supportive Care in Cancer

MASCC/ESMO Antiemetic Guideline 2013 Multinational Association of Supportive Care in Cancer Organizing and Overall Meeting Chairs: Richard J. Gralla, MD Fausto Roila, MD Maurizio Tonato, MD J ø rn Herrstedt, MD.

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MASCC/ESMO Antiemetic Guideline 2013 Multinational Association of Supportive Care in Cancer

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  1. MASCC/ESMO Antiemetic Guideline 2013 Multinational Associationof Supportive Care in Cancer Organizing and Overall Meeting Chairs: Richard J. Gralla, MD Fausto Roila, MD Maurizio Tonato, MD Jørn Herrstedt, MD

  2. These slides are provided to all by the Multinational Association of Supportive Care in Cancer and can be used freely provided no changes are made and the MASCC logo and date of the information are retained. For questions please contact: Prof. Alex Molassiotis- alex.molasiotis@polyu.edu.hk or alex.molassiotis@manchester.ac.uk Chair, MASCC Antiemetic Study Group

  3. ANTIEMETIC GUIDELINE CONSENSUS: MASCC/ESMO - A few comments on this guideline set - • This set of guideline slides represents the latest edition of the guideline process. • This set of panels has been endorsed by the MASCC antiemetic guideline committee. • The guidelines are based on the Perugia Consensus Conference on Antiemetic Therapy June 2009. • Latest update January 2013.

  4. Matti Aapro, MD Enzo Ballatori, PhD Emilio Bria, MD Rebecca Clark-Snow, RN, BSN, OCN Lawrence Einhorn, MD Birgitte Espersen, RN Petra Feyer, MD Richard Gralla, MD Steven Grunberg, MD Jørn Herrstedt, MD Paul Hesketh, MD Karin Jordan, MD Mark Kris, MD Ernesto Maranzano, MD Alexander Molassiotis, RN, PhD Gary Morrow, PhD Ian Olver, MD, PhD Bernardo Rapoport, MD Cynthia Rittenberg, RN, MN, AOCN Fausto Roila, MD Mitsue Saito, MD Maurizio Tonato, MD David Warr, MD PARTICIPANTS IN THE PERUGIAANTIEMETIC GUIDELINE PROCESS: MASCC/ESMO

  5. CONTINENTS AND COUNTRIES OF PARTICIPANTS IN ANTIEMETIC GUIDELINE PROCESS: MASCC/ESMO Asia Africa Australia/Oceania Europe North America Japan South Africa Australia Denmark Germany France Italy Switzerland United Kingdom Canada United States of America

  6. SUMMARY ACUTE NAUSEA AND VOMITING + + APR or FOS 5HT3 DEX + 5HT3 DEX + APR + + 5HT3 DEX APR or FOS 5HT3 + DEX + APR + PALO DEX PALO + DEX DEX OR 5HT3 OR DRA DEX 5HT3 = serotonin receptor antagonist DEX = DEXAMETHASONE APR = APREPITANT; FOS= FOSAPREPITANT PALO = PALONOSETRON DRA = dopamine receptor antagonist * NOTE: If the NK1 receptor antagonist is not available for AC chemotherapy, palonosetron is thepreferred 5-HT3 receptor antagonist.The Antiemetic Subcommittee of The Multinational Association of Supportive Care in Cancer. - Ann Oncol 2010; www.mascc.org.

  7. SUMMARY DELAYED NAUSEA AND VOMITING DEX* APR* + 5HT3 DEX + APR APR or none** 5HT3 + DEX + APR DEX PALO + DEX DEX DEX = DEXAMETHASONE APR= APREPITANT * DEX only, if FOSAPREPITANT used on Day 1 ** If FOSAPREPITANT used on Day 1 The Antiemetic Subcommittee of The Multinational Association of Supportive Care in Cancer. Ann Oncol 2010; www.mascc.org .

  8. ANTIEMETIC GUIDELINES: MASCC/ESMO- The Process - Each committee worked on its area of concentration prior to the Perugia Meeting. At Perugia, each committee chair presented the findings of that committee to the entire group, and included the suggested rating of the level of evidence / confidence of the guideline. Group discussion and consensus voting then followed each presentation. What were the criteria for consensus? Degree of consensus required: 67% or greater agreement among the panelists was required to change a guideline. Basis of evidence to change an existing guideline: Compelling evidence was required based on well-conducted trials, generally with a comparator felt to be consistent with guidelines and representing best practice. Generally at least a 10% difference was considered to be the minimum degree of benefit sufficient for change.

  9. ANTIEMETIC GUIDELINES: MASCC/ESMO- Committees and their Areas (1/2) - • Emetic classification of antineoplastic agents • Acute emesis: Highly emetic chemotherapy • Delayed emesis: Highly emetic chemotherapy • Acute emesis: Moderately emetic chemotherapy • Delayed emesis: Moderately emetic chemotherapy

  10. ANTIEMETIC GUIDELINES: MASCC/ESMO- Committees and their Areas (2/2) - VI. Emesis induced by minimal or low emetic risk chemotherapy VII. Additional Issues: Refractory emesis, rescue antiemetic therapy, multiple-day chemotherapy, high-dose chemotherapy VIII. Anticipatory emesis IXA. Radiotherapy-induced emesis IXB. Antiemetics in children receiving chemotherapy X. Future Considerations: Research Directions, Study Design, Economic Considerations

  11. ANTIEMETIC GUIDELINES: MASCC/ESMO Process for the future: Keeping the Guidelines Accurate, Up-to-Date, and Valid Ongoing process to address emerging evidence in the future: • Committees are permanent • Each chair queries the committee every 6 monthsregarding whether there is new information which may affect the guideline • A steering committee queries the chairs for these suggestions • If evidence appears compelling, all group members are notified for their opinions • If consensus is achieved, the Web-Guideline document (MASCC) is updated.

  12. MASCC/ESMO Antiemetic Guidelines Committee I (1/5): The Four Emetic Risk Groups

  13. MASCC/ESMO Antiemetic Guidelines Committee I (2/5): Emetic Risk Groups – Single IV Agents

  14. MASCC/ESMO Antiemetic Guidelines Committee I (3/5): Emetic Risk Groups – Single IV Agents

  15. MASCC/ESMO Antiemetic Guidelines Committee I (4/5): Emetic Risk Groups – Single IV Agents

  16. MASCC/ESMO Antiemetic Guidelines 2011 Committee I (5/5): Emetic Risk Groups – Single Oral Agents

  17. COMMITTEE II: Guideline for the Prevention of Acute Nausea and Vomiting Following Chemotherapy of High Emetic Risk: To prevent acute nausea and vomiting following chemotherapy of high emetic risk, a three-drug regimen including single doses of a 5-HT3 receptor antagonist, dexamethasone, and aprepitant (or fosaprepitant) given before chemotherapy is recommended. Level of confidence : High Level of consensus: High

  18. COMMITTEE III: Guideline for the Prevention of Delayed Nausea and Vomiting Following Chemotherapy of High Emetic Risk: In patients receiving cisplatin treated with a combination of aprepitant (or fosaprepitant*), a 5-HT3 receptor antagonist and dexamethasone to prevent acute nausea and vomiting, the combination of dexamethasone and aprepitant* is suggested to prevent delayed emesis, on the basis of its superiority to dexamethasone alone. *However, if fosaprepitant is used in Day 1, only dexamethasone is required at days 2-4 post-chemotherapy. Level of confidence: High Level of consensus: Moderate

  19. COMMITTEE IV (1/3): Guideline for the Prevention of Acute Nausea and Vomiting Following Chemotherapy of Moderate Emetic Risk: Women receiving a combination of anthracycline plus cyclophosphamide represent a situation with a particularly great risk of nausea and vomiting. To prevent acute nausea and vomiting, a three-drug regimen including single doses of a 5-HT3 receptor antagonist, dexamethasone, and aprepitant (or fosaprepitant), given before chemotherapy is recommended. Level of confidence: High Level of consensus: High * NOTE: If the NK1 receptor antagonist is not available for AC chemotherapy, palonosetron is the preferred 5-HT3 receptor antagonist.

  20. COMMITTEE IV (2/3): Guideline for the Prevention of Acute Nausea and Vomiting Following Chemotherapy of Moderate Emetic Risk: In patients who receive chemotherapy of moderate emetic risk, not including a combination of anthracycline plus cyclophosphamide, palonosetron plus dexamethasone is recommended for prophylaxis of acute nausea and vomiting. Level of confidence: moderate Level of consensus: moderate

  21. COMMITTEE IV (3/3): Guideline for the Prevention of Acute Nausea and Vomiting Following Chemotherapy of Moderate Emetic Risk: The recommended dose of dexamethasone for prophylaxis of acute nausea and vomiting from chemotherapy of moderate emetic risk is 8 mg intravenously x 1. Level of confidence: Moderate Level of consensus: High

  22. Recommended Doses of Serotonin Receptor(5-HT3) Antagonists for Acute Emesis + 5HT3 DEX + APR 5HT3 + DEX + APR PALO + DEX DEX * Randomized studies have tested the 8 mg twice daily schedule ** The 1 mg dose preferred by some panelists *** Oral dosing recommended rather than IV due to potential QT interval prolongation

  23. Recommended Corticosteroid* (dexamethasone) Dosing * While corticosteroids other than dexamethasone are effective antiemetics, the dose and schedule of dexamethasone coupled with its wide availability in various dose forms established it as the guideline agent of choice ** The 12 mg dose of dexamethasone is the only one tested with aprepitant in large randomized trials

  24. Recommended NK1 Receptor Antagonist Dosing* * As of this update, Aprepitant and Fosaprepitant are the only approved antiemetic NK1 antagonists. ** Fosaprepitant is an intravenously administered pro-drug of aprepitant. In the countries in which fosaprepitant is available, it is indicated to replace the three-day course of oral aprepitant (125 mg) only. It should be adminisered at a dose of 150mg IV on day 1 ONLY. If aprepitant is used on the day of chemotherapy, it should be followed on each of the next two days by oral aprepitant 80 mg daily. [Fosaprepitant was approved on its similar pharmacokinetic profile (Lasseter et al. J Clin Pharm. 47, 834 - 840; 2007) when tested against aprepitant, not by comparative antiemetic clinical trials].

  25. COMMITTEE V (1/3): Guideline for the Prevention of Delayed Nausea and Vomiting Following Chemotherapy of Moderate Emetic Risk: Patients who receive moderately emetic chemotherapy known to be associated with a significant incidence of delayed nausea and vomiting should receive antiemetic prophylaxis for delayed emesis. Level of confidence: High Level of consensus: High

  26. COMMITTEE V (2/3): Guideline for the Prevention of Delayed Nausea and Vomiting Following Chemotherapy of Moderate Emetic Risk: In patients with breast cancer receiving a combination of anthracycline plus cyclophosphamide treated with a combination of aprepitant (or fosaprepitant), a 5-HT3 receptor antagonist and dexamethasone to prevent acute nausea and vomiting, aprepitant* should be used to prevent delayed nausea and vomiting (*or none if fosaprepitant is used on day 1). MASCC Level of confidence: Moderate MASCC Level of consensus: Moderate

  27. COMMITTEE V (3/3): • Guideline for the Prevention of Delayed Nausea and Vomiting Following Chemotherapy of Moderate Emetic Risk: • In patients receiving chemotherapy of moderate emetic risk (which does not include a combination of anthracycline plus cyclophosphamide) in which palonosetron is recommended, multiday oral dexamethasone treatment is the preferred treatment for the prevention of delayed nausea and vomiting. • Level of confidence: Moderate • Level of consensus: Moderate

  28. COMMITTEE VI (1/3): Guideline for prevention of acute nausea and vomiting in patients receiving low risk emetic agents: A singleantiemetic agent such as dexamethasone, a 5-HT3 receptor antagonist or a dopamine receptor antagonist, such as metoclopramide, is suggested for prophylaxis in patients receiving agents of low emetic risk. Level of confidence: No confidence possible Level of consensus: Moderate

  29. COMMITTEE VI (2/3): • Guideline for prevention of acute nausea and vomiting in • patients receiving minimal risk antineoplastic agents*: • No antiemetic should be routinely administered before chemotherapy in patients without a history of nausea and vomiting. • Level of confidence: No confidence possible • Level of consensus: High *While unusual at this emetic level, if a patient experiences emesis it is advised that with subsequent chemotherapytreatments the regimen for the next higher emetic level should be given.

  30. COMMITTEE VI (3/3): • Guideline for prevention of delayed nausea and vomiting in • patients receiving low or minimal risk antineoplastic agents*: • No antiemetic should be administered for the prevention of • delayed emesis induced by low or minimally emetic chemotherapy. • Level of confidence: No confidence possible • Level of consensus: High *While unusual at this emetic level, if a patient experiences emesis it is advised that with subsequent chemotherapytreatments the regimen for the next higher emetic level should be given.

  31. COMMITTEE VII: Guideline for patients receiving multiple-day cisplatin: Patients receiving multiple-day cisplatin should receive a 5-HT3 receptor antagonist plus dexamethasone for acute nausea and vomiting and dexamethasone for delayed nausea and vomiting. Level of confidence: High; Level of consensus: High For cisplatin given on days 1-5, the addition of an NK1 receptor antagonist (aprepitant or fosaprepitant) could be considered starting no later that day 3. The optimal administration schedule for the NK1 receptor antagonist is not yet defined. Level of confidence: Low; Level of consensus: Low No guideline was felt to be appropriate for rescue antiemesis or high-dose (i.e. transplant) chemotherapy. 5-HT3 receptor antagonists should be dosed day 1-5, except for palonosetron that should be dosed on days 1, 3 and 5 only. Note:

  32. COMMITTEE VIII(1/2): • Guidelines for prevention of anticipatory nausea and vomiting • The best approach for anticipatory emesis is the best possible control of acute and delayed emesis. • MASCC level of confidence: High • MASCC level of consensus: High

  33. COMMITTEE VIII(2/2): Guideline for the prevention ofanticipatory nausea and vomiting Behavioral therapies, in particular progressive muscle relaxation training, systematic desensitization and hypnosis, can be used to treat anticipatory nausea and vomiting. Level of confidence: High Level of consensus: High Benzodiazepines are the only drugs that reduced the occurrence of anticipatory nausea and vomiting but their efficacy tended to decrease as chemotherapy treatments continue. Level of confidence: Moderate Level of consensus: Moderate

  34. COMMITTEE IXA (1/5)- Levels of Emetic Risk with Radiation Therapy - TBI: total body irradiation, HBI: half body irradiation, UBI: upper body irradiation * in concomitant radiochemotherapy the antiemetic prophylaxis is according to the chemotherapy-related antiemetic guidelines of the corresponding risk category, unless the risk of emesis is higher with radiotherapy than chemotherapy

  35. COMMITTEE IXA (2/5): • Guideline for the prevention of nausea and vomiting in Patients receiving highly emetic radiation therapy: TBI, Total nodal irradiation • Patients receiving highly emetic radiation therapy should receive • a 5-HT3 receptor antagonist plus dexamethasone. • Level of confidence: High (Moderate with the addition of dexamethasone)Level of consensus: High

  36. COMMITTEE IXA (3/5): • Guideline for the prevention of nausea and vomiting in patients receiving moderately emetic radiation therapy: Upper abdomen, HBI, UBI • Patients receiving moderately emetic radiation therapy should receive a 5-HT3 receptor antagonist and optional short course dexamethasone. • Level of confidence: High (Moderate with the addition of dexamethasone) • Level of consensus: High

  37. COMMITTEE IXA (4/5): • Guideline for the prevention of nausea and vomiting in patients receiving radiation therapy of low emetic risk: Cranium,craniospinal, H & N, lower thorax region, pelvis • Patients receiving radiation therapy of low emetic risk should receive prophylaxis or rescue with a 5-HT3 receptor antagonist. • Level of confidence: Moderate (Low for rescue) • Level of consensus: High

  38. COMMITTEE IX (5/5): • Guideline for the prevention of nausea and vomiting in patients receiving radiation therapy of minimal emetic risk: Extremities, breast • Patients receiving radiation therapy of minimal emetic risk should receive rescue with a dopamine receptor-antagonist or a 5-HT3 receptor antagonist. • Level of confidence: Low • Level of consensus: High

  39. COMMITTEE IXB (1/3)- Antiemetics in children - • Guideline for the prevention of nausea and vomiting following chemotherapy of high and moderate emetic risk in children: • All pediatric patients should receive antiemetic prophylaxis with a combination of a 5-HT3 receptor antagonist and dexamethasone. • Level of confidence: Moderate • Level of consensus: High

  40. COMMITTEE IXB (2/3)- Antiemetics in children - • Guideline for the prevention of delayed nausea and vomiting following chemotherapy of high and moderate emetic risk in children: • No appropriate studies are available for the prevention of delayed nausea and vomiting in children and therefore no formal recommendation is possible. • Many panelists feel that in the absence of studies, children should be treated in a manner similar to that of adults receiving chemotherapy of this risk. Doses should be adjusted appropriately for children.

  41. COMMITTEE IXB (3/3)- Antiemetics in children - • Guideline for the prevention of nausea and vomiting following chemotherapy of minimal and low emetic risk in children: • No appropriate studies are available in this setting for children, and therefore no formal recommendation is possible. • Many panelists feel that in the absence of studies, children should be treated in a manner similar to that of adults receiving chemotherapy of this risk. Doses should be adjusted appropriately for children.

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