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Wednesday, March 30, 2011 12:30pm – 12:45pm Lunch 12:45pm – 2:00pm Program

Best Practices for the Management of Chemotherapy-Induced Nausea and Vomiting (CINV): A Value-Based Approach. Wednesday, March 30, 2011 12:30pm – 12:45pm Lunch 12:45pm – 2:00pm Program Lowe’s Philadelphia Hotel • Philadelphia, PA.

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Wednesday, March 30, 2011 12:30pm – 12:45pm Lunch 12:45pm – 2:00pm Program

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  1. Best Practices for the Management ofChemotherapy-Induced Nausea and Vomiting(CINV): A Value-Based Approach Wednesday, March 30, 2011 12:30pm – 12:45pm Lunch 12:45pm – 2:00pm Program Lowe’s Philadelphia Hotel • Philadelphia, PA Held in conjunction with the Association for Value-Based Cancer Care’s (AVBCC’s) First Annual Stakeholder Integration Conference

  2. Sequencing, Dosing, Potential Interactions, and Adverse Events of Novel Agents Beth Faiman, RN, MSN, CNP, AOCN Nurse Practitioner Specializing in Myeloma Cleveland Clinic Foundation

  3. Chemotherapy-Induced Nausea and Vomiting (CINV) • Consequences of CINV: • Non-compliance with treatment • Treatment interruptions • Unwillingness or inability to eat and/or drink • Nutritional deficits • Decreased quality of life, survival? • Treatment (dose, type of agent) • Personal factors (age, history of CINV, ETOH use, concurrent radiation) Feyer, P., & Jordan, K. Update and new trends in antiemetic therapy: the continuing need for novel therapies. Annals of Oncology.

  4. Characteristics of Delayed-Onset CINV • Nausea and vomiting >24 hrs after chemo • Up to 7 days following treatment • More common if treated with high doses of chemotherapy • Stomach upset up to 72 hours following chemo • With or without preventative therapy NCCN Guidelines v3.2011. Available: http://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf . Accessed February 23, 2011.

  5. Classification and Risk for CINV NCCN Guidelines v3.2011. Available: http://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf . Accessed February 23, 2011.

  6. Is Your Patient at Risk for CINV? • Level 1 Level 2Level 3Level 4 • (>10%) (10%–30%) (31%–90%) (>90%) • Bleomicin Bortezomib CarboplatinCarmustine • BusulfanCetuximabCyclophoshamideCisplatin • VinbalstineCytarabine (>1.5 g/m2) Cyclophosphamide • Vinorelbine (>100 mg/m2) Cytarabine (>1.5 g/m2) • Fludrabine Docetaxel Daunorubicin Dacarbazine • Cladribine Etoposide Doxorubicin Mechlorethamine • Bevacizumab Flouracil Epirubicin Streptozocin • Gemcitabine Idarubicin • Ixabepilone Ifosfamide • Lapatinib Irinotecan • Methotrexate Oxaliplatin • Mitomicyn • Mitoxantrone • Paclitaxel • Pemetrexed • Temsirolimus • Topotecan • Trastuzumab Minimally emetogenic Low risk Moderate High Risk From: Tuca, A. (2009). Use of granisetrontransdermal system in the prevention of chemotherapy-induced nausea and vomiting: a review. Cancer Management and Research, Volume 2010:2 Pages 1 - 12 DOI 10.2147/CMR.S4953, NCCN guidelines v3.2011

  7. Chemotherapy-Induced Nausea and Vomiting (CINV): Novel Agents • Prophylaxis and treatment of CINV includes novel and traditional therapies: • 5-hydroxytryptamine 3 (5-Ht3) receptor antagonists • Neurokinin 1 ( NK1) receptor antagonists, dopamine receptor antagonists • Corticosteroids, benzodiazepines, neuroleptics and cannabinoids Feyer, P., & Jordan, K. Update and new trends in antiemetic therapy: the continuing need for novel therapies. Annals of Oncology ; NCCN Guidelines v3.2011. Available: http://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf . Accessed February 23, 2011.

  8. Antiemetic Prevention is Based on Risk Category • Delayed: Prophyllaxis 2-3 days after (ASCO); 2-4 days (NCCN) • ASCO, NCCN and MSACC: • All unanimously suggest a combination of a5-HT3RA, dexamethasone, and aprepitant within 24 hoursfor acute CINV with highly emetogenic chemotherapy • Questions remain regarding best use of aprepitant, dexamethasone, lorazepam for delayed onset CINV in moderate or severely emetogenic regimens

  9. Jordan, K. et al. Oncologist 2007;12:1143-1150

  10. General Recommendations for CINV: Sequencing Kris MG, Hesketh PJ, Somerfield MR, et al. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006.J ClinOncol. 2006;24:2932–2947; NCCN Guidelines v3.2011. Available: http://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf . Accessed February 23, 2011.

  11. Dose and Sequencing: Low-Risk Emetogenic Regimens ASCO: • Dexamethasone(8 mg) if appropriate • No routine preventive use of antiemetic for delayed emesis NCCN: • Metoclopramide w/wodiphenhydramine; • Dexamethasone(12 mg) or • Prochlorperazine, w/wolorazepam

  12. Dose and Sequencing of Novel Agents: Moderately Emetogenic - D1 • 5HT3 agonist : • Dolasetron 100mg PO or • Granisetron 1 mg PO BID or 2 mg daily or • Ondansetron 16-24mg PO or up to 8-12mg IV or • Palonesetron 0.25mg IV day 1 only • PLUS Dexamethasone 12mg PO/IV • w/wo NK1 agonist: • Aprepitant 125mg PO (with dex) • Fosaprepitant 115mg IV • Casoprepitant • Lorazepam .5mg-2mg PO/IV/SL q4-6h PRN • H2 blocker, PPI Kris MG, Hesketh PJ, Somerfield MR, et al. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006.J ClinOncol. 2006;24:2932–2947; NCCN Guidelines v3.2011. Available: http://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf . Accessed February 23, 2011. Grunberg, S., Warr, D., Gralla, R., Rapoport, B., Hesketh, P., Jordan, K., et al. (2010). Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity—state of the art. Supportive Care in Cancer, 1-5.

  13. Dose and Sequencing of Novel Agents: Moderately Emetogenic- Day 2-4 • 5HT3 agonist- Monotherapy • Dolasetron 100mg PO or • Granisetron 1 mg PO BID or 2 mg daily or • Ondansetron 8-16mg PO BID OR • Dexamethasone monotherapy 8mg PO/IV • w/wo NK1 agonist (if used D1): • Aprepitant 80mg PO • Lorazepam .5mg-2mg PO/IV/SL q4-6h PRN • H2 blocker, PPI • PRN breakthrough: • Olanzapine, cannabinoids, phenothiazine

  14. Dose and Sequencing of Novel Agents: Highly Emetogenic-D1 5HT3 agonist : • Dolasetron 100mg PO or • Granisetron 1 mg PO BID or 2 mg daily or • Ondansetron 16-24mg PO or up to 8-12mg IV or • Palonesetron 0.25mg IV day 1 only • PLUS Dexamethasone 12mg PO/IV • With NK1 agonist: • Aprepitant 125mg PO (with dex) • Fosaprepitant150mg • Casoprepitant • Lorazepam .5mg-2mg PO/IV/SL q4-6h PRN • H2 blocker, PPI Kris MG, Hesketh PJ, Somerfield MR, et al. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006.J ClinOncol. 2006;24:2932–2947; NCCN Guidelines v3.2011. Available: http://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf . Accessed February 23, 2011. Grunberg, S., Warr, D., Gralla, R., Rapoport, B., Hesketh, P., Jordan, K., et al. (2010). Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity—state of the art. Supportive Care in Cancer, 1-5.

  15. Dose and Sequencing of Novel Agents: Highly Emetogenic- Day 2-4 5HT3 agonist- Monotherapy • Dolasetron 100mg PO or • Granisetron 1 mg PO BID or 2 mg daily or • Ondansetron 8-16mg PO BID OR Dexamethasone monotherapy 8mg PO/IV With NK1 agonist: • Aprepitant 80mg PO • Lorazepam .5mg-2mg PO/IV/SL q4-6h PRN • H2 blocker, PPI • PRN breakthrough: • Olanzapine, cannabinoids, phenothiazine

  16. Interactions/Considerations:Novel Agents • Aprepitant • Metabolized by cytochrome P450 (CYP) 3A4 • AVOID pimozide, terfenadine, astemizole, or cisapride • Warfarin –Decreased INR • Decreased efficacy of hormonal contraceptives (up to 28 days after) • Dexamethasone should be decreased 50% when used in combination with aprepitant EMEND package insert. Accessed online February 23, 2011 at http://www.merck.com/product/usa/pi_circulars/e/emend_iv/emend_iv_pi.pdf

  17. Considerations with Novel Agents • Dexamethasone • Highly effective for HEC • Underutilized antiemetic but affects nearly every body system • Side effects (select) • moderate-to-severe insomnia (45%), • indigestion/epigastric discomfort • agitation • increased appetite • weight gain and acne Faiman, B., Bilotti, E., Mangan, P., & Rogers, K. (2008). Steroid-Associated Side Effects in Patients With Multiple Myeloma: Consensus Statement of the IMF Nurse Leadership Board. Clinical Journal of Oncology Nursing, 12(0), 53-62; NCCN guidelines

  18. Side Effect Management of Novel Agents • Most are well tolerated • Less effective if not prescribed appropriately • Risk –stratify patients • How emetogenic is the regimen? Previous CINV • Patient variability/patient-related risk • Female sex, age, emesis during pregnancy, motion sickness, alcohol use, tumor burden • Other: anxiety, concomitant medications, oral chemotherapy/polypharmacy, concurrent medical conditions, hydration

  19. Key Points • Patients with cancer and who receive chemotherapy are at risk to develop CINV • Each patient should be evaluated for personal risk • Moderate to highly emetogenic chemotherapy requires prophyllacticantiemetics PLUS abortive therapy

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