ANTIEMETICS and FEBRILE NEUTROPENIA. Matti S. Aapro Genolier Switzerland

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1 ANTIEMETICS and FEBRILE NEUTROPENIA Matti S. Aapro Genolier Switzerland 2010 Multinational Association of Supportive Care in Cancer TM All rights reserved worldwide.

2 Disclosures Collaborations in this field: Teva, Sanofi, Sandoz, Roche, Novartis, Merck, Johnson & Johnson, Hospira, Helsinn, Amgen CLINIQUE DE GENOLIER 2 2

3 Take Home Message Supportive care makes excellent cancer care possible Dorothy M.K. Keefe, MASCC immediate past-president

4 Effective CINV Management in the Elderly Patient Specific issues in elderly patients

5 Prevention of Nausea and Vomiting Jørn Herrstedt MD Professor, Dr. Med. SDU University of Southern Denmark OUH Odense University Hospital

6 Antiemetic Guidelines have no Specific Age-Related Recommendations!

7 Patient-Related Risk Factors

8 Age-Related Risk Factors CINV Organ function Absorption and distribution Liver Kidney Bone marrow Comorbidity Polypharmacy Dehydration and/or electrolyte disturbances Compliance

9

10 Cardiovascular Issues in Old Generation 5-HT3RAs In December 2010, FDA advised that Anzemet injection (dolasetron mesylate) should no longer be used to prevent CINV in pediatric and adult patients due to new data demonstrating its ability to increase the risk of torsades de pointes. Based on Kytril (granisetron hydrochloride) SPC section 5,2: : QT prolongation has been reported with KYTRIL. Use with caution in patients with pre-existing arrhythmias or cardiac conduction disorders FDA safety announcement : Ondansetron may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm. Ondansetron 32 mg withdrawn in 2012

11 MASCC/ESMO Antiemetic Guideline 2010 UPDATED ONLINE in 2013 Multinational Association of Supportive Care in Cancer Organizing and Overall Meeting Chairs: Richard J. Gralla, MD Fausto Roila, MD Maurizio Tonato, MD Jørn Herrstedt, MD 2010 Multinational Association of Supportive Care in Cancer TM All rights reserved worldwide.

12 MASCC/ESMO Antiemetic Guideline Summary of Acute and Delayed Prevention Emetic risk group Risk (% pts) Acute prevention Delayed prevention High >90% AC combinations - 5-HT 3 RA + DEX + (fos)aprepitant 5-HT 3 RA * + DEX + (fos)aprepitant DEX + aprepitant aprepitant Moderate 30-90% Palonosetron + DEX DEX Low 10-30% single agent (DEX, 5-HT 3 DRA) No routine prophylaxis Minimal <10% No routine prophylaxis No routine prophylaxis Recommended 5-HT 3 RAs: Palo, Grani, Onda, Dola oral, Tropi DEX, dexamethasone; AC, anthracycline-cyclophosphamide DRA: dopamine receptor antagonist Aprepitant in delayed phase depends on (fos)apretitant use in acute phase * If a NK-1 RA is not available then palonosetron is the preferred 5-HT 3 RA also in AC regimens Adapted from reference 3 nd

13 CONCLUSION of course I agree with Prof Herrstedt Adhere to guidelines Careful assessment of: The cancer and its impact Organ function Polymorbidity Polypharmacy Compliance Keep it simple Close follow-up

14 Emesis and Cancer Treatment Approach to the Problem In controlling emesis, the strategy is prevention rather than treatment 1. Gralla RJ, Osoba D, Kris MG et al. Recommendations for the use of antiemetics: Evidencebased, clinical practice guidelines. J Clin Oncol 1999;17(9):

15 Radiotheray-induced Emesis (RINV) Group MASCC Irradiated Area Recommendation TBI 5-HT 3 -RA + DEX Upper abdomen 5-HT 3 -RA +/- DEX Lower thorax, pelvis, H&N 5-HT 3 -RA 1 Breast, extremities 5-HT 3 -RA 2 or DOPA-RA 2 ASCO NCCN TBI and upper abdomen Lower thorax Head & neck, breast etc. TBI and upper abdomen Other sites See MASCC 5-HT 3 -RA Rescue, see MASCC See MASCC Rescue 1. Prophylaxis or rescue. 2. Rescue only. 5-HT 3 -RA = serotonin 3 -receptor antagonist. DEX = dexamethasone

16 PREVENTION AND MANAGEMENT OF FEBRILE NEUTROPENIA

17 Myeloid growth factors for chemotherapy associated neutropenia Myelosuppressive chemotherapy Neutropenia Febrile neutropenia (FN) Complicated lifethreatening infection and prolonged hospitalization Chemotherapy dose delays and dose reductions Decreased relative dose intensity (RDI) Reduced survival Kuderer NM, et al. Cancer 2006;106: Chirivella I, et al. J Clin Oncol 2006;24:668 Bosly A, et al. Ann Hematol 2008;87:

18 Chemotherapy with G-CSF support Relative risk for all-cause mortality and relative dose intensity Lyman GH et al. J Clin Oncol 2010;28:

19 Guidelines for Myeloid Growth Factor Support European Organisation for Research and Treatment of Cancer (EORTC) 1 American Society of Clinical Oncology (ASCO) 2 National Comprehensive Cancer Network (NCCN) 3 European Society for Medical Oncology (ESMO) 4 1 Aapro et al. Eur J Cancer 2011;47:8 32; 2 Smith et al. J Clin Oncol 2006;24: ; 3 National Comprehensive Cancer Network 2011; 4 Crawford et al. Annals of Oncology 2010;21(Suppl 5):v248 51;. 19

20

21 WHAT TO DO IF FN HITS: PATIENT EVALUATION AND EMPIRICAL ANTIBIOTICS Prof. Jean KLASTERSKY Jules Bordet Institute Université Libre de Bruxelles Brussels - Belgium 21

22 Klastersky, Jean. (2013). Febrile Neutropenia. London: Springer Healthcare 22

23 Klastersky, Jean. (2013). Febrile Neutropenia. London: Springer Healthcare 23

24 A MASCC score index 21 predicts a risk of complications < 5%

25 EORTC Trial XV Low risk patients (530 episodes) MASCC > 21 other restrictive criteria able to take oral medications Double blind randomization Moxifloxacin (once daily) Ciprofloxacin Amoxycilline clavulanate Success: 80% Survival: 99% Outpatient management no serious comorbidity home environnment OK Success: 82% Survival: 99% compliance and consent OK J. Clin. Oncol.,

26 IDSA 2010 Guidelines Freifeld et al, Clin Infect Dis 2011

27 Independent risk factors of serious complications by multivariable logistic regression analysis Independent risk factors Latency of the first dose of antibiotics Importance Normalized importance Pneumonia Platelet count 50,000/µl Comorbidity Pulse rate 100 beat/min Hematol Oncol 2013, J-J Lynn et al. 27

28 TAKE-HOME MESSAGES If FN hits Evaluate the risk of complications (MASCC score) Start antibiotics early (within 1 hour) For low risk: observe 12 to 24 hours before sending back home For non-low risk: evaluate for severe sepsis / septic shock and consider ICU Monotherapy is adequate in most cases (! But consider local microbiologic epidemiology) Critically re-evaluate after 48 hours 28

29 SUPPORTIVE CARE IN CANCER 28th International Symposium MASCC/ISOO AVEC SÉANCE AFSOS June 2015, Copenhagen, Denmark

30

31 DECEMBER 5: A JOINT MASCC SIOG SESSION Chairs: D. Keefe (AUS) ; G. Zulian (CH) Bone health: a key factor in elderly and not so elderly patients with cancer M. Aapro (CH) Mucositis and new drugs: to prevent or to treat? D. Keefe (AUS) Depression: an issue in survivorship for elderly cancer patients. L. Balducci (USA) Ovarian cancer: issues in the long term for elderly patients C. Steer (AUS)

32 Thank you for your kind attention See you later!

33 33

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