PREVENTION OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING IN ELDERLY CANCER PATIENTS JØRN HERRSTEDT, M.D. COPENHAGEN UNIVERSITY HOSPITAL HERLEV, DENMARK

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1 PREVENTION OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING IN ELDERLY CANCER PATIENTS JØRN HERRSTEDT, M.D. COPENHAGEN UNIVERSITY HOSPITAL HERLEV, DENMARK

2 HISTORY OF ANTIEMETICS 1979 A corticosteroid is superior to placebo. THE OLD ERA 1981 High-dose metoclopramide (hd-mcp) is effective A corticosteroid improves effect of hd-mcp First clinical trial with a serotonin receptor antagonist (5-HT 3 -RA). THE SEROTONIN ERA 1991 A corticosteroid improves the effect of 5-HT 3 -RAs (HEC) A dopamine antagonist improves the effect of a 5-HT 3 -RA A corticosteroid improves the effect of 5-HT 3 -RAs (MEC) First clinical trial with a neurokinin 1 -receptor antagonist (NK 1 -RA). THE NEW ERA 2003 NK 1 -RA improves effect of 5-HT 3 -RA plus corticosteroid (HEC) NK 1 -RA improves effect of 5-HT 3 -RA plus corticosteroid (MEC). Baker et al., NEJM Gralla et al., NEJM Allan et al., BMJ Leibundgut & Lancranjan, The Lancet Roila et al., JCO Herrstedt et al., NEJM IGAR, NEJM Kris et al., JNCI Hesketh et al., JCO Poli-Bigelli et al., Cancer Warr et al., JCO 2005.

3 5-HT 3 -receptor antagonists Azasetron Y Batanopride BMY Bemesetron MDL Dazopride AHR-5531 Dolasetron MDL 73,147EF Anzemet R Eusetron RG Granisetron BRL Kytril R Itasetron DAU 6215 Lerisetron F-0930 Ondansetron GR Zofran R Palonosetron RS Aloxi R Pancopride LAS Ramosetron YM060 Renzapride BRL Tropisetron ICS Navoban R Zacopride AHR Zatosetron LY

4 Palonosetron vs Ondansetron in Patients Receiving Moderately Emetogenic Chemotherapy Gralla RJ et al. Palonosetron Improves Prevention of Chemotherapy-induced Nausea and Vomiting Following Moderately Emetogenic Chemotherapy: Results of a Double-blind Randomized Phase III Trial Comparing Single Doses of Palonosetron with Ondansetron. Ann Oncol 2003;14:

5 Complete Response Acute and Delayed Emesis Acute (0-24 h) Delayed ( h) Overall (0-120 h) Palonosetron 0.25 mg (n=189) 81.0%* 74.1%* 69.3%* Ondansetron 32 mg (n=185) 68.6% 55.1% 50.3% *97.5% CIs and two-sided Fisher s exact test (significance level = 0.025) indicate a difference between palonosetron and ondansetron. Complete Response (CR) = no emesis, no rescue medication.

6 NK 1 -receptor antagonists CI-1021* CJ 11,974 Ezlopitant CP 99,994 CP 122,721 FK 888 GR GR Vofopitant GW GW Casopitant HSP-117 L L L-754,030 Aprepitant Emend R L-758,298*** LY306740** NKP-608** RP RPR ** Dapitant SR ** Nolpitantium * Previously PD ; ** Not investigated as an antiemetic; *** Prodrug to L

7 HIGH EMETIC RISK CHEMOTHERAPY (HEC) Hesketh PJ et al. J Clin Oncol 2003;21: Poli-Bigelli S et al. Cancer 2003;97: Schmoll HJ et al. Ann Oncol 2006;17:

8 HEC - Aprepitant Phase III Trials Treatment Groups (n = 1099) APR Day 1 Days 2-3 O D A D A P 80 Day 4 D 8 + P CONT P 8 x 2 P 8 x 2 O=ondansetron; D=dexamethasone; A=aprepitant; P=placebo 1. Hesketh PJ et al. JCO 2003;21: Poli-Bigelli S et al. Cancer 2003;97:

9 HEC - Aprepitant Phase III Trial Treatment Groups (n = 489) Day 1 Days 2-3 O D A O D A O Day 4 APR P x P 80 P x P D CONT P x 2 8 x 2 8 x 2 8 x 2 P O=ondansetron; D=dexamethasone; A=aprepitant; P=placebo Schmoll HJ et al. Ann Oncol 2006;17:

10 HEC Studies: Cycle 1 Primary Endpoint: Complete Response (0-120 h) Percentage of Patients p<0.001 p<0.001 p= % 72% 52% 63% 43% Hesketh Poli-Bigelli Schmoll Aprepitant Regimen Standard Regimen 61%

11 MODERATE EMETIC RISK CHEMOTHERAPY (MEC) Warr DG et al. J Clin Oncol 2005;23:

12 MEC - Aprepitant Phase III Trial Treatment Groups (n = 866) Day 1 Days 2-3 OND DEX APR OND APR APR 8 mg x 2 12 mg 125 mg Placebo 80 mg CONT 8 mg x 2 20 mg Placebo 8 mg x 2 Placebo OND = ondansetron p.o. Anthracycline plus DEX = dexamethasone p.o. Cyclophosphamide APR = aprepitant p.o. CONT = placebo-controlled arm Warr DG et al. J Clin Oncol 2005;23:

13 MEC Study: Cycle 1 Primary Endpoint: Complete Response (0-120 h) p<0.001 Aprepitant Regimen (N=433) Standard Regimen (N=424) Percentage of Patients p= % 42% 76% p=ns 59% 59% 56% 10 0 Complete Response (CR) No Vomiting No Rescue Therapy Components of CR Warr DG et al. J Clin Oncol 2005;23:

14 MULTIPLE CYCLES OF MODERATE EMETIC RISK CHEMOTHERAPY (MEC) Herrstedt J et al. Cancer 2005;104:

15 Sustained No Vomiting Rate 80 76% Aprepitant Regimen Standard Regimen 70% 67% 60 63% Percentage of Patients % 48% 42% 39% Log-rank test, p<0.001 Number at Risk: Time (Cycle) since First Chemotherapy Aprepitant Regimen Standard Regimen

16 GUIDELINES ON ANTIEMETICS MASCC ASCO ESMO ASHP NCCN CCO

17 Prophylaxis of acute nausea and vomiting Emetic risk group High Antiemetics Serotonin antagonist + dexamethasone + aprepitant Anthracycline + Cyclophosphamide (AC) Moderate (other than AC) Low Minimal Serotonin antagonist + dexamethasone + aprepitant Serotonin antagonist + dexamethasone Dexamethasone No routine prophylaxis The Antiemetic Subcommittee of The Multinational Association of Supportive Care in Cancer. Ann Oncol 2006;17:

18 Prophylaxis of delayed nausea and vomiting Emetic risk group Antiemetics High Dexamethasone + aprepitant Anthracycline + Cyclophosphamide (AC) Moderate (other than AC) Low Minimal Aprepitant or dexamethasone Dexamethasone A serotonin antagonist may be used as an alternative No routine prophylaxis No routine prophylaxis The Antiemetic Subcommittee of The Multinational Association of Supportive Care in Cancer. Ann Oncol 2006;17:

19 WHAT ABOUT ANTIEMETIC THERAPY IN ELDERLY?

20 RISK FACTORS - CINV Emetic potential of chemotherapy Patients Antiemetic prophylaxis

21 RISK FACTORS - CINV Emetic potential of chemotherapy Elderly often receive less toxic (less emetogenic) chemotherapy. Patients Antiemetic prophylaxis

22 PATIENTS Efficacy Risk Factors Age Gender Previous chemotherapy Alcohol consumption Motion sickness Nausea and vomiting in pregnancy

23 PATIENTS Toxicity Risk Factors Age? Variations in pharmacokinetics Absorption Renal function Hepaticfunction Polypharmacy Side effects from other medication Risk of interactions Compliance Comorbidity

24 PHARMACOKINETICS AND PHARMACODYNAMICS PALONOSETRON Age Population PK analysis and clinical safety and efficacy data did not reveal any differences between cancer patients > 65 years of age and younger patients (18-64 years). No dose adjustment is required for these patients. Renal and hepatic function Dosage adjustment is not necessary in patients with any degree of renal or hepatic impairment.

25 PHARMACOKINETICS AND PHARMACODYNAMICS APREPITANT Age The pharmacokinetics of aprepitant are not significantly affected by race, gender, body weight, or age. Renal and hepatic function Dose adjustment of aprepitant is not necessary in patients with renal insufficiency or mild to moderate hepatic insufficiency.

26 DRUG INTERACTIONS PALONOSETRON Palonosetron is not an inhibitor or an activator of CYP enzymes. Therefore the potential for clinically significant drug interactions with palonosetron appears to be low.

27 DRUG INTERACTIONS APREPITANT The aprepitant regimen for CINV produces slight induction of CYP2C9 activity. Drugs with narrow therapeutic indices that are known to be metabolized by CYP2C9 may have transiently lower plasma concentrations when coadministered with aprepitant. e.g. warfarin, phenytoin. For patients on warfarin INR should be appropiately monitored. Increases the bioavailability of oral steroids.

28 DRUG INTERACTIONS OTHER Risk of interaction with SSRIs have been described. Increased toxicity of paroxetine given concomitantly with ondansetron. Decreased effect of ondansetron given concomitantly with fluoxetine. Metoclopramide decreases the effect of levodopa. Phenothiazines increase the sedative effect of hypnotics, antihistamines, alcohol and analgesics and enhance the effect of antihypertensives.

29 Cardiovascular COMORBIDITY Prolongation of QT C with serotonin antagonists and droperidol. Epilepsy Increased risk of convulsions with metoclopramide and prochlorperazine. Diabetes Increased risk of constipation with serotonin antagonists due to autonomic neuropathy. Increased risk of hyperglycemia with steroids.

30 CONCLUSIONS The risk of CINV is lower in elderly. Guidelines include no specific recommendations for the prophylaxis of CINV in elderly. No dose adjustment of aprepitant or serotonin antagonists is necessary due to decrease in renal or hepatic function (NB: ondansetron/apreptant). Due to polypharmacy the risk of interactions is higher in elderly. Comorbidity/Compliance should be evaluted.

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