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An outpatient clinic for patients on oral anticancer drugs Raadpleging Orale antitumorale Therapie St-Lucas ROTS-project BOPP-Days Blankenberge Tine Hendrickx AZ Sint-Lucas Gent February 3, 2012 EVOLUTION IN CANCER AND IN CANCER TREATMENT • > 50.000 new cases/year in Belgium • Life-threatening → chronic disease • Intravenous → oral treatment (eg.TKI’s) – Advantages – Disadvantages/Problems 1 ADVANTAGES OF ORAL ANTICANCER THERAPY • Targeted therapy – Less side-effects, better tolerance – Prolonged drug exposure • Economical benefit – Reduced use of healthcare resources (medical supplies, nurses,…) • Flexibility – Greater patient convenience, better QoL CONCERNS WITH ORAL ANTICANCER THERAPY 1. Administration • Compliance E.g.: – Tamoxifen (Nolvadex®): 49% of patients discontinues treatment before 5 years* – Imatinib (Glivec®): Only 14,2% fully compliant. 1/3 non-adherent** • Administration errors • • • • • Multiple tablets per day Different dosages of a single drug Influence of food Complex dosing regimens Intake problems • Swallowing difficulties • Nausea and vomiting • Polypharmacy * Breast Cancer Research 2008, 10 (suppl 4):S17 ** Blood 2009, May 28, 113(22):5401 2 CONCERNS WITH ORAL ANTICANCER THERAPY Example: Patient with metastatic breast cancer Tyverb 1250mg 1xd / Xeloda 2000mg/m²/day BSA: Height 1m65; Weight 57kg => 1,6m² CONCERNS WITH ORAL ANTICANCER THERAPY Example: Patient with metastatic breast cancer Tyverb 1250mg 1xd / Xeloda 2000mg/m²/day BSA: Height 1m65; Weight 57kg => 1,6m² Xeloda 1600mg in the morning, within 30’ after meal Tyverb 1250mg, one hour before or one hour after meal Xeloda 1600mg in the evening, within 30’ after meal Xeloda: 2 weeks – 1 week off – 2 weeks - … Tyverb: continuous 3 Drug-food interaction The low-fat breakfast produced mean increases in lapatinib area under the concentration-time curve (AUC) of 167% (2.67-fold) and maximum concentration (Cmax) of 142% (2.42-fold). The high-fat breakfast produced mean increases in lapatinib AUC of 325% (4.25-fold) and Cmax of 203% (3.03-fold) compared with the fasted state. * Koch KM, J Clin Oncol 27:1191-1196 CONCERNS WITH ORAL ANTICANCER THERAPY 2. Toxicity - Targeted therapy => works on specific receptors, which leads to specific adverse reactions - Narrow therapeutic-toxic index - Side effects of targeted therapy differs from conventional chemotherapy • Can also be serious • High impact on quality of life 4 CONCERNS WITH ORAL ANTICANCER THERAPY 2. Toxicity • • • • • • • • • • • • • Dermatologic Diarrhea Nausea Bone marrow suppression Hypertension Oedema Hypothyroidism Stomatitis Pneumonitis Pleural effusion Hypercholesterolemia Bleeding … Dermatologic side-effects 5 Dermatologic side-effects Dermatologic side-effects 6 CONCERNS WITH ORAL ANTICANCER THERAPY 3. Drug interactions • Anticancer drugs: narrow TTI • Metabolisation via the liver (eg. via CYP3A4) ► combination with CYP inhibitors: more adverse reactions ► combination with CYP inducers: risk of treatment failure Some examples of TKI’s + CYP3A4 inhibitors • Dasatinib + ketoconazole: ↑ AUC 5x and Cmax 4x • Erlotinib + ketoconazole: ↑ AUC 86% • Lapatinib + ketoconazole: ↑ AUC 3.5x, Cmax 2x and t1/2 1.7x • Sunitinib + ketoconazole: ↑ AUC 51% * KNMP – WINAp 13oct2011 Some examples of TKI’s + CYP3A4 inducers • Gefitinib + rifampicine: ↓ AUC 83% • Gefitinib + fenytoïne: ↓ AUC 47% and Cmax 26% • Lapatinib + carbamazepine: ↓ AUC 3.5x and Cmax 2.4x • Pazopanib + carbamazepine: ↓ AUC 30% and C24 50% * KNMP – WINAp 22jul2011 7 CONCERNS WITH ORAL ANTICANCER THERAPY 4. Direct costs Examples: Tyverb® à 1250mg: € 2.600,-/month Sutent® 50mg: € 3.900,-/month Afinitor® 10mg: € 4.000,-/month Revlimid® 25mg: € 5.800,-/month CONCERNS WITH ORAL ANTICANCER THERAPY 5. Multiple health professionals involved • • • • • • Medical oncologist Hospital pharmacist Nurse Family practitioner Local pharmacist Other physicians ⇒ Who to contact in case of problems/questions? 8 ‘ROTS’ Outpatient clinic • ROTS: ‘Raadpleging voor patiënten op Orale antitumorale Therapie Sint-Lucas’ • Separate consultation room • Fixed opening hours • Direct accessibility: 09/224 54 98 [email protected] ROTS Raadpleging voor patiënten op Orale antitumorale Therapie Sint-Lucas Katrien Eeckhaut, verpleegkundige Tine Hendrickx, apotheker vzw Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Groenebriel 1, 9000 Gent Tel. 09 224 54 98 [email protected] www.azstlucas.be ‘ROTS’ Outpatient clinic • Aim: to provide individual pharmaceutical care to patients on oral targeted anticancer therapy • Collaboration between oncology nurse specialist and clinical pharmacist • Started in April 2010 9 ‘ROTS’ Outpatient clinic How? • By providing information to patient, physicians, and other health workers • By providing a patient-tailored pharmaceutical plan • By setting up one front office for patient, oncologist, nurses, family physician, etc oncologist patient GP pharmacist other specialists ROTS patients’ family nurse ‘ROTS’ Outpatient clinic 1. Administration → frequent (telephone) contact 2. Toxicities → advice, information leaflets, diaries, care products 3. Drug interactions → drug surveillance 4. Direct costs → restricted dispensing 5. Multiple health professionals involved → accessible via telephone or email 10 Results of the first 18 months • 511 contacts for 67 new patients (ALL patients were referred to ROTS) • Referring physicians: oncologists 34%; pulmonologists 34%; radiotherapists 13%; gastroenterologists 9%; hematologists 9% • The intake visit takes on average 31min, follow-up visit 19 min • Frequent side-effects were skin problems, nausea/vomiting, diarrhea, stomatitis and hypertension Treatment Topics phone contact/email (n=183) Tyverb/Xeloda side effects 54% Tarceva Af initor drug interactions 21% intake/ administration Sutent Nexavar 13% Glivec other 12% 0% 10% Tasigna 20% 30% 40% 50% 60% Sprycel Votrient ‘ROTS’ outpatient clinic Conclusion Close follow-up and monitoring of patients by pharmacist is of utmost importance A quarter of all anticancer drugs under development will be marketed as an oral formulation 11