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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
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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**
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Administration errors
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Multiple tablets per day
Different dosages of a single drug
Influence of food
Complex dosing regimens
Intake problems
• Swallowing difficulties
• Nausea and vomiting
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Polypharmacy
* Breast Cancer Research 2008, 10 (suppl 4):S17
** Blood 2009, May 28, 113(22):5401
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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
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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
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Targeted therapy => works on specific receptors,
which leads to specific adverse reactions
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Narrow therapeutic-toxic index
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Side effects of targeted therapy differs from
conventional chemotherapy
• Can also be serious
• High impact on quality of life
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CONCERNS WITH
ORAL ANTICANCER THERAPY
2. Toxicity
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Dermatologic
Diarrhea
Nausea
Bone marrow suppression
Hypertension
Oedema
Hypothyroidism
Stomatitis
Pneumonitis
Pleural effusion
Hypercholesterolemia
Bleeding
…
Dermatologic side-effects
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Dermatologic side-effects
Dermatologic side-effects
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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
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Sunitinib + ketoconazole: ↑ AUC 51%
* KNMP – WINAp 13oct2011
Some examples of TKI’s + CYP3A4 inducers
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Gefitinib + rifampicine: ↓ AUC 83%
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Gefitinib + fenytoïne: ↓ AUC 47% and Cmax 26%
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Lapatinib + carbamazepine: ↓ AUC 3.5x and Cmax 2.4x
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Pazopanib + carbamazepine: ↓ AUC 30% and C24 50%
* KNMP – WINAp 22jul2011
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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
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Medical oncologist
Hospital pharmacist
Nurse
Family practitioner
Local pharmacist
Other physicians
⇒ Who to contact in case of problems/questions?
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‘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
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‘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
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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
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