How specialist breast cancer nurses set the platform for improved outcomes
Combining extensive clinical knowledge of advanced breast cancer with a great understanding of the support needs of their patients, breast cancer specialist nurses play an essential role as gatekeepers of effective patient communication.1
Why is effective communication so important?
When starting a patient on treatment it is critical to guide them through the process, including dosing, administration, monitoring and any additional information – but most importantly, by communicating this in a way that the patient understands.2 If a patient is not well informed there is a risk of non-adherence or side-effect mismanagement. As such, breast cancer specialist nurses are integral to instilling patient confidence and making sure they receive the optimal benefits of treatment.3
Dr Victoria Harmer, Macmillan Consultant Nurse at Imperial College Healthcare NHS Trust, elaborates on why translating clinical information into language patients can understand is so important: “When women are about to begin a new treatment, not only are they often still coming to terms with the reality that their cancer has returned or is now life limiting, but they are then required to take on additional, often detailed information on how and when to take new medication. This instruction is critical, and must be delivered within a context that makes it meaningful to the patient - not only to convey the importance of taking their treatment as prescribed to receive maximum benefit, but also so they know what symptoms to report and to whom.”
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Why the voice of breast cancer specialist nurses needs to be even louder
Despite the invaluable role breast cancer specialist nurses play in the care and education of women with advanced breast cancer, the current level of support available is well below the level of need. In a recent survey by Breast Cancer Care, some alarming statistics were brought to light:
To put this into perspective, according to the Cancer Patient Experience Survey 2015 in England,9 results showed 95% of patients with primary breast cancer were given access to a Clinical Nurse Specialist who could support them through treatment.8 The disparity in this support needs to be addressed.
The impact of limited specialist breast cancer care provision leaves many breast cancer nurse specialists under pressure and constrained by time in supporting their patients.10 By ignoring this unmet need in advanced breast cancer care, the risk of barriers developing through lack of effective patient communication is great – with consequences such as patients not fully benefitting from their treatment becoming a concerning reality.11,12
It is vital breast cancer specialist nurses receive the requisite support to enable them to carry out their essential role as gatekeepers of effective patient communication. Visit www.novartis.co.uk to see some of the ways Novartis is working with breast cancer specialist nurses to improve care across the UK.
KIS17-C090; October 2017
ADVERTISEMENT COMMISSIONED AND PAID FOR BY NOVARTIS PHARMACEUTICALS UK LTD. CONTENT DEVELOPED BY ISO.HEALTH AND APPROVED BY NOVARTIS. FOR HEALTHCARE PROFESSIONALS ONLY
1. Amir Z et al. The professional role of breast cancer nurses in multi-disciplinary breast cancer care teams. Eur J Oncol Nurs. 8(4):306–14 (2004).
2. Roe H & Lennan E. Role of nurses in the assessment and management of chemotherapy-related side effects in cancer patients. Nursing: Res Rev. 4:103–155 (2014).
3. Oakley C et al. Safe practice and nursing care of patients receiving oral anti-cancer medicines: a position statement from UKONS. ecancermedicalscience. 4:177. doi:10.3332/ecancer.2010.177. (2010).
4. European Medicines Agency. Kisqali (ribociclib) Summary of Product Characteristics 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004213/WC500233997.pdf
5. Hortobagyi G et al. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. New Eng J Med. 375:1738–1748 (2016).
6. Hortobagyi G. et al. Updated results from MONALEESA-2, a phase 3 trial of first-line ribociclib + letrozole in hormone receptor-positive (HR+), HER2-negative (HER2–), advanced breast cancer (ABC). Presented at the American Society of Clinical Oncology Annual Meeting 2017. Poster 1038.
7. American Cancer Society. Breast Cancer Facts & Figures 2015-2016. Atlanta: American Cancer Society, Inc. 2015.
8. Breast Cancer Care. Secondary. Not second rate. Secondary breast cancer. Part four: Nursing care. 2017. Available at: https://www.breastcancercare.org.uk/sites/default/files/secondary-nursing-report.pdf
9. National Cancer Patient Experience Survey 2015. Available at: http://www.ncpes.co.uk/index.php/reports/2015-reports/national-reports/2489-cpes-2015-national-report-pdf/file
10. Brown H et al. Measuring up? The health of NHS cancer services. Commissioned by Cancer Research UK 2014. Available at: http://www.cancerresearchuk.org/sites/default/files/measuring_up_health_of_nhs_cancer_services_sept2014.pdf
11. Breast Cancer Care. Ensuring nursing provision for people with metastatic breast cancer. A toolkit for healthcare professionals 2012. Available at: https://www.breastcancercare.org.uk/sites/default/files/files/sbc_nursing_toolkit_2012_0.pdf
12. Reed E et al. Quality of life and experience of care in women with metastatic breast cancer: a cross-sectional survey. J Pain Sympt Manag 43;4:747–758 (2012).
(Please refer to the SmPC before prescribing Kisqali)
Kisqali® (ribociclib succinate)
Presentation: Film-coated tablet containing ribociclib succinate, equivalent to 200 mg ribociclib.
Indication: Kisqali, in combination with an aromatase inhibitor, is indicated for the treatment of
postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative locally advanced or metastatic breast cancer as initial
endocrine-based therapy. Dosage: The recommended dose is 600 mg once daily; taken orally
with or without food at the same time every day for 21 days, followed by 7 days off treatment,
resulting in a complete cycle of 28 days. The treatment should be continued as long as the
patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs. Kisqali
should be used together with 2.5 mg letrozole or another aromatase inhibitor (AI). The AI
should be taken orally once daily continuously throughout the 28-day cycle. If the patient vomits
after taking the dose or misses a dose, an additional dose should not be taken. The next
prescribing dose should be taken at the usual time. Dose Modification: Management of severe
or intolerable adverse drug reactions may require temporary dose interruption, reduction or
discontinuation of Kisqali (See Special Warnings & Precautions). Dose reduction should be
achieved by decrements of 200 mg daily. If further dose reduction below 200 mg/day is required,
the treatment should be permanently discontinued. Full blood counts (FBC) should be
performed before and after initiating Kisqali treatment. FBC should be monitored every 2 weeks
for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, then as clinically
indicated. For neutropenia, no dose modifications required for grade 1 or 2. For grade 3, interrupt
the dose until recovery to grade ≤2, then resume at same dose level. If toxicity recurs at grade 3,
interrupt the dose until recovery, then resume Kisqali and reduce by 1 dose level. For grade 3
febrile neutropenia interrupt the dose until recovery to grade ≤2, resume Kisqali and reduce by 1
dose level. For grade 4 interrupt the dose until recovery to grade ≤2, resume Kisqali and reduce
by 1 dose level. Liver function tests (LFTs) should be performed before and after initiating Kisqali
treatment. LFTs should be performed every 2 weeks for the first 2 cycles, at the beginning of
each of the subsequent 4 cycles, then as clinically indicated. If grade ≥2 abnormalities are noted,
more frequent monitoring is recommended. No dose adjustment is required for grade 1. For grade
2: if baseline at grade <2, interrupt until recovery to ≤ baseline grade, then resume Kisqali at
same dose, and if grade 2 recurs, resume Kisqali at next lower dose level; if baseline at
grade 2, no dose interruption. For grade 3: interrupt Kisqali until recovery to ≤ baseline
grade then resume at next lower dose level. If grade 3 recurs, discontinue Kisqali. For
grade 4: discontinue Kisqali. If patients develop ALT and/or AST >3xULN along with total
bilirubin >2xULN irrespective ofbaseline grade, discontinue Kisqali. ECG should be assessed
before and after initiating treatment with Kisqali. ECG should be repeated at approximately
day 14 of the first cycle and at the beginning of the second cycle, then as clinically indicated.
In case of QTcF prolongation during treatment, more frequent ECG monitoring is recommended.
ECGs with QTcF >480 msec the dose should be interrupted. If the QTcF resolves to <481 msec,
resume the treatment at same dose level and if QTcF >481 msec recurs, interrupt the dose until
QTcF resolves to <481 and then resume Kisqali at the next lower dose level. If QTcF >500 msec
on at least 2 separate ECGs, interrupt Kisqali until QTcF <481 msec then resume Kisqali at next
lower dose level. If QTcF >500 msec or >60 msec change from baseline occurs in combination
with torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious
arrhythmia, permanently discontinue Kisqali. For other toxicities no dose adjustment required for
grade 1 or 2, initiate appropriate medical therapy and monitor as clinically indicated. For grade 3,
interrupt until recovery to grade ≤1, then resume Kisqali at the same dose. If grade 3 recurs resume
Kisqali at the next lower dose level. For grade 4, discontinue Kisqali. Concomitant use of strong
CYP3A4 inhibitors should be avoided and an alternative concomitant medicinal product with less
potential to inhibit CYP3A4 inhibition should be considered. If patients must be given a strong
CYP3A4 inhibitor concomitantly with ribociclib, the Kisqali dose should be reduced to 400 mg once
daily. Contraindications: Hypersensitivity to the active substance or to peanut, soya or any other
listed excipients. Special Warnings and Precautions:Critical Visceral Disease: The efficacy and
safety of ribociclib have not been studied in patients with critical visceral disease. Neutropenia
Based on the severity of the neutropenia, Kisqali treatment may have to be interrupted, reduced or
discontinued. QT Interval prolongation: Treatment with Kisqali should be initiated only in patients
with QTcF values less than 450 msec. Appropriate monitoring of serum electrolytes (including
potassium, calcium, phosphorus and magnesium) should be performed before initiating treatment,
at the beginning of the first 6 cycles and then as clinically indicated. Any abnormality should be
corrected before initiating treatment with Kisqali. The use of Kisqali with medicinal products known
to prolong QTc interval and/or strong CYP3A4 inhibitors should be avoided as this may lead to
clinically meaningful prolongation of the QTcF interval. Kisqali should be avoided in patients with
long QT syndrome, significant cardiac disease and electrolyte abnormalities. Hepatobiliary toxicity,
CYP3A4 substrates, soya lecithin: see other sections. Based on findings in animals, ribociclib can
cause foetal harm when administered to a pregnant woman. Kisqali may have a minor influence
on the ability to drive and use machinery; patients should be cautious in case they experience
fatigue. Undesirable Effects:Very common: abdominal pain, abnormal liver function tests
(ALT, AST & blood bilirubin increased), alopecia, anaemia, asthenia, back pain, constipation,
decreased appetite, diarrhoea, dyspnoea, fatigue, headache, insomnia, leukopenia,
lymphopenia, nausea, neutropenia, peripheral oedema, pruritus, pyrexia, rash, stomatitis,
urinary tract infection and vomiting. Common: decreased weight, dry eye, dysgeusia, dyspepsia,
electrocardiogram QT prolonged, epistaxis, erythema, febrile neutropenia, hepatotoxicity,
hypocalcaemia, hypokalaemia, hypophosphataemia, increased lacrimation, increased blood
creatinine, syncope and thrombocytopenia. Interactions: Ribociclib is primarily metabolised by
CYP3A4. Medicinal products that can influence CYP3A4 enzyme activity may alter the
pharmacokinetics of ribociclib. Ribociclib is a moderate to strong CYP3A4 inhibitor and may
interact with medicinal substrates that are metabolised via CYP3A4, which can lead to increased
serum concentrations of the concomitantly used medicinal product. Co administration of Kisqali
with medicinal products with a known potential to prolong the QT interval such as anti arrhythmic
medicinal products and other medicinal products that are known to prolong the QT interval should
be avoided. Please refer to the SmPC for other possible interactions.
Basic NHS Cost: 21 tablets = £983.33, 42 tablets = £1,966.67, 63 tablets = £2,950.00.
Marketing Authorisation (MA) Holder: Novartis Europharm Ltd, Frimley Business Park, Camberley, GU16 7SR, UK.
MA Number: EU/1/17/1221/001-012
Legal category: POM
Further information is available from Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. Tel: 01276 692255.
Adverse events should be reported.
Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Novartis on 01276 698370, at firstname.lastname@example.org or online through the patient safety information tool at https://psi.novartis.com