Free Oral vinorelbine: a practical approach to patient management
Mark Foulkes Nurse consultant in cancer care/trust lead cancer nurse, Berkshire Cancer Centre, Royal Berkshire NHS Foundation Trust, Reading, England
Carole Farrell Teaching fellow/honorary lecturer, University of Manchester, Manchester, England
Thomas Allum Macmillan patient information and support service manager, Imperial College Healthcare NHS Trust, London, England
Jane Beveridge Deputy nurse director, Weston Park Hospital, Sheffield, England
Victoria Harmer Consultant nurse in breast care, Imperial College Healthcare NHS Trust, London, England
Oral vinorelbine has been a well-established cytotoxic treatment for non-small cell lung cancer and metastatic breast cancer since 2004. This article summarises the applications of the drug, the advantages and challenges of using an oral agent in palliative oncology settings and how oral vinorelbine has been used to develop nurse-led services and chemotherapy outside traditional hospital environments. The article includes two case studies to place this treatment in a clinical context.
Cancer Nursing Practice. doi: 10.7748/cnp.2018.e1467Citation
Foulkes M, Farrell C, Allum T et al (2018) Oral vinorelbine: a practical approach to patient management. Cancer Nursing Practice. doi: 10.7748/cnp.2018.e1467Peer review
This article has been subject to external double-blind peer review and checked for plagiarism using automated softwareCorrespondence
Mark Foulkes has previously received honoraria for consultancy and advisory roles for Pierre Fabre Ltd
Published online: 02 May 2018
Aims and intended learning outcomes
The aim of this article is to review the oral preparation of the vinca-alkaloid cytotoxic drug vinorelbine in treating non-small cell lung cancer and metastatic breast cancer. After reading this article and completing the time outs, you should be able to:
• Describe and identify the groups of patients who are prescribed vinorelbine.
• Summarise the side effects of vinorelbine and how these might be managed in clinical practice.
• Discuss the benefits and risks of prescribing oral chemotherapy and how the risks might be managed and mitigated.
• Outline nurses’ roles in managing oral vinorelbine and how the principles could be extended to other oral systemic anti-cancer therapies.
Time out 1
Can you recall caring for a patient who received treatment with oral vinorelbine? If so, try to remember your first encounter with oral vinorelbine as a cytotoxic drug:
• What struck you as potentially beneficial and challenging about its use in supporting patients?
• What new responsibilities or opportunities did the drug present you with?
• Note your recollections so you can compare them with the points discussed in this article
• If you have not cared for anyone receiving oral vinorelbine, discuss the potential effects on patient care with a colleague
The oral preparation vinorelbine has helped to transform delivery of chemotherapy around the world. It has supported the development of protocol-based and nurse-led models of delivery alongside traditional methods of administering intravenous (IV) cytotoxics.
The past ten years have seen widespread use of oral agents in chemotherapy as they allow patients to remain at home for longer and reduce visits to hospital clinics and chemotherapy units. However, as more chemotherapy was delivered outside of hospital environments, dosage errors began to occur with some oral agents. For example, the National Patient Safety Agency (NPSA) (2008) found that half the adverse incident reports it received identified wrong doses and errors in the strength, frequency or quantity of oral anti-cancer therapies. It also noted that non-cancer specialists with little or no expertise were asked to prescribe and monitor oral chemotherapy. Consequently, it recommended oral chemotherapy should have the same safeguards as IV delivery, and that doctors, nurses, pharmacists and other healthcare professionals must prescribe, dispense and administer oral anti-cancer medicines to the same standard as IV therapy, and use similar monitoring processes. The NPSA report resulted in cancer nurses becoming more involved in monitoring oral agents such as vinorelbine.
Vinorelbine is a synthetically-produced vinca-alkaloid cytotoxic agent which has been used extensively in the UK over the past 14 years for the treatment of non-small cell lung cancer (NSCLC) and metastatic breast cancer (MBC) (National Institute for Health and Care Excellence (NICE) 2016, 2017). Like all vinca-alkaloids, vinorelbine prevents cell division by binding with the proteins that make up tubulin. This stops tubulin – which is made up of smaller building blocks or protein monomers – from being built within the cell. Cells require tubulin to form the mitotic spindle in the metaphase stage of cell division. If mitosis is arrested in metaphase then cell death, or apoptosis, ensues. Cancer cells are particularly vulnerable to interference with tubulin aggregation due to their higher level of cell division (Cuendet and Pezzuto 2008).
Vinorelbine differs from other vinca-alkaloids in that there is an oral preparation as well as IV, which makes it flexible for use across a range of care models. This article focuses on the oral form of the drug.
High-quality randomised controlled trials comparing the oral preparation with IV suggest the former is equally effective and well tolerated (Jassem et al 2001, Gebbia and Puozzo 2005). In addition, a pharmacokinetic study indicated that the oral preparation has reliable bioequivalence at 40% of the IV dose and can be used safely (Bourgeois et al 2007).
In the UK, vinorelbine is used to treat grade three or four NSCLC either as a single agent or, more commonly, in combination with a platinum-containing agent (NICE 2017). It is also used to treat stage three or four breast cancer that has relapsed following treatment with a chemotherapy regimen containing an anthracycline (Swanton and Johnson 2011).
Preliminary early phase studies (Steele et al 2000) indicated that vinorelbine may be active against mesothelioma and could be useful as a second-line agent. However, there are no results from randomised trials to date, although a Cancer Research UK trial is investigating the action of vinorelbine in advanced mesothelioma.
In lung cancer, vinorelbine is given on day one and day eight of a 21-day cycle with a platinum drug, carboplatin or cisplatin, given only on day one. Some patients receive single-agent oral vinorelbine on days one and eight. In metastatic breast cancer, vinorelbine is normally given weekly for three weeks of a four-week cycle or it can be used as part of a combined therapy with other cytotoxic agents (Clatterbridge 2014, NICE 2016, 2017).
Oral vinorelbine is produced as 20mg, 30mg and 80mg soft capsules, which can be made up into the correct dose for patients based on their height, weight and body surface area. The capsules are made of gelatin and the active ingredient is the liquid inside, which is an irritant and therefore capsules should not be divided, punctured or taken if damaged, and should be taken with water and food. The capsules should be stored at a temperature between 2ºC and 8ºC, so they must be kept in a refrigerator (Pierre Fabre 2016). It is important that patients are made aware of this and can manage the risk of storing the tablets at home.
Side effects and clinical monitoring
The main side effects of oral vinorelbine are haematological, nausea and vomiting and constipation.
The haematological effect is bone marrow suppression leading to a reduction of total white cell count (leukocytopenia). Neutrophils can be particularly affected, resulting in neutropaenia in around 70% of patients, while around 3% will develop febrile neutropaenia. Reduction in the number of circulating erythrocytes is seen in around 67% of patients, but this is generally mild. A reduction in platelets (thrombocytopaenia) is seen in approximately 10% of patients but does not normally require specific intervention (Pierre Fabre 2016).
As with all cytotoxic chemotherapy agents, patients who receive oral vinorelbine should have effective and rigorous clinical monitoring to manage potential side effects, assess clinical effectiveness and monitor their experiences during treatment. A full blood count should be taken before chemotherapy, ideally on the day of treatment or the day before.
Neutropaenia, which in the context of chemotherapy is defined as a neutrophil count of less than 1.0 X 109L and falling (although local guidelines may differ slightly) will result in deferral of treatment until the white count rises above the locally agreed threshold, usually for a week in the first instance. Anaemia should be treated with a blood transfusion rather than by deferment and treating anaemia effectively can improve quality of life (Calabrich and Katz 2011). The decision to transfuse patients should, however, be balanced against the degree to which they are symptomatic, the potential risks and the local guidelines.
Nausea and vomiting
This is more common with the oral form of the drug than the IV preparation with around 70% of patients developing nausea and 50% vomiting at least once. Oral vinorelbine is rated as moderate to highly emetogenic by most local guidelines. Vomiting usually occurs within 24 hours and can be well controlled with an oral 5HT-3 receptor antagonist, such as ondansetron or granisetron. This is given one hour before administration, and the manufacturer also recommends a snack an hour before therapy.
Dexamethasone 6mg twice a day can also be given on day one, with the option of a reducing schedule for the next four days – 4mg twice a day on day two, 4mg daily on day three and 2mg daily on days four and five. In addition, patients can be given metoclopramide or domperidone as required (Kent and Medway Cancer Collaborative 2015).
Constipation occurs in around 30% of patients and is caused by disruption of the autonomic nervous system in the bowel (Moudi et al 2013). Only around 1% will become severely constipated. Generally, it can be controlled if patients keep up their oral fluid intake, eat five portions of fruit and vegetables a day and maintain their usual levels of activity, or in people with a history of constipation concomitant laxatives should be considered (McMillan et al 2013).
In addition to a formal assessment of side effects a performance status, for example using the World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status scale (Box 1), should be recorded before chemotherapy to determine patients’ overall tolerance and response to treatment. Research based on the UK Systemic Anti-Cancer Therapy database found that patients with a poorer performance status score have a higher rate of chemotherapy-related mortality (Wallington et al 2016). This systemic approach to using toxicity data provided by patients is effective (Di Maio et al 2016) and is particularly important in palliative settings where vinorelbine is frequently used to control disease that is certain to recur.
Continuous assessment of patients receiving palliative chemotherapy is essential as treatment can reduce patients’ quality of life (Prigerson et al 2015). This is particularly important if WHO/ECOG performance status is scored less than two. In palliative settings oral vinorelbine has significant advantages, reducing the need for cannulation and outpatient department visits. Concordance with the treatment suggests that the consent process, which includes ensuring patients understand the benefits and can therefore make an informed choice, is effective.
As with all chemotherapy agents, it is good practice to have a specific consent form for oral vinorelbine that outlines the risks and benefits of the treatment and includes a list of potential side effects. Written consent should be obtained in clinic by a doctor or nurse and confirmed when patients attend their first treatment. The issue of consent, including the aims of treatment, is particularly important for patients receiving vinorelbine in palliative settings as it enables them to make informed decisions about whether to start and continue treatment.
The use of vinorelbine in treating NSCL and MBC is approved and sanctioned in the UK by NICE (2016, 2017). Many people with MBC will have had adjuvant chemotherapy regimens that contain an anthracycline and a taxane, and this should be considered when determining the best options for chemotherapy in metastatic settings. Vinorelbine is largely prescribed as a single agent in patients with MBC, although combination with oral capecitabine can also be considered (James et al 2010, Petrelli et al 2016).
The two case studies place theoretical knowledge of management of patients with MBC and NSCLC, who are receiving oral vinorelbine, in a clinical context.
Case study 1: Metastatic breast cancer
Rachel is 74 and was diagnosed with breast cancer in 2009. Before retirement she worked as a senior administrator for a large insurance company. She became a widow following the death of her husband, Geoff, in early 2016. Despite this relatively recent bereavement she had been back to enjoying life as she has two grown-up daughters and five grandchildren who keep her busy.
On initial diagnosis Rachel’s condition was characterised as a ductal carcinoma, which was oestrogen-receptor (ER) positive human epidermal growth factor 2 (HER2) negative, T2 N (6/24) M0. She had a mastectomy followed by adjuvant chemotherapy in the form of six cycles of 5-fluorouracil, epirubicin and cyclophosphamide-FEC. She also had a course of radiotherapy and tamoxifen which she took for five years, and she remained well during follow-up with no signs of cancer recurrence. Tamoxifen was discontinued in 2014 and she was discharged from follow-up in 2015.
In 2016 she saw her GP with increasing shortness of breath. Subsequent investigation and imaging showed a right-sided pleural effusion with central lymphadenopathy and possible peritoneal deposits. Although drainage of the pleural effusion resolved her breathlessness, cytology revealed carcinomatous cells. A peritoneal biopsy confirmed recurrent metastatic breast cancer which was weakly ER positive.
Against IV chemotherapy
The multidisciplinary team suggested further chemotherapy and Rachel was referred to an oncologist to discuss treatment options. Despite her illness she remained active, caring for her youngest grandchild and visiting her holiday home in France with her family. Her performance status score was one. During her discussion with the oncologist, Rachel said she didn’t want to receive IV chemotherapy again as she didn’t find attending the chemotherapy unit easy because she lived some distance from the treatment centre. Her veins had also suffered from previous IV delivery and she had been traumatised by chemotherapy-related alopecia. Her hair had since grown back, and she was proud of her appearance. In addition, she was aware that the aim of the treatment was palliative and she felt chemotherapy would have too great an effect on her life for what she believed might be limited benefit.
Consequently, the oncologist decided that oral chemotherapy might be better and suggested oral vinorelbine as a single agent. The dosage schedule was straightforward and the possibility of a pre-treatment telephone assessment on some days meant Rachel would not need to attend as many appointments. After consulting with her family, she consented to oral vinorelbine. The regimen would be given on day one, day eight and day 15 every three weeks. Day one was given after assessment by the oncology team at the treatment centre, while days eight and 15 were self-administered at home following a telephone assessment by one of the senior chemotherapy nurses after checking Rachel’s blood results.
Few side effects
Rachel tolerated the first three cycles well. She experienced mild nausea, which was controlled by oral anti-emetics and had intermittent constipation, which she managed by drinking more fluids and eating more fruit, although she required a mild laxative on one occasion. The telephone assessments on day eight and 15 proved effective and enabled Rachel to manage her treatment without travelling to hospital.
Following three cycles a repeat computed tomography scan showed that the peritoneal disease remained stable and the lymphadenopathy had regressed. Rachel had a further three cycles and, despite mild fatigue and anaemia, she tolerated oral vinorelbine well. Following completion of the six cycles, Rachel remained stable for 14 months before relapsing with multiple bone metastases for which she received palliative radiotherapy to her spine and pelvis.
Time out 4
Question on case study 1
What do you think are the main priorities of treatment from Rachel’s perspective? What are the main implications for the nurses caring for Rachel?
Case study 2: Non-small cell lung cancer
Robert is 59 and was diagnosed with non-small cell lung cancer (NSCLC) after an eight-week history of worsening cough and one week of dyspnoea. His wife, Rita, convinced him to attend the GP who referred him for a chest X-ray which revealed a large left upper lobe mass and a small left-sided pleural effusion. Robert was referred as an emergency through the two-week wait suspected cancer route and was seen by a chest physician who ordered a chest/abdomen/pelvis CT scan and a lung biopsy. Robert and his wife were informed at this appointment that a diagnosis of lung cancer was likely.
The scan confirmed that Robert had a large tumour in the left upper lobe of his lung with a pleural effusion and mediastinal lymphadenopathy. The biopsy indicated it was a squamous NSCLC with a stage of T4N2M0. The multidisciplinary team decided that this was an inoperable cancer and suggested referral to an oncologist for palliative chemotherapy, provided that Robert’s performance status was one or two with no substantial co-morbidities.
Doubted tablet would work
Robert lived with Rita and two large dogs, was still working as an electrician and had two adult children who lived close by. He had smoked 20 cigarettes a day since the age of 16 although he’d stopped smoking shortly before his diagnosis. Although shocked to learn he had cancer, Robert remained philosophical and was keen to have treatment. Rita, however, was upset because the cancer could not be cured and was on the edge of tears throughout the consultation with the oncologist and specialist nurse.
Despite his cough and shortness of breath Robert could function normally and spent a lot of time in his garden which was his main hobby. His performance status was one and therefore oral vinorelbine and carboplatin was suggested as the most appropriate chemotherapy treatment. Rita doubted that a tablet could be as effective as IV therapy, but it was explained to her that it was and that the regimen would offer Robert a good chance of a positive response and extend his life with minimal compromise. Robert consented to treatment and attended a chemotherapy pre-assessment clinic five days later before starting treatment three days after that. He tolerated day one of the regime well, which involved attending the chemotherapy unit for IV carboplatin and oral vinorelbine. He experienced mild nausea at home which was well controlled with oral anti-emetics. Day eight of the regimen consisted of oral vinorelbine and Robert was assessed over the telephone by a chemotherapy specialist nurse who checked his blood results and potential toxicities. Robert liked the flexibility of the telephone assessment since he did not need to travel to hospital, and bloods were taken at his GP surgery rather than at the outpatient clinic.
After three cycles of treatment, a repeat CT scan showed a good response to the treatment with shrinkage of the primary tumour and reduction in size of the lymphadenopathy. The oncologist recommended that Robert should have three further cycles of IV carboplatin and oral vinorelbine.
Following cycle four, however, Robert became more breathless and unwell and had a pyrexia of 38°C. He rang the out of hours service and was assessed by a nurse using the UK Oncology Nursing Society (UKONS) (2016) triage tool. In view of the pyrexia Robert was asked to attend his local emergency department. Investigations showed that he had borderline neutropaenia (0.9) and a chest X-ray indicated a possible chest infection. Robert was admitted and given IV antibiotics and was discharged after four days feeling ‘well’ and ‘back to normal’.
The next cycle of chemotherapy was deferred by a week to enable further recovery. Robert completed two more cycles of chemotherapy. Although Robert and Rita knew that the tumour would grow and cause more difficulties he had a good symptomatic response from the chemotherapy and temporary reduction in the size of his cancer. Robert maintained a ‘more normal life’ throughout the chemotherapy and continued with some gardening.
Time out 5
Question on case study 2
What do you think are the main treatment priorities from Robert’s perspective? What are the main implications for nurses caring for Robert?
Patients’ experiences of oral vinorelbine and implications for nursing
There is strong evidence that patients are fearful about treatment with chemotherapy and are concerned about side effects (Ching et al 2010), as illustrated by Rachel’s case study. Evidence suggests that nurses are more effective than medical staff at assessing patients holistically and addressing their needs. For example, a systematic review concluded that nurse-led care can be more beneficial than doctor-led care when measured by physical outcomes, patient satisfaction and care organisation (Caird et al 2010). This is particularly the case with oral vinorelbine, which lends itself to nurse-led assessment and management and provides an excellent model for nurse-led or protocol-led chemotherapy delivery (Lennan et al 2012).
Patients undergoing chemotherapy are likely to develop a range of physical and psychological side effects. Paraskevi (2012) found that most side effects resolved following completion of chemotherapy, although some continued for several months or even years, and around 20% of women with breast cancer had symptoms of post-traumatic stress disorder.
Like Robert and Rachel, patients with NSCLC and MBC frequently have co-morbidities. Many patients with MBC have received adjuvant or palliative chemotherapy previously, therefore it is vital to assess individuals correctly.
Liu et al (1997) found that patients who received palliative chemotherapy preferred oral chemotherapy for three main reasons: its general convenience; because taking the medication at home offered a better chemotherapy experience and as they had previous problems with IV access and delivery.
However, most patients did not wish to sacrifice drug efficacy for oral preference, and more than 70% said they would not accept a less effective drug or a shorter response time from an oral therapy. As with Robert’s wife Rita, patients and carers may require reassurance that oral drugs can be as effective as IV.
Oral therapy, in contrast to IV, raises the issue of concordance when the drug is taken at home. In a meta-analysis of studies of concordance in oral chemotherapy, Bassan et al (2014) found that it improved with better ‘therapy education’, where patients and carers had greater understanding of the treatment and how it would affect the disease process. It is vital that patients receiving oral vinorelbine are given written and verbal information, and that their understanding of how to take it, as well as potential side effects and what to do if they experience them, is verified. Regular assessment, either in person or by telephone, by a trained healthcare professional is crucial and a cornerstone of therapy education.
Novel approaches to care and developing the role of nursing
Vinorelbine was one of the first chemotherapy agents to show how oral preparations can reduce waiting times in chemotherapy clinics and units (Taylor et al 2005, James et al 2010). Oral preparation also lends itself to assessment and administration by nurses. Figure 1 illustrates the differences in models of vinorelbine delivery:
The time patients spend in the department can be reduced from more than four hours to around 30 minutes with a nurse-led approach, oral delivery and blood tests on the day before the appointment.
In people with NSCLC, vinorelbine is usually given in combination with cisplatin or carboplatin. The regimen involves giving the IV platinum alongside the vinorelbine on day one and only vinorelbine on day eight.
An innovative approach in Kent involves patients attending on day eight solely to see a chemotherapy nurse who assesses them, checks their full blood count and treatment-related toxicities and administers vinorelbine (Taylor et al 2005, James et al 2010). Patients then return for a medical assessment on day one of the following cycle. Not only was this strategy well received by patients, it greatly reduced waiting times and has been adopted by other cancer centres across the UK.
In Lanarkshire, Scotland, the day eight assessment is carried out through a telephone clinic with a specialist nurse who reviews patients’ blood tests that have been taken the day before (Lennan et al 2012). An assessment of treatment-related toxicities is completed over the telephone and if there are no problems patients take their oral vinorelbine which they have stored at home since day one. This means they do not have to attend the clinic.
Vinorelbine nurse-led clinics have provided a model for other clinics with different oral agents, such as temozolomide and kinase inhibitors, and in units where subsequent doses of chemotherapy are prescribed by pharmacists or nurses (Lennan et al 2012). It seems likely that demand for these types of clinics will increase given the growth in oral therapies.
In patients with MBC oral vinorelbine can be administered weekly when given as a single agent, which can enable proactive management by suitably-skilled nurses or pharmacists who can assess patients in clinic or by telephone (Roe and Lennan 2014).
Assessment of patients on oral vinorelbine
The most important element of assessment of patients on chemotherapy is to gain an accurate measurement of their toxicity grading and performance status before moving to the next dose. In nurse-led settings this is best accomplished by using a checklist of possible toxicities. Although this can be in paper format, there is an increased use of electronic assessment forms linked to electronic prescribing systems. Table 2 is an example of a checklist for oral vinorelbine. As nurses become more skilled at carrying out these assessments it is likely the interaction will become more ‘natural’ rather than simply working through a checklist. Concerns that patients are not fit for chemotherapy should result in urgent assessment at cancer centres/units unless an emergency community intervention or hospital admission is required.
Assessment of haematological toxicities is also vital and nurses undertaking the assessments must have access to recent blood results, usually taken in the preceding 24 hours. This should be taken into account when setting up services of this type.
Over the past 14 years oral vinorelbine has become a well-established treatment for patients with NSCLC and MBC. It is generally well tolerated and effective for both cancer groups in palliative settings. The oral formulation offers many advantages in terms of flexibility, improved patient experience and adaptability to nurse-led assessments in clinic and at home. In general patients have high acceptability of oral drugs and this mode of delivery provides nurses with the opportunity to become more proactive in managing patients.
Oral cancer treatments raise issues of concordance, patient choice and the need for effective education and consent.
The case studies described in the article illustrate how treatment and care relationships occur in a wider context and that the merits of drugs may be judged by how patients manage the regimen and tolerate side effects as well as the lifestyle freedoms they gain or preserve.
Alongside these advantages, there are challenges for nurses in terms of managing patients with advanced or metastatic disease outside traditional medical environments, as these require planning to ensure patients’ safety.
Time out 7
Now that you have completed the article you might like to write a reflective account as part of your revalidation. Guidelines to help you are at rcni.com/reflective-account
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