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Home administration of bortezomib: making a difference to myeloma patients• lives

European Journal of Oncology Nursing xxx (2009) 1–3 Home administration of bortezomib: Making a difference to myelomapatients’ lives Teresa Meenaghan Michael O’Dwyer Patrick Hayden ,Amjad Hayat ,Margaret Murray ,Maura Dowling a St Josephs Ward, Galway University Hospital, Newcastle Road, Galway, Irelandb Haematology Department, Galway University Hospital, Newcastle Road, Galway, Irelandc School of Nursing and Midwifery, Aras Moyola, National University of Ireland, Galway, Ireland Keywords:BortezomibMyelomaHome administration age and eligible for stem cell transplant. However, they must alsohave good performance status and without other co-morbidities.
Multiple myeloma is a clonal malignancy of plasma cells, char- Initiatives in the home administration of chemotherapy are acterized by anaemia, renal dysfunction, lytic bone lesions and the presence of excess monoclonal immunoglobulin. It is the second With regard to the home administration of bortezomib, a pilot feasibility project of home administration of bortezomib to patients It remains a complex disease to diagnose and treat.
with myeloma has recently been reported from Bournmouth However, our understanding of the biology of myeloma continues Hospital in England ). However, that pilot to develop, and hence a number of new potential therapies have program only included patients with relapsed disease and patients been identified, with improved outcomes and survival had to live within a 12 mile radius of the hospital. In addition, Day 1 and Day 4 doses were administered in the hospital, and blood The introduction of novel agents, such as immunomodulatory samples were taken on each visit. Three of our patient group were drugs or proteasome inhibitors, either alone or in combination with newly diagnosed, receiving initial treatment for their myeloma.
traditional agents for the treatment of myeloma has led to a major Furthermore, all patients on our program received first doses of improvement in patient outcomes, including survival, in the past bortezomib safely at home. In addition, bloods on our program are decade. Based on significant improvements in response rates and only taken on Day 8; the platelet nadir is day 11 so checking on day overall survival in elderly patients when combined with melphalan 8 detects any significant drop prior to this. Finally, our patients live in elderly patients (Bortezomib, a protea- as far away as 100 miles from the hospital.
some inhibitor, is now licensed as front line treatment for myeloma.
Bortezomib combined with dexamethasone has also proven to bea very effective induction therapy in younger patients prior to autologous stem cell transplant and isnow viewed by some as the new standard for initial therapy of Galway University Hospital (GUH) is a regional Irish hospital younger patients. Younger patients are those less than 65 years of serving a local urban and widely dispersed rural population. Giventhe emerging data supporting its use in all categories of patientswith multiple myeloma, there has been a major increase in the useof bortezomib as treatment of multiple myeloma patients attending * Corresponding author. Tel.: þ353 91 493833; fax: þ353 91 494537.
GUH. Since bortezomib requires frequent intravenous administra- tion (usually twice a week, for two consecutive weeks with a 10 day rest period) this has impacted significantly on the hospital’s hae- matology day unit facility, which has severe capacity issues. The 1 Tel.: þ353 91 524222; fax: þ353 91 544723.
administration of bortezomib only takes ten seconds. However, 1462-3889/$ – see front matter Ó 2009 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ejon.2009.09.003 Please cite this article in press as: Meenaghan, T., et al., Home administration of bortezomib: Making a difference to myeloma patients’ lives,European Journal of Oncology Nursing (2009), doi:10.1016/j.ejon.2009.09.003 T. Meenaghan et al. / European Journal of Oncology Nursing xxx (2009) 1–3 between blood sampling, review by an attending doctor and Each nurse typically administers two to three doses each dispensing and administration, patients can frequently spend up to Tuesday, Thursday and Friday. The administrating nurse documents 6 h per visit in the day unit. Moreover, many of these patients each administration and results of laboratory tests are sent to the would have to travel long distances to the unit and as a result patient’s treating haematologist. Patients are routinely evaluated experience significant inconvenience. It was therefore decided to prior to commencing each cycle of therapy (or more frequently if explore an alterative arrangement for the administration of required) by the medical registrar and clinical nurse specialist in haematology (the program’s co-ordinating nurse).
Two years of preparation were required before beginning the Each patient has routine bloods performed (FBC, U&E and pilot program. This involved sourcing a suitable home adminis- myeloma blood markers). Patients also undergo a physical assess- tration company and ensuring the pharmacy had the capacity to ment and are questioned about possible adverse effects of borte- reconstitute the drug early in the day to allow the administering zomib (i.e. peripheral neuropathy, constipation, diarrhoea).
company deliver it safely to all the patients on the program. Theprocess for nursing staff co-ordinating the service had also to be organised. In addition, the team had to determine what side effectsthe nurse would assess on each visit and record on the hand held A number of barriers had to be overcome in order to implement computer recording system. Three administering nurses are on the the initiative. Support for the home administration of bortezomib program and the first home administration of bortezomib was from all hospital personnel was needed, this included hospital administered in early December 2008.
management, haematologists, pharmacy staff and haematology dayward nursing staff. In addition, nursing personnel to coordinate theservice were required. Finally, another challenge has been the Implementation of home administration of bortezomib delivery of bortezomib, once reconstituted, to the patient withinthe 8 h window before expiry. This has required close coordination Initially, the Haematologist identifies suitable patients. These and planning between the home administration nurse and the patients are asked if they would like to enrol on the pilot program.
hospital pharmacy to ensure the collection of bortezomib as soon as All patients who have met the inclusion criteria have opted to join possible after it has been prepared.
the program. Inclusion criteria are: needing bortezomib formyeloma, willing to enrol on the program, good performance status(i.e. able to attend appointments, good cardiac and renal function), able to give verbal consent and able to demonstrate good under-standing of what the program involved (i.e. compliance with other As this was a pilot program, it was planned to initially enrol drugs, such as steroids, melphalan, lenalidomide and cyclo- a maximum of 10 patients only. To date (September 2009) however, phosphomide, given with bortezomib). Patients are excluded from we have enrolled a total of 23 patients. All patients who received the program is they are unable to give consent and fail to demon- bortezomib as induction therapy prior to stem cell harvest and strate an understanding of what the program involves. Moreover, transplant have completed therapy and have successfully harvested patients with poor venous access are excluded because difficult and transplanted. Three other patients were discontinued treat- cannulation requiring anaesthetic involvement is not suitable for ment as a result of other medical complications (i.e. Parkinson’s and home administration (two patients required central line insertion Cardiac complication). One patient died from pneumonia. One for this reason). In addition, the administering nurse undertakes patient was not responding and had her treatment changed. All a risk assessment, using a nine item risk assessment tool which other patients continue on their planned treatment.
assesses the following: General access to the patient’s home, Over 300 home administrations of bortezomib have been given.
general safety in the patient’s home, patient consent, the home Since the program has commenced, about 15 doses have been environment, communication, clinical nursing, storage of medical missed. The reasons for the missing doses were varied; because of and nursing supplies, pets, and moving, lifting and handling.
bank holidays (e.g. Christmas day), and because one patient missed Home administration of bortezomib is then coordinated by the a few doses due to her developing bilateral leg neuropathy. This haematology clinical nurse specialist and treatment options and patient’s dose was reduced and she is now tolerating treatment well.
decisions are managed by the patient’s Haematologist. Bortezomib No other problems related to home administration have been is supplied from the hospital pharmacy. Patients who are identified encountered and no significant complications of therapy have been as suitable for the home administration of bortezomib attend the observed. Extravasation of bortezomib does not cause tissue haematology day ward on day 0. Clinical examination and evalua- damage. Its principal side effects include gastrointestinal effects, tion of relevant laboratory results are carried out and chemo- fatigue, transient thrombocytopenia and reversible peripheral therapy is prescribed. The prescription is then sent to pharmacy neuropathy, which are generally manageable and the administering company (a company outside the hospital, No patient developed nausea. Although four patients did experi- which employs state registered nurses to administer treatments in ence neutropenia, this was felt to be due to concurrent myelosup- the home). On day 0, each patient is also seen by the haematology pressive chemotherapy (e.g. melphalan and lenalidomide), and clinical nurse specialist, and possible side effects and risks associ- there were no episodes of neutropenic sepsis. Some patients have ated with bortezomib are discussed. Patients are also given an experienced some constipation and diarrhoea, but not severe information booklet on bortezomib, which lists its side effects, self- enough to stop treatment. In addition, no bleeding complication care measures and who to contact should the need arise.
was experienced by any of the patients. Once the presence of Patients are not required to receive their first dose of bortezo- possible specific side effects is assessed for (i.e. peripheral mib at the hospital; first doses are given at the patient’s home by neuropathy, gastric upset, and febrile episodes), the risks associated the administering nurse, who performs systematic clinical evalu- with home administration of bortezomib are minimal.
ation for side effects and detection of contraindications for the While the sample size is too small to make any valid compar- administration of bortezomib. Additionally on day 8 of each cycle, ison, the responses achieved by patients on home administration samples for the full blood count and biochemistry profile are are what would have been expected with standard administration and there is no reason to question the efficacy of this approach.
Please cite this article in press as: Meenaghan, T., et al., Home administration of bortezomib: Making a difference to myeloma patients’ lives,European Journal of Oncology Nursing (2009), doi:10.1016/j.ejon.2009.09.003 T. Meenaghan et al. / European Journal of Oncology Nursing xxx (2009) 1–3 Feedback from patients reveals that they are very satisfied with the pilot; in particular, the need to identify each person’s role in the program and find the service convenient with minimum order to avoid overlap and confusion. In addition, good communi- negative impact on quality of life. Indeed, it is more likely that cation between the nurse co-ordinating the service and the quality of life improves rather than deteriorates during bortezomib administering nurse is vital so that there is prompt reporting of therapy ). To quote one patient: ‘‘I could be gone a patient’s side effects. Finally, to avoid wastage and contain costs, from half-nine until half-four or more.a trip is a day wasted, a day the co-ordinating nurse needs to maintain good communication lost in my life’’. The patient’s partner added that: ‘‘Sometimes she with the pharmacy so that they are aware of dose adjustments and wouldn’t sleep for two or three nights thinking about it’’. The patient any changes in a patient’s therapy.
also commented that, ‘‘When you’re at the hospital, you hear whatthe doctors and nurses are saying but it doesn’t always sink in. At home, you can pay attention, listen to what you’re being told’’. Shealso commented that she was now more confident and her partner We wish to declare that we have no relationships with the added to this by saying that ‘‘.Sometimes the tension grows in the pharmaceutical company Jannseen Cilag, funding the pilot program person who’s being treated.you don’t see that when she’s being and TCP, the administering company that could be viewed as pre- senting a potential conflict of interest.
Another patient also commented on the difficulties experienced with the hospital visits: ‘‘You’d just sit there. Sometimes, they’d be sobusy .it was very hard’’. She also talked about the anxiety she felt before hospital visits: ‘‘You’d be worried the night before; there’d be We would like to thank the support of the pharmaceutical more tension (for you) in the hospital.you’d be less likely to pick up company, Jannseen Cilag, for funding this pilot program, and TCP (Temperature Control Pharmacy) the administering company.
A third patient also commented on the anxiety provoked thinking about the hospital visits: ‘‘I wouldn’t sleep that well thenight before; it was a lot of hassle’’. She also added that the nurse coming to her home to administer her treatment was ‘‘lovely.she Colson, K., Doss, D.S., Swift, R., Tariman, J., 2008. Expanding role of bortezomib in [nurse] came at three and I was able to do my own thing before; then multiple myeloma. Cancer Nursing 31 (3), 239–249.
the next time she came at eleven and that was beautiful altogether’’.
Devenney, B., Erickson, C., 2004. Multiple myeloma, an overview. Clinical Journal of Harousseau, J.L., Attal, M., Leleu, X., Troncy, J., Pegourie, B., Stoppa, A.M., et al., 2006.
Bortezomib plus dexamethasone as induction treatment prior to autologousstem cell transplantation in patients with newly diagnosed multiple myeloma: This program illustrates the positive effects for patients with results of an IFM phase II study. Haematologica 91 (11), 1498–1505.
multiple myeloma when bortezomib is administered in their own Kumar, S.K., Rajkumar, S.V., Dispenzieri, A., Lacy, M.Q., Hayman, S.R., Buadi, F.K., et al., 2008. Improved survival in multiple myeloma and the impact of novel home. Moreover, the central role played by nurses in developing therapies. Blood 111 (5), 2516–2520.
and delivering this program as part of the multidisciplinary team is Lashlee, M., O’Hanlon Curry, J., 2007. Pediatric home chemotherapy: infusing ‘‘quality of life’’ Journal of Pediatric Oncology Nursing 24 (5), 294–298.
McCarthy, H., Hammond, L., Ryman, N., Hall, R. A pilot feasibility study of home The program is now well established, and consideration is administration of bortezomib to patients with relapsed myeloma. X11 Inter- currently focused on the possibility of other regional centres with national Myeloma Workshop, Washington, DC, 26th February 2009.
a laminar flow unit (aseptic unit) preparing bortezomib for home San Miguel, J.F., Schlag, R., Khuageva, N.K., Dimopoulos, M.A., Shpilberg, O., Kropff, M., et al., 2008. Bortezomib plus melphalan and prednisone for initial administration. We are also currently undertaking an audit to treatment of multiple myeloma. New England Journal of Medicine 359 (9), examine the cost of the program. The team have learnt a lot from Please cite this article in press as: Meenaghan, T., et al., Home administration of bortezomib: Making a difference to myeloma patients’ lives,European Journal of Oncology Nursing (2009), doi:10.1016/j.ejon.2009.09.003

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