As CAR-T therapy starts to transition from clinical trials into routine practice, patient care and management of side-effects will become a key focus. A multi-disciplinary team (MDT) with specialist training in CAR-T will be necessary to ensure that patients are monitored appropriately and effectively. The management and treatment of cytokine release syndrome (CRS), which can be life-threatening, will be particularly important for the MDT.
Sessions describing the roles of nurses and pharmacists took place at the 44th European Society for Blood and Marrow Transplantation (EBMT) annual meeting. On 19 March 2018, oral abstract NG10-5 was presented by Rose Ellard, a specialist hematology research nurse at King’s College Hospital NHS Foundation Trust. The talk described nurse experience for the early detection of CRS in CAR T-cell patients.
Based on nurse experience from her hospital, Ms Ellard found that their current guidelines for treating CRS (Lee et al, 2014) were outdated and they found that it was better to treat it earlier than recommended by the guidelines. Tocilizumab was given to patients who had fevers for 24-48 hours however, it is not licensed for this condition in the UK and so it is used off-label.
Ms Ellard emphasized the importance for nurses to be educated on CAR-T therapy and on the management of adverse events. Ms Ellard added that, “it’s not just CRS but also neurotoxicity, infection and tumor lysis syndrome that are known challenging side effects of the treatment”. She highlighted that, “sometimes CRS requires treatment in an intensive care unit (ICU) so it is important to maintain close links with these colleagues”. Nurses need to be able to effectively communicate all aspects of the therapy to patients and their families and to answer their questions.
She explained that there is limited formal teaching for nurses on CAR-T therapy in the UK and currently, there are no nursing guidelines. So far, Ms Ellard and her team have carried out training at ward-level. She concluded that “ward communication is crucial” and “we learn more with every patient that we treat”.
A pharmacist day session took place on 20 March 2018, on the pharmacist’s role in CAR-T therapy. Presentations were given by Bechara Mfarrej, biologist at the cell therapy facility at the Institut Paoli-Calmettes in Marseille, France on CAR-T cells clinical development and management of toxicities. Tiene Bauters, clinical pharmacist at the pediatric hemato-oncology and stem cell transplantation at Ghent University Hospital, Belgium, further discussed the role of the pharmacist in the JACIE process.
Mr Mfarrej described the different grading assessments of CRS and how they will be managed, as the toxicity severity increases, the treatment will become more aggressive. He noted that the management of these toxicities is still under debate.
Mr Mfarrej also highlighted the FACT standards for immune effector cells that are published guidelines that include standards for managing CAR-T patients. A section is included for pharmacists on how to manage toxicities, communicate with different teams and aid continuing professional development.
The following talk by Ms Bauters described the FACT-JACIE standards for pharmacists with the 7th edition published on the 01 March 2018. In order to be compliant with the standards, there needs to be an available pharmacy that provides 24-hour immediate access to medication. Pharmacist training and knowledge should include hemato-oncology patient care and the process of cellular therapy and the pharmacist should be licensed to practice within the jurisdiction of the clinical program.
The standards also recommend appointing designated pharmacists who will require sufficient training in developing and implementing controlled documents for the pharmaceutical management of cellular therapy recipients. The knowledge required by designated pharmacists include; management of adverse events, therapeutic drug monitoring, monitoring drug interactions and the ability to recognize medications required for organ dysfunction.
In conclusion, the presentations on the role of the MDT in managing CAR-T patients demonstrated the large scale of co-ordination required amongst specialist doctors, nurses, emergency units, pharmacists and social workers. As more is learned from treating patients with CAR-T, ongoing training will be essential so that the knowledge on the support of this treatment is kept up to date.