Oncology and Haematology Research

1. Oncology and Haematology Research Senior Research Nurse Nicola Slawson & Research Nurse Bethany Armstead

2. Why is research important in healthcare? • Plays a key role in helping the NHS understand, adapt and respond to the challenges it faces. • The Research and Governance Framework is a requirement of the DOH (2006) • Provides evidence for clinicians to enable the delivery of high quality best practice, giving health care professionals confidence in clinical decisions … • Enables the NHS to focus resources and provide evidence and rationale to support expenditure on treatments • It identifies new ways of preventing, diagnosing and treating disease. (NIHR CRN CC 2011) … which improves patient survival, experience and quality of life in the future. • Patient’s on clinical trials often do better than those that are not.

3. Patient’s Perspective – Why be involved in research? • Increased monitoring - input from more healthcare professionals, more often. • Access to new treatments that aren’t available through NICE or the Cancer Drugs Fund. • Altruism – to help others in the future, like to contribute and ‘give back’. • To be involved in something beyond their own illness – the feeling of being part of something bigger and of creating a positive out of a negative situation. • Access to treatments that appear to to have a good effect but are currently not NHS funded as more research is needed to prove efficacy and safety.

4. NIHR & GCPNational Institute for Health Research & Good Clinical Practice • The NIHR Clinical Research Network focuses on clinical research delivery throughout the NHS. It aims to make it possible for all patients and health care professionals to participate in clinical research. • “Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. Compliance with GCP provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable.” https://www.nihr.ac.uk/our-faculty/clinical-research-staff/learning-and-development/national-directory/good-clinical-practice/ • Provides the infrastructure to support commercial and non-commercial high quality research in the NHS, including clinical trials with quality and expertise. • Patient participation is always voluntary and consent can be withdrawn at any time without reason being given. • The patient and their own welfare is always the priority with their autonomy protected at all times. • To improve the quality and speed and coordination of clinical research.

5. Importance of Research in Cancer Services Increase Surivival One-year survival (England & Wales) Ten-year survival (England & Wales) 2010-2011 67% 1971-1972 45% 1971-1972 24% 2000-2001 41.5% This is due to a combination of earlier detection, diagnosis and advancement of treatments. http://www.cancerresearchuk.org/health-professional/cancer-statistics/survival/all-cancers-combined (last accessed 09/02/18)

6. http://www.cancerresearchuk.org/health-professional/cancer-statistics/survival/all-cancers-combined (Last accessed 09/02/18)

7. Research in cancer services goal is; Improve Quality of Life • Reduced inpatient hospital stay • Reduced hospital visits • Move from IV to subcut delivery of drugs • Improve outcome – length of disease free survival • Improved and faster diagnosis through new screening methods • Reduced Toxiticies More cost effective treatment

8. Haematology and Oncology Studies • Epidemiology • Observational • CTIMPS (Clinical Trial of an Investigational Medicinal Product) – experimental drugs, licenced drugs in different combinations/for different disease. • Pharmacogenomics / genetic profiling- the study of how genes affect a person's response to drugs or inherited mutations . • Biomarkers – which enable measurement of response to therapeutic intervention. • Disease monitoring using molecular approaches.

9. Genetic Profiling Increased interest in genetic testing of cancerous cells to see what mutation has occurred and cell changes that occur as a result ie: function, apoptosis, etc. • Genetic profiling of cancerous cells to determine which treatments will give the best response • Genetic testing for inherited mutations – familial risk of developing certain cancers • For example • CLL P53 gene deletion present • ALL – Philadelphia chromosome (translocation) genetic mutation in chromosome 22 of leukaemia cancer cells – use standard chemo and Tyrosine Kinase inhibitors BRCA2 in breast cancer

10. Anti-cancer drugs -not just Chemotherapy Reduction in severe, “classic chemotherapy” type symptoms • Targeted therapies Treatments that ‘attack’ specific genes or proteins rather than chemotherapy which is systemic and targets all cells, specifically fast growing cells. Eg – Venetoclax , Mylotarg Targeted treatments work by targeting specific molecules involved in the growth of cancer cells. • Immunotherapy (Monoclonal Antibodies) substances made by the body or in a laboratory to improve or restore immune system function EgAbemaciclib + endocrine therapy v endocrine alone in early breast cancer.

11. Funding Treatment is expensive. With new drugs and technologies comes new higher prices. Research results play a pivotal role in providing the evidence for new drugs and technologies to be approved for funding. Funding and availability goes beyond simply proving that a drug, for example, works in the way intended. Proof then needs to be provided to show how it compares to standard treatment and the resource impact it would have on the NHS. Although a drug may be proven to be effective it may not be approved for initial treatment but for subsequent therapies, sometimes strictly as a 2nd, 3rd or 4th line treatment. This is often due to costing implications.

12. What we do to help you. • Send out letter to GP’s – these include vital information such as who to contact for queries, any non-permitted concomitant medication, any other exclusion (ie Saville oranges for Venetoclax) • Provide patients with information sheets regarding the trail and their treatments • Patient diaries • Patient alert cards • Answer any queries you have

13. What can you do to help us and your patients? • GP letters – Have a working knowledge of you patients • If a patient on a trial becomes unwell or is admitted to hospital please ask them or their relatives to contact us or contact us yourself. • Sometimes we have to contact you requesting information including medications and past medical history.

14. Trial Results UK FAST SCOT (Short Course Oncology Therapy) Breast cancer trial of radiotherapy hypofractionation for treatment of early breast cancer. Comparing 50Gy in 25 fractions (standard) to 28.5 Gy or 30Gy in 5 once-weekly fractions of 5.7/6.0. Colorectal cancer trial comparing 24 weeks of treatment vs 12 weeks (clinician choice of treatment of either Oxaliplatin/capecitabine or Oxaliplatin/5FU) • Showed that 12 weeks treatment length is not inferior to 24 weeks. • Showed that there is a subset of high risk patients that may still benefit from 24 weeks treatment. • Is now standard treatment in appropriate cases. • https://www.oncology.ox.ac.uk/trial/scot • At 3 year follow up showed that 28.5GY in 5 fractions is comparable to 50Gy in 25 fractions. • 28.5Gy in 5 Fractions is significantly milder than 30Gy in 5 fractions, in terms of adverse effects in the breast. • https://www.ncbi.nlm.nih.gov/pubmed/21752481

15. Trial Results Myeloma XI AML 17 This trial was looking at different treatments for acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) that had a high risk of coming back A trial comparing standard and experimental treatment and new maintenance treatment regimes for Multiple Myeloma • No benefit to higher dose of Daunorubicin during induction treatment (except those with a mutation in a gene called FLT3) • Higher rate of toxicities in those receiving the higher dose including low platelets and raised liver enzyme levels • http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-acute-myeloid-leukaemia-aml-17#undefined • Showed that Lenalidomide maintenance treatment doubled length of survival free progression to 37 months compared with 19 months. • Recommends that Lenalidomide be used in this setting as part of standard myeloma care, however, pending approval by NICE. • https://www.myeloma.org.uk/news/myeloma-xi-trial-results-show-significant-increase-in-myeloma-patient-remission/

16. Research at Blackpool Victoria Hospital • 1st UK patient entered into screening for Columba (Feb 2018) This graph shows our recruitmentto NIHR portfolio adoptedresearch studies against our target and actual recruitmentof the last financial year.

17. Any Questions?