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Research by the University of Southampton has helped transform the understanding and treatment of chronic lymphocytic leukaemia (CLL), the most common leukaemia, affecting around 2,400 patients each year in the UK and 17,000 in the USA. Southampton's widely cited studies revealing the existence of two subsets of CLL have been crucial in giving clinicians and patients in the UK and overseas a much clearer indication of the likely disease course. The predictive information is now included in all clinical trials and in international guidelines, delivering greatly improved care. The research has also inspired the development of a new drug given "breakthrough" status by the Food and Drug Administration in the United States.
Measurement of hormones is essential to the understanding and diagnosis of endocrine diseases. White and her research group have developed unique antibodies that are widely used in diagnostic assays for adrenocorticotrophic hormone (ACTH) and related peptides, including the first and only kit for measuring pro-opiomelanocortin (POMC), the precursor of ACTH. These assays are used worldwide for diagnosis, decisions on treatment, monitoring for recurrence of tumours and prognosis in a number of patient groups with life-threatening endocrine disorders. Global sales of the ACTH Elecsys tests by Roche exceeded 6 million kits since 2008. AstraZeneca has used the POMC and ACTH assays in its drug discovery programmes in the cardiovascular and metabolic diseases therapy area. The antibodies therefore have had health impact in relieving suffering and in improving patient care, as well as commercial impact in worldwide sales of assays and influencing drug development strategies.
Bladder cancer is the fifth most common form of cancer, with over 70% of cases presenting as non-muscle invasive bladder carcinomas (NMIBC). Research in the Institute of Cancer Therapeutics at the University of Bradford led to the evaluation of Apaziquone (EO9) in phase II clinical trials against high risk NMIBC in The Netherlands, and two multi-centre phase III clinical trials involving 106 centres across the USA, Canada and Europe. A total of 1,746 patients with low or high risk NMIBC received EO9 and significant reductions in the rates of recurrence at two years have been reported. Our research has impacted upon the health and welfare of patients with NMIBC.
The HiLo trial has changed management for patients with well-differentiated thyroid cancer. Patients undergoing radioiodine ablation therapy are now given a low dose of radioactive iodine, which has fewer side effects, compared to the previous (standard) high dose. Also, to prepare patients for ablation they now have recombinant human TSH (thyrotropin alfa), which is associated with a better quality of life before and during ablation. The combination of low dose radioiodine and thyrotropin alfa means that patients can be treated as outpatients rather than inpatients. This is a more convenient treatment package, reducing health service and societal costs.
Research at the University of Bristol (UoB) led to the Department of Health (DH) decision in 1997 that screening for prostate cancer would not be introduced in the UK until there was evidence that benefits outweighed harms. UoB-led and collaborative research subsequently provided evidence to support informed decision-making in the NHS. A formal review by the DH in 2010 endorsed the policy and confirmed that any change would be based on evidence from the team's randomised trials. This research has ensured UK men have avoided known harms of prostate cancer screening in the context of uncertain benefits, and saved the UK economy £ billions.
Research on clinically important red blood cell membrane proteins has helped avoid unnecessary treatment of Rhesus negative pregnant women and enabled the early diagnosis of a rare kidney disease. During the late 1990s, researchers at the University of Bristol, in collaboration with the Blood Service in Bristol, cloned, sequenced and characterised many red blood cell membrane proteins important for transfusion, including the Rhesus proteins and Band 3/AE1 (SLC4AE1 gene). The work on Rhesus proteins facilitated the use of less invasive genetic screening methods to ascertain whether treatment was required to avoid Haemolytic Disease of the Foetus or Newborn (HDFN). In the UK, 5,000 women have been screened since 2001. Within the first six months of implementation of a Danish national screening program in January 2010, 862 women avoided unnecessary treatment. Reducing unnecessary treatment of mothers has saved resources and avoided unnecessary exposure to human derived blood products. In addition, research that has identified specific SLC4AE1 gene mutations that cause the rare kidney disease called distal renal tubular acidosis has enabled the early diagnosis and treatment of the disease, resulting in improved outcomes for patients.
Research at Cardiff University is underpinning the abandonment of the 100-year-old surgical practice of removing all axillary lymph nodes in cases of breast cancer. Such surgery frequently caused arm lymphoedema, loss of arm mobility and lymphatic system damage. Cardiff led the seminal ALMANAC trial which showed that full node clearance was unnecessary if a biopsy of the first draining `sentinel' node was cancer-free. Cardiff then spearheaded the impact on practice through a training and awareness programme for surgeons, primarily in the UK, but also in China, India, Brazil and Turkey. By 2010 these efforts had established the Sentinel Lymph Node Biopsy (SLNB) procedure as standard in the UK, while the study was also cited in USA guidelines. The main beneficiaries of the impact are the 50-75% of breast cancer patients who now enjoy lower levels of pain, shoulder disability and arm lymphoedema. Healthcare providers also benefit financially from a reduced need for extensive surgery.
Research in Leeds showed, conclusively for the first time, improved outcomes for cancer patients managed in multidisciplinary specialised cancer care teams. Our research and systemic overview provided the evidence for a new government policy to reconfigure cancer care services into Cancer Networks, Centres and Units. This required radical evidence-based changes including centralisation of many cancer surgical services. A rigorous implementation plan based on research evidence, was initiated under Leeds leadership and sustained in subsequent government policies. It changed clinical guidelines and professional standards, altered practice for all UK cancer patients and contributed to improved cancer survival.
The MRC Conventional versus Laparoscopic-Assisted Surgery In Colorectal Cancer trial (CLASICC) is the largest and most successful UK trial of a technology applied to general surgery. It addressed an area of huge clinical uncertainty, providing a rigorous evaluation of a new technology and enabling its safe and widespread implementation. The impact of CLASICC has been global, confirming the advantages for patients (quicker recovery) and healthcare providers (cost-effectiveness) and so influencing national and international policy in favour of the laparoscopic technique. It informed NICE guidance and led to a major DH initiative that has seen the UK become one of the largest providers in the world of laparoscopic colorectal cancer surgery. CLASICC is regarded as a benchmark surgical trial, combining high quality trial design with rigorous quality assurance, which has informed the design of many subsequent colorectal cancer studies.
Colorectal cancer is a common disease, which frequently causes death or morbidity, either because of failure to control the primary tumour or failure to prevent distant metastases. Leeds researchers have devised new treatment approaches using chemotherapy and radiotherapy and tested them in large randomised controlled trials which have led to major changes in clinical practice in the management of rectal cancer and advanced colorectal cancer (aCRC), driving clinical decision-making and improving outcomes for patients. This includes better-evidenced treatment for elderly patients and patient stratification on the basis of molecular biomarkers.