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Case Study 4. Improving chemotherapy, radiotherapy and patient outcomes for colorectal cancer through patient-focused integrated clinical trials

Summary of the impact

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.

Submitting Institution

University of Leeds

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Oncology and Carcinogenesis

3. A New Standard of Care for Locally Advanced Prostate Cancer

Summary of the impact

Locally advanced prostate cancer (where a tumour has extended outside the prostate gland to surrounding tissues) will affect around 20,000 men per year in the US, and 4,000 men per year in the UK. Prior to the underpinning research, there was no consensus on the standard of care, with hormone therapy often being given alone. The International randomised clinical trial, led by Cardiff researchers showed that treating locally advanced disease with a combination of radiotherapy and hormone therapy halved the risks of dying of prostate cancer. Consequently, it is now a standard of care, enshrined in European and North American guidelines, that all such patients who are fit enough to receive it, should now be offered combined modality radiotherapy plus hormone therapy.

Submitting Institution

Cardiff University

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis, Public Health and Health Services

Targeted intraoperative radiotherapy at the time of lumpectomy for patients with early breast cancer as an alternative to conventional 3-6 weeks of postoperative radiotherapy

Summary of the impact

Research from UCL Division of Surgery has transformed the breast cancer treatment paradigm so women can complete their local treatment intraoperatively (~30 min), with reduced toxicity. Our work has challenged the dogma of giving several weeks of whole breast radiotherapy (EBRT) after lumpectomy for breast cancer with our idea of irradiating only the tumour bed in selected cases; we have developed and evaluated new technology called TARGeted Intraoperative radioTherapy (TARGIT) within the novel approach of risk-adapted radiotherapy. To date, TARGIT has saved 180,000 hospital visits and could save £60M(UK)/ $280M(USA)/year.

Submitting Institution

University College London

Unit of Assessment

Clinical Medicine

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Oncology and Carcinogenesis

C: Detailed analysis of trial of lapatinib in combination with capecitabine in advanced, HER2+ breast cancer leads to marketing authorisation worldwide

Summary of the impact

Impact: Health and welfare; additional effective therapy for women with advanced, HER2+ breast cancer.

Significance: Allows approximately 10,000 patients a year, whose disease is no longer being controlled by trastuzumab, to receive a more effective therapy than chemotherapy with capecitabine alone.

Beneficiaries: Patients with incurable metastatic HER2+ subtype breast cancer; policy-makers; commerce.

Attribution: Cameron (UoE) was joint chief-investigator on the global pivotal registration trial that led to the marketing authorisation of the drug lapatinib in combination with capecitabine.

Reach: World-wide: the drug is approved in >100 countries and generated >£650M in sales for manufacturer GlaxoSmithKline.

Submitting Institution

University of Edinburgh

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Oncology and Carcinogenesis

Neoadjuvant chemotherapy for invasive bladder cancer

Summary of the impact

Researchers at the MRC Clinical Trials Unit conducted a systematic review and meta-analysis of individual patient data on neoadjuvant chemotherapy for invasive bladder cancer. This work has been cited as evidence in 19 national and international clinical practice guidelines from 2008 to 2013. In most cases, the guidelines citing this review substantiate their clinical recommendations by directly quoting the review content.

Submitting Institution

University College London

Unit of Assessment

Public Health, Health Services and Primary Care

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Oncology and Carcinogenesis, Public Health and Health Services

Systemic therapies for ovarian cancer

Summary of the impact

University of Glasgow research has led to the adoption of first-line chemotherapy for ovarian cancer, which has improved patient survival by 11% and has been used to treat 66% of women with ovarian cancer since January 2011 in the West of Scotland Cancer Care Network alone. These therapies are recommended by guidelines for ovarian cancer treatment in the USA, Europe and the UK. The USA guidelines are disseminated to 4.3 million people worldwide and the European guidelines reach 15,000 health professionals. The UK guidelines are used to identify those drugs that are funded by the NHS and used in NHS hospitals.

Submitting Institution

University of Glasgow

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis

Standardised radiotherapy dose fractionation for breast cancer treatment

Summary of the impact

Clinical research led by The Institute of Cancer Research (ICR) has resulted in new standardised curative radiotherapy dose-fractionation regimens being adopted across the UK for over 25,000 women per year with early breast cancer. As a direct result of the trials led by the ICR, NICE introduced new guidance in 2009 recommending a 15-fractions-over-3-weeks radiotherapy regimen (hypofractionation) instead of the previous 25-fractions-over-5-weeks schedule. Patient welfare is substantially improved with savings in travel time and costs for attending treatment, and the NHS benefits from reduced treatment costs. This new treatment schedule is now being adopted internationally.

Submitting Institution

Institute of Cancer Research

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Oncology and Carcinogenesis

A safer and shorter treatment for thyroid cancer

Summary of the impact

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.

Submitting Institution

University College London

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis

Improving tolerability, convenience and cost of bowel cancer chemotherapy

Summary of the impact

Bowel cancer is the third most frequently diagnosed cancer worldwide. University of Glasgow researchers have established Xeloda (an oral 5-fluorouracil precursor) and XELOX (a chemotherapeutic regimen combining Xeloda with oxaliplatin) as highly effective, targeted therapies for patients with bowel cancer. Since 2008, European regulatory approval of these therapies has been incorporated into major international clinical guidelines. The research has transformed patient care by improving the treatment experience, with more convenient dosing schedules and fewer side effects compared with previous chemotherapy procedures. Xeloda and XELOX have transformed chemotherapy for bowel cancer and decreased therapeutic costs, potentially saving around £4,762 (Xeloda) and £947 (XELOX) per patient for the NHS.

Submitting Institution

University of Glasgow

Unit of Assessment

Clinical Medicine

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Clinical Sciences, Oncology and Carcinogenesis

Reducing the toxicity of pemetrexed treatment in malignant pleural mesothelioma.

Summary of the impact

Malignant pleural mesothelioma (MPM) is a treatable but incurable cancer that originates in the cells lining the lungs. Over 14,000 people worldwide are diagnosed annually with MPM. Antifolates are often used in cancer therapy, but side effects are a major issue. A retrospective analysis of cancer trials and phase 1 trial of MPM patients, carried out by Newcastle in collaboration with Eli Lilly Pharmaceuticals, determined that plasma homocysteine levels were a good predictor of drug toxicity in cancer patients treated with the antifolate pemetrexed, and that this drug was well tolerated by patients with low homocysteine levels. It was also determined that pemetrexed treatment should be supplemented with vitamin B12 as well as folic acid, to reduce drug toxicity. Ultimately, this permitted the continued development of pemetrexed, which otherwise would have been too toxic for clinical use. It is now the only licensed drug for MPM treatment in combination with platinum-based chemotherapy.

Submitting Institution

Newcastle University

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Public Health and Health Services

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