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Radiotherapy for ductal carcinoma in situ reduces recurrence

Summary of the impact

The primary treatment for ductal carcinoma in situ (DCIS, cancer confined to the milk ducts of the breast) is surgery, and breast-conserving surgery is increasingly preferred over mastectomy. The UK/ANZ DCIS trial, co-led by Queen Mary researchers, showed that following surgery, women with DCIS are significantly less likely to develop invasive disease if given radiotherapy, and that this protection persists long term. NICE recommends that, following adequate breast conserving surgery, adjuvant radiotherapy should be offered to patients with DCIS. This recommendation is also current in the United States, Canada, Australia, and many European countries. Based on current figures, we estimate that in UK alone, around 260 women each year are spared a recurrence of breast cancer as a result of this research.

Submitting Institution

Queen Mary, University of London

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

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

Improved Life Expectancy with Fewer Side-Effects in Breast Cancer Using an Innovative Switching Strategy

Summary of the impact

Laboratory research at Imperial College supported the concept of switching adjuvant treatment of breast cancer (i.e. tamoxifen for 2-3 years to exemestane for 2-3 years) which has now been shown in Imperial-led clinical trials to improve overall survival of breast cancer patients for at least 5 years post-switching. In association with this, the effects of switching on endometrial, skeletal and joint function have shown few long-term deleterious effects. This way of treating breast cancer has now gained acceptance worldwide, as being more efficacious and resulting in fewer longterm, serious side effects. It is the recommended treatment in international guidelines.

Submitting Institution

Imperial College London

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

Introduction of aromatase inhibitors for the treatment of breast cancer

Summary of the impact

The ATAC trial was conceived, designed and implemented by UCL investigators, and has resulted in a dramatic, global change in the management of breast cancer. It directly compared tamoxifen, the standard treatment for breast cancer for 25 years, with anastrozole, a novel aromatase inhibitor. It convincingly demonstrated superiority for the new agent, in terms of both progression-free survival and adverse effect profile. Tamoxifen had been the world's most widely prescribed anti-cancer drug but was supplanted by anastrozole as a consequence of this trial.

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

The introduction of combination chemo-radiotherapy to reduce the need for cystectomy in patients with muscle invasive bladder cancer

Summary of the impact

Muscle invasive bladder cancer is the sixth most common cancer and remains a major cause of death and suffering worldwide. The standard treatment for advanced bladder cancer has been surgical removal of the bladder (cystectomy) which is associated with considerable morbidity. Many (20%) patients are elderly, with significant co-morbidities and hence are high risk for a major operation. In the past patients who were not able to undergo surgery were offered palliative radiotherapy. Research at the University of Birmingham has shown that the addition of low toxicity chemotherapy to radiotherapy is as effective as cystectomy in controlling disease progression and has minimal impact on bladder function. This new approach is an excellent alternative to cystectomy and has been adopted as a new standard of care thus demonstrating considerable impact on clinical practice and patient outcome.

Submitting Institution

University of Birmingham

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis

5. Cardiff research yields evidence for benefits of sentinel node biopsy and spearheads training in the technique as a standard of care in breast cancer surgery

Summary of the impact

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.

Submitting Institution

Cardiff University

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Oncology and Carcinogenesis

Anastrozole for oestrogen receptor positive breast cancer

Summary of the impact

Approximately 80% of all breast cancer is hormone receptor positive localised cancer in postmenopausal women. For 30 years the universal standard adjuvant endocrine treatment for these women was five years of tamoxifen, but side effects and recurrences limited its usefulness. Results from the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial led to a major worldwide change in the standard recommended treatment, from tamoxifen to anastrozole (an aromatase inhibitor). From 2009 this treatment became UK national policy (recommended by NICE), and guidance in other countries (eg Australia, USA) has also been revised. Anastrozole is now routinely offered to women with hormone receptor positive breast cancer in UK and (extrapolating from trial data) we estimate over a thousand are spared a recurrence in UK annually.

Submitting Institution

Queen Mary, University of London

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis

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

Parabens in personal care products: providing marketing tools for industry, informing European policy and raising public awareness

Summary of the impact

Governments, industry and the public have benefitted from research on the potential role of parabens, which are used widely as preservatives in personal care products, in the development of breast cancer. The research, conducted at the University of Reading since the 1990s, has established the oestrogenic activity of parabens in human cells, confirmed and quantified the presence of parabens in human breast tissue and established that parabens can stimulate the proliferation of human breast cancer cells at concentrations measured in the breast tissue. The findings of this research have received widespread media coverage, which has raised public awareness of the issue. As a result, producers and retailers of natural and organic cosmetic products have benefitted through the adoption of these research findings into marketing information available to their customers. Scientific Committees have used the research findings to inform their opinions on the risk of parabens that have been submitted to the European Commission. As well, non-government organisations have benefitted from having scientific evidence to support their public awareness initiatives and campaigns to invoke change in policy.

Submitting Institution

University of Reading

Unit of Assessment

Biological Sciences

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis

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