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Medicine

Changing treatment paradigms in gastrointestinal cancers

Through large-scale clinical trials and other studies, Southampton research has defined new standards of care and changed clinical practice for cancers of the gastrointestinal tract worldwide. This includes improved follow-up protocols for patients with colorectal cancer, and new standards of care for biliary tract cancer.

Context

The University of Southampton’s medical and surgical oncology research teams have together pursued a strategy of undertaking large-scale multicentre clinical trials combining clinical end-point with exploratory translational analyses.

The work has focused on colorectal cancer, a common cancer with high societal impact, and rarer conditions of unmet need such as biliary tract cancer, resulting in clinical trials that have changed clinical practice around the world.

FACS trial (2003-2014, NIHR) for improved patient experience and cost savings following colorectal surgery

Gastrointestinal cancer

The Follow-up After Colorectal Surgery (FACS) trial, led by Professor John Primrose, explored the use of computer tomography (CT) and tumour marker examination after colorectal surgery.

In a follow-up of 1,202 patients with completely resected colorectal cancer, results showed that more intensive monitoring is of no benefit to the patient, so cost and patient inconvenience can be reduced markedly.

The FACS trial has set the standard on the follow-up of patients with resected colorectal cancer and has informed all guidance on colorectal cancer follow-up globally since the results were published in 2014, including NICE Guidance NG151.

For the 20,000 patients in the UK, this results in a national saving of around £40 million per year, mainly by reducing the number of CT scans. Globally, around one million patients will suffer colorectal cancer requiring follow-up, and hence very substantial global savings could be expected depending on local practices.

SCOT study (2008 to date, MRC) for reduction in adjuvant chemotherapy

The MRC Short Course Oncology Therapy (SCOT) study, led by Professor Tim Iveson, is the largest trial of adjuvant chemotherapy in colorectal cancer ever conducted. It has demonstrated that for most patients, three months’ chemotherapy after surgery is sufficient, compared to the previous treatment duration of six months.

These results were immediately incorporated into national and international guidelines, with NICE Guidance NG151 recommending that halving the treatment “will reduce treatment time and costs, meaning people have chemotherapy side effects for a shorter time, and will lower the incidence of long-term toxicity”.

An economic analysis of SCOT suggests a saving of almost £5,000 per patient. Applied conservatively to 50% of global stage 3 patients receiving post-operative chemotherapy, this saves approximately £1.7 billion per year.

New EPOC trial (2005 to date, CRUK) for patients with operable colorectal liver metastases

The New EPOC trial, involving 257 patients with metastatic colorectal cancer, demonstrated that the common practice of adding cetuximab to conventional chemotherapy resulted in a two-year reduction in overall survival in patients with operably colorectal liver metastases.

Changing this practice has had a major impact on the survival of patients in this cohort globally, as supported by the 2016 guidelines of the European Society of Medical Oncology (ESMO) and a Lancet Editorial

BILCAP trial (2004-2009) for biliary tract cancer

The BILCAP trial examined the use of capecitabine chemotherapy in 447 patients with resected biliary tract cancer and demonstrated improved median overall survival by 16% with no measurable reduction in quality of life. Up to this point patients had not received any post-operative treatment and were subject to clinical observation only.

Based on a conservative estimate of 500,000 annual biliary tract cancer cases globally, implementation of this process around the world could result in a saving more than 4,000 lives every year. 

Trials for minimally invasive surgery (2015 to present, CRUK)

Minimally invasive surgery (MIS) is developing rapidly in surgery of the liver and pancreas, but this is technology-driven with little evidence of patient benefit. Professor Primrose and colleagues have critically examined this development of MIS, including within two CRUK-funded trials (ORANGE 2 and ORANGE SEGMENTS). They have organised two global consensus conferences to established guidelines enabling safer introduction of MIS.

The recommendation for more research in MIS is included in the 2018 NICE guidance NG85 on pancreas cancer, chaired by Primrose.

Key Publications

List of all staff members in
Staff MemberPrimary Position
John PrimroseProfessor of Surgery
Tim IvesonProfessor of Gastro-Intestinal Oncology
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