New research by scientists from Queen’s University Belfast, Cardiff University, Imperial College London, and others, suggests that providing a break in treatment to patients with advanced bowel cancer could not only benefit a patient’s quality of life but could also help save UK £1.2 billion (US $ 1.43 billion/ Euro 1.42 billion) for the National Health Service (NHS) in England.[1]

In the United Kingdom, every 60 minutes 5 people, nearly 120 people every day, are diagnosed with bowel cancer, totalling 43,000 new cases of the disease. Hence, bowel cancer, a general term for cancer that begins in the large bowel, and is also referred to as colorectal cancer, in the United Kingdom (UK), is the fourth most common cancer in the UK and the second leading cause of cancer deaths affecting both men and women, with more than 16,500 patients per year dying of the disease.

Early detection
Bowel cancer is treatable and curable especially if diagnosed early. Nearly everyone survives bowel cancer if diagnosed at the earliest stage. However this drops significantly as the disease develops. Early diagnosis really does save lives.

When bowel cancer can’t be completely removed by surgery, patients may be offered chemotherapy to shrink the tumor. Cetuximab (Erbitux®; Eli Lilly and Company/Merck Healthcare KGaA) may also be offered alongside the less toxic chemotherapy. Cetuximab works by targeting tumours with a defect in a particular pathway in the tumour cell.

When patients have a break from chemotherapy, they will continue to receive cetuximab alone. Despite a previous clinical trial that showed intermittent cetuximab to be a safe alternative to continuous cetuximab, treatment breaks beyond six weeks were prohibited in England. [2] In other words, patients were required to continue to take cetuximab when on a break from chemotherapy, despite evidence that a break in cetuximab does not have any negative impact on patient outcome but can potentially benefit the patient’s quality of life.

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This new research, led by Queen’s University Belfast in collaboration with the UK’s leading bowel cancer charity, Bowel Cancer UK, and a series of investigators across the UK, involved a historical analysis of both intermittent and continuous cetuximab approaches to determine their impact on both quality-of-life and treatment costs. The research has been published in the Journal of Cancer Policy, the key policy journal for cancer

Economic modeling
Using a health economic modeling and analysis simulation the researchers compared the outcome of partitioned survival modeling (PSM) and Markov Chain Monte-Carlo (MCMC) to determine costs and quality-adjusted-life-years for intermittent cetuximab versus continuous cetuximab in the treatment of first-line treatment for KRAS wild-type metastatic colorectal cancer (mCRC). They found that employing a treatment break approach with cetuximab would not have any negative impact on a patient’s quality-of-life and outcome, but could potentially save up to UK £1.2 billion for the health service (intermittent cetuximab reduced costs by UK £ 35,763 (PSM; p < 0.001) or UK £ 30,189 (MCMC) per patient annually, while preserving treatment efficacy and enhancing health related QoL)

This work formed part of the crucial evidence that Bowel Cancer UK presented to NHS England to justify a change in bowel cancer treatment policy. This led to a temporary policy change by NHS England, removing the treatment break restrictions during the COVID-19 pandemic.

“Bowel cancer is the fourth most common cancer in the UK. We’ve been campaigning for several years to remove the treatment breaks policy in England, so we warmly welcome this scientifically-validated new evidence,” noted Lisa Wilde, MD, Director of Research and External Affairs at Bowel Cancer UK.

“It is clear that allowing people with advanced bowel cancer to take a break from their treatment benefits patients and saves the NHS money,” she said.

“At the beginning of the COVID-19 pandemic, NICE (National Institute for health and Care Excellence) produced interim treatment guidance to maximise the safety of patients with cancer and make the best use of NHS resources, including allowing some patients to take breaks from their treatment. We’ve been working with NHS England to develop new guidance and hope to see this evidence reflected within the new recommendations,” Wilde added.

Cost minimization
“This study is the first of its kind to use a cost minimization approach to look at the real costs of cancer therapies in the clinical trial setting. It highlights how substantial cost savings can potentially be achieved by reducing treatment, while also reinforcing the importance of therapy breaks to potentially increase tumor responsiveness to treatment once the therapy is reintroduced,” explained Professor Mark Lawler, MD, Chair in Translational Cancer Genomics, Professor of Digital Health at Queen’s University Belfast, and senior author on the study.

“Our study highlights how precise health economic evidence can influence health policy, championing reduced treatment intensity approaches without compromising patient outcomes, which is of particular relevance when addressing the reduced capacity and severe treatment backlogs experienced during the COVID pandemic,” Lawler said.

“Allowing patients to avail of treatment breaks not only can provide good value but also can enhance their quality of life and outcome,” concluded Raymond Henderson, Ph.D., Senior Health Technology Assessment Manager at Salutem Insights and lead author on the paper.

Highlights of prescribing information
Cetuximab (Erbitux®; Eli Lilly and Company/Merck Healthcare KGaA)[Prescribing Information][Summary of Product Characteristics]

[1] Henderson RH, French D, McFerran E, Adams R, Wasan H, Glynne-Jones R, Fisher D, Richman S, Dunne PD, Wilde L, Maughan TS, Sullivan R, Lawler M. Spend less to achieve more: Economic analysis of intermittent versus continuous cetuximab in KRAS wild-type patients with metastatic colorectal cancer. J Cancer Policy. 2022 Jun 16;33:100342. doi: 10.1016/j.jcpo.2022.100342. Epub ahead of print. PMID: 35718327. [Article]
[2] Wasan H, Meade AM, Adams R, Wilson R, Pugh C, Fisher D, Sydes B, Madi A, Sizer B, Lowdell C, Middleton G, Butler R, Kaplan R, Maughan T; COIN-B investigators. Intermittent chemotherapy plus either intermittent or continuous cetuximab for first-line treatment of patients with KRAS wild-type advanced colorectal cancer (COIN-B): a randomised phase 2 trial. Lancet Oncol. 2014 May;15(6):631-9. doi: 10.1016/S1470-2045(14)70106-8. Epub 2014 Apr 3. PMID: 24703531; PMCID: PMC4012566.

Featured image by Colin Watts on Unsplash. Used with permission.

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