Case study: Shorter radiotherapy treatment benefits women with early-stage breast cancer
Improving breast cancer treatment through research
Breast cancer is the most common cancer affecting women in the UK and worldwide. Around 150 new cases are diagnosed in the UK each day, amounting to nearly 56,000 cases every year. Fortunately, early-stage breast cancer is highly treatable and patients are usually prescribed radiotherapy after surgery as part of their treatment.
Until recently, the standard radiotherapy treatment recommended by NICE for women and men with early breast cancer was 40 Gy (unit of radiotherapy dose) given in 15 fractions (doses) over three weeks. These treatment guidelines were informed by a series of Standardisation of Breast Radiotherapy (START) trials, which were part-funded by the Department of Health and Social Care. The trials showed that fewer, larger fractions over a shorter time period was as safe and effective as earlier radiotherapy treatments spanning five weeks.
In 2011, the NIHR Health Technology Assessment Programme funded a 10-year trial to test whether treatment schedules could be reduced further by delivering fewer doses while still achieving the same beneficial effects from radiotherapy. The aim of the FAST-Forward trial was to test whether a course of five doses over one week could be as effective as the standard 15 doses, without compromising on patient safety.
Led by a team of researchers at the Institute of Cancer Research (ICR) in London, the FAST-Forward trial was also supported by the NIHR Clinical Research Network, the NIHR Biomedical Research Centre at The Royal Marsden NHS Foundation Trust and Cancer Research UK.
Murray Brunt, Professor of Clinical Oncology at Keele University, led the team and explained the rationale for the FAST-Forward trial saying: “There was no reason to assume that 15 doses represented the lower limits of this shorter and accelerated approach. Five daily fractions had potential for major benefits in terms of convenience and costs for both patients and healthcare services in the UK and globally.”
Fewer treatments are effective and safe
Between 2011 and 2014, the FAST-Forward trial recruited 4,096 patients who had undergone surgery for early-stage breast cancer from 97 hospitals around the UK. Patients were randomly allocated to one of three treatment groups: a control group and two test groups who received different doses of radiation. The control group received the standard treatment of 15 daily fractions over three weeks, amounting to an overall dose of 40 Gy. To see which one-week schedule was most similar to the control group’s treatment and outcomes, the test groups each received five daily treatments within one week, with a total dose of either 27 Gy or 26 Gy.
Published in The Lancet in 2020, FAST-Forward’s results showed that five years after radiotherapy, the number of patients whose cancer had returned in the treated breast or chest wall was very low in all three groups. In the control group, around 2 in 100 (2.1%) women had a relapse compared with 1.7% in the 27 Gy group and 1.4% in the 26 Gy group. Long-term side effects were similar after the 26 Gy one-week schedule compared with the standard three-week schedule.
This showed that radiotherapy given in fewer but higher doses every day for a week could be just as effective and safe for treating early-stage breast cancer patients than the existing three-week schedule. The team recommended that 26 Gy in five daily doses was adopted as standard of treatment. Commenting on the trial’s results, Professor Brunt said:
“This trial sees the culmination of 30 years of UK research into breast radiotherapy. It showed that a one-week schedule of radiotherapy promises to become the new international standard for patients with operable breast cancer and who need radiotherapy.”
Professor Murray Brunt
Around 80% of patients diagnosed with early breast cancer undergo surgery to remove the tumour prior to radiotherapy, with 63% undergoing subsequent radiotherapy. Reducing standard radiotherapy treatment for breast cancer from three weeks to one week was estimated to save the NHS over £40 million per year.
A new standard of care for most breast cancer patients
Publication of the trial’s results was timely as the outbreak of Covid-19 in early 2020 led to NHS services and treatments being much reduced. The pandemic affected every part of the breast cancer pathway; however, the NHS moved quickly to issue guidance on safely treating cancer. Influenced by the FAST-Forward study, the Royal College of Radiologists published emergency international guidance recommending that the five-dose treatment schedule be put into effect immediately for patients with early-stage breast cancer.
A survey of radiotherapy units by the charity Radiotherapy UK showed that 80% had implemented these changes by April 2020. As such, the NHS was able to reduce patient visits to hospital for treatment from 15 to five – reducing the risk of Covid-19 infection. Its recommendations were later included in the Royal College of Radiologists national consensus guidelines in October 2020.
Carolyn O’Donovan, Radiotherapy Service Manager at University Hospitals of North Midlands NHS Trust, described the impact of reduced treatment sessions for breast cancer patients, saying: “It’s impossible to overstate the significance of the change in national practice that this has had and the positive effect it will have for breast cancer patients, many of whom will have their treatment pathway for radiotherapy reduced by two thirds.”
“The work of Professor Brunt and the team will permanently change radiotherapy practice for the treatment of breast cancer.”
Carolyn O’Donovan, Radiotherapy Service Manager
The shorter treatment schedule was well received by patients too, with one FAST-Forward participant saying: “Personally, I found the five-session radiotherapy system absolutely brilliant. Knowing that I only had to get through one week of treatment made it all so much more bearable. And I also found it worked much better for me in terms of my professional life, because it meant I could get back to my business more quickly.”
Fast-Forward’s results also influenced a European Society for Radiotherapy and Oncology Advisory Committee in Radiation Oncology Practice (ESTRO-ACROP) consensus statement. Published in The Lancet Oncology, it recommended that five daily radiotherapy doses can be offered for patients who do not need lymph node radiotherapy worldwide, either as standard of care or within a research study.
Charlotte Coles, an NIHR Research Professor and Professor of Breast Cancer Clinical Oncology at the University of Cambridge, is also a member of ESTRO-ACROP. She explained how the FAST-Forward results would help change standards of care in Europe and the rest of the world, saying: “Changing from three or even five weeks in some places to one week will make breast radiotherapy treatment a realistic goal for everyone who needs it.”
Reflecting on the outcomes of the study so far, Professor Brunt noted that: “It is important to continue monitoring the patients in our trial to 10 years after their treatment to provide reassurance around the longer-term safety and effectiveness of the five-daily treatment schedule. The patients, staff at recruiting centres and at the ICR-Clinical Trials and Statistics Unit have, and are continuing to, contribute to pivotal research that is changing UK and global practice.”
The study was funded by the NIHR Health Technology Assessment (HTA) Programme.
More information about the study is available on the NIHR’s Funding & Awards website and How taking part in research helped me get my life back on track and overcome cancer.
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