Impact case study database

There are approximately 55,200 new breast cancer cases in the UK annually (2014–2017). Radiotherapy is an important part of the treatment for these patients with 63% of breast cancer patients receiving radiotherapy as part of their primary treatment.

International guidelines/recommendation and uptake of the improved radiotherapy techniques. The interim results of the START trials led to the NICE recommendation in 2009 that a 15-fraction regimen over 3 weeks (total 40Gy) should be the standard treatment protocol, replacing commonly used 5-week schedules (total 50Gy) and remaining the standard of care since 2009 [A]. NHS commissioning guidance states: “ At least 80% of patients for whom radiotherapy is indicated as part of treatment for breast cancer should receive no more than 15 fractions”. Uptake of the 40Gy in 15-fraction protocol (3-week schedule) has been widespread across the UK. Data from April 2019 showed that the use of 40Gy in 15 fractions was used for 92% of weekly courses in adjuvant breast cancer treatment [B]. This 40Gy in 15-fraction protocol in breast cancer radiotherapy has also been adopted globally and is recommended by the American Society for Radiation Oncology (ASTRO), the National Comprehensive Cancer Network (NCCN), the European Society for Radiotherapy, and the Brazilian Society for Radiotherapy (SBRT). In Canada, by 2014, 75%–85% of patients were reported to be following the 40Gy in 15-fraction protocol developed in the START trials [C].

The results from the FAST-Forward trial are already changing clinical practice. The trial found that delivering a shorter course (26Gy in 5 fractions, 1-week schedule) compared to women who have undergone surgery for early-stage breast cancer was as safe and effective as the standard of 3 weeks, which will reduce treatment times and save healthcare resources. Professor Nick Lemoine, Medical Director of the NIHR Clinical Research Network (CRN), said:

"Breast cancer is the most common cancer amongst women and the largest user of radiotherapy facilities in the UK. NIHR is committed to funding practice-changing research and this landmark study supports that position. This study shows how innovation can be both clinical and cost-effective and it's an important marker for broader impact of healthcare treatments and tests for those who plan, provide or receive care from NHS and social care services.” [D]

The FAST-Forward approach, 26Gy in 5 fractions (1-week schedule), means that the number of hospital visits is reduced from 15 to only 5 and is expected to save the NHS GBP40,000,000 annually. For example, Swansea’s Singleton Hospital introduced the FAST-Forward approach in June 2020 as their standard of care. This quick adoption was made possible by a GBP12,000,000 investment in new equipment at the radiotherapy department, funded by the Welsh Government and Swansea Bay University Health Board. The reduction in treatment times could allow the hospital to treat more patients every year [E]. In addition, in May 2020, the 26y in 5 fractions (1-week schedule) regimen was recommended for immediate adoption during the COVID-19 pandemic by an international panel of experts [F]. By adopting these recommendations it allows centres to target radiotherapy to those with the highest risk of relevant breast recurrence, protects patients and health care professionals from potential exposure to COVID-19, and reduces the workload for health care providers and/or infrastructure at the moments that resources face strain due to the pandemic. The use of the 26Gy in 5 fractions (1-week schedule) radiotherapy regimen rapidly increased during the first lockdown in England from 0.2% in April 2019 to 60% in April 2020 [B]. To enable this impact, the FAST-Forward protocol and radiotherapy planning pack were made publically available on the ICR external website.

Following the initial results of the IMPORT LOW trial, the UK Royal College of Radiologists 2016 breast radiotherapy consensus stated that partial-breast radiotherapy could be considered for selected patients using the IMPORT LOW technique [G]. In addition, the Danish Breast Cancer Oncology Group adopted this partial-breast radiotherapy technique in 2016 [H]. It is currently being applied in Australia and enquiries regarding the technique have been received from other international groups, including North America. Moreover this approach is recognised as an important improvement for generations of women diagnosed with breast cancer. The British Association of Surgical Oncologists introduced a best practice recommendation in the wake of this trial to insert surgical clips around the tumour bed for all patients undergoing breast conserving surgery, in order to optimise partial-breast radiotherapy [I].

Patient benefit of the improved radiotherapy techniques. With the START regimen, women are spending less time and money travelling for treatment, and also report less late tissue damage effects (e.g. breast shrinkage and induration)—without any loss of cancer control. We estimate each patient saves over 14 hours in travel and appointment—a total of 345,166 hours each year for all patients.

The IMPORT LOW approach has significant benefits for patients as it can substantially reduce the side effects, with >50% of women in the study having no long-term side effects at all 5 years after treatment (Ref. 4 and Ref. 5). In addition, it has facilitated the development of 3D intensity modulated radiotherapy, a more accurate way of delivering radiotherapy, throughout the UK. 30 UK radiotherapy centres participated in the trial, many of which were using 2D breast radiotherapy routinely at the start of the trial [I]. There are no extra training or resources required by sites so the treatment is easily implementable without any additional costs or resources.

Cost saving for the NHS and global healthcare as a result of improved radiotherapy techniques. The NHS is saving substantially on treatment costs and also has increased capacity for radiotherapy delivery. The START protocol (40Gy in 15 fractions) has been recommended since 2009. We have estimated that 25,000 women per year were treated with the START protocol (2009 to 2019) with a saving of GBP1,610 per patient which represents a total NHS saving of GBP40,000,000 per year. Therefore during the REF impact period, the START protocol has saved the NHS an estimated GBP240,000,000 (2014 to 2019). The FAST-Forward protocol (26Gy in 5 fractions) being adopted from 2020 onwards will bring further cost saving.

The change from the previous conventional course of 50Gy in 25 fractions (5-week schedule) to 40Gy in 15 fractions (START protocol, 3-week schedule) has seen a decrease in cost per patient from USD13,358 to USD8,328 in the United States—a decrease of 38%. Australian data shows a comparable cost decrease of 32% (from USD8,272 to USD5,613). These figures consider both the additional costs per fraction delivered and the associated weekly management costs, which are substantially burdensome beyond week 4 of breast cancer treatment [J].