Patient- and clinician-assessed five-year normal tissue effects following one-week versus three-week axillary radiotherapy for breast cancer: Results from the phase III FAST-Forward trial randomised nodal sub-study
Year: 2025
Type: article
Abstract: BACKGROUND AND PURPOSE: FAST-Forward showed that 26 Gray (Gy) in 5 fractions (Fr) over one week adjuvant radiotherapy to breast or chest wall was as safe and effective as a three-week schedule (40 Gy/15Fr) for early breast cancer. The nodal sub-study investigated whether a one-week schedule is safe for adjuvant axillary radiotherapy. MATERIALS AND METHODS: In this randomised, non-inferiority, non-blinded sub-study (ISRCTN19906132), patients with invasive breast cancer (pT1-3, pN1-3a, M0) following surgery requiring axillary radiotherapy (any or all levels 1-4) were randomised to 40 Gy/15Fr (three weeks, control), 26 Gy/5Fr or 27 Gy/5Fr (one week) atlas-based radiotherapy planning, including quality assurance. The 27 Gy/5Fr group closed early due to three-year main trial normal tissue effects suggesting 26 Gy/5Fr would be optimal; this analysis focusses on comparison between 26 Gy/5Fr and control. Primary endpoint was five-year patient-reported moderate or marked arm or hand swelling, aiming to exclude a 10 % increase (assuming 10 % incidence with control; 90 % power, one-sided α = 0.05, n = 172 per group). RESULTS: 469 patients were randomised from 50 UK centres (182 40 Gy/15Fr, 183 26 Gy/5Fr, 104 27 Gy/5Fr). Median age 61 years; 250 (54 %) and 182 (39 %) had grade 2 and 3 tumours respectively; 261 (56 %) had axillary dissection. Of those who completed a five-year questionnaire, 11/107 (10 %) 40 Gy/15Fr and 13/116 (11 %) 26 Gy/5Fr reported moderate or marked arm or hand swelling, difference 1 % (90 % confidence interval -6%, 8 %, p = 0.49). Other arm and shoulder symptoms were similar between groups with no cases of brachial plexopathy. CONCLUSION: Five-year patient-reported normal tissue effects suggest 26 Gy/5Fr/1-week hypofractionation is safe for breast cancer patients requiring adjuvant axillary radiotherapy.
Source: Radiotherapy and Oncology
Authors: A. Murray Brunt, Fay H. Cafferty, Duncan Wheatley, Mark A. Sydenham, Anna M. Kirby, Charlotte E. Coles, Jaymini Patel, Abdulla Alhasso, Charlie Chan, Susan Cleator, Helen Fleming, Daljit Gahir, Andy Goodman, Clare Griffin, Joanne S. Haviland, Cliona Kirwan, Zohal Nabi, Karen Poole, Elinor Sawyer, Judith Sinclair, Navita Somaiah, Isabel Syndikus, Karen Venables, John Yarnold, Judith M. Bliss
Institutions: Institute of Cancer Research, Keele University, Royal Cornwall Hospital Trust, Royal Cornwall Hospital, University of Cambridge, Beatson West of Scotland Cancer Centre, Imperial College Healthcare NHS Trust, National Cancer Research Institute, University Hospitals of North Midlands NHS Trust, Torbay Hospital, University of Manchester, Manchester University NHS Foundation Trust, Mount Vernon Cancer Centre, Guy's Hospital, St Thomas' Hospital, King's College London, Guy's and St Thomas' NHS Foundation Trust, Royal Marsden NHS Foundation Trust, Clatterbridge Cancer Centre NHS Foundation Trust, Mount Vernon Hospital, Mount Vernon Hospital
Language: English
Subfield: Cancer Research
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $3,770
OpenAlex ID: W4410074166