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  • Publication
    Partial Breast Radiotherapy for Women with Early Breast Cancer: 10-Year Outcomes from IMPORT LOW (CRUK/06/003)
    (Elsevier, 2023-10-12) Kirby, Anna; Griffin, Laura; Brunt, Adrian; Cafferty, Fay; Alhasso, Abdulla; Chan, Charlie; Haviland, Joanne; Jefford, Monica; Sawyer, Elinor; Sydenham, Mark; Syndikus, Isabel; Tsang, Yat; Wheatley, Duncan; Yarnold, John; Coles, Charlotte; Bliss, Judith; Chan, Charlie; Medical and Dental
    Purpose/Objective(s) IMPORT LOW is a randomized, multi-center phase III trial testing partial breast radiotherapy (RT) using intensity modulated RT in women with early-stage breast cancer at lower than average risk of ipsilateral breast tumor relapse (IBTR). Five-year results concluded non-inferiority for reduced-dose & partial-breast RT with similar normal tissue effects (reduced for breast appearance & hardness as reported by patients; Lancet, 2017). Here we report outcomes after 10 years. Materials/Methods Women age ≥50 who had breast conservation surgery, for invasive breast cancer (excluding classical lobular carcinoma) pT1-2 (≤3cm) N0-1, any grade, with microscopic margins of ≥2 mm, were eligible. Patients were randomized (1:1:1) to 40Gy/15F to whole breast (control); 36Gy/15F to whole breast & 40Gy/15Fr to partial breast (reduced-dose); or 40Gy/15F to partial breast (partial-breast). The primary endpoint is IBTR. 10-year clinician assessed adverse effects were collected. Patient assessments were not recorded at 10 years. Efficacy analysis was intention to treat. Results 2016 patients were recruited from 05/2007 to 09/2010 from 30 UK RT centers (674 control, 673 reduced-dose, 669 partial-breast). Median age was 63 years (IQR 57-68); 42%, 48% & 10% of patients had tumors that were grade 1, 2 & 3 respectively; 3% were node positive. Median follow-up is 121 (IQR 120-124) months. 10-year follow-up forms were received for 518, 520 & 510 whole, reduced & partial groups respectively. 10-year rates of IBTR are 2.8% (95%CI 1.8-4.5), 1.9% (1.1-3.4) & 2.8% (1.7-4.5) in the whole-breast, reduced-dose & partial-breast groups respectively. Absolute treatment differences in IBTR compared with control for reduced-dose is -1.02% (95%CI -1.97, 0.96) & -0.02% (-1.38, 2.58) for partial-breast. 10-year overall survival rates are 87.8% (95%CI 84.9, 90.1), 87.2% (84.3, 89.6) & 90.3% (87.7, 92.4) for control, reduced-dose & partial-breast groups respectively. Clinician assessed adverse effects indicate low rates of moderate/marked events at 10 years (Table 1). Conclusion At 10 years, rates of IBTR & clinician assessed moderate/marked adverse effects remain very low across all treatment groups demonstrating that reduced-dose & partial-breast RT are safe & effective RT techniques.
  • Publication
    Dose-escalated simultaneous integrated boost radiotherapy in early breast cancer (IMPORT HIGH): a multicentre, phase 3, non-inferiority, open-label, randomised controlled trial
    (Elsevier, 2023-06-08) Coles, Charlotte; Haviland, Joanne; Kirby, Anna; Griffin, Clare; Sydenham, Mark; Titley, Jenny; Bhattacharya, Indrani; Brunt, Murray; Chan, Charlie; Donovan, Ellen; Eaton, David; Emson, Marie; Hopwood, Penny; Jefford, Monica; Lightowlers, Sara; Sawyer, Elinor; Syndikus, Isabel; Tsang, Yat; Twyman, Nicola; Yarnold, John; Bliss, Judith; Chan, Charlie; Medical and Dental
    Background A tumour-bed boost delivered after whole-breast radiotherapy increases local cancer-control rates but requires more patient visits and can increase breast hardness. IMPORT HIGH tested simultaneous integrated boost against sequential boost with the aim of reducing treatment duration while maintaining excellent local control and similar or reduced toxicity. Methods IMPORT HIGH is a phase 3, non-inferiority, open-label, randomised controlled trial that recruited women after breast-conserving surgery for pT1–3pN0–3aM0 invasive carcinoma from radiotherapy and referral centres in the UK. Patients were randomly allocated to receive one of three treatments in a 1:1:1 ratio, with computer-generated random permuted blocks used to stratify patients by centre. The control group received 40 Gy in 15 fractions to the whole breast and 16 Gy in 8 fractions sequential photon tumour-bed boost. Test group 1 received 36 Gy in 15 fractions to the whole breast, 40 Gy in 15 fractions to the partial breast, and 48 Gy in 15 fractions concomitant photon boost to the tumour-bed volume. Test group 2 received 36 Gy in 15 fractions to the whole breast, 40 Gy in 15 fractions to the partial breast, and 53 Gy in 15 fractions concomitant photon boost to the tumour-bed volume. The boost clinical target volume was the clip-defined tumour bed. Patients and clinicians were not masked to treatment allocation. The primary endpoint was ipsilateral breast tumour relapse (IBTR) analysed by intention to treat; assuming 5% 5-year incidence with the control group, non-inferiority was predefined as 3% or less absolute excess in the test groups (upper limit of two-sided 95% CI). Adverse events were assessed by clinicians, patients, and photographs. This trial is registered with the ISRCTN registry, ISRCTN47437448, and is closed to new participants. Findings Between March 4, 2009, and Sept 16, 2015, 2617 patients were recruited. 871 individuals were assigned to the control group, 874 to test group 1, and 872 to test group 2. Median boost clinical target volume was 13 cm3 (IQR 7 to 22). At a median follow-up of 74 months there were 76 IBTR events (20 for the control group, 21 for test group 1, and 35 for test group 2). 5-year IBTR incidence was 1·9% (95% CI 1·2 to 3·1) for the control group, 2·0% (1·2 to 3·2) for test group 1, and 3·2% (2·2 to 4·7) for test group 2. The estimated absolute differences versus the control group were 0·1% (–0·8 to 1·7) for test group 1 and 1·4% (0·03 to 3·8) for test group 2. The upper confidence limit for test group 1 versus the control group indicated non-inferiority for 48 Gy. Cumulative 5-year incidence of clinician-reported moderate or marked breast induration was 11·5% for the control group, 10·6% for test group 1 (p=0·40 vs control group), and 15·5% for test group 2 (p=0·015 vs control group). Interpretation In all groups 5-year IBTR incidence was lower than the 5% originally expected regardless of boost sequencing. Dose-escalation is not advantageous. 5-year moderate or marked adverse event rates were low using small boost volumes. Simultaneous integrated boost in IMPORT HIGH was safe and reduced patient visits.
  • Publication
    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
    (2025-05-04) Brunt, Murray; Cafferty, Fay; Wheatley, Duncan; Sydenham, Mark; Kirby, Anna; Coles, Charlotte; Patel, Jaymini; Alhasso, Abdulla; Chan, Charlie; Cleator, Susan; Fleming, Helen; Gahir, Daljit; Goodman, Andy; Griffin, Clare; Haviland, Joanne; Kirwan, Cliona; Nabi, Zohal; Poole, Karen; Sawyer, Elinor; Sinclair, Judith; Somaiah, Navita; Syndikus, Isabel; Venables, Karen; Yarnold, John; Bliss, Judith; Chan, Charlie; Medical and Dental
    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. Keywords: Breast neoplasms; Clinical trials; Lymphatic irradiation; Patient reported outcomes; Radiotherapy; Radiotherapy dose hypofractionation.
  • Publication
    Partial-breast radiotherapy after breast conservation surgery for women with early breast cancer (UK IMPORT LOW): 10-year outcomes from a multicentre, open-label, randomised, controlled, phase 3, non-inferiority trial
    (Elsevier, 2025-07-26) Kirby, Anna; Finneran, Laura; Griffin, Clare; Brunt, Adrian; Cafferty, Fay; Alhasso, Abdulla; Chan, Charlie; Haviland, Joanne; Jefford, Monica; Sawyer, Elinor; Sydenham, Mark; Syndikus, Isabel; Tsang, Yat; Wheatley, Duncan; Yarnold, John; Coles, Charlotte; Bliss, Judith; Chan, Charlie; Medical and Dental
    Background: The IMPORT LOW trial evaluated partial-breast radiotherapy with intensity-modulated radiotherapy in women with early-stage breast cancer at below average risk of ipsilateral breast tumour recurrence (IBTR). 5-year results concluded non-inferiority of IBTR for reduced-dose and partial-breast radiotherapy, with similar or lower frequency of adverse effects compared with whole-breast radiotherapy. We report outcomes after 10 years. Methods: IMPORT LOW was a randomised, open-label, multicentre, non-inferiority, phase 3 trial. Women were eligible if they were aged 50 years or older and had had breast conservation surgery for unifocal invasive ductal adenocarcinoma, pT1-2 (tumour size of ≤3 cm), N0-1 (none to three positive axillary nodes), grades 1-3, with microscopic margins of non-cancerous tissue of 2 mm or more. Patients were ineligible if they had a previous malignancy of any kind (except non-melanomatous skin cancer), had undergone mastectomy, or had received neoadjuvant or concurrent adjuvant chemotherapy. Patients were randomly assigned (1:1:1) by randomly permuted blocks to radiotherapy regimens of 40 Gy in 15 fractions to the whole breast (whole-breast group), 36 Gy in 15 fractions to the whole breast plus 40 Gy in 15 fractions to the partial breast (reduced-dose group), or 40 Gy in 15 fractions to the partial breast (partial-breast group). Participants were stratified by treatment centre, without masking. The primary endpoint was IBTR. 10-year outcomes were analysed in the intention-to-treat population. Clinician-reported late adverse effects were evaluated in all participants with available data analysed according to allocated treatment. The study is registered in the ISRCTN registry (ISRCTN12852634) and is now complete. Findings: 2018 patients were recruited between May 3, 2007, and Oct 5, 2010, from 30 radiotherapy centres in the UK and randomly assigned to the whole-breast group (n=675), reduced-dose group (n=674), or partial-breast group (n=669). Two participants subsequently withdrew consent. Median age was 63 years (IQR 58-68). 854 (42%) of 2016 patients had grade 1 tumours, 959 (48%) had grade 2 tumours, and 200 (10%) had grade 3 tumours (three tumours were ungradable); 59 (3%) had node-positive disease. Median follow-up was 120 months (IQR 119-122) for the whole-breast group, 121 months (IQR 120-122) for the reduced-dose group, and 120 months (IQR 119-122) for the partial-breast group. By 10 years, IBTR events were reported for 45 of 2016 participants: 17 of 674 in the whole-breast group, 11 of 673 in the reduced-dose group, and 17 of 669 in the partial-breast group, with cumulative incidence of 2·8% (95% CI 1·8-4·5), 1·9% (1·1-3·5), and 3·0% (1·9-4·8), respectively. The estimated absolute difference in 10-year IBTR incidence was -1·02% (95% CI -1·98 to 0·99) for the reduced-dose group and 0·16% (-1·28 to 2·89) for the partial-breast group compared with the whole-breast group. Similar low levels of moderate or marked adverse effects were recorded for participants in all three groups in 10-year clinical assessments. Breast shrinkage had the highest incidence (30 [9%] of 321 in the whole-breast group, 28 [9%] of 322 in the reduced-dose group, and 22 [7%] of 333 in the partial-breast group). Interpretation: Long-term follow-up provides further evidence that partial-breast and reduced-dose radiotherapy are as safe and effective as whole-breast radiotherapy in patients with low-risk early breast cancer. These results reaffirm the use of partial-breast radiotherapy delivered with intensity-modulated radiotherapy in this population as standard of care. Funding: Cancer Research UK.
  • Publication
    CSP2023: 312 - The evaluation of a free community Multi-Disciplinary Team (MDT) Menopause educational session to facilitate awareness and access to Pelvic-Health Physiotherapy
    (Elsevier, 2024-06-18) Eatwell, Hazel; Eatwell, Hazel; Allied Health Professional
    Purpose: All women will experience the menopause, and although symptoms such as hot flushes, mood swings, insomnia, night sweats and weight changes are becoming more frequently discussed, pelvic symptoms of menopause are less well known yet affect over 50% of women and can cause great discomfort and anxiety.
  • Publication
    Cracking the code of self-care: translating eye-roll-inducing buzzwords into genuine well-being
    (Pelvic, Obstetric and Gynaecological Physiotherapy, 2024-10-07) Turner, Jo; Turner, Jo; Allied Health Professional
    Many of us actively seek opportunities to offer care, compassion, love and pleasure to others, but are much less comfortable receiving the same things. We are quite happy if an activity can be filed under the heading of self-preservation, but less so if it seems as if there is any possibility that it might be deemed self-indulgent. Some individuals also feel that the world of self-care and well-being has been hijacked by consumerism, but burnout is a genuine concern in healthcare. More than one-third of healthcare professionals report feeling exhausted, and 50% of physiotherapy students show high levels of perfectionism, a trait that is highly correlated with burnout. This paper discusses various strategies to address these issues.
  • Publication
    Education of Dental Hygienists and Dental Therapists Working With Head and Neck Cancer Patients in Oral and Maxillofacial Surgery Departments in the United Kingdom—A Quantitative Study
    (Wiley, 2024-11-04) Harding, Jocelyn; Eaton, Kenneth; Harding, Jocelyn; Additional Clinical Services
    Aim To investigate Dental Hygienists' (DHs) and Dental Therapists' (DTs) current undergraduate and postgraduate education with regard to the treatment of head and neck cancer (HANC) in Oral & Maxillofacial Surgery (OMFS) departments in the United Kingdom. Methods A purposive sample of DHs and DTs, who were employed, or had been previously employed, in OMFS departments in the United Kingdom were asked to complete an online questionnaire about their education in the care and management of patients with HANC. The questionnaire was sent to members of the British Society of Dental Hygiene and Therapy (BSDHT), and the British Association of Dental Therapy (BADT) and was also posted via online forums. Results The questionnaire received 55 responses (response rate 83%): 54 female respondents and 1 male. Thirty-one (56%) respondents had not undertaken any HANC training. However, on starting work in an OMFS department, nine (16%) respondents reported being provided with HANC training. Conclusion The results suggest that the UK review and standardise the provision of HANC training in the DH and DT educational curricula. Furthermore, it is recommended that the DH and DT curricula, at both undergraduate and postgraduate level, should include psychology training.
  • Publication
    CSP2023: 94 - ACL Graft type - bone-patella-bone vs hamstring graft. Short and long term outcomes, a clinical audit
    (Elsevier, 2024-06-18) Hale, Laura; Hale, Laura; Allied Health Professional
    No abstract available
  • Publication
    CSP2023: 418 - A phenomenological exploration of the newly qualified physiotherapist lived experience within the independent sector
    (Elsevier, 2024-06-18) Piff, Matthew; Piff, Matthew; Allied Health Professional
    Purpose: Newly qualified physiotherapists (NQPs) are new to Nuffield Health and often not employed in the independent sector due to differing workforce structures, service needs, and patient/insurer expectations. Nuffield Health introduced NQPs to diversify its workforce, meet increasing work demands and create development opportunities for the wider physiotherapy cohort. Prior to the employment of NQPs Nuffield Health created a preceptorship programme and learning materials to help early development. The purpose of this study was to explore the lived experience of the NQPs within the first 6 months of employment.