Mount Vernon Cancer Centre

The clinical benefits of intensity-modulated proton therapy (IMPT) compared with intensity-modulated radiation therapy (IMRT) for patients with oropharyngeal squamous cell carcinoma remain uncertain with respect to treatment-related effects on physical function and quality of life. We aimed to compare late functional, patient-reported, disease control, and survival outcomes between IMPT and IMRT. We did a phase 3 trial (TORPEdO) in 20 UK National Health Service hospitals. We randomly assigned (2:1) patients with locally advanced oropharyngeal squamous cell carcinoma to IMPT or IMRT (70 Gy in 33 fractions, for 6·5 weeks) with two cycles of high-dose cisplatin (100 mg/m2, every 3 weeks). Co-primary endpoints at 12 months were gastrostomy-tube dependence (use of feeding tube for nutrition) or severe weight loss (≥20% from baseline) and University of Washington quality of life (UW-QoL) mean physical composite score for saliva, taste, chewing, swallowing, speech and appearance. The study was registered with the ISRCTN registry, ISRCTN16424014; recruitment is complete and follow-up is ongoing. Between Feb 25, 2020, and June 13, 2023, we randomly assigned 205 patients (99 [48%] with T3 or T4 disease and 44 [22%] with bilateral neck lymph node involvement (N2[c]); 136 [66%] to IMPT and 69 [34%] to IMRT). 163 (80%) patients were male and 42 (20%) were female. Ethnicity data were self-reported by 177 (86%) patients; most were White British (167 [94%]). At 12 months, gastrostomy-tube dependence occurred in two (2%) of 119 patients in the IMPT group and in one (2%) of 59 patients in the IMRT group and severe weight loss occurred in 20 (18% [97·5% CI 11 to 28]) of 110 patients in the IMPT group and in three (6% [1 to 17]) of 53 patients in the IMRT group (combined odds ratio 2·80 [97·5% CI 0·75 to 10·4]; p=0·079). Mean UW-QoL physical composite scores at 12 months were 78·3 in the IMPT group versus 77·1 in the IMRT group (difference 1·3 [97·5% CI -3·7 to 6·2]; p=0·56). There were 14 serious adverse events in 12 patients (nine assessed as unrelated to the study treatment [four in the IMPT group and five in the IMRT group] and five study treatment-related [one IMPT vs four IMRT]); the most common events were acute kidney injury (five [36%]) and thromboembolism (four [29%]). There were no treatment-related deaths. At a median follow-up of 28·3 months (IQR 26·5 to 39·3), 24-month freedom from loco-regional recurrence rates were 94% (99% CI 86-98) in the IMPT group versus 97% (82-100) in the IMRT group (hazard ratio [HR] 2·6 [99% CI 0·3 to 20·3; 95% CI 0·5-12·4]; p=0·24), and overall survival rates were 95% (86 to 98) in the IMPT group versus 95% (81-99) in the IMRT group (HR 1·6 [99% CI 0·3 to 8·8; 95% CI 0·4 to 5·9; p=0·47). IMPT and IMRT had similar late physical quality of life scores, gastrostomy-tube dependence, local control, and overall survival. In health-care settings where IMPT is not used routinely for oropharyngeal squamous cell carcinoma, IMRT remains the standard of care. Cancer Research UK.

Abstract Background: Mammographic screening programmes reduce breast cancer mortality but detect many small good-prognosis tumours which may not progress. Screen-detected cancers are currently treated with standard surgery and adjuvant therapies, with associated morbidities. There is a need to reduce overtreatment of good prognosis tumours and numerous studies are evaluating omission of radiotherapy in low-risk disease. However, there is little evidence for surgical de-escalation, although percutaneous minimally invasive treatment approaches have been described. Vacuum-assisted excision (VAE) is in widespread use for management of lesions of uncertain malignant potential and benign lesions. SMALL (ISRCTN 12240119) aims to determine the feasibility of using this approach to treat small invasive tumours detected within the UK NHS Breast Screening Programme. Methods: SMALL is a phase III multicentre RCT comparing standard surgery with VAE for screen-detected cancers. Main eligibility criteria are age ≥47 years, unifocal grade 1 tumours with maximum diameter 15mm, strongly ER/PR+ve and HER2-ve, with negative axillary staging. Patients are randomised 2:1 to VAE or surgery, with no axillary surgery in the VAE arm. Completeness of excision is assessed radiologically, and if excision is incomplete, patients undergo surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm but may be omitted following surgery. Co-primary end-points are1. Non-inferiority comparison of the requirement for a second procedure following excision2. Single arm analysis of local recurrence (LR) at 5 years following VAE Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure. This ensures sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. To ensure that the trial as a whole only has 5% alpha, the significance level for each co-primary outcome is set at 2.5% with 90% power. The Data Monitoring Committee will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A novel feature of SMALL is integration of a QuinteT Recruitment Intervention (QRI), which aims to optimise recruitment to the study. Recruitment challenges are identified by analysing recruiter/patient interviews and audio-recordings of trial discussions, and by review of trial screening logs, eligibility and recruitment data and study documentation. Solutions to address these are developed collaboratively, including individual/group recruiter feedback and recruitment tips documents. Results: SMALL opened in December 2019. Recruitment halted in 2020 for 5 months due to COVID-19. At 9th July 2025, 49 centres are open, with 640 patients randomised. The randomisation rate is approximately 45%, and per site recruitment rate is 0.4-0.5 patients/month. Drawing from QRI findings and insights from patient representatives, a recruitment tips document has been circulated (on providing balanced information about treatments, encouraging recruiters to engage with patient preferences, and explaining randomisation). Individual recruiter feedback is ongoing, and wider feedback is being delivered across sites via recruitment training workshops. Patient interviews are ongoing to explore patient views and experiences of the trial. Conclusion: SMALL continues to have excellent recruitment, is expected to complete recruitment in 2026 and have a global impact on treatment of breast cancer within mammographic screening programmes. SMALL is funded by the UK NIHR HTA programme award 17/42/32 Citation Format: S. McIntosh, C. Coles, D. Dodwell, K. Elder, B. Elsberger, J. Foster, C. Gaunt, J. Henderson, C. Mabena, J. Morgan, Z. Nabi, I. Lyburn, S. Paramasivan, S. Pinder, S. Pirrie, S. Potter, T. Roberts, N. Sharma, E. Southgate, H. Stobart, A. Talwalkar, S. Taylor-Phillips, W. Teh, E. Turner, M. Wallis, D. Rea. Small: open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer - a UK phase III randomised multi-centre trial [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-09-12.

BackgroundAdvances in cancer care require ongoing monitoring of patient satisfaction using rigorous questionnaires. The EORTC Quality of Life Group has cross-culturally developed a patient satisfaction core questionnaire (PATSAT-C33) to be used in any hospital cancer care settings and an outpatient satisfaction module (OUT-PATSAT7) to address specific aspects of ambulatory care. This multi-center international prospective study aimed to validate the PATSAT-C33 and OUT-PATSAT7, including assessing its acceptability.MethodsPatients (N = 690) affected by any cancer site or stage equally distributed by age and gender, were enrolled in in- and out-patient cancer settings from 20 institutions, 12 countries and 5 geographic/cultural areas. Among them, 675 completed the PATSAT-C33 alongside the EORTC QLQ-C30, Oberst’s perception of care quality 5-item, and ‘intention to recommend the hospital’ 1-item. Among the 532 outpatients, 526 also completed the OUT-PATSAT7. A subset completed a two-week retest (N = 120 & 96 for the PATSAT-C33 & OUT-PATSAT7, respectively) or one-year responsiveness-to-change assessment (RCA) (N = 166 & 155). Comprehensive psychometric testing was performed.ResultsFull item completion was high (85% & 88%), 83% of patients took ≤ 20 min to complete both questionnaires (40 items); 5% of patients required help with understanding questionnaire items. Confirmatory factor analyses evidenced satisfactory fit on the eleven PATSAT-C33 and two OUT-PATSAT7 multi-item scales (CFI/TLI > 0.90; RMSEA < 0.10 and = 0.108, respectively). Internal consistency was good to excellent (all ≥ 0.80); test–retest reliability was fair (0.48, 1 scale), good (0.60–0.74, 11 scales) to excellent (≥ 0.75, 7 scales). Convergent validity was supported by correlations of ≥ 0.40 with related Oberst’s scales and < 0.30 with unrelated QLQ-C30 scales. Known-groups differences was shown for comorbidity, toxicity, global health, care expectations and intention to recommend the hospital. Change over time was captured in groups defined based on change in global health, cancer care setting, and the receipt of supportive care over the past year.ConclusionsThis study supports the psychometric robustness of the EORTC PATSAT-C33 and OUT-PATSAT7 and their promising usefulness in monitoring cancer care within and across cancer care settings from different cultures and cancer patient populations.Trial registrationClinicalTrials.gov ID: NCT05989191, August 2, 2023.Supplementary InformationThe online version contains supplementary material available at 10.1186/s12885-025-15119-3.

Prostate cancer (PCa) screening using prostate-specific antigen (PSA) thresholding and systematic biopsies reduces advanced disease presentations and cancer-specific mortality, but also leads to overdiagnosis. Magnetic resonance imaging (MRI) integration may maintain screening benefits, while reducing overdiagnosis and unnecessary biopsies. This review analyses the benefit-harm balance when MRI is integrated as first-line and second-stage (after PSA >3ng/ml) test in PCa screening. Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, we performed a PROSPERO-registered systematic review (CRD420251006926). Literature searches identified five first-line and four second-stage MRI screening studies. We assessed MRI strategies (first-line/second-stage and risk thresholds), biopsy avoidance, and biopsy methods (targeted/systematic) for histological outcomes (grade group [GG] ≥2/GG 1 cancer detection and benign biopsies). Benefit-to-harm ratios of >1 suggest a positive net benefit. First-line MRI screening detects twice as many men with GG ≥2 cancer as second-stage MRI screening but has more MRI-negative men (range, 66-89% vs 56-61%). Second-stage MRI significantly reduced biopsy rates (range, 42-79%) compared with systematic biopsy rates in all PSA-positive men. Subsequently, GG ≥2/GG 1 cancer detection ratios increased in MRI-positive men undergoing targeted and systematic biopsies (range, 1.9-6.2) and targeted biopsies alone (range, 1.8-7.0), compared with systematic biopsies alone (range, 0.8-1.4). First-line and second-stage MRI screening allowed biopsy avoidance in three to 55 and two to 15 men, respectively, for each benign diagnosis. All benefit-to-harm ratios showed positive net benefits (>1). Heterogeneity in the study protocols limits generalisability. Targeted biopsies in second-stage MRI screening optimise clinically significant PCa detection, while reducing the number of biopsies. First-line MRI screening requires further assessments of its feasibility. PCa screening quality assurance requires standardised MRI interpretations and biopsy protocols.

Most individuals diagnosed with high-risk breast cancer are treated with anthracycline-containing neoadjuvant chemotherapy (NAC). There is interest to identify individuals for whom anthracyclines can be avoided. A paucity of data exists on the extent to which anthracyclines are omitted in the neoadjuvant setting and its associated effectiveness. To investigate the extent to which anthracycline-free NAC is used in the treatment of breast cancer and the impact of its omission on risks of mortality. Population-based analysis of individuals diagnosed with stage I-III invasive breast cancer between 2012 and 2021 treated with NAC and surgery in Ontario, Canada. Baseline characteristics of patients who did and did not receive an anthracycline were compared. Five-year cumulative risks of breast cancer and all-cause mortality were calculated. Cause-specific hazard ratios (HRs) and 95% CIs were calculated using adjusted multivariable proportional hazards models for the whole cohort and subsets stratified by stage and receptor subtype. The cohort includes 6672 patients; 6126 received an anthracycline, 546 received an anthracycline-free regimen. Median follow-up was 3.9years. The 5-year cumulative incidence of breast cancer mortality was 12.3% for individuals treated with an anthracycline-free regimen and 14.5% for those who received ananthracycline (p = 0.10). On multivariable analysis, individuals treated with non-anthracycline NAC did not experience an increased risk of breast cancer mortality (HR = 0.88; 95% CI: 0.65,1.18, p = 0.38) or all-cause mortality (HR 0.86; 95% CI 0.67, 1.10, p = 0.23). For patients with stage Ior II HER2+ disease, treatment with non-anthracycline NAC was associated with excellent survival. Most individuals treated with NAC received an anthracycline but its omission for selected patients with early HER2+ breast cancer was associated with excellent outcomes.

ABSTRACTProstate cancer remains a significant health challenge in the United Kingdom, demanding continuous improvement in patient care delivery. While survival rates are relatively high compared with other cancer types, persistent issues, such as late diagnoses, health inequalities and mounting pressure on healthcare services, necessitate a transformative approach. During the National Prostate Cancer Scientific Summit 2023, stakeholders involved in prostate cancer care from across the United Kingdom engaged in multidisciplinary and multi‐organisation roundtable discussions to facilitate knowledge exchange and showcase best practice. These collaborative discussions informed the roadmap presented here, which outlines a series of key recommendations designed to optimise prostate cancer management in the United Kingdom, addressing critical challenges and capitalising on opportunities for innovation and collaboration. The overall goal is to create a more equitable, efficient and patient‐centred prostate cancer service, ultimately improving outcomes and saving lives.

IntroductionMammographic screening identifies many women with small breast cancers with favourable biological features, which have an excellent prognosis. Some of these may never have become clinically apparent without screening and are commonly described as ‘overdiagnosed’ cancers. Despite this, all patients with screen-detected cancers are currently treated with surgical excision and sentinel lymph node biopsy, although this may represent overtreatment. There is, therefore, a need for less invasive approaches to reduce treatment burden for patients while maintaining current excellent oncological outcomes. Vacuum-assisted excision (VAE) may represent such an alternative treatment approach, and the SMALL (Open Surgery versus Minimally invasive-vacuum Assisted excision for smaLL screen-detected breast cancer) trial aims to investigate the use of VAE for the safe de-escalation of surgical treatment for such excellent prognosis invasive breast cancers.MethodsSMALL is a prospective, multicentre, randomised phase III trial of VAE versus surgery in patients with small, biologically favourable screen-detected invasive breast cancer. SMALL has an innovative hybrid design with coprimary endpoints. These include a randomised non-inferiority comparison of surgical re-excision rates following initial treatment, and a single-arm analysis of local recurrence at 5 years following VAE. Secondary outcomes include complication rates, overall survival, quality of life and a health economic analysis. The trial includes a QuinteT Recruitment Intervention to support recruitment.Ethics and disseminationEthical approval was obtained from the Office for Research Ethics (Northern Ireland) for all UK sites. Results will be submitted for publication in a peer-reviewed journal, presented, shared with patient partners and with relevant professional organisations to inform future guideline development for the management of screen-detected breast cancer.Trial registration numberISRCTN12240119.