The Christie School of Oncology: Christie Research Publications Repository
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Brridging Gaps in Remote Cancer Care: Commentary on the Adjuvant Abemaciclib Monitoring Model
No full textCorrigendum to"International expert consensus on the clinical integration of circulating tumor cells in solid tumors" [Eur. J. Cancer 231 (2025) 116050]
No full textConventional versus high-complexity total pelvic exenteration for locally advanced and locally recurrent rectal cancer: an international multicenter study
No full textBACKGROUND: Pelvic exenteration is the treatment of choice for selected patients with locally advanced primary and recurrent rectal cancer. Involvement of major pelvic neurovascular structures and bone was historically considered a contraindication due to unacceptably high rates of morbidity and low R0 resection rates. OBJECTIVE: To compare the outcomes of these"high-complexity" exenterative resections to those of"conventional" pelvic exenteration. DESIGN: International multicenter retrospective cohort study. SETTINGS: Sixteen specialized exenteration centers. PATIENTS: Those who underwent total pelvic exenteration for locally advanced primary and recurrent rectal cancer between 2018 and 2023 at participating centers. MAIN OUTCOME MEASURES: Perioperative resource utilization, morbidity, mortality, and R0 resection rates were reported. RESULTS: Seven hundred sixty-three patients underwent total pelvic exenteration, of whom 478 (63%) and 285 (37%) required conventional and high-complexity procedures, respectively. High-complexity pelvic exenteration was associated with longer operating time (600 vs 480 minutes, p < 0.001 for locally advanced primary rectal cancer, 623 vs 480 minutes, p < 0.001 for locally recurrent rectal cancer), intensive care stay (2 vs 1 day, p < 0.001 and 3 vs 1 day, p < 0.001), hospital stay (19 vs 15 days, p = 0.008 and 23 vs 15 days, p < 0.001), and higher blood loss (2000 vs 1236 mL, p < 0.001 and 3000 vs 1600 mL, p < 0.001). Morbidity and mortality outcomes and R0 resection rates were similar between the groups. LIMITATIONS: Generalizability of findings outside of expert units. CONCLUSIONS: High-complexity pelvic exenteration for the treatment of rectal cancer is associated with similar morbidity, mortality, and R0 resection rates, but it has a significantly higher operative time, blood loss, and hospital resource utilization compared to conventional pelvic exenteration. In high-volume, specialized centers, these techniques are considered the standard of care for appropriately selected patients with tumors that involve major pelvic bone or neurovascular structures
ESMO-ESTRO consensus statements on the safety of combining radiotherapy with immune checkpoint inhibitors, VEGF(R) inhibitors, or multitargeted tyrosine kinase inhibitors
No full textBackground: The combination of radiotherapy (RT) with targeted agents or immunotherapy may result in improved outcomes, but it can also increase toxicity. However, there is a paucity of high-quality toxicity data, leading to an absence of evidence-based guidelines. Design: To address this, European Society for Medical Oncology (ESMO) and European SocieTy for Radiotherapy and Oncology (ESTRO) initiated a series of systematic reviews followed by a Delphi consensus process to develop multidisciplinary, evidence-based consensus statements regarding the safety of combining RT with such agents. The current publication describes the combination of RT with immune checkpoint inhibitors (ICIs), vascular endothelial growth factor (receptor) [VEGF(R)] inhibitors, or multitargeted tyrosine kinase inhibitors (TKIs). By systematically covering different drug classes and irradiated areas, 76 clinical scenarios were evaluated during two Delphi rounds with 20 international experts. Safety statements were developed for each scenario, based on the systematic literature reviews. Results: A total of 5921 records were screened during the systematic literature review process for ICIs, VEGF(R) inhibitors, and multitargeted TKIs, and 159 reports were selected for inclusion in the final literature reviews and the database. During the two Delphi rounds, agreement was reached regarding the safety statements for 74 clinical scenarios. Conclusions: Generally, the expected toxicity of combining RT with ICIs is low, particularly for programmed death (-ligand) 1 inhibitors. For most combinations with VEGF(R) inhibitors and multitargeted TKIs, exercising caution is recommended. The evidence-based safety statements developed during this comprehensive project provide practical guidance on combining RT with targeted cancer therapies and immunotherapy
Cancer diagnoses, referrals, and survival in people with a learning disability in the UK: a population-based, matched cohort study
No full textBackground People with a learning disability (LD, also known as intellectual disability) face poorer health outcomes, yet the burden of cancer in this population is poorly understood. This study investigated cancer-related outcomes in people with a LD compared to the general population. Methods A matched cohort study was conducted using linked primary care, hospital, mortality, and cancer registry data from Clinical Practice Research Datalink (CPRD) Aurum. In total, 180,911 individuals with a LD were matched with 3,405,467 controls. Outcomes included urgent suspected cancer (USC) referrals, cancer diagnoses, treatment within six months, and overall survival (OS) post-diagnosis. Findings Individuals with a LD had fewer USC referrals within 28 days of possible cancer symptoms (adjusted risk ratio [aRR] 0.52, 95% confidence interval [CI] 0.49-0.55). LD was associated with several cancers, including sarcoma (adjusted hazard ratio [aHR] 1.98, 1.65-2.39), central nervous system (aHR 3.42, 2.99-3.90), testicular (aHR 2.06, 1.61-2.62), and uterine cancers (aHR 1.69, 1.40-2.05) as well as cancer before age 50 years (aHR 1.74, 1.63-1.86). Absolute incidence was lower in individuals with a LD compared to without (3396 [1.9%] vs 67,506 [2.0%]) due to increased all-cause mortality (aHR 3.19, 3.12-3.27). LD was associated with fewer diagnoses via USC referrals (aRR 0.81, 0.76-0.86), fewer treatments within six months (aRR 0.83, 0.80-0.85) and shorter OS (median 4.4 years, 95% CI 3.9-5.1 vs 9.1 years, 8.8-9.5; aHR 1.73, 1.65-1.83). Melanoma, breast, and prostate cancers were less common but had up to a fourfold increased risk of death after diagnosis in individuals with a LD. Interpretation Individuals with a LD have higher cancer risk, more diagnoses outside USC pathways, fewer treatments, and poorer prognosis. Fewer diagnoses of some cancers, alongside worse outcomes, may indicate under-investigation. As premature all-cause mortality improves, cancer burden in this population may rise disproportionately. (c) 2025 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
Bladder preservation strategies in muscle-invasive bladder cancer: recommendations from the International Bladder Cancer Group
No full textBackground and objective: Patient-centric management necessitates providing care aligned with patients' values, preferences, and expressed needs. Therefore, critical assessment of bladder preservation therapies (BPTs) as alternatives to radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC) and practical recommendations on the optimal selection of patients for BPTs are needed urgently. Methods: A global committee of bladder cancer experts was assembled to develop BPT recommendations for MIBC. Working groups reviewed the literature and drafted recommendations, which were voted on by International Bladder Cancer Group (IBCG) members using a modified Delphi process. During a live meeting in August 2023, voting results and supporting evidence were presented, and recommendations were refined based on discussions. Final recommendations achieved >= 75% agreement during the meeting, with further refinements through web conferences and e-mail discussions. Key findings and limitations: Patients with newly diagnosed MIBC should be offered evaluation in a multidisciplinary setting for consideration of BPTs. The main alternative to RC is trimodal therapy (TMT), and favorable prognostic factors for TMT include unifocal cT2 stage, lack of hydronephrosis, and no multifocal carcinoma in situ (CIS). Other options should be reserved for very select patients who are ineligible for or who decline TMT or RC after thorough consideration of benefits versus risks. These include partial cystectomy (PC) for urachal adenocarcinoma and PC or radical transurethral resection alone for solitary tumors amenable to resection with adequate margins and without concomitant CIS or histologic subtypes. Conclusions and clinical implications: The IBCG consensus recommendations provide practical guidance on BPTs for MIBC. (c) 2025 European Association of Urology. Published by Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies
Expansion cohorts in phase 1 oncology trials: a systematic review of their design, implementation and outcomes
No full textThe urgent need for drug development for cancer patients and the complexity of novel therapies have led to the increasing importance of expansion cohorts (EC) within phase 1 trial design. We conducted a systematic review of oncology phase 1 trials with EC published from 2019 to 2023. The objective was to assess the characteristics, purpose and outcomes of EC. A mixed-effects meta-regression model was conducted to analyse response rates. 479 published phase 1 trials with EC were included (median number of EC patients per trial: 27). The EC objective was stated in 55.7% of studies (76.8% safety, 16.5% dosing, 25.8% pharmacokinetics, 22.1% pharmacodynamics, 77.5% preliminary efficacy). 117 trials (24.4%) included a statistical justification plan. The mean Overall Response Rate (ORR) was 20.2% in solid tumours and 46.8% in haematological malignancies. Among drug classes, Antibody-drug conjugates showed the highest ORR (32.1%). Higher ORR was significantly associated with combination therapies, haematological trials, trials with statistical justification for EC sample size and trials not containing Immunotherapy. EC have evolved to become large dynamic studies assessing both preliminary efficacy and safety. This study highlights the importance of clearly stated EC objectives and sample size justification to enhance the rigour and interpretability of early-phase evidence
Corrigendum to"adjuvant immunotherapy in the modern management of resectable melanoma: current status and outlook to 2028": [ESMO Open 10 (2025) 104295]
No full textThe Use of First-Void Urine to Screen Women Aged 60-79 for HPV in the UK: The Catch-Up Screen Study
No full textOBJECTIVE: Almost half the deaths from cervical cancer in the UK are among women aged over 65 who were already above the upper age of screening when primary HPV screening was introduced in the UK in 2019. Our aim is to test the feasibility of a national catch-up HPV testing programme. DESIGN: This first phase of the Catch-Up Screen study involved randomizing over 3000 invited participants to receive a urine HPV test and a follow-up telephone call or text message. SETTING: GP practices in Hull and Manchester, UK. POPULATION: Women aged 60-79 who have not undergone primary HPV screening. METHODS: Eligible women were selected from GP practice records, and 3074 were invited to provide an at-home first-void urine sample for HPV testing. MAIN OUTCOME MEASURES: Uptake of at-home urine screening according to screening history, area-level index of deprivation, and randomised follow-up method. RESULTS: Overall, 59% (1816) of invited women returned a urine sample for HPV testing. Response varied by screening history and index of area-level deprivation, but 39% of those who declined their last invited NHS screen responded favorably and took part in Catch-Up Screen. Telephone reminders yielded a 5% absolute increase in response compared to the text message arm (p = 0.007). CONCLUSIONS: An at-home first-void urine sample is a viable method for a national catch-up HPV test and has the potential to address decreasing national coverage among older women being invited for their last screen