Search

Summary Background Stereotactic ablative body radiotherapy (SABR) is increasingly being used to treat oligometastatic cancers, but high-level evidence to provide a basis for policy making is scarce. Additional evidence from a real-world setting is required. We present the results of a national study of patients with extracranial oligometastases undergoing SABR, representing the largest dataset, to our knowledge, on outcomes in this population so far. Methods In 2015, National Health Service (NHS) England launched a Commissioning through Evaluation scheme that funded a prospective, registry-based, single-arm, observational, evaluation study of patients with solid cancer and extracranial oligometastases treated with SABR. Prescribed doses ranged from 24–60 Gy administered in three to eight fractions. The study was done at 17 NHS radiotherapy centres in England. Patients were eligible for the scheme if aged 18 years or older with confirmed primary carcinoma (excluding haematological malignancies), one to three extracranial metastatic lesions, a disease-free interval from primary tumour development to metastases of longer than 6 months (with the exception of synchronous colorectal liver metastases), a WHO performance status of 2 or lower, and a life expectancy of at least 6 months. The primary outcome was overall survival at 1 year and 2 years from the start of SABR treatment. The study is now completed. Findings Between June 15, 2015, and Jan 30, 2019, 1422 patients were recruited from 17 hospitals in England. The median age of the patients was 69 years (IQR 62–76), and the most common primary tumour was prostate cancer (406 [28·6%] patients). Median follow-up was 13 months (IQR 6–23). Overall survival was 92·3% (95% CI 90·5–93·9) at 1 year and 79·2% (76·0–82·1) at 2 years. The most common grade 3 adverse event was fatigue (28 [2·0%] of 1422 patients) and the most common serious (grade 4) event was increased liver enzymes (nine [0·6%]). Notreatment-related deaths were reported. Interpretation In patients with extracranial oligometastatic cancer, use of SABR was associated with high overall survival and low toxicity. ’The study findings complement existing evidence from a randomised, phase 2 trial, and represent high-level, real-world evidence supporting the use of SABR in this patient cohort, with a phase 3 randomised, controlled trial to confirm these findings underway. Based on the selection criteria in this study, SABR was commissioned by NHS England in March, 2020, as a treatment option for patients with oligometastatic disease. Funding NHS England Commissioning through Evaluation scheme.

Background: Selective dorsal rhizotomy (SDR) is an irreversible surgical procedure involving the division of selected sensory nerve roots, followed by intensive physiotherapy. The aim is to improve function and quality of life in children with cerebral palsy and a Gross Motor Function Classification System (GMFCS) level of II or III (walks with or without assistive devices, respectively). We assessed gross motor function before and after SDR and postoperative quality of life in a study commissioned by NHS England. Methods: We did a prospective observational study in five hospitals in England who were commissioned to perform SDR on children aged 3–9 years with spastic diplegic cerebral palsy. The primary outcome was score changes in the 66-item Gross Motor Function Measure (GMFM-66) and seven domains of the Cerebral Palsy Quality of Life Questionnaire ([CP-QoL] social wellbeing and acceptance, feelings about functioning, participation and physical health, emotional wellbeing and self-esteem, access to services, family health, and pain and impact of disability) from before to 24 months after SDR. Findings: From Sept 4, 2014, to March 21, 2016, 137 children underwent SDR. The mean age was 6·0 years (SD 1·8). The mean GMFM-66 score increased after SDR with an annual change of 3·2 units (95% CI 2·9 to 3·5, n=137). Of the seven CP-QoL domains, five showed significant improvements over time: feelings about functioning mean annual change 3·0 units (95% CI 2·0 to 4·0, n=133), participation and physical health 3·9 units (2·5 to 5·3, n=133), emotional wellbeing and self-esteem 1·3 units (0·2 to 2·3, n=133), family health 2·0 units (0·7 to 3·3, n=132), and pain and impact of disability −2·5 units (−3·9 to −1·2, n=133). 17 adverse events were reported in 15 children, of which none were severe and 15 (88%) resolved. Interpretation: SDR improved function and quality of life in the 24 months after surgery in children with cerebral palsy classified as GMFCS levels II and III. On the basis of these findings, an interim national policy decision was made that SDR would be funded for eligible children in England from 2018. Funding: National Institute for Health and Care Excellence, National Institute for Health Research Biomedical Research Centre, NHS England.

Aims To compare the cost-effectiveness of stereotactic ablative body radiation therapy (SABR) with radiofrequency ablation and surgery in adult patients with metastatic liver cancer and hepatocellular carcinoma (HCC). Materials and methods Two patient cohorts were assessed: liver oligometastases and HCC. For each patient cohort, a decision analytic model was constructed to assess the cost-effectiveness of interventions over a 5-year horizon. A Markov process was embedded in the decision model to simulate the possible prognosis of cancer. Data on transition probabilities, survival, side-effects, quality of life and costs were obtained from published sources and the SABR Commissioning through Evaluation (CtE) scheme. The primary outcome was the incremental cost-effectiveness ratio with respect to quality-adjusted life-years. The robustness of the results was examined in a sensitivity analysis. Analyses were conducted from a National Health Service and Personal Social Services perspective. Results In the base case analysis, which assumed that all three interventions were associated with the same cancer progression rates and mortality rates, SABR was the most cost-effective intervention for both patient cohorts. This conclusion was sensitive to the cancer progression rate, mortality rate and cost of interventions. Assuming a willingness-to-pay threshold of £20 000 per quality-adjusted life-year, the probability that SABR is cost-effective was 57% and 50% in liver oligometastases and HCC, respectively. Conclusions Our results indicate a potential for SABR to be cost-effective for patients with liver oligometastases and HCC. This finding supports further investigation in clinical trials directly comparing SABR with surgery and radiofrequency ablation.

Background Long-term oncologic and functional outcomes after robot-assisted radical cystectomy (RARC) for bladder cancer (BCa) are lacking. Objective To report oncologic and functional outcomes in a cohort of patients who have completed a minimum of 5 yr and a maximum of 8 yr of follow-up after RARC and extracorporeal urinary diversion. Design, setting, and participants In this paper, we report on the experience from one of the first European urology centres to introduce RARC. Only patients between 2004 and 2006 were included to ensure follow-up of ≥5 yr. We report on an analysis of oncologic outcomes in 14 patients (11 males and 3 females) with muscle-invasive/high-grade non–muscle-invasive or bacillus Calmette-Guerin–refractory carcinoma in situ who opted to have RARC. Intervention RARC with pelvic lymphadenectomy was performed using the three-arm standard da Vinci Surgical System (Intuitive Surgical, CA, USA). Urinary diversion, either ileal conduit ( n =12) or orthotopic neobladder ( n =2), was constructed extracorporeally. Outcome measurements Parameters were recorded in a prospectively maintained database including assessment of renal function, overall survival, disease-specific survival, development of metastases, and functional outcomes. Statistical analysis Results were analysed using descriptive statistical analysis. Survival data were analysed and presented using the Kaplan-Meier survival curve. Results and limitations Five of the 14 patients have died. Three patients died of metastatic disease, and two died of unrelated causes. Two other patients are alive with metastases, and another has developed primary lung cancer. Six patients are alive and disease-free. These results show overall survival of 64%, disease-specific survival of 75%, and disease-free survival of 50%. None of the patients had deterioration of renal function necessitating renal replacement therapy. Three of four previously potent patients having nerve-sparing RARC recovered erectile function. The study is limited by the relatively small number of highly selected patients undergoing RARC, which was a novel technique 8 yr ago. The standard da Vinci Surgical System made extended lymphadenectomy difficult. Conclusions Within limitations, in our experience RARC achieved excellent control of local disease, but the outcomes in patients with metastatic disease seem to be equivalent to the outcomes of open radical cystectomy.

Summary Introduction: The role of minimally invasive radical cystectomy as opposed to open surgery for bladder cancer is not yet established. We present comparative outcomes of open, laparoscopic and robotic-assisted radical cystectomy Material and Methods: Prospective cohort comparison of 158 patients from 2003–2008 undergoing open radical cystectomy (ORC) (n = 52), laparoscopic radical cystectomy (LRC) (n = 58) or robotic-assisted radical cystectomy (RARC) (n = 48) performed by a team of three surgeons at two hospitals. Peri-operative data, complication rates, length of hospital stay, oncological outcome (including lymph node status) and survival were recorded. Statistical analyses were adjusted to account for potential confounding factors such as ASA grade, gender, age, diversion type and final histology. Results: RARC took longer than LRC and ORC. Patients were about 30 times more likely to have a transfusion if they had ORC than if they had RARC (p

INTRODUCTION Conventional publicly funded out-patient services in many specialties are characterised by delays, fragmented diagnostic processes, and overloaded clinics. This is bad for patients as it is clinically dangerous; bad for managers who spend hours managing the failure; bad for doctors who respond by overloading clinics; and bad for purchasers who have to fund the multiple out-patient visits needed. Sound clinical and financial reasons exist for introducing more efficient diagnostic processes. PATIENTS AND METHODS A total of 330 consecutive patients referred to the urology department of Guy' and St Thomas' NHS Foundation Trust were invited to attend one of nine one-stop clinics staffed by consultant urologists with specialist registrars, nurses, and clerical staff. Pre-clinic blood and urine tests were ordered based on the referral letter. Clinics had facilities to perform cystoscopy, ultrasound, and urinary flow studies. Correspondence was generated in real time, and a copy given to the patient. RESULTS Overall, 257 patients attended the clinics. Twenty-three patients cancelled appointments and 50 patients did not attend. Pre-clinic tests were requested in 133 patients and were completed by 86% of the patients who attended. Of patients, 42% were diagnosed and discharged; 28% were listed for surgery, extracorporeal shock wave lithotripsy (ESWL), or referred to another specialty. About 30% of patients needed further out-patient review; in approximately two-thirds to complete a diagnosis and one-third to review the results of therapy initiated. An estimated 350 appointments and 550 patient visits to hospital were saved. CONCLUSIONS A one-stop method of consultation is efficient across a range of urological presenting complaints, and dramatically reduces the need for follow–up consultations. It has potential to: (i) reduce delays to being seen in out-patients; (ii) lead to more cost-effective care; and (iii) increase safety and patient satisfaction. It should become the standard of care in urology, and is probably applicable in many other disciplines.

Background: Bile acid malabsorption (BAM) is one possible explanation for chronic diarrhea. BAM may be idiopathic, or result from ileal resection or inflammation including Crohn’s disease, or may be secondary to other conditions, including cholecystectomy, peptic ulcer surgery, and chronic pancreatitis. No “gold standard” exists for clinical diagnosis of BAM, but response to treatment with a bile acid sequestrant (BAS) is often accepted as confirmation. The SeHCAT (tauroselcholic [selenium-75] acid) test uses a radiolabeled synthetic bile acid and provides a diagnostic test for BAM, but its performance against “trial of treatment” is unknown. Fibroblast growth factor 19 (FGF-19) and 7-alpha-hydroxy-4-cholesten-3-one (C4) also offer potential new biomarkers of BAM.Objective: This protocol describes a multicenter prospective study to evaluate the diagnostic accuracy of SeHCAT and 2 biomarkers in predicting BAM as assessed by trial of treatment.Methods: Participating gastroenterology centers should have a minimum workload of 30 SeHCAT patients per annum. Patients should not be pregnant, on medication that could confound follow-up, or have any severe comorbidity. All eligible patients attending a gastrointestinal appointment will be invited to participate. On attending the SeHCAT test, blood and fecal samples will be collected for analysis of FGF-19 by enzyme-linked immunosorbent assay and for C4 and fractionated bile acids by liquid chromatography–mass spectrometry. A capsule containing radiolabeled SeHCAT will be administered orally and a scan performed to measure SeHCAT activity. Patients will return on day 7 to undergo a second scan to measure percentage SeHCAT retention. The test result will be concealed from clinicians and patients. BAS will be dispensed to all patients, with a follow-up gastroenterologist appointment at 2 weeks for clinical assessment of treatment response and adherence. Patients responding positively will continue treatment for a further 2 weeks and all patients will have a final follow-up at 8 weeks. The diagnostic accuracy of the SeHCAT test and biomarkers will be analyzed at different thresholds using sensitivity, specificity, positive and negative predictive value, likelihood ratios, and area under the curve in a sample of 600 patients. Multivariable logistic regression models will be used to assess the association between presence of BAM and continuous SeHCAT retention levels after adjustment for confounders.Results: Funding is being sought to conduct this research.Conclusions: The SeHCAT test for diagnosis of BAM has been in common use in the United Kingdom for more than 30 years and an evidence-based assessment of its accuracy is overdue. The proposed study has some challenges. Some forms of BAS treatment are unpleasant due to the texture and taste of the resin powder, which may negatively affect recruitment and treatment adherence. Trial of treatment is not as “golden” a standard as would be ideal, and itself warrants further study.