Radical cystectomy (bladder removal) against intravesical BCG immunotherapy for high-risk non-muscle invasive bladder cancer (BRAVO): a protocol for a randomised controlled feasibility study

INTRODUCTION: High-risk non-muscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease that can be difficult to predict. While around 25% of cancers progress to invasion and metastases, the remaining majority of tumours remain within the bladder. It is uncertain whether patients with HRNMIBC are better treated with intravesical maintenance BCG (mBCG) immunotherapy or primary radical cystectomy (RC). A definitive randomised controlled trial (RCT) is needed to compare these two different treatments but may be difficult to recruit to and has not been attempted to date. Before undertaking such an RCT, it is important to understand whether such a comparison is possible and how best to achieve it. METHODS AND ANALYSIS: BRAVO is a multi-centre, parallel-group, mixed-methods, individually randomised, controlled, feasibility study for patients with HRNMIBC. Participants will be randomised to receive either mBCG immunotherapy or RC. The primary objective is to assess the feasibility and acceptability of performing the definitive phase III trial via estimation of eligibility and recruitment rates, assessing uptake of allocated treatment and compliance with mBCG, determining quality-of-life questionnaire completion rates and exploring reasons expressed by patients for declining recruitment into the study. We aim to recruit 60 participants from six centres in the UK. Surgical trials with disparate treatment options find recruitment challenging from both the patient and clinician perspective. By building on the experiences of other similar trials through implementing a comprehensive training package aimed at clinicians to address these challenges (qualitative substudy), we hope that we can demonstrate that a phase III trial is feasible. ETHICS AND DISSEMINATION: The study has ethical approval (16/YH/0268). Findings will be made available to patients, clinicians, the funders and the National Health Service through traditional publishing and social media. TRIAL REGISTRATION NUMBER: ISRCTN12509361; Pre results

Radical cystectomy in the elderly â Is this a safe treatment option?

Objective: To determine if significant differences exist in the perioperative outcomes of patients aged >75 years treated with radical cystectomy (RC) compared to younger patients, as RC is frequently not offered to âelderlyâ patients with bladder cancer because of supposed increased risks of complications. Patients and methods: We retrospectively analysed prospectively collected data of all patients that underwent RC in our centre from May 2013 to June 2015. In all, 81 consecutive RCs were identified and included in our study. Patients were divided into two age groups: Group A, aged <75 years (51 patients) and Group B, aged â¥75 years (30). Co-morbidities and perioperative outcomes were compared between the groups. Fisherâs exact test was used for statistical analysis. Results: In 68 patients RC was performed laparoscopically and the remaining 13 patients underwent open RC. The mean (range) age was 70.7 (36â85) years. There were 37 patients with muscle-invasive disease and 42 had non-muscle-invasive disease. The median hospital stay was not significantly different between the two age groups (10 vs 11 days). There was no significant difference in the preoperative Charlson co-morbidity index. The 30-day mortality rate was 4% for those aged <75 years and 6.6% for those aged â¥75 years, with overall perioperative complication rates of 57% vs 66%, respectively. Most complications were minor (ClavienâDindo Grade IâII) and there was no statistically significant difference between the two cohorts. There was also no statistically significant difference in blood transfusion rates. Conclusion: RC in patients aged â¥75 years has similar perioperative morbidity when compared with younger patients and can be offered in selected elderly patients. Thus, age should not be an absolute contraindication for RC. Keywords: Bladder cancer, Elderly, Cystectomy, Minimally invasive, Laparoscop

An unusual presentation of non-small cell lung carcinoma

Lung cancer is the most common malignancy in the Western world and usually presents with respiratory symptoms. The diagnosis of lung cancer is normally made by chest radiography followed by histological confirmation with either radiological or endoscopically guided biopsies. Very rarely, imaging does not help with the initial diagnosis. Haematuria is a common presentation and generally requires urological follow-up with radiological and cystoscopic examination. The differential diagnosis includes urothelial and renal cancers. We present the case of a patient who initially presented to urologists with haematuria and was thought to have a urological malignancy. Contrast enhanced computerised tomography (CT) of both the chest and abdomen after initial endoscopic examination was non-diagnostic. It was only laparoscopic removal of enlarged para-aortic lymph nodes which ultimately provided the diagnosis of non-small cell lung carcinoma