The current use of the EORTC QLQ-NMIBC24 and QLQ-BLM30 questionnaires for the assessment of health-related quality of life in bladder cancer patients: a systematic review.

PURPOSE: Investigating the use of the EORTC bladder cancer (BC) modules by evaluating: (a) study contexts/designs; (b) languages/countries in which the modules were administered; (c) their acceptance by patients/investigators; and (d) their psychometric properties. METHODS: A systematic review was performed with studies from 1998 until 20/10/2021 in five databases. Articles/conference abstracts using the EORTC-QLQBLM30 (muscle invasive BC) and the EORTC-QLQNMIBC24 (previously referred to as QLQ-BLS24; non-muscle invasive BC) were included. Two authors independently screened titles/abstracts/full-texts and performed data extraction. RESULTS: A total of 76 eligible studies were identified. Most studies included the BLM30 (n = 53), were in a urological surgery context (n = 41) and were cross-sectional (n = 35) or prospective (n = 30) in design. The BC modules were administered in 14 languages across 19 countries. Missing data were low-moderate for all non-sex related questions (< 1% to 15%). Sex-related questions had higher rates of missing data (ranging from 6.9% to 84%). Most investigators did not use all scales of the questionnaires. One validation study for the original BLS24 led to the development of the NMIBC24, which adopted a new scale structure for which good structural validity was confirmed (n = 3). Good reliability and validity was shown for the NMIBC24 module, except for malaise and bloating/flatulence scales. Psychometric evidence for BLM30 is lacking. CONCLUSION: These results provide insight into how the EORTC BC quality of life modules could be further improved. Current work is ongoing to update the modules and to determine if the two modules can be combined into a single questionnaire that works well in both the NMIBC and MIBC settings.

EAU-ESMO consensus statements on the management of advanced and variant bladder cancer-an international collaborative multi-stakeholder effort: under the auspices of the EAU and ESMO Guidelines Committees†.

BACKGROUND: Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial. OBJECTIVE: To bring together a large multidisciplinary group of experts to develop consensus statements on controversial topics in bladder cancer management. DESIGN: A steering committee compiled proposed statements regarding advanced and variant bladder cancer management which were assessed by 113 experts in a Delphi survey. Statements not reaching consensus were reviewed; those prioritised were revised by a panel of 45 experts before voting during a consensus conference. SETTING: Online Delphi survey and consensus conference. PARTICIPANTS: The European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), experts in bladder cancer management. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Statements were ranked by experts according to their level of agreement: 1-3 (disagree), 4-6 (equivocal), 7-9 (agree). A priori (level 1) consensus was defined as ≥70% agreement and ≤15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus). RESULTS AND LIMITATIONS: Overall, 116 statements were included in the Delphi survey. Of these, 33 (28%) statements achieved level 1 consensus and 49 (42%) statements achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease and the evolving role of checkpoint inhibitor therapy in metastatic disease. CONCLUSIONS: These consensus statements provide further guidance on controversial topics in advanced and variant bladder cancer management until a time where further evidence is available to guide our approach.

Availability of prostate cancer exercise rehabilitation resources and practice patterns in Belgium: Results of a cross-sectional study.

Exercise is recommended for prostate cancer (PCa) patients treated with androgen deprivation therapy. The goal of the study was to assess the availability of hospital-based rehabilitation resources and national practice patterns for PCa in Belgium. A questionnaire was conducted with rehabilitation physical therapists in all Belgian hospital with urology and rehabilitation departments. Practice patterns were compared with the American College of Sports Medicine guidelines. PCa prevalence data were obtained from the Belgian Cancer Registry and attitude of physicians towards physical activity was documented. We included 98 Belgian hospitals. Only 25% of the PCa population had access to PCa-specific programmes. The occupancy rate of PCa-specific rehabilitation slots was 69%. The main perceived barriers to organise PCa-specific rehabilitation were existence of general programmes (40%) and low referrals (18%). All PCa programmes consisted of aerobic and resistance exercise and 62% included flexibility. Minimal criteria for frequency and duration per session were followed in 83%. The majority (89%) of physicians believed in the positive effects of supervised exercise programmes. The majority of PCa programmes follow the evidence-based guidelines except for flexibility exercises. The minority of PCa patients has access to specific programmes, although not all treatment slots are occupied.

Dynamic contrast-enhanced imaging has limited added value over T2-weighted imaging and diffusion-weighted imaging when using PI-RADSv2 for diagnosis of clinically significant prostate cancer in patients with elevated PSA.

AIM: To determine the added value of dynamic contrast-enhanced imaging (DCE) over T2-weighted imaging (T2-WI) and diffusion-weighted imaging (DWI) for detection of clinically significant prostate cancer (csPC) in patients with elevated prostate-specific antigen (PSA). METHODS AND MATERIALS: Two hundred and forty-five patients with elevated PSA underwent multiparametric (mp) magnetic resonance imaging (MRI) of the prostate before biopsy. mpMRI was performed using a 3 T MRI system without an endorectal coil. Patients underwent transrectal ultrasound-guided systematic 12 core biopsy followed by radical prostatectomy (n=68), radiation therapy (n=91), or clinical follow-up for at least 2 years (n=86). csPC was defined as Gleason score ≥3+4 and/or tumour volume of ≥0.5 ml, and/or tumour stage ≥T3a. The MRI findings were scored according to the Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) and an alternative overall assessment category (PI-RADSv2Alt) based on only T2-WI and DWI. RESULTS: In 144 patients (58.8%), csPC was found within 2 years after MRI. With scoring according to the PI-RADSv2 guidelines, DCE was not needed for determination of the overall assessment category in 80.8% (198/245) of patients. Receiver operating characteristic (ROC) analysis showed an area under the curve of 0.79 (95% confidence interval [CI]: 0.74-0.85) for PI-RADSv2 and 0.79 (95% CI: 0.73-0.85) for PI-RADSv2Alt. CONCLUSION: The added value of DCE over T2-WI and DWI is limited when using PI-RADSv2 for diagnosis of csPC in patients with elevated PSA before biopsy. An alternative overall assessment score using only T2-WI and DWI yielded similar performance to PI-RADSv2.

An evidence map and synthesis review with meta-analysis on the risk of incisional hernia in colorectal surgery with standard closure.

PURPOSE: To assess the incidence of incisional hernia (IH) across various type of incisions in colorectal surgery (CS) creating a map of evidence to define research trends, gaps and areas of future interest. METHODS: Systematic review of PubMed and Scopus from 2010 onwards. Studies included both open (OS) and laparoscopic (LS). The primary outcome was incidence of IH 12 months after index procedure, secondary outcomes were the study features and their influence on reported proportion of IH. Random effects models were used to calculate pooled proportions. Meta-regression models were performed to explore heterogeneity. RESULTS: Ninetyone studies were included reporting 6473 IH. The pooled proportions of IH for OS were 0.35 (95% CI 0.27-0.44) I2 0% in midline laparotomies and 0.02 (95% CI 0.00-0.07), I2 52% for off-midline. In case of LS the pooled proportion of IH for midline extraction sites were 0.10 (95% CI 0.07-0.16), I2 58% and 0.04 (95% CI 0.03-0.06), I2 86% in case of off-midline. In Port-site IH was 0.02 (95% CI 0.01-0.04), I2 82%, and for single incision surgery (SILS) of 0.06-95% CI 0.02-0.15, I2 81%. In case of stoma reversal sites was 0.20 (95% CI 0.16-0.24). CONCLUSION: Midline laparotomies and stoma reversal sites are at high risk for IH and should be considered in research of preventive strategies of closure. After laparoscopic approach IH happens mainly by extraction sites incisions specially midline and also represent an important area of analysis.

Adjuvant Radiotherapy After Radical Cystectomy for Patients with High-risk Muscle-invasive Bladder Cancer: Results of a Multicentric Phase II Trial.

BACKGROUND: High-risk muscle-invasive bladder cancer (MIBC) has a poor prognosis. Old trials showed that external beam radiotherapy (EBRT) after radical cystectomy (RC) decreases the incidence of local recurrences but induces severe toxicity. OBJECTIVE: To evaluate the toxicity and local control rate after adjuvant EBRT after RC delivered with volumetric arc radiotherapy. DESIGN, SETTING, AND PARTICIPANTS: This is a multicentric phase 2 trial. From August 2014 till October 2020, we treated 72 high-risk MIBC patients with adjuvant EBRT after RC. High-risk MIBC is defined as ≥pT3-MIBC ± lymphovascular invasion, fewer than ten lymph nodes removed, pathological positive lymph nodes, or positive surgical margins. INTERVENTION: Patients received 50 Gy in 25 fractions with intensity-modulated radiotherapy to the pelvic lymph nodes ± cystectomy bed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome is acute toxicity. We report on local relapse-free rate (LRFR), clinical relapse-free survival (CRFS), overall survival (OS), and bladder cancer-specific survival (BCSS). RESULTS AND LIMITATIONS: The median follow-up is 18 mo. Forty-two patients (61%) developed acute grade 2 gastrointestinal (GI) toxicity. Four patients (6%) had acute grade 3 GI toxicity. One patient had grade 5 diarrhea and vomiting due to obstruction at 1 mo. Two-year probabilities of developing grade ≥3 and ≥2 GI toxicity were 17% and 76%, respectively. Urinary toxicity, assessed in 17 patients with a neobladder, was acceptable with acute grade 2 and 3 urinary toxicity reported in 53% (N = 9) and 18% (N = 3) of the patients, respectively. The 2-yr LRFR is 83% ± 5% and the 2-yr CRFS rate is 43% with a median CRFS time of 12 mo (95% confidence interval: 3-21 mo). Two-year OS and BCSS are 52% ± 7% and 62% ± 7%, respectively. Shortcomings are the nonrandomized study design and limited follow-up. CONCLUSIONS: Adjuvant EBRT after RC can be administered without excessive severe toxicity. PATIENT SUMMARY: In this report, we looked at the incidence of toxicity and local control after adjuvant external beam radiotherapy (EBRT) following radical cystectomy (RC) in high-risk muscle-invasive bladder cancer patients. We found that adjuvant EBRT was feasible and resulted in good local control. We conclude that these data support further enrollment of patients in ongoing trials to evaluate the place of adjuvant EBRT after RC.

Standard of Care Versus Metastases-directed Therapy for PET-detected Nodal Oligorecurrent Prostate Cancer Following Multimodality Treatment: A Multi-institutional Case-control Study.

BACKGROUND: Most prostate cancer (PCa) patients with a biochemical failure following primary multimodality treatment (surgery and postoperative radiotherapy) relapse in the nodes. OBJECTIVE: To perform a matched-case analysis in men with lymph node recurrent PCa comparing standard of care (SOC) with metastasis-directed therapy (MDT). DESIGN, SETTING, AND PARTICIPANTS: PCa patients with a prostate-specific antigen (PSA) progression following multimodality treatment were included in this retrospective multi-institutional analysis. INTERVENTION: The SOC cohort (n=1816) received immediate or delayed androgen deprivation therapy administered at PSA progression. The MDT cohort (n=263) received either salvage lymph node dissection (n=166) or stereotactic body radiotherapy (n=97) at PSA progression to a positron emission tomography-detected nodal recurrence. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint, cancer-specific survival (CSS), was analyzed using the Kaplan-Meier method, log-rank test, Cox proportional hazards models, and propensity score-matched analyses. RESULTS AND LIMITATIONS: At a median follow-up of 70 (interquartile range: 48-98) mo, MDT was associated with an improved CSS on univariate (p=0.029) and multivariate analysis (hazard ratio: 0.33, 95% confidence interval [CI]: 0.17-0.64) adjusted for the year of radical prostatectomy (RP), age at RP, PSA at RP, time from RP to PSA progression, Gleason score, surgical margin status, pT- and pN-stage. In total, 659 men were matched (3:1 ratio). The 5-yr CSS was 98.6% (95% CI: 94.3-99.6) and 95.7% (95% CI: 93.2-97.3) for MDT and SOC, respectively (p=0.005, log-rank). The main limitations of our study are its retrospective design and lack of standardization of systemic treatment in the SOC cohort. CONCLUSIONS: MDT for nodal oligorecurrent PCa improves CSS as compared with SOC. These retrospective data from a multi-institutional pooled analysis should be considered as hypothesis-generating and inform future randomized trials in this setting. PATIENT SUMMARY: Prostate cancer patients experiencing a lymph node recurrence might benefit from local treatments directed at these lymph nodes.

Lymphangioleiomyomatosis Presenting with Perirenal Hemorrhage.

Lymphangioleiomyomatosis (LAM) is a rare debilitating disease of unknown etiology, classically described as almost exclusively affecting women of childbearing age. The disease most commonly involves the lungs and is characterized by hamartomatous smooth muscle cell proliferations along blood vessels, airways and lymphatics. Most patients present with pulmonary symptoms, including shortness of breath, recurrent pneumothorax and pleural effusions. Extrapulmonary manifestations of LAM as the initial presentation of the disease are highly unusual. We present the case of a patient in whom LAM was incidentally discovered when the patient presented with retroperitoneal hemorrhage from a ruptured renal angiomyolipoma.

Cognitive factors influencing treatment decision-making in patients with localised prostate cancer: development of a standardised questionnaire.

BACKGROUND: Men diagnosed with localised prostate cancer have to make a well-informed treatment choice between (robot-assisted) radical prostatectomy, external beam radiotherapy and, in selected cases, brachytherapy and active surveillance. We developed and validated a questionnaire to determine the cognitive reasons motivating this choice. MATERIALS AND METHODS: The Prostate Cancer Decision-Making Questionnaire (PC-DMQ) was designed in-house and validated through the Delphi method. Finally, we tested the questionnaire in a cohort of 24 men, recently diagnosed with localised PC, before undergoing RARP (n = 16), EBRT (n = 6), brachytherapy (n = 1) or active surveillance (n = 1). RESULTS: The experts reached consensus after three rounds. In the patient cohort, 75% of men undergoing RARP chose this treatment because 'it provides the best chance of cure'. Reasons to choose EBRT were not as explicit: 33.3% chose this treatment because 'it provides the best chance of cure' and 33.3% because 'the maintenance of potency is important to them'. CONCLUSIONS: The PC-DMQ is a comprehensive and standardised tool that allows further research into cognitive factors that influence treatment decision-making in patients with localised PC.

Genotype/phenotype correlation of the G85E mutation in a large cohort of cystic fibrosis patients.

In this European study, the phenotype in 68 patients, homozygous or compound heterozygous for the G85E mutation, was investigated. Each index case was compared with two cystic fibrosis (CF) patients from the same clinic, matched for age and sex: one with pancreatic sufficiency (PS) and one with pancreatic insufficiency (PI). When comparing 31 G85E/F508del and F508del/F508del patients, there were no differences in median age at diagnosis, mean sweat chloride value, most recent weight for height, most recent forced expiratory volume in one second % predicted, prevalence of chronic Pseudomonas aeruginosa colonisation and typical CF complications. However, PI was less frequent in the G85E/F508del group. Comparison of 55 G85E patients (with second mutation known and not classified as mild) with PS controls (n=44) showed that the G85E patients had a significantly higher sweat chloride, more often failure to thrive at diagnosis, higher prevalence of PI, worse current weight for height, higher prevalence of chronic P. aeruginosa colonisation and liver cirrhosis. Pulse-chase experiments revealed that G85E cystic fibrosis transmembrane conductance regulator failed to mature on a M470 as well as on a V470 background. Therefore, G85E is a class II mutation. Although there is variability in its clinical presentation, G85E mutation results in a severe phenotype.