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64 result(s) for "Ruffion, Alain"
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Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial
Radiotherapy is the standard salvage treatment after radical prostatectomy. To date, the role of androgen deprivation therapy has not been formally shown. In this follow-up study, we aimed to update the results of the GETUG-AFU 16 trial, which assessed the efficacy of radiotherapy plus androgen suppression versus radiotherapy alone. GETUG-AFU 16 was an open-label, multicentre, phase 3, randomised, controlled trial that enrolled men (aged ≥18 years) with Eastern Cooperative Oncology Group performance status of 0 or 1, with histologically confirmed adenocarcinoma of the prostate (but no previous androgen suppression or pelvic radiotherapy), stage pT2, T3, or T4a (bladder neck involvement only) and pN0 or pNx according to the tumour, node, metastasis (TNM) staging system, whose prostate-specific antigen (PSA) concentration increased from 0·1 ng/mL to between 0·2 ng/mL and 2·0 ng/mL after radical prostatectomy, without evidence of clinical disease. Patients were assigned through central randomisation (1:1) to short-term androgen suppression (subcutaneous injection of 10·8 mg goserelin on the first day of irradiation and 3 months later) plus radiotherapy (3D conformal radiotherapy or intensity modulated radiotherapy of 66 Gy in 33 fractions, 5 days a week for 7 weeks) or radiotherapy alone. Randomisation was stratified using a permuted block method (block sizes of two and four) according to investigational site, radiotherapy modality, and prognosis. The primary endpoint was progression-free survival in the intention-to-treat population. This post-hoc one-shot data collection done 4 years after last data cutoff included patients who were alive at the time of the primary analysis and updated long-term patient status by including dates for first local progression, metastatic disease diagnosis, or death (if any of these had occurred) or the date of the last tumour evaluation or last PSA measurement. Survival at 120 months was reported. Late serious adverse effects were assessed. This trial is registered on ClinicalTrials.gov, NCT00423475. Between Oct 19, 2006, and March 30, 2010, 743 patients were randomly assigned, 374 to radiotherapy alone and 369 to radiotherapy plus goserelin. At the time of data cutoff (March 12, 2019), the median follow-up was 112 months (IQR 102–123). The 120-month progression-free survival was 64% (95% CI 58–69) for patients treated with radiotherapy plus goserelin and 49% (43–54) for patients treated with radiotherapy alone (hazard ratio 0·54, 0·43–0·68; stratified log-rank test p<0·0001). Two cases of secondary cancer occurred since the primary analysis, but were not considered to be treatment related. No treatment-related deaths occurred. The 120-month progression-free survival confirmed the results from the primary analysis. Salvage radiotherapy combined with short-term androgen suppression significantly reduced risk of biochemical or clinical progression and death compared with salvage radiotherapy alone. The results of the GETUG-AFU 16 trial confirm the efficacy of androgen suppression plus radiotherapy as salvage treatment in patients with increasing PSA concentration after radical prostatectomy for prostate cancer. The French Health ministry, AstraZeneca, la Ligue Contre le Cancer, and La Ligue de Haute-Savoie.
Real-World Use of Intradetrusor Botulinum Toxin Injections: A Population-Based Study from France
In recent decades, intradetrusor injections of botulinum toxin A (BoNT-A) have been widely applied to treat incontinence in both idiopathic overactive bladder (iOAB) and neurogenic detrusor overactivity incontinence (NDOI). This analysis, based on the French National Hospital Discharge Database (PMSI), aims to describe real-world trends in intradetrusor BoNT-A use between 2014 and 2022. Among 32,864 patients who received at least one intradetrusor BoNT-A injection, 18,320 (55.7%) had conditions coded under iOAB, 13,376 (40.7%) under NDOI, and 1168 (3.6%) under other indications. The overall mean interval between two intradetrusor BoNT-A injections was 9.7 months, ranging from 8.7 months in patients with multiple sclerosis (MS) to 11.5 months in patients with cerebral pathologies. The median number of injections was two (quartile 1–quartile 3, 1–4) in patients with spina bifida, whereas it was five (2–10) in those with MS. Only 31% of patients with iOAB received more than two intradetrusor BoNT-A injections. Regardless of its indication, BoNT-A was well tolerated. Adverse events occurring during or requiring hospitalization included infections (3.8%), hematuria (0.53%), and bleeding episodes necessitating transfusions (0.11%), all recorded within the initial month following BoNT-A injection. Our analysis of the PMSI database highlights a broad spectrum of intradetrusor BoNT-A injection practices.
Non-invasive prediction of recurrence in bladder cancer by detecting somatic TERT promoter mutations in urine
Background: Urothelial bladder cancer (UBC) is characterised by a high risk of recurrence. Patient monitoring is currently based on iterative cystoscopy and on urine cytology with low sensitivity in non-muscle-invasive bladder cancer (NMIBC). Telomerase reverse transcriptase (TERT) is frequently reactivated in UBC by promoter mutations. Methods: We studied whether detection of TERT mutation in urine could be a predictor of UBC recurrence and compared this to cytology/cystoscopy for patient follow-up. A total of 348 patients treated by transurethral bladder resection for UBC were included together with 167 control patients. Results: Overall sensitivity was 80.5% and specificity 89.8%, and was not greatly impacted by inflammation or infection. TERT remaining positive after initial surgery was associated with residual carcinoma in situ . TERT in urine was a reliable and dynamic predictor of recurrence in NMIBC ( P <0.0001). In univariate analysis, TERT positive-status after initial surgery increased risk of recurrence by 5.34-fold ( P =0.0004). TERT positive-status was still associated with recurrence in the subset of patients with negative cystoscopy ( P =0.034). Conclusions: TERT mutations in urine might be helpful for early detection of recurrence in UBC, especially in NMIBC.
The neurogenic bladder in multiple sclerosis: review of the literature and proposal of management guidelines
Vesicourethral dysfunction is very frequent in multiple sclerosis (MS) and has functional consequences for patients' quality of life and also an organic impact following complications of the neurogenic bladder on the upper urinary tract. While the functional impact and its management are well documented in the literature, the organic impact remains underestimated and there are no consensual practical guidelines for the screening and prevention of MS neurogenic bladder complications. The aim of this review of the literature, focused on identifying the risk factors of urinary tract complications in MS, is to put forward well informed considerations to help in the definition of practical guidelines for the follow-up of the neurogenic bladder in MS in order to improve its prevention and patient management. Four main risk factors have been identified for upper urinary tract damage: the duration of MS, the presence of an indwelling catheter, high-amplitude neurogenic detrusor contractions and permanent high detrusor pressure. Detrusor-sphincter dyssynergia, age over 50 and male sex may form three additional risk factors. Recommendations for long-term urological follow-up, taking into account these specific risks are constructed according to the procedures recommended by the French Health Authorities. Multiple Sclerosis 2007; 13: 915-928. http://msj.sagepub.com
Combined model-based and deep learning-based automated 3D zonal segmentation of the prostate on T2-weighted MR images: clinical evaluation
Objective To train and to test for prostate zonal segmentation an existing algorithm already trained for whole-gland segmentation. Methods The algorithm, combining model-based and deep learning–based approaches, was trained for zonal segmentation using the NCI-ISBI-2013 dataset and 70 T2-weighted datasets acquired at an academic centre. Test datasets were randomly selected among examinations performed at this centre on one of two scanners (General Electric, 1.5 T; Philips, 3 T) not used for training. Automated segmentations were corrected by two independent radiologists. When segmentation was initiated outside the prostate, images were cropped and segmentation repeated. Factors influencing the algorithm’s mean Dice similarity coefficient (DSC) and its precision were assessed using beta regression. Results Eighty-two test datasets were selected; one was excluded. In 13/81 datasets, segmentation started outside the prostate, but zonal segmentation was possible after image cropping. Depending on the radiologist chosen as reference, algorithm’s median DSCs were 96.4/97.4%, 91.8/93.0% and 79.9/89.6% for whole-gland, central gland and anterior fibromuscular stroma (AFMS) segmentations, respectively. DSCs comparing radiologists’ delineations were 95.8%, 93.6% and 81.7%, respectively. For all segmentation tasks, the scanner used for imaging significantly influenced the mean DSC and its precision, and the mean DSC was significantly lower in cases with initial segmentation outside the prostate. For central gland segmentation, the mean DSC was also significantly lower in larger prostates. The radiologist chosen as reference had no significant impact, except for AFMS segmentation. Conclusions The algorithm performance fell within the range of inter-reader variability but remained significantly impacted by the scanner used for imaging. Key Points • Median Dice similarity coefficients obtained by the algorithm fell within human inter-reader variability for the three segmentation tasks (whole gland, central gland, anterior fibromuscular stroma) . • The scanner used for imaging significantly impacted the performance of the automated segmentation for the three segmentation tasks . • The performance of the automated segmentation of the anterior fibromuscular stroma was highly variable across patients and showed also high variability across the two radiologists .
Greenlight laser photoselective vaporization vs open simple prostatectomy: long-term functional outcomes after treatment of large volume prostates (> 80 cc)
Purpose To compare long-term outcomes between photoselective vaporization (PVP) and Open simple prostatectomy (OSP) for prostates > 80 cc. Methods Men operated either by PVP or OSP for BPH > 80 cc were included in two expert centres. Functional and uroflowmetric outcomes were assessed pre- and postoperatively. Data were collected prospectively in the PVP group and retrospectively in the OSP group and compared at long-term follow-up. Complications and re-intervention rates were used as main outcomes. Results 332 men underwent surgery: 132 PVP were performed in a fist expert-centre and 200 OSP were performed in a second one with a median follow-up of 54 and 48 months, respectively. Mean Prostate volume was similar between OSP and PVP group (119 vs 116 cc). Major complications were more common in the OSP group (12.5 vs 1.5%, p  < 0.001). At long-term follow-up, Qmax was higher and PVR was lower ( p  < 0.05) in the OSP group. IPSS score was similar between groups ( p  = 0.45) but the Qol was better in the OSP group (0.9 vs. 1.6; p  < 0.05). There were more re-interventions in the PVP group compared to OSP (15.2 vs. 0%, p  < 0.005). Conclusion PVP is a good alternative for prostates > 80 cc particularly for fragile patients as it is associated with a lower complication rate. At long-term follow-up, IPSS was similar between groups, but Qol was better in the OSP group. Patients treated by PVP should be informed that they could require reoperation in 15% of the cases.
Suprapubic phalloplasty in transmen: surgical results and critical review
This article presents the surgical outcomes of a consecutive series of 71 transmen undergoing pre-expanded suprapubic phalloplasty (SPP) in a specialized center. The median [IQR] duration to finalize this three-stage phalloplasty procedure was 7 months [6–7]. Median [IQR] follow-up was 39.4 months [19.7–81.2]. Among those included, 25 (35.2%) had a urethroplasty, and 40 (56.3%) a penile prosthesis as additional procedures. Complications were the result of disorders of wound healing (dehiscence, infection, partial necrosis) or tissue expander (migration, infection). Sixty patients (84.5%) experienced at least one complication during the phalloplasty procedure, mostly minor complications Clavien < IIIa (81.8%). Among these, 16 (22.5%) underwent at least one reintervention, 2 of whom underwent two reinterventions (18 reinterventions in total for Clavien ≥ IIIa complication). There was no loss of phalloplasty. Among the wide variety of techniques developed for phalloplasty, the suprapubic technique seems to be a valuable option for transmen on the path to genital gender affirming surgery.
Synthetic mid-urethral slings for the treatment of stress urinary incontinence in women with neurogenic lower urinary tract dysfunction: a systematic review
Introduction and hypothesisThe aim of our study was to evaluate the efficiency and safety of synthetic mid-urethral slings (sMUS) for the treatment of stress urinary incontinence (SUI) in women with neurogenic lower urinary tract dysfunction (NLUTD).MethodsA systematic review was performed and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. MEDLINE, Embase and Cochrane controlled trials databases were systematically searched from January 1995 to April 2021. Studies including adult women with NLUTD who had a sMUS for SUI were considered for inclusion. Primary outcome was success of the surgery according to study criteria. Secondary outcomes were complications, especially de novo urgency, urinary retention, tape exposure and revision for complications.ResultsA total of 752 abstracts were screened and 9 studies were included, representing 298 patients. The mean age was 52 years and median follow-up was 41.3 months. sMUS insertion was successful in 237 patients (79.5%). The median rate of de novo urgency was 15.7% (range 8.3–30%). In patients with spontaneous voiding, the median rate of retention was 19.3% (range 0–46.7%) and 21 out of 26 patients required intermittent self-catheterisation. Four cases of tape exposure were reported, and 8 patients underwent a revision for complications.ConclusionsThis review suggests that sMUS might offer interesting success rates and acceptable morbidity and could be considered for the treatment of SUI in women with NLUTD. Further studies are required to define which patients would be more likely to benefit from this intervention, as well as its place among the other surgical treatments for SUI.
Quality control of rigid endoscopes: a comparative study between ScopeControl® and surgeons’ evaluation
BackgroundIn central sterile services departments (CSSD), the functionality of rigid endoscopes, which are complex and fragile reusable devices, is usually controlled visually and is considered a complex and subjective task. ScopeControl® was developed to provide an automated quality control of rigid endoscopes by measuring the value of six parameters: viewing angle (VA), field of view (FV), color correctness (CC), light transmission (LT), fibers transmission (FT), and focus (FC). The aim of the present study was to assess the ability of ScopeControl® to pre-emptively identify endoscope defects before the surgeon considers them as defective.MethodsThe same endoscope was evaluated by surgeons during surgery using a scoring scale as well as the CSSD staff using the ScopeControl® during reprocessing. The ScopeControl® categorized the endoscope into 3 groups: “passed,” “in danger,” and “failed.” Correlations between the surgeon’s evaluation and results of the ScopeControl® were calculated.ResultsOne hundred sixty-six controls were carried out concerning 51 different endoscopes. According to the surgeon’s evaluation, 78.9% and 80.7% of controls were considered as satisfactory for image and brightness quality, respectively. Results obtained using ScopeControl® found that 13.3% of controls were considered as “passed,” 31.3% “in danger,” and 55.4% “failed,” with poor correlation with the surgeons’ evaluation. LT and FT parameters represented 95.2% of the reasons for failures. The ability of the ScopeControl® to detect endoscope defects earlier than surgeons was validated by tracking the results of endoscopes used and controlled several times.ConclusionThe ScopeControl® achieved an objective and consistent quality control of endoscopes and showed poor correlation with the surgeon’s opinion. In practice, the ScopeControl® could avoid the use of defective endoscopes in the surgery unit and thus improve the quality of the surgical procedure.
PARP inhibitors in prostate cancers, is it time for combinations?
Despite several improvements in outcomes, metastatic prostate cancer remains deadly. Alterations in the homologous recombination repair (HRR) pathway are associated with more aggressive disease. Olaparib and rucaparib, two poly-ADP-ribose polymerase (PARP) inhibitors, have received approval from the authorities of several countries for their anti-tumoral effects in patients with metastatic castration-resistant prostate cancers harboring HRR gene alterations, in particular BRCA2. More recently, it has been hypothesized that new hormonal therapies (NHTs) and PARP inhibitors (PARPi) could have synergistic actions and act independently of HRR deficiency. This review proposes to discuss the advantages and disadvantages of PARPi used as monotherapy or in combination with NHTs and whether there is a need for molecular selection.