Publications by authors named "Jorg R Oddens"

23 Publications

  • Page 1 of 1

The challenge of prostate biopsy guidance in the era of mpMRI detected lesion: ultrasound-guided versus in-bore biopsy.

Br J Radiol 2021 Jul 29:20210363. Epub 2021 Jul 29.

Department of Urology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.

The current recommendation in patients with a clinical suspicion for prostate cancer is to perform systematic biopsies extended with targeted biopsies, depending on mpMRI results. Following a positive mpMRI [i.e. Prostate Imaging Reporting and Data System (PI-RADS) ≥3], three targeted biopsy approaches can be performed: visual registration of the MRI images with real-time ultrasound imaging; software-assisted fusion of the MRI images and real-time ultrasound images, and in-bore biopsy within the MR scanner. This collaborative review discusses the advantages and disadvantages of each targeting approach and elaborates on future developments. Cancer detection rates seem to mostly depend on practitioner experience and selection criteria (biopsy naïve, previous negative biopsy, prostate-specific antigen (PSA) selection criteria, presence of a lesion on MRI), and to a lesser extent dependent on biopsy technique. There is no clear consensus on the optimal targeting approach. The choice of technique depends on local experience and availability of equipment, individual patient characteristics, and onsite cost-benefit analysis. Innovations in imaging techniques and software-based algorithms may lead to further improvements in this field.
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http://dx.doi.org/10.1259/bjr.20210363DOI Listing
July 2021

Hospital volume is associated with postoperative mortality after radical cystectomy for treatment of bladder cancer.

BJU Int 2021 Jan 6. Epub 2021 Jan 6.

Department of Research and Development, Netherlands Comprehensive Cancer Organization, Utrecht, The Netherlands.

Objective: To contribute to the debate regarding the minimum volume of radical cystectomies (RCs) that a hospital should perform by evaluating the association between hospital volume (HV) and postoperative mortality.

Patients And Methods: Patients who underwent RC for bladder cancer between 1 January 2008 and 31 December 2018 were retrospectively identified from the Netherlands Cancer Registry. To create a calendar-year independent measure, the HV of RCs was calculated per patient by counting the RCs performed in the same hospital in the 12 months preceding surgery. The relationship of HV with 30- and 90-day mortality was assessed by logistic regression with a non-linear spline function for HV as a continuous variable, which was adjusted for age, tumour, node and metastasis (TNM) stage, and neoadjuvant treatment.

Results: The median (interquartile range; range) HV among the 9287 RC-treated patients was 19 (12-27; 1-75). Of all the included patients, 208 (2.2%) and 518 (5.6%) died within 30 and 90 days after RC, respectively. After adjustment for age, TNM stage and neoadjuvant therapy, postoperative mortality slightly increased between an HV of 0 and an HV of 25 RCs and steadily decreased from an HV of 30 onwards. The lowest risks of postoperative mortality were observed for the highest volumes.

Conclusion: This paper, based on high-quality data from a large nationwide population-based cohort, suggests that increasing the RC volume criteria beyond 30 RCs annually could further decrease postoperative mortality. Based on these results, the volume criterion of 20 RCs annually, as recently recommended by the European Association of Urology Guideline Panel, might therefore be reconsidered.
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http://dx.doi.org/10.1111/bju.15334DOI Listing
January 2021

Deep Learning-based Recurrence Prediction in Patients with Non-muscle-invasive Bladder Cancer.

Eur Urol Focus 2020 Dec 22. Epub 2020 Dec 22.

Department of Biomedical Engineering and Physics, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands; Department of Biomedical Engineering and Physics, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands; Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Background: Non-muscle-invasive bladder cancer (NMIBC) is characterized by frequent recurrence of the disease, which is difficult to predict.

Objective: To combine digital histopathology slides with clinical data to predict 1- and 5-yr recurrence-free survival of NMIBC patients using deep learning.

Design, Setting, And Participants: Data of patients undergoing a transurethral resection of a bladder tumor between 2000 and 2018 at a Dutch academic medical center were selected. Corresponding histological slides were digitized. A three-step approach was used to predict 1- and 5-yr recurrence-free survival. First, a segmentation network was used to detect the urothelium on the digital histopathology slides. Second, a selection network was trained for the selection of patches associated with recurrence. Third, a classification network, combining the information of the selection network with clinical data, was trained to give the probability of 1- and 5-yr recurrence-free survival.

Outcome Measurements And Statistical Analysis: The accuracy of the deep learning-based model was compared with a multivariable logistic regression model using clinical data only.

Results And Limitations: In the 1- and 5-yr follow-up cohorts, 359 and 281 patients were included with recurrence rates of 27% and 63%, respectively. The areas under the curve (AUCs) of the model combining digital histopathology slide data with clinical data were 0.62 and 0.76 for 1- and 5-yr recurrence predictions, respectively, which were higher than those of the model using digital histopathology slide data only (AUCs of 0.56 and 0.72, respectively) and the multivariable logistic regression (AUCs of 0.58 and 0.57, respectively).

Conclusions: In our population, the deep learning-based model combining digital histopathology slides and clinical data enhances the prediction of recurrence (within 5 yr) compared with models using clinical data or image data only.

Patient Summary: By combining histopathology images and patient record data using deep learning, the prediction of recurrence in bladder cancer patients is enhanced.
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http://dx.doi.org/10.1016/j.euf.2020.12.008DOI Listing
December 2020

Hospital-specific probability of cystectomy affects survival from muscle-invasive bladder cancer.

Urol Oncol 2020 12 8;38(12):935.e9-935.e16. Epub 2020 Sep 8.

Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands; Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.

Objectives: Radical cystectomies (RCs) are increasingly centralized, but bladder cancer can be diagnosed in every hospital The aim of this study is to assess the variation between hospitals of diagnosis in a patient's chance to undergo a RC before and after the volume criteria for RCs, to identify factors associated with this variation and to assess its effect on survival.

Methods And Materials: Patients diagnosed with muscle-invasive bladder cancer (cT2-4a,N0/X,M0/X) without nodal or distant metastases between 2008 and 2016 were identified through the Netherlands Cancer Registry. Multilevel logistic regression analysis was used to investigate the hospital specific probability of undergoing a cystectomy. Cox proportional hazard regression analysis was used to assess the case-mix adjusted effect of hospital-specific probabilities on survival.

Results: Of the 9,215 included patients, 4,513 (49%) underwent a RC. The percentage of RCs varied between 7% and 83% by hospital of diagnosis before the introduction of the first volume criteria (i.e., 2008-2009; minimum of 10 RCs). This variation decreased slightly to 17%-77% after establishment of the second volume criteria (i.e., 2015-2016; minimum of 20 RCs). Age, cT-stage and comorbidity were inversely and socioeconomic status was positively associated with RC. Both being diagnosed in a community hospital and/or being diagnosed in a hospital fulfilling the RC volume criteria were associated with increased use of RC compared to academic hospitals and hospitals not fulfilling the volume criteria. For each 10% increase in the percentage of RC in the hospital of diagnosis, 2-year case-mix adjusted survival increased 4% (hazard ratio 0.96, 95% confidence interval 0.94-0.98).

Conclusion: Probability of RC varied between hospitals of diagnosis and affected 2-year overall survival. Undergoing a RC was associated with age, cT-stage, socioeconomic status, type of hospital, and whether the hospital of diagnosis fulfilled the RC volume criteria. Future research is needed to identify patient, tumor, and hospital characteristics affecting utilization of curative treatment as this may benefit overall survival.
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http://dx.doi.org/10.1016/j.urolonc.2020.08.014DOI Listing
December 2020

Transperineal Laser Ablation Treatment for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction: Protocol for a Prospective In Vivo Pilot Study.

JMIR Res Protoc 2020 Jan 21;9(1):e15687. Epub 2020 Jan 21.

Department of Urology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.

Background: Standard surgical treatments for lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) use a transurethral approach. Drawbacks are the need for general or spinal anesthesia and complications such as hematuria, strictures, and cloth retention. Therefore, a minimal invasive technique under local anesthesia is desired to improve patient safety. Recently, SoracteLite transperineal laser ablation (TPLA) has been introduced as a novel minimal invasive treatment for BPO. The system used is unique because 4 laser sources are independently available. This 1064-nm diode laser induces coagulative necrosis. Moreover, TPLA is unique because it has a transperineal approach and can be performed under local anesthesia in an outpatient setting.

Objective: The primary objective of this study is to determine the safety and feasibility of TPLA treatment for men, who are fit for standard surgery, with LUTS due to BPO. The secondary objectives are to determine functional outcomes by flowmetry and patient-reported outcome measures (PROMs), side effects, and tissue changes observed on imaging.

Methods: This study is a prospective, single center, interventional pilot study IDEAL framework stage 2a and will include 20 patients. Eligible patients are men ≥40 years of age, with a prostate volume of 30 to 120 cc, have urodynamically proven bladder outlet obstruction, and have a peak urinary flow of 5 to 15 mL per second. All patients will undergo TPLA of their prostate under local anesthesia by using the EchoLaser system. Depending on the prostate volume, 2 to 4 laser fibers will be placed bilaterally into the prostate. Patient follow-up consists of uroflowmetry, PROMs, and imaging by using contrast-enhanced ultrasound. Total follow-up is 12 months following treatment.

Results: Presently, recruitment of patients is ongoing. Publication of first results is expected by early 2020.

Conclusions: TPLA offers the potential to be a novel minimal invasive technique for treatment of LUTS due to BPO in men fit for standard desobstruction. This study will evaluate the safety and feasibility of TPLA and report on functional outcomes and tissue changes observed on imaging following TPLA treatment.

International Registered Report Identifier (irrid): DERR1-10.2196/15687.
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http://dx.doi.org/10.2196/15687DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7001043PMC
January 2020

EAU-ESMO Consensus Statements on the Management of Advanced and Variant Bladder Cancer-An International Collaborative Multistakeholder Effort: Under the Auspices of the EAU-ESMO Guidelines Committees.

Eur Urol 2020 02 19;77(2):223-250. Epub 2019 Nov 19.

Department of Biomedical Sciences, Humanitas University, Milan, Italy; Humanitas Research Hospital, Milan, Italy.

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 prior to 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), and 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 statements, 33 (28%) achieved level 1 consensus and 49 (42%) 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 when further evidence is available to guide our approach.

Patient Summary: This report summarises findings from an international, multistakeholder project organised by the EAU and ESMO. In this project, a steering committee identified areas of bladder cancer management where there is currently no good-quality evidence to guide treatment decisions. From this, they developed a series of proposed statements, 71 of which achieved consensus by a large group of experts in the field of bladder cancer. It is anticipated that these statements will provide further guidance to health care professionals and could help improve patient outcomes until a time when good-quality evidence is available.
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http://dx.doi.org/10.1016/j.eururo.2019.09.035DOI Listing
February 2020

Study protocol of a phase II clinical trial of oral metformin for the intravesical treatment of non-muscle invasive bladder cancer.

BMC Cancer 2019 Nov 21;19(1):1133. Epub 2019 Nov 21.

Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.

Background: Non-muscle-invasive bladder cancer (NMIBC) is the most common neoplasm of the urinary tract and requires life-long invasive surveillance to detect disease recurrence. Currently, there are no effective oral therapies that delay disease recurrence or progression. We recently demonstrated that in mice, metformin accumulates unchanged in the urine. Urothelial cells are exposed to metformin concentrations ~ 240-fold higher than in serum. This was effective in the treatment of mouse bladder cancer models.

Methods: We describe the protocol of a multi-centre, open-label, phase II clinical trial of metformin in up to 49 evaluable patients with intermediate-risk NMIBC with the aim to determine the overall response to administration of oral metformin for 3 months on a marker tumour deliberately left following transurethral resection of multiple, papillary NMIBC tumours. All patients will receive metformin orally at doses up to 3000 mg per day. Metformin treatment will start within 2 weeks following transurethral resection of all tumours except one marker lesion. After 3 months of metformin treatment, the effect of metformin on the marker lesion is evaluated by cystoscopy and biopsy under anaesthesia. Residual tumour, if present at this evaluation, will be resected. In case of complete disappearance of the marker lesion, the former tumour area will be biopsied. The primary outcome is the complete response rate of the marker lesion, as determined by decentralised scoring of pre- and post-treatment cystoscopy images by expert independent urologists. Secondary outcomes are the partial response rate, overall safety of metformin and the duration of the time to recurrence.

Discussion: Preclinical studies show the potential role of oral metformin treatment in the management of NMIBC. It could offer an alternative to current adjuvant intravesical treatment. If positive, the reported results of this study could warrant further phase III trials to compare the efficacy of metformin against current treatments of intravesical installations with chemotherapy or Bacillus Calmette-Guérin (BCG).

Trial Registration: This trial is registered in ClinicalTrials.gov under NCT03379909.
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http://dx.doi.org/10.1186/s12885-019-6346-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6873510PMC
November 2019

The Role of Fluorescence In Situ Hybridization for Predicting Recurrence after Adjuvant bacillus Calmette-Guérin in Patients with Intermediate and High Risk Nonmuscle Invasive Bladder Cancer: A Systematic Review and Meta-Analysis of Individual Patient Data.

J Urol 2020 02 24;203(2):283-291. Epub 2019 Sep 24.

Department of Urology, Amsterdam University Medical Center, University of Amsterdam, The Netherlands.

Purpose: The objective of this study was to assess the value of fluorescence in situ hybridization to predict early recurrence in patients with nonmuscle invasive bladder cancer at intermediate and high risk treated with bacillus Calmette-Guérin.

Materials And Methods: We performed a systematic review using MEDLINE®, Embase® and the Cochrane Library. Individual patient data from prospective observational studies of fluorescence in situ hybridization in patients treated with bacillus Calmette-Guérin were included. A 2-stage individual patient data meta-analysis was done to assess the value of fluorescence in situ hybridization to predict tumor recurrence after bacillus Calmette-Guérin induction therapy.

Results: From a total of 4 studies we obtained individual data on 422 patients, of whom 408 with a median followup of 18.8 months were included in the final analysis. When fluorescence in situ hybridization was positive, the recurrence HR was 1.20 (95% CI 0.81-1.79) before bacillus Calmette-Guérin (time 0), 2.23 (95% CI 1.31-3.62) at 6 weeks (time 1), 3.70 (95% CI 2.34-5.83) at 3 months (time 2) and 23.44 (95% CI 5.26-104.49) at 6 months (time 3).

Conclusions: A positive fluorescence in situ hybridization test after bacillus Calmette-Guérin correlated with higher risk of recurrent tumor. Fluorescence in situ hybridization could aid urologists in risk stratifying and counseling patients. Based on the HR and the narrowest CI the preferred timing of fluorescence in situ hybridization is 3 months after transurethral resection of bladder tumor. This is also in time for patients in whom induction therapy fails to enter clinical trials or change the treatment strategy.
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http://dx.doi.org/10.1097/JU.0000000000000566DOI Listing
February 2020

Value of Serial Multiparametric Magnetic Resonance Imaging and Magnetic Resonance Imaging-guided Biopsies in Men with Low-risk Prostate Cancer on Active Surveillance After 1 Yr Follow-up.

Eur Urol Focus 2019 05 10;5(3):407-415. Epub 2018 Jan 10.

Department of Radiology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. Electronic address:

Background: Active surveillance (AS) aims to reduce overtreatment of low-risk prostate cancer (PC). Incorporating multiparametric magnetic resonance imaging (mp-MRI) and MR-guided biopsy (MRGB) in an AS protocol might contribute to more accurate identification of AS candidates.

Objective: To evaluate the value of 3T mp-MRI and MRGB in PC patients on AS at inclusion and after 12-mo follow-up.

Design, Setting, And Participants: Patients with cT1c-cT2 PC, prostate-specific antigen (PSA) ≤10ng/ml, PSA density <0.2ng/ml/ml, and Gleason scores (GSs) of ≤6 and ≤2 positive biopsy cores were included and followed in an AS protocol including mp-MRI and MRGB. The mp-MRI and MRGB were performed at <3 and 12 mo after diagnosis. Reclassification was defined as GS >6, >2 positive cores at repeat transrectal ultrasound-guided biopsy (TRUSGB), presence of PC in >3 separate cancer foci upon both MRGB and TRUSGB, or cT3 tumor on mp-MRI.

Outcome Measurements And Statistical Analysis: Reclassification rates, treatment after discontinuation, and outcome on radical prostatectomy after discontinuing AS were reported. Uni- and multivariate analyses were performed to identify predictors of reclassification after 1 yr.

Results And Limitations: From 2009 to 2013, a total of 111 of 158 patients were consecutively and prospectively included. Around initial diagnosis, 36 patients were excluded from the study protocol; mp-MRI+MRGB reclassified 25/111 (23%) patients, and 11 patients were excluded at own request. Reasons for reclassification were as follows: GS upgrade (15/25, 60%); cT3 disease (3/25, 12%); suspicion of bone metastases (1/25, 4%); and multifocal disease upon MRGB (6/25, 24%). Repeat examinations after 1 yr showed reclassification in 33/75 patients (44%). Reasons were the following: GS upgrade upon TRUSGB (9/33, 27%); volume progression upon TRUSGB (9/33, 27%); cT3 disease upon mp-MRI (1/33, 3%); GS upgrade upon MRGB (1/33, 3%); volume progression upon MRGB (1/33, 3%); multifocal disease upon MRGB (2/33, 6%); and upgrade or upstage upon both TRUSGB and MRGB (10/33, 30%). On logistic regression analysis, the presence of cancer at initial mp-MRI and MRGB examinations was the only predictor of reclassification after 1 yr (odds ratio 5.9, 95% confidence interval 2.0-17.6).

Conclusions: Although mp-MRI and MRGB are of additional value in the evaluation of PC patients on AS, the value of mp-MRI after 1 yr was limited. As a considerable percentage of GS ≥7 PC after 1 yr was detected only by TRUSGB, TRUSGB cannot be omitted yet.

Patient Summary: More aggressive tumors are detected if low-risk prostate cancer patients are additionally monitored by magnetic resonance imaging. However, some high-grade tumors are detected only by transrectal ultrasound-guided biopsy.
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http://dx.doi.org/10.1016/j.euf.2017.12.008DOI Listing
May 2019

Cancer survivors' preference for follow-up care providers: a cross-sectional study from the population-based PROFILES-registry.

Acta Oncol 2017 Feb 9;56(2):278-287. Epub 2017 Jan 9.

a Department of Research , Netherlands Comprehensive Cancer Organization , Utrecht , The Netherlands.

Background: The best practice for the organization of follow-up care in oncology is under debate, due to growing numbers of cancer survivors. Understanding survivors' preferences for follow-up care is elementary for designing patient-centred care. Based on data from prostate cancer and melanoma survivors, this study aims to identify: 1) preferences for follow-up care providers, for instance the medical specialist, the oncology nurse or the general practitioner; 2) characteristics associated with these preferences and 3) the preferred care provider to discuss cancer-related problems.

Material And Methods: Survivors diagnosed with prostate cancer (N = 535) and melanoma (N = 232) between 2007 and 2013 as registered in The Netherlands Cancer Registry returned a questionnaire (response rate was 71% and 69%, respectively). A latent class cluster model analysis was used to define preferences and a multinomial logistic regression analysis was used to identify survivor-related characteristics associated with these preferences.

Results: Of all survivors, 29% reported no preference, 40% reported a preference for the medical specialist, 20% reported a preference for both the medical specialist and the general practitioner and 11% reported a preference for both the medical specialist and the oncology nurse. Survivors who were older, lower/intermediate educated and women were more likely to have a preference for the medical specialist. Lower educated survivors were less likely to have a preference for both the medical specialist and the general practitioner. Overall, survivors prefer to discuss diet, physical fitness and fatigue with the general practitioner, and hereditary and recurrence with the medical specialist. Only a small minority favored to discuss cancer-related problems with the oncology nurse.

Conclusion: Survivors reported different preferences for follow-up care providers based on age, education level, gender and satisfaction with the general practitioner, showing a need for tailored follow-up care in oncology. The results indicate an urgency to educate patients about transitions in follow-up care.
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http://dx.doi.org/10.1080/0284186X.2016.1267398DOI Listing
February 2017

Increasing age is not associated with toxicity leading to discontinuation of treatment in patients with urothelial non-muscle-invasive bladder cancer randomised to receive 3 years of maintenance bacille Calmette-Guérin: results from European Organisation for Research and Treatment of Cancer Genito-Urinary Group study 30911.

BJU Int 2016 Sep 2;118(3):423-8. Epub 2016 Apr 2.

Department of Urology, Gent University Hospital, Ghent, Belgium.

Objective: To determine the relationship of age to side-effects leading to discontinuation of treatment in patients with stage Ta-T1 non-muscle-invasive bladder cancer (NMIBC) treated with maintenance bacille Calmette-Guérin (BCG).

Patients And Methods: We evaluated toxicity for 487 eligible patients with intermediate- or high-risk Ta-T1 (without carcinoma in situ) NMIBC randomised to receive 3 years of maintenance BCG therapy (247 BCG alone and 240 BCG + isoniazid) in European Organisation for Research and Treatment of Cancer Genito-Urinary Group trial 30911. The percentage of patients who stopped for toxicity and the number of treatment cycles that they received were compared in four age groups, ≤60, 61-70, 71-75 and >75 years, using the Mantel-Haenszel chi-square test for trend.

Results: The percentage of patients stopping BCG for toxicity was 17.9% in patients aged ≤60 years, 21.9% in patients aged 61-70 years, 22.9% in patients aged 71-75 years, and 16.4% in patients aged >75 years (P = 0.90). For both systemic and local side-effects, there was likewise no significant difference.

Conclusion: In patients with intermediate- and high-risk Ta-T1 NMIBC treated with BCG, no differences in toxicity as a reason for stopping treatment were detected based on patient age.
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http://dx.doi.org/10.1111/bju.13474DOI Listing
September 2016

Chemohyperthermia with Mitomycin-C Compared with Bacillus Calmette-Guérin: A "Hot" Topic.

Eur Urol 2016 06 9;69(6):1053-4. Epub 2016 Feb 9.

Senior Statistical Scientist Emeritus, European Organization for Research and Treatment of Cancer Headquarters, Brussels, Belgium.

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http://dx.doi.org/10.1016/j.eururo.2016.01.038DOI Listing
June 2016

Systematic Review and Individual Patient Data Meta-analysis of Randomized Trials Comparing a Single Immediate Instillation of Chemotherapy After Transurethral Resection with Transurethral Resection Alone in Patients with Stage pTa-pT1 Urothelial Carcinoma of the Bladder: Which Patients Benefit from the Instillation?

Eur Urol 2016 Feb 16;69(2):231-44. Epub 2015 Jun 16.

Hospital Motol and Second Faculty of Medicine, Charles University, Department of Urology, Prague, Czech Republic.

Context: The European Association of Urology non-muscle-invasive bladder cancer (NMIBC) guidelines recommend that all low- and intermediate-risk patients receive a single immediate instillation of chemotherapy after transurethral resection of the bladder (TURB), but its use remains controversial.

Objective: To identify which NMIBC patients benefit from a single immediate instillation.

Evidence Acquisition: A systematic review and individual patient data (IPD) meta-analysis of randomized trials comparing the efficacy of a single instillation after TURB with TURB alone in NMIBC patients was carried out.

Evidence Synthesis: A total of 13 eligible studies were identified. IPD were obtained for 11 studies randomizing 2278 eligible patients, 1161 to TURB and 1117 to a single instillation of epirubicin, mitomycin C, pirarubicin, or thiotepa. A total of 1128 recurrences, 108 progressions, and 460 deaths (59 due to bladder cancer [BCa]) occurred. A single instillation reduced the risk of recurrence by 35% (hazard ratio [HR]: 0.65; 95% confidence interval [CI], 0.58-0.74; p<0.001) and the 5-yr recurrence rate from 58.8% to 44.8%. The instillation did not reduce recurrences in patients with a prior recurrence rate of more than one recurrence per year or in patients with an European Organization for Research and Treatment of Cancer (EORTC) recurrence score ≥5. The instillation did not prolong either the time to progression or death from BCa, but it resulted in an increase in the overall risk of death (HR: 1.26; 95% CI, 1.05-1.51; p=0.015; 5-yr death rates 12.0% vs 11.2%), with the difference appearing in patients with an EORTC recurrence score ≥5.

Conclusions: A single immediate instillation reduced the risk of recurrence, except in patients with a prior recurrence rate of more than one recurrence per year or an EORTC recurrence score ≥5. It does not prolong either time to progression or death from BCa. The instillation may be associated with an increase in the risk of death in patients at high risk of recurrence in whom the instillation is not effective or recommended.

Patient Summary: A single instillation of chemotherapy immediately after resection reduces the risk of recurrence in non-muscle-invasive bladder cancer; however, it should not be given to patients at high risk of recurrence due to its lack of efficacy in this subgroup.
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http://dx.doi.org/10.1016/j.eururo.2015.05.050DOI Listing
February 2016

The effect of age on the efficacy of maintenance bacillus Calmette-Guérin relative to maintenance epirubicin in patients with stage Ta T1 urothelial bladder cancer: results from EORTC genito-urinary group study 30911.

Eur Urol 2014 Oct 16;66(4):694-701. Epub 2014 Jun 16.

Department of Urology, Gent University Hospital, Ghent, Belgium.

Background: Although maintenance bacillus Calmette-Guérin (BCG) is the recommended treatment in high-risk non-muscle-invasive bladder cancer (NMIBC), its efficacy in older patients is controversial.

Objective: To determine the effect of age on prognosis and treatment outcome in patients with stage Ta T1 NMIBC treated with maintenance BCG.

Design, Setting, And Participants: A total of 957 patients with intermediate- or high-risk Ta T1 (without carcinoma in situ) NMIBC were randomized in European Organization for Research and Treatment of Cancer (EORTC) trial 30911 comparing six weekly instillations of epirubicin, BCG, and BCG plus isoniazid followed by three weekly maintenance instillations over 3 yr.

Outcome Measurements And Statistical Analysis: Cox multivariate proportional hazards regression models were used to assess the relative importance of age for recurrence, progression, overall survival, and NMIBC-specific survival with adjustment for EORTC risk scores.

Results And Limitations: Overall, 822 eligible patients were included: 546 patients in the BCG with or without INH arms and 276 in the epirubicin arm. In patients treated with BCG with or without INH, 34.1% were >70 yr of age and 3.7% were >80 yr. With a median follow-up of 9.2 yr, patients >70 yr had a shorter time to progression (p=0.028), overall survival (p<0.001), and NMIBC-specific survival (p=0.049) after adjustment for EORTC risk scores in the multivariate analysis. The time to recurrence was similar compared with the younger patients. BCG was more effective than epirubicin for all four end points considered, and there was no evidence that BCG was any less effective compared with epirubicin in patients >70 yr.

Conclusions: In intermediate- and high-risk Ta T1 urothelial bladder cancer patients treated with BCG, patients >70 yr of age have a worse long-term prognosis; however, BCG is more effective than epirubicin independent of patient age.

Patient Summary: Intravesical bacillus Calmette-Guérin for non-muscle-invasive bladder cancer is less effective in patients >70 yr of age, but it is still more effective than epirubicin.

Trial Registration: This study was registered with the US National Cancer Institute clinical trials database (protocol ID: EORTC 30911; http://www.cancer.gov/clinicaltrials/search/view?cdrid=77075&version=HealthProfessional&protocolsearchid=12442243#StudyIdInfo_CDR0000077075).
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http://dx.doi.org/10.1016/j.eururo.2014.05.033DOI Listing
October 2014

Value of 3-T multiparametric magnetic resonance imaging and magnetic resonance-guided biopsy for early risk restratification in active surveillance of low-risk prostate cancer: a prospective multicenter cohort study.

Invest Radiol 2014 Mar;49(3):165-72

From the Departments of *Radiology, and †Urology, Radboud University Nijmegen Medical Centre; ‡Department of Urology, Canisius Wilhelmina Hospital, Nijmegen; §Department of Urology, Jeroen Bosch Hospital, Den Bosch; ∥Department of Urology, Alysis Zorggroep, Arnhem; ¶Department of Urology, Erasmus University Medical Centre, Rottterdam; and #Department of Pathology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.

Objectives: The objective of this study was to evaluate the role of 3-T multiparametric magnetic resonance imaging (MP-MRI) and magnetic resonance-guided biopsy (MRGB) in early risk restratification of patients on active surveillance at 3 and 12 months of follow-up.

Materials And Methods: Within 4 hospitals participating in a large active surveillance trial, a side study was initiated. Pelvic magnetic resonance imaging, prostate MP-MRI, and MRGB were performed at 3 and 12 months (latter prostate MP-MRI and MRGB only) after prostate cancer diagnosis in 1 of the 4 participating hospitals. Cancer-suspicious regions (CSRs) were defined on prostate MP-MRI using Prostate Imaging Reporting And Data System (PI-RADS) scores.Risk restratification criteria for active surveillance discontinuance were (1) histopathologically proven magnetic resonance imaging suspicion of node/bone metastases and/or (2) a Gleason growth pattern (GGP) 4 and/or 5 and/or cancer multifocality (≥3 foci) in MRGB specimens of a CSR on MP-MRI.

Results: From 2009 to 2012, a total of 64 of 82 patients were consecutively and prospectively included and underwent MP-MRI and a subsequent MRGB. At 3 and 12 months of follow-up, 14% (9/64) and 10% (3/30) of the patients were risk-restratified on the basis of MP-MRI and MRGB. An overall CSR PI-RADS score of 1 or 2 had a negative predictive value of 84% (38/45) for detection of any prostate cancer and 100% (45/45) for detection of a GGP 4 or 5 containing cancer upon MRGB, respectively. A CSR PI-RADS score of 4 or higher had a sensitivity of 92% (11/12) for detection of a GGP 4 or 5 containing cancer upon MRGB.

Conclusions: Application of MP-MRI and MRGB in active surveillance may contribute in early identification of patients with GGP 4 or 5 containing cancers at 3 months of follow-up. If, during further follow-up, a PI-RADS score of 1 or 2 continues to have a negative predictive value for GGP 4 or 5 containing cancers, a PI-RADS standardized reported MP-MRI may be a promising tool for the selection of prostate cancer patients suitable for active surveillance.
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http://dx.doi.org/10.1097/RLI.0000000000000008DOI Listing
March 2014

Evaluation of diffusion-weighted MR imaging at inclusion in an active surveillance protocol for low-risk prostate cancer.

Invest Radiol 2013 Mar;48(3):152-7

Department of Urology, Canisius-Wilhelmina Hospital, Radboud University Nijmegen Medical Center, The Netherlands.

Purpose: We aimed to determine whether diffusion-weighted magnetic resonance imaging, by means of the apparent diffusion coefficient (ADC), is able to guide magnetic resonance-guided biopsy in patients fit for active surveillance (AS) and identify patients harboring high-grade Gleason components not suitable for AS.

Materials And Methods: Our study was approved by the institutional review board of all participating hospitals, and all patients signed informed consent at inclusion. Fifty-four consecutive patients with low-risk prostate cancer (PCa) underwent multiparametric magnetic resonance imaging (MP-MRI) at inclusion for AS. Cancer-suspicious regions (CSRs) upon 3-T MP-MRI were identified in all patients, and magnetic resonance-guided biopsy was performed in all CSRs to obtain histopathological verification. For all CSRs, a median ADC (mADC) was calculated. Wilcoxon signed ranks and Mann-Whitney tests was performed to detect differences between the groups. We used the area under the receiver operating characteristic curve to evaluate the accuracy of mADC to predict the presence of PCa in a CSR. Level of statistical significance was set at P < 0.05.

Results: Mean mADC in the CSRs with PCa was 1.04 × 10⁻³ mm²/s (SD, 0.29), whereas the CSRs with no PCa displayed a mean mADC of 1.26 × 10⁻³ mm²/s (SD, 0.25; P < 0.001). Cancer-suspicious regions with a high-grade Gleason component displayed a mean mADC of 0.84 × 10⁻³ mm²/s (SD, 0.35) vs a mean mADC for the low-grade CSRs of 1.09 × 10⁻³ mm²/s (SD, 0.25; P < 0.05). A diagnostic accuracy of mADC for predicting the presence of PCa in a CSR with an area under the receiver operating characteristic curve of 0.73 was established (95% confidence interval, 0.61-0.84).

Conclusions: Median ADC is able to predict the presence and grade of PCa in CSRs identified by MP-MRI.
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http://dx.doi.org/10.1097/RLI.0b013e31827b711eDOI Listing
March 2013

[Ketamine-associated urological symptoms].

Ned Tijdschr Geneeskd 2012 ;156(10):A4176

Jeroen Bosch ziekenhuis, afd. Urologie,'s-Hertogenbosch, the Netherlands.

Ketamine is used as an anaesthetic and in third-line pain management. Furthermore, recreational use of the drug is becoming increasingly popular due to its dissociative and hallucinogenic effects. Ketamine can affect the urothelium, possibly with long-term damage to the bladder and kidneys. An otherwise healthy, 22-year-old female smoker was referred to our clinic. Shortly after starting recreational ketamine she experienced gross haematuria, urgency, frequency and dysuria. There had been no febrile episodes or flank pain. Her urine cultures were sterile. Physical examination, blood tests, urinary cytology and abdominal ultrasound results were normal. A severely inflamed bladder was seen during cystoscopy. Biopsies showed denuded urothelium and inflammation of the submucosa without malignancy. The precise mechanism of ketamine-associated urological symptoms is currently unknown. Treatment, therefore, is symptom-targeted and cessation of ketamine is imperative. We recommend that ketamine use is considered in patients with otherwise unexplained urological symptoms.
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April 2012

Prostate-sparing cystectomy: long-term oncological results.

BJU Int 2009 Nov 22;104(9):1239-43. Epub 2009 Jun 22.

Departments of Urology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amstedam, the Netherlands.

Objective: To analyse the oncological outcome of prostate-sparing cystectomy (PSC).

Patients And Methods: Between 1994 and 2006, 63 men were treated with PSC after meeting the inclusion criteria (no tumour at the bladder neck, no prostate cancer). The results were compared with patients who had a standard cystoprostatectomy (SC) during the same study period, after matching for clinical and pathological characteristics.

Results: The 3- and 5-year disease-specific survival rates were 77% and 66% in the PSC group, and 68% and 64% in the SC group (log-rank, P = 0.6). The local recurrence rate was 7.9% and 16% for the PSC and the SC groups, respectively, and the respective distant recurrence rate was 29% and 33%. Subsequent prostate cancer was detected in 3% in the PSC group. None of these patients died from prostate cancer. In the SC group the final pathology showed that 18% had prostate cancer.

Conclusion: Local recurrences were not diagnosed more often in the PSC than the SC group. The outcomes of both procedures are comparable with contemporary cystoprostatectomy series. We consider this procedure oncologically safe and offer this to selected patients. However, selection is the key to success, and our results should further be corroborated by the experience of others.
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http://dx.doi.org/10.1111/j.1464-410X.2009.08615.xDOI Listing
November 2009

External beam radiation therapy followed by interstitial radiotherapy with iridium-192 for solitary bladder tumours: results of 111 treated patients.

Eur Urol 2009 Jul 21;56(1):113-21. Epub 2008 Aug 21.

Department of Urology, University Medical Center Utrecht, The Netherlands.

Background: Evaluation of bladder-preserving treatment protocol.

Objective: To evaluate the long-term results of iridium-192 brachytherapy-based bladder-sparing treatment strategy in patients with solitary invasive bladder tumours.

Design, Setting, And Participants: We performed a retrospective analysis of 111 patients with solitary T1G3-T2Gall bladder tumours (< or = 5 cm), who were treated with iridium-afterloading brachytherapy between February 1988 and May 2007.

Intervention: After transurethral tumour resection, external beam radiotherapy (28 Gy; 12 fractions) was given, followed by brachytherapy (Iridium-192; 40 Gy). Partial cystectomy was part of the treatment strategy in nine patients. In five of those patients a T3 tumour was found, and they were included in the analysis.

Measurements: The 5-, 10- and 15-yr overall survival rate (OS); disease-specific survival rate (DSS); and disease-free survival rate (DFS) estimates were determined using the Kaplan-Meier method.

Results And Limitations: Mean follow-up period was 6.2 yr (range: 0.2-16.3 yr). At the last follow-up 75 patients were alive without evidence of disease, whereas 17 patients had died without evidence of disease. Nineteen patients died of bladder cancer after a mean follow-up period of 2.9 yr (range: 0.5-9.0). OS rates at 5 yr, 10 yr, and 15 yr were 70%, 55%, and 51%, respectively. DSS rates at 5 yr, 10 yr, and 15 yr were 82%, 73% and 73%, respectively. DFS rates at 5 yr, 10 yr, and 15 yr were 60%, 47%, and 23%, respectively. Higher tumour stage (T3 vs T1) was negatively associated with DSS (hazard ratio [HR]:19.8; p=0.01) and DFS (HR: 4.67; p=0.02). No prognostic factor was found for OS. Local recurrence occurred in 27% of patients and salvage cystectomy was performed in 9% of patients. Bladder function was able to be preserved in 99 of 111 patients (89%).

Conclusions: In patients with solitary stage T1-T2 bladder cancer (< or = 5 cm) who refuse radical cystectomy or who are poor candidates for major surgical procedures, this modality is a valuable treatment alternative.
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http://dx.doi.org/10.1016/j.eururo.2008.07.043DOI Listing
July 2009

Holmium laser lithotripsy for ureteral calculi: predictive factors for complications and success.

J Endourol 2008 Feb;22(2):257-60

Department of Urology, University Medical Center Utrecht, Utrecht, The Netherlands.

Purpose: To define possible predictive factors for success and complications for ureteroscopic holmium laser lithotripsy procedures.

Patients And Methods: All 105 ureteroscopic holmium laser lithotripsy procedures performed between 1996 and 2005 were analyzed. Data recorded were sex, age, stone size, stone location, complications, success rate (stone-free rate after 3 months), operative time, and surgeon experience for this procedure. For further analysis, surgeon experience was divided into four groups based on the number of procedures performed. Multivariate analysis was used to define possible predictive factors for complications and successful procedures.

Results: Total success rate was 84.8%. Complications were present in 13 patients (12.4%). Success rate was significantly (P = 0.03) related to surgeon experience, with 92.9% success in the most experienced group and 50% in the least experienced group. Furthermore, significantly more complications occurred with decreased experience (P = 0.03): complication rate was 4.2% in the highest experience group and 41.7% in the least experienced group. In our series, sex, stone location, size, and age did not significantly influence complication and success rates.

Conclusion: Surgeon experience is a predictive factor for complications and success for ureteroscopic holmium laser lithotripsy for ureteric calculi. Experienced surgeons have fewer complications, and the success rate is higher. Sex, stone location, size, and age were not significantly related to complication or success rates.
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http://dx.doi.org/10.1089/end.2007.0299DOI Listing
February 2008

Non-operative treatment for perforated gastro-duodenal peptic ulcer in Duchenne muscular dystrophy: a case report.

BMC Surg 2004 Jan 8;4. Epub 2004 Jan 8.

Department of Orthopaedics, VU medical centre, Amsterdam, The Netherlands.

Background: Clinical characteristics and complications of Duchenne muscular dystrophy caused by skeletal and cardiac muscle degeneration are well known. Gastro-intestinal involvement has also been recognised in these patients. However an acute perforated gastro-duodenal peptic ulcer has not been documented up to now.

Case Presentation: A 26-year-old male with Duchenne muscular dystrophy with a clinical and radiographic diagnosis of acute perforated gastro-duodenal peptic ulcer is treated non-operatively with naso-gastric suction and intravenous medication. Gastrointestinal involvement in Duchenne muscular dystrophy and therapeutic considerations in a high risk patient are discussed.

Conclusion: Non-surgical treatment for perforated gastro-duodenal peptic ulcer should be considered in high risk patients, as is the case in patients with Duchenne muscular dystrophy. Patients must be carefully observed and operated on if non-operative treatment is unsuccessful.
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http://dx.doi.org/10.1186/1471-2482-4-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC324410PMC
January 2004
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