Publications by authors named "Jacques Irani"

107 Publications

Efficacy and toxicity following salvage high-dose-rate brachytherapy for locally recurrent prostate cancer after radiotherapy.

Brachytherapy 2022 Jul-Aug;21(4):424-434. Epub 2022 Mar 21.

Radiotherapy Department, Gustave Roussy, Villejuif, France. Electronic address:

Introduction: The management of local relapse after prostate cancer radiotherapy is frequently based on androgen deprivation therapy. The aim of the study was to report Gustave Roussy's experience with salvage prostate brachytherapy.

Patients And Methods: All cases of localized prostate cancer presenting in an irradiated area who received salvage high dose rate (HDR) brachytherapy from 2013 to 2020 were retrospectively reviewed.

Results: A total of 64 patients were included. Median follow up was 30.5 months. Median initial EBRT dose was 70 Gy [Q1-Q3: 70 - 74]. Median PSA at brachytherapy was 6.8 ng/mL [Q1-Q3: 4.4 - 8.7] with a median interval between first and salvage irradiation of 10 years [Q1-Q3: 6.9 - 12.6]. The modality of the first irradiation was an exclusive EBRT in 73% of the cases, mostly with a 3D technique (82%). Dose prescription was two fractions of 12 Gy or 13 Gy associated with androgen deprivation therapy for 63% of the patients. About 23% of the patients were castrate-resistant. Disease free survival at 2 years was 58% in the whole population and 66% in hormone sensitive patients. The only factors associated with disease free survival on multivariate analysis was a high-risk disease at initial diagnosis (HR = 3.59, IC95 [1.75; 7.39], p = 0.0005). Grade 3 urinary and rectal toxicities occurred in 1.5% and 1.5% of the patients, respectively.

Conclusion: HDR salvage brachytherapy seems to be a safe option for patients presenting with an isolated local relapse of prostate cancer.
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http://dx.doi.org/10.1016/j.brachy.2022.01.005DOI Listing
July 2022

Efficacy of HIVEC in patients with high-risk non-muscle invasive bladder cancer who are contraindicated to BCG and in patients who fail BCG therapy.

Int J Hyperthermia 2021 ;38(1):1633-1638

Department of Surgical Oncology 2, Institut Paoli Calmettes Cancer Center, Marseille, France.

Purpose: To evaluate Hyperthermic-Intra-Vesical Chemotherapy (HIVEC) efficacy regarding 1-year disease-free survival (RFS) rate and bladder preservation rate in patients with High-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who fail BCG therapy or are contraindicated to BCG.

Methods: Between June 2016 and October 2019, patients treated with HIVEC for mostly high-risk NMIBC who failed BCG or BCG-naive if BCG contraindicated have been included in our study. These patients had a theoretical indication for cystectomy but were ineligible for surgery or refused it.

Results: Fifty-three patients, median age 72 [39-93] years, were included in this study ( = 29 BCG-failure and  = 24 BCG-naive). The median follow-up was 18 months. The bladder preservation rate was 92.4%. The 12 months-RFS rate was 60.5%. The RFS rates for BCG-naive and BCG-failure groups were respectively 70% and 52.2% at 12 months. Three patients progressed to muscle infiltration, all in the BCG-failure group and all in the very high-risk EORTC group. Two of them developed metastatic disease and died from bladder cancer.

Conclusion: Chemohyperthermia using HIVEC achieved a RFS rate of 60% at 1 year and enabled a bladder preservation rate of 92%. Given the low risk of progression in the BCG-naive group, HIVEC could be a good alternative. Conversely, for patients with very high-risk tumors that fail BCG, cystectomy should remain the standard of care and HIVEC may be discussed cautiously for patients who are not eligible for surgery and well informed of the risk of progression to muscle-invasive disease.
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http://dx.doi.org/10.1080/02656736.2021.2002435DOI Listing
December 2021

Adherence to Treatment Guidelines and Associated Survival in Older Patients with Prostate Cancer: A Prospective Multicentre Cohort Study.

Cancers (Basel) 2021 Sep 18;13(18). Epub 2021 Sep 18.

Univ Paris Est Creteil, INSERM, IMRB, F-94010 Creteil, France.

The guidelines on prostate cancer treatment in older men recommend evaluating the patient's underlying health status before treatment selection. We aimed to evaluate the frequency of a guideline-discordant treatment (GDT), identify factors associated with GDT, and assess the relationship between GDT and overall survival. We studied patients with prostate cancer aged 70 or older included in the ELCAPA cohort between 2010 and 2019. Multivariable logistic regression assessed GDT-associated factors. The restricted mean survival time (RMST) assessed the 24- and 36-month OS using stabilized inverse probability of treatment weighting of propensity scores. We included 356 patients (median age: 81 years), and 164 (46%) received a GDT (95% confidence interval (CI) = (41-51%)). Patients with metastases were less likely to receive a GDT (adjusted odds ratio (95% CI) = 0.34 (0.17-0.69); = 0.003). After weighting, the RMST at 24 months was shorter in the GDT group (13.9 months, vs. 17 months for compliant treatments; difference (95% CI): -3.1 months (-5.3, -1.0); = 0.004). RMST at 36 months was 18.5 months, vs. 21.8 months (difference: -3.3 months (-6.7, 0.0); = 0.053). GDT is common in older patients with prostate cancer and especially those with non-metastatic disease. GDT was associated with worse survival, independently of health status and tumour characteristics.
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http://dx.doi.org/10.3390/cancers13184694DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8468518PMC
September 2021

Pre-transplant morphometry by computed tomography scan and post-transplant dialysis risk in overweight or obese kidney transplant recipients.

Int Urol Nephrol 2021 Dec 18;53(12):2469-2475. Epub 2021 Sep 18.

Department of Urology and Transplantation Surgery, Hôpital de Bicêtre, AP-HP. Université Paris Saclay, 78 rue du général Leclerc, Le Kremlin-Bicêtre, 94270, Paris, France.

Purpose: Adipose distribution and sarcopenia could better assess kidney transplantation outcomes than body mass index (BMI) and have been poorly evaluated among obese and overweight recipients. We aimed to evaluate morphometric radiologic markers to predict post-operative dialysis within this population.

Methods: We conducted a retrospective study including patients with a BMI > 25 kg/m undergoing kidney transplantation during 5 years. Subcutaneous adipose tissue surface (SAT), visceral adipose tissue surface (VAT), and psoas surface were measured on CT scans sections. A model predictive of post-transplantation dialysis was elaborated through a multivariable logistic regression and was compared to a model including only BMI.

Results: Overall, 248 patients were included whom mean (SD) BMI and age were, respectively, 29.7 kg/m2 (3.6) and 56 years (12.7). Of them, 83 (33.5%) needed dialysis: 14 (5.7%) for primary kidney failure and 69 (27.8%) for delayed kidney function. On multivariable analysis, SAT, VAT and deceased donor were significantly associated with post-operative dialysis (respectively, OR [95%CI]:1.6 [1.1-2.6], 1.6[1.1-2.6], and 7.5 [1.6-56]). The area under the curve of this predictive model was 0.70 versus 0.64 for a BMI-based model.

Conclusion: High VAT and SAT were associated with post-transplantation dialysis. A predictive model based on these morphometrics could provide a better appreciation of graft recovery after transplantation among obese and overweight recipients. External validation is needed.
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http://dx.doi.org/10.1007/s11255-021-02995-4DOI Listing
December 2021

BCG-unresponsive high-grade non-muscle invasive bladder cancer: what does the practicing urologist need to know?

World J Urol 2021 Nov 27;39(11):4037-4046. Epub 2021 Mar 27.

University Hospital of Bicêtre-Paris Sud-Saclay University, Le Kremlin Bicêtre, Paris, France.

Purpose: Bacille Calmette-Guérin (BCG) is a well-established treatment for preventing or delaying tumour recurrence following high-grade nonmuscle invasive bladder cancer (NMIBC) resection. However, many patients will experience recurrence or progression during or following BCG. This scenario has been one of the most challenging in urologic oncology for several decades since BCG implementation. Finally, significant progress has occurred lately. The aim of this review was to summarize for the practising urologist the current treatment options available in 2020 or expected to be ready for routine use in the near future for patients with high-risk NMIBC who experience BCG failure.

Methods: Narrative review using data through the end of 2020.

Results: First, the definition of BCG unresponsive disease which is critical in counseling and managing patients has finally reached a consensus. Second, some promising options other than radical cystectomy are finally available and many other should be in a near future. The options can be categorized as chemotherapy, device-assisted therapy, check-point inhibitors, new intravesical and systemic agents and sequential combinations of these newer modalities with conventional therapy.

Conclusions: Considering the options that are currently under scrutiny, many of which in phase III trials, clinicians should have at their disposal several new treatment options in the next five years.
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http://dx.doi.org/10.1007/s00345-021-03666-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7997797PMC
November 2021

Prognostic Impact of pT3 Subclassification in a Multicentre Cohort of Patients with Urothelial Carcinoma of the Renal Pelvicalyceal System Undergoing Radical Nephroureterectomy: A Propensity Score-weighted Analysis After Central Pathology Review.

Eur Urol Focus 2021 Sep 24;7(5):1075-1083. Epub 2020 Oct 24.

Sorbonne University, GRC 5 Predictive ONCO-URO, AP-HP, Urology, Pitie-Salpetriere Hospital, F-75013 PARIS, France. Electronic address:

Background: The current pathological tumour-node-metastasis (pTNM) classification for upper tract urothelial carcinoma (UTUC) does not include any risk stratification of pT3 renal pelvicalyceal tumours.

Objective: To assess the prognostic impact of pT3 subclassification in a multicentre cohort of patients with UTUC of the renal pelvicalyceal system undergoing radical nephroureterectomy (RNU).

Design, Setting, And Participants: Data from all consecutive patients treated with RNU for pT3 renal pelvicalyceal UTUC at 14 French centres from 1995 to 2013 were reviewed retrospectively.

Intervention: A central pathology review (CPR) was used to stratify pT3 patients into those with infiltration of the renal parenchyma on a microscopic level (pT3a) versus those with infiltration of the renal parenchyma visible on gross inspection of the resection specimen and/or invasion of peripelvic fat (pT3b).

Outcome Measurements And Statistical Analysis: Inverse probability weighting (IPW)-adjusted Cox regression analyses were used to compare recurrence-free survival (RFS) and cancer-specific survival (CSS) between pT3a and pT3b patients.

Results And Limitations: Overall, 202 patients were included and further stratified into pT3a (n = 98; 48.5%) and pT3b (n = 104; 51.5%) subgroups. Median time to follow-up in the weighted population was 68 (interquartile range, 50-95) mo. In IPW-adjusted Cox regression analyses, pT3b versus pT3a substage was associated with a significant adverse effect on RFS (hazard ratio [HR] = 2.02; 95% confidence interval [CI] = [1.36-3.01]; p < 0.001) and CSS (HR = 1.84; 95% CI = [1.20-2.82]; p = 0.005). The study is limited by its retrospective design.

Conclusions: Using IPW-adjusted analyses after the CPR, we observed that RNU patients with pT3b renal pelvicalyceal UTUC had adverse prognosis as compared with those with pT3a disease. As such, this subclassification could help refine the current pTNM system for UTUC.

Patient Summary: In this report, we looked at the prognostic interest of stratifying patients with pT3 renal pelvicalyceal upper tract urothelial carcinoma based on the extent of local invasion. We found that those with extensive infiltration (pT3b) had adverse prognosis as compared with those with limited infiltration (pT3a). This information could be provided on pathology reports to further guide clinical decision making.
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http://dx.doi.org/10.1016/j.euf.2020.10.004DOI Listing
September 2021

Surgical complications risk in obese and overweight recipients for kidney transplantation: a predictive morphometric model based on sarcopenia and vessel-to-skin distance.

World J Urol 2021 Jun 12;39(6):2223-2230. Epub 2020 Aug 12.

Department of Urology, Hôpital de Bicêtre, AP-HP, Université Paris Saclay, Le Kremlin-Bicêtre, 94270, France.

Purpose: Sarcopenia or adipose tissue distribution within obese and overweight renal transplanted have been poorly evaluated. Our objective was to evaluate morphometric markers to predict surgical complications in kidney transplantation.

Methods: We retrospectively included patients with a BMI > 25 kg/m undergoing kidney transplantation from 2012 to 2017. Following measurements were performed on CT-scan sections: Sub-cutaneous Adipose Tissue surface (SAT), Visceral Adipose Tissue surface (VAT), Vessel-to-Skin distance (VSK), Abdominal Perimeter (AP), and Psoas surface. A multivariable logistic regression model with BMI was compared to a model containing morphometric variables to determine the best predictive model for surgical complications.

Results: 248 patients were included, 15 (6%) experienced transplant nephrectomy, 18 (7.3%) urinary leakage, and 29 (11.7%) subcapsular renal hematoma. Multivariable logistic regression evidenced that sarcopenia and VSK were risk factors of surgical complication within a year post-transplantation (respectively, OR = 0.9, 95%CI (0.8-0.9), p = 0.04 and OR = 1.2, 95%CI (1.1-1.3), p = 0.002). Area under the curve for a predictive model including VSK, age and psoas surface was 0.69, whereas BMI model was 0.65.

Conclusion: Combined morphometric parameters of obesity were associated with surgical complications in kidney transplantation. Morphometric threshold may provide a more accurate and objective criteria than BMI to evaluate kidney transplantation outcomes. External validation is needed.
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http://dx.doi.org/10.1007/s00345-020-03407-5DOI Listing
June 2021

Ultrasound Molecular Imaging of Renal Cell Carcinoma: VEGFR targeted therapy monitored with VEGFR1 and FSHR targeted microbubbles.

Sci Rep 2020 04 30;10(1):7308. Epub 2020 Apr 30.

IR4M, Univ. Paris-Sud, CNRS, Université Paris-Saclay, Orsay, France.

Recent treatment developments for metastatic renal cell carcinoma offer combinations of immunotherapies or immunotherapy associated with tyrosine kinase inhibitors (TKI). There is currently no argument to choose one solution or another. Easy-to-use markers to assess longitudinal responses to TKI are necessary to determine when to switch to immunotherapies. These new markers will enable an earlier adaptation of therapeutic strategy in order to prevent tumor development, unnecessary toxicity and financial costs. This study evaluates the potential of ultrasound molecular imaging to track the response to sunitinib in a clear cell renal carcinoma model (ccRCC). We used a patient-derived xenograft model for this imaging study. Mice harboring human ccRCC were randomized for sunitinib treatment vs. control. The tumors were imaged at days 0, 7, 14 and 28 with ultrasound molecular imaging. Signal enhancement was quantified and compared between the two groups after injections of non-targeted microbubbles and microbubbles targeting VEGFR1 and FSHR. The tumor growth of the sunitinib group was significantly slower. There was a significantly lower expression of both VEGFR-1 and FSHR molecular ultrasound imaging signals in the sunitinib group at all times of treatment (Days 7, 14 and 28). These results confirm the study hypothesis. There was no significant difference between the 2 groups for the non-targeted microbubble ultrasound signal. This study demonstrated for the first time the potential of VEGFR1 and FSHR, by ultrasound-based molecular imaging, to follow-up the longitudinal response to sunitinib in ccRCC. These results should trigger developments for clinical applications.
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http://dx.doi.org/10.1038/s41598-020-64433-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7193565PMC
April 2020

Temporary contraindication of obese recipients in kidney transplantation: A new morphometric tool for decision support.

Clin Transplant 2020 04 18;34(4):e13829. Epub 2020 Mar 18.

Department of Urology, Hôpital Bicêtre, AP-HP. Université Paris Saclay, Le Kremlin-Bicêtre, France.

Background: Morbid obesity, based on body mass index (BMI) and/or clinical examination, can be a temporary contraindication (TCI) of kidney transplantation. However, BMI alone does not evaluate the intra- or extra-peritoneal distribution of fatty tissue, and clinical examination alone is subjective. The objective was to evaluate the interest of morphometric criteria to ensure reproducible and consensual decision of TCI.

Methods: We retrospectively included patients with a BMI >30 transplanted or temporarily contraindicated because of their weight from 2012 to 2017. The following measurements were performed on CT scan sections using a semiautomatic Hounsfield density detection software: subcutaneous adipose tissue surface (SAT), visceral adipose tissue surface (VAT), vessel-to-skin distance (VSK), abdominal perimeter (AP), and psoas index. Performance of morphometric measures to predict TCI was assessed through ROC analysis.

Results: Ninety-seven patients were included: 76 kidney transplant recipients and 21 on the TCI list. The area under the curve (AUC, 95%CI) for the BMI model to predict TCI was 0.81 (0.72-0.90). A 5-variable model including BMI, VAT, VSK, AP, and age gave an AUC of 0.88 (0.78-0.98).

Conclusions: Morphometric obesity parameters are associated with TCI decision-making for kidney transplantation: When combined with BMI in a "morphometric tool," they were predictive of a TCI decision.
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http://dx.doi.org/10.1111/ctr.13829DOI Listing
April 2020

EAU-EANM-ESTRO-ESUR-SIOG Prostate Cancer Guideline Panel Consensus Statements for Deferred Treatment with Curative Intent for Localised Prostate Cancer from an International Collaborative Study (DETECTIVE Study).

Eur Urol 2019 Dec 3;76(6):790-813. Epub 2019 Oct 3.

Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands.

Background: There is uncertainty in deferred active treatment (DAT) programmes, regarding patient selection, follow-up and monitoring, reclassification, and which outcome measures should be prioritised.

Objective: To develop consensus statements for all domains of DAT.

Design, Setting, And Participants: A protocol-driven, three phase study was undertaken by the European Association of Urology (EAU)-European Association of Nuclear Medicine (EANM)-European Society for Radiotherapy and Oncology (ESTRO)-European Association of Urology Section of Urological Research (ESUR)-International Society of Geriatric Oncology (SIOG) Prostate Cancer Guideline Panel in conjunction with partner organisations, including the following: (1) a systematic review to describe heterogeneity across all domains; (2) a two-round Delphi survey involving a large, international panel of stakeholders, including healthcare practitioners (HCPs) and patients; and (3) a consensus group meeting attended by stakeholder group representatives. Robust methods regarding what constituted the consensus were strictly followed.

Results And Limitations: A total of 109 HCPs and 16 patients completed both survey rounds. Of 129 statements in the survey, consensus was achieved in 66 (51%); the rest of the statements were discussed and voted on in the consensus meeting by 32 HCPs and three patients, where consensus was achieved in additional 27 statements (43%). Overall, 93 statements (72%) achieved consensus in the project. Some uncertainties remained regarding clinically important thresholds for disease extent on biopsy in low-risk disease, and the role of multiparametric magnetic resonance imaging in determining disease stage and aggressiveness as a criterion for inclusion and exclusion.

Conclusions: Consensus statements and the findings are expected to guide and inform routine clinical practice and research, until higher levels of evidence emerge through prospective comparative studies and clinical trials.

Patient Summary: We undertook a project aimed at standardising the elements of practice in active surveillance programmes for early localised prostate cancer because currently there is great variation and uncertainty regarding how best to conduct them. The project involved large numbers of healthcare practitioners and patients using a survey and face-to-face meeting, in order to achieve agreement (ie, consensus) regarding best practice, which will provide guidance to clinicians and researchers.
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http://dx.doi.org/10.1016/j.eururo.2019.09.020DOI Listing
December 2019

Clinical interest of PD-L1 immuno-histochemistry expression as a predictive factor of Bacillus Calmette Guerin (BCG) efficacy in refractory high-risk non-muscle-invasive bladder cancer (NMIBC).

World J Urol 2020 Jun 5;38(6):1517-1524. Epub 2019 Sep 5.

Department of Urology, Charles Nicolle Rouen University Hospital, 1 rue de Germont, 76031, Rouen Cedex, France.

Objective: To assess PD-L1 expression in tumor (TC) and tumor infiltrating immune cells (IC) as a predictive factor of BCG therapy failure in high-risk NMIBC.

Materials And Methods: Patients treated with complete resection followed by bladder BCG instillation for high-risk NMIBC were included. Early recurrence (ER) was defined as tumor recurrence after BCG induction course. The association between ER and immuno-histochemistry PD-L1 (E1L3N clone) expression by tumors cells (TC) and tumor infiltrating immune cells (IC) was investigated using an exact Fisher test variant.

Results: A total of 186 patients were included, of whom 38 (20.4%) were ER, 35 (18.8%) were positive for TC PD-L1 expression and 60 (32.3%) were positive for IC PD-L1. ER was not significantly (p = 0.97) more frequent in the TC PD-L1 ≥ 1% group (n = 7, 20.0%) than in the TC PD-L1-negative group (n = 31, 20.5%). Patients with IC PD-L1 negative had ER in 15 (19.2%) cases and patients with IC PD-L1 ≥ 1% had ER in 23 (21.3%) cases. PD-L1-positive expression for IC (threshold > 1%) was correlated with immune infiltrate density (95.2% dense immune infiltrate vs 47.2% low immune infiltrate, p < 0.05), with increased expression of PD-L1 by IC after BCG therapy (p = 0.006).

Conclusion: No association was observed between immuno-histochemistry PD-L1 positivity and ER after BCG therapy. Nevertheless, the relationship between immune infiltrate and PD-L1 positivity confirmed the interest of assessing the immune infiltrate density to define tumor's profile.
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http://dx.doi.org/10.1007/s00345-019-02896-3DOI Listing
June 2020

Evaluation of pain and catheter-related bladder discomfort relative to balloon volumes of indwelling urinary catheters: A prospective study.

Investig Clin Urol 2019 Jan 6;60(1):35-39. Epub 2018 Dec 6.

Department of Urology, Bicêtre Hospital, Le Kremlin-Bicêtre, France.

Purpose: To evaluate patients' tolerance to indwelling urinary catheters (IUCs) before and after reducing their balloon volumes. IUCs are a source of discomfort or pain.

Materials And Methods: All consecutive patients hospitalized in our department with IUCs were included during the study period with some exclusion. Each patient was his/her own control before and two hours after reduction of the balloon volume (RBV) by half using two types of assessments, a visual analog scale for pain and a catheter-related bladder discomfort (CRBD) symptom questionnaire.

Results: Forty-nine patients were included in our study that completed the assessments. The mean scores for pain before and after RBVs were 2.80 and 2.02, respectively. The difference was significant (p<0.05). The mean grades of the CRBD before and after RBVs were 1.02 and 0.75, respectively. The difference was significant (p<0.05).

Conclusions: A 50% RBV has shown a significant amelioration in tolerating the catheter.
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http://dx.doi.org/10.4111/icu.2019.60.1.35DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318203PMC
January 2019

Mutational Profile of Aggressive, Localised Prostate Cancer from African Caribbean Men Versus European Ancestry Men.

Eur Urol 2019 01 21;75(1):11-15. Epub 2018 Sep 21.

CeRePP, Paris, France; Sorbonne Université, GRC n(∘)5, ONCOTYPE-URO, Paris, France; Assistance Publique Hôpitaux de Paris, Department of Urology, Academic Hospital Paris Est, Paris, France. Electronic address:

Causes of high mortality of prostate cancer in men of African ancestry living in the French West Indies are still debated, between suspicions of environmental factors and genetic susceptibility. We report an integrated genomic study of 25 tumour tissues from radical prostatectomy of aggressive (defined by International Society of Urological Pathology ≥3) prostate cancer patients (10 African Caribbean and 15 French Caucasian) using single nucleotide polymorphism arrays, whole-genome sequencing, and RNA sequencing. The results show that African Caribbean tumours are characterised by a more frequent deletion at 1q41-43 encompassing the DNA repair gene PARP1, and a higher proportion of intrachromosomal rearrangements including duplications associated with CDK12 truncating mutations. Transcriptome analyses show an overexpression of genes related to androgen receptor activity in African Caribbean tumours, and of PVT1, a long non-coding RNA located at 8q24 that confirms the strong involvement of this region in prostate tumours from men of African ancestry. Patient summary: Mortality of prostate cancer is higher in African Caribbean men than in French Caucasian men. Specificities of the former could be explained by genomic events linked with key genes such as DNA damage pathway genes PARP1, CDK12, and the oncogenic long non-coding RNA gene PVT1 at the 8q24 prostate cancer susceptibility locus.
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http://dx.doi.org/10.1016/j.eururo.2018.08.026DOI Listing
January 2019

Epidemiology, biology and treatment of sarcomatoid RCC: current state of the art.

World J Urol 2019 Jan 1;37(1):115-123. Epub 2018 Jun 1.

Institute of Urologic Oncology (IUO), David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.

Long recognized to confer an extremely poor prognosis, sarcomatoid dedifferentiation of renal cell carcinoma (sRCC) is a tumor phenotype that is finally beginning to be better understood on the molecular and genetic levels. With an overall incidence that ranges from 1 to 32% depending on associated RCC subtype, the survival of sarcomatoid RCC patients rarely exceeds 2 years. The main reasons for its poor outcome include its aggressive biology, its tendency to present at an advanced or metastatic stage at the time of diagnosis, its high rate of tumor recurrence after nephrectomy, and its limited response to systemic therapies. Molecular pathology studies suggest that sarcomatoid dedifferentiation originates from a focal epithelial-mesenchymal transition (EMT) arising in the carcinomatous component of the tumor. It is hoped that the growing understanding of the molecular biology of sRCC will soon make it possible to adapt treatments based on the identification of actionable tumor alterations. The deliberate inclusion of these patients in the multicenter clinical trials of immune, targeted and combination therapies is a necessary next step in pioneering future treatment strategies.
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http://dx.doi.org/10.1007/s00345-018-2355-yDOI Listing
January 2019

Observational Studies Requested by European Health Authorities: Governmental Interference or an Enhancement of Everyday Urological Practice? The Hexvix® Observational Patients Evaluation Study as an Example of What to Expect.

Urol Int 2017 9;99(3):358-366. Epub 2017 Aug 9.

Department of Urology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.

Objective: The Hexvix® Observational Patients Evaluation (HOPE) study was designed to determine the extent of distribution of the use of hexaminolevulinate in the diagnosis of non-muscle invasive bladder cancer (NMIBC) and assess patient and treatment characteristics associated with different endoscopic modalities and to address the French authorities' request for information on routine practices for NMIBC diagnosis and surveillance.

Patients And Methods: A prospective, observational study in 30 centres in France with fluorescence endoscopy equipment available. All candidates for endoscopy with transurethral resection who gave their consent were eligible. The primary endpoint was the proportion of patients with an NMIBC diagnosis performed with hexaminolevulinate.

Results: 506 patients were included: 252 (49.8%) diagnosed with hexaminolevulinate and 254 (50.2%) with white-light endoscopy alone. There were more patients with tumour recurrence, multiple lesions, lesions with a diameter <3 cm, stage Ta disease, and grade 1 lesions in the hexaminolevulinate group. The first quartile median recurrence-free survival time was 310 days in the hexaminolevulinate group and 144 days in the standard-endoscopy group (p = 0.0015).

Conclusion: Hexaminolevulinate was in frequent use in France with specific patient and disease characteristics associated with its use. HOPE illustrates the type of data that can be gained in post-authorisation studies to address requests from European health authorities.
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http://dx.doi.org/10.1159/000477973DOI Listing
June 2018

Oddities Sporadic Neurofibroma of the Urinary Bladder. A Case Report.

Urol Case Rep 2017 Sep 12;14:42-44. Epub 2017 Jul 12.

Department of Urology, Bicêtre Hospital, Le Kremlin Bicêtre, France.

Neurofibromas of the urinary bladder are an exceedingly rare entity and are considered mostly in conjunction with the disease of neurofibromatosis type 1. The fortuitous discovery of vesical plexiform neurofibromas without other stigmata of the disease is presented in a 57-year-old male patient. The course of his condition, modalities of investigation and a non-precedent treatment plan are demonstrated.
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http://dx.doi.org/10.1016/j.eucr.2017.06.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5510488PMC
September 2017

[The pathologist, urologist's air traffic controller].

Authors:
Jacques Irani

Ann Pathol 2017 Jun;37(3):221-222

Service d'urologie, hôpital Bicêtre, 78, rue du Général-Leclerc, 94270 Le Kremlin-Bicêtre, France. Electronic address:

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http://dx.doi.org/10.1016/j.annpat.2017.05.001DOI Listing
June 2017

Angiosarcoma of the Bladder: Review of the Literature and Discussion About a Clinical Case.

Urol Case Rep 2017 Jul 27;13:97-100. Epub 2017 Apr 27.

Department of Urology, Andrology and Renal Transplantation, CHU Bicêtre, Le Kremlin-Bicêtre, France.

Our reported case is a 72 year-old man who presented with hematuria. A transurethral resection of the bladder tumor (TURB-T) has been performed. Histopathological diagnosis was an epithelioid angiosarcoma. CT scan revealed a bladder thickening. The treatment consisted in a complete pelvectomy with urinary and digestive diversion. Following the operation, the patient developed liver and pulmonary metastasis. He died 5 months after the initial diagnosis.
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http://dx.doi.org/10.1016/j.eucr.2016.12.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5412009PMC
July 2017

Final results of the phase III URO-BCG 4 multicenter study: efficacy and tolerance of one-third dose BCG maintenance in nonmuscle invasive bladder cancer.

Anticancer Drugs 2017 03;28(3):335-340

aUrology Department, Charles Nicolle University Hospital bInserm 1404, Onco-Urology Group, Clinical Investigation Center, Rouen cUrology Department, Nantes University Hospital, Nantes dUrology Department, Amiens University Hospital, Amiens eUrology Department, Lyon University Hospital, Lyon fUrology Department, Kremlin Bicêtre University Hospital, Paris gUrology Department, Toulouse University Hospital, Toulouse, France.

The objective of this study was to assess at 3 years bacillus Calmette-Guerin (BCG) maintenance treatment for NMIBC using one-third dose schedule and fewer instillations every 3 or 6 months. This was a phase III randomized study including patients with intermediate-risk or high-risk NMIBC, who received, after a full-dose induction schedule, three-weekly instillations of one-third dose BCG every 6 months (group I) and two-weekly instillations every 3 months (group II) during 3 years. We assessed oncological efficacy, BCG side effects, leukocyturia, and prostate-specific antigen. No tumor recurrence was reported at 36 months for 55 (82.09%) patients in group I versus 64 (90.14%) patients in group II (P=0.241). Muscle invasion was observed in six patients at 36 months (P=0.942). In terms of BCG toxicity, grade II and III local or systemic side effects were, respectively, reported in 8.7 and 23.9% of patients during the first year. Nevertheless, the adverse events (AEs) score at 36 months underlined a lower median value of 0.8 in group I versus 1.1 in group II (P=0.037). Furthermore, 9.9% major AEs occurred in group II versus 3% in group I (P=0.031). Leukocyturia and prostate-specific antigen level were not associated significantly with either tumor recurrence or muscle progression. We observed a significant difference in the AEs score at 36 months, suggesting less toxicity in patients who were treated with one-third dose of BCG for 3 consecutive weeks every 6 months.
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http://dx.doi.org/10.1097/CAD.0000000000000456DOI Listing
March 2017

Chemotherapy in hormone-sensitive metastatic prostate cancer: Evidences and uncertainties from the literature.

Cancer Treat Rev 2017 Apr 10;55:211-217. Epub 2016 Sep 10.

Department of Urology, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014 Paris, France.

Data from the literature support with strong evidence the addition of docetaxel to androgen-deprivation therapy (ADT) for men with metastatic prostate cancer, and starting therapy for the first time. A meta-analysis of three randomized controlled trials showed a significant improvement of overall survival when ADT was combined with docetaxel when compared to ADT alone (HR=0.77; 95% CI: 0.68-0.87; p<0.0001). Consequently, combination therapy should be considered presently as the new standard of care, using 6 cycles of docetaxel, without prednisone. However, candidates for this upfront combination therapy in whom the balance between its side effects and benefits is favorable are still to be identified more precisely. Patients' stratification according to Gleason score, previous local treatment and age or performance status were shown to have a prognostic impact. The volume of metastases, as defined in the CHAARTED study for instance, could be an interesting predictive factor. However, data accumulated until now remain only hypothesis generating and further analysis and studies are needed to establish any potential discriminating factors. Several new efficient therapeutic options are now available in prostate cancer management and should be evaluated against a chemo-hormonal combination therapy. Other trials are warranted to establish the role of docetaxel in earlier stages of the disease, the combination with the new hormonal therapies as well as the best management options after docetaxel.
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http://dx.doi.org/10.1016/j.ctrv.2016.09.008DOI Listing
April 2017

The efficacy of BCG TICE and BCG Connaught in a cohort of 2,099 patients with T1G3 non-muscle-invasive bladder cancer.

Urol Oncol 2016 11 14;34(11):484.e19-484.e25. Epub 2016 Sep 14.

Formerly Department of Biostatistics, EORTC Headquarters, Brussels, Belgium.

Background: Potential differences in efficacy of different bacillus Calmette-Guérin (BCG) strains are of importance for daily practice, especially in the era of BCG shortage.

Objective: To retrospectively compare the outcome with BCG Connaught and BCG TICE in a large study cohort of pT1 high-grade non-muscle-invasive bladder cancer patients.

Design, Setting, And Participants: Individual patient data were collected for 2,451 patients with primary T1G3 tumors from 23 centers who were treated with BCG for the first time between 1990 and 2011.

Outcome Measurements And Statistical Analysis: Using Cox multivariable regression and adjusting for the most important prognostic factors in this nonrandomized comparison, BCG Connaught and TICE were compared for time to recurrence, progression, and the duration of cancer specific survival and overall survival.

Results And Limitations: Information on the BCG strain was available for 2,099 patients: 957 on Connaught and 1,142 on TICE. Overall, 765 (36%) patients received some form of maintenance BCG, 560 (59%) on Connaught and 205 (18%) on TICE. Without maintenance, Connaught was more effective than TICE only for the time to first recurrence (hazard ratio [HR] = 1.48; 95% CI: 1.20-1.82; P<0.001). With maintenance, TICE was more effective than Connaught for the time to first recurrence (HR = 0.66; 95% CI: 0.47-0.93; P = 0.019) with a trend for cancer specific survival (HR = 0.36; 95% CI: 0.14-0.92; P = 0.033). For time to progression and overall survival, Connaught and TICE had a similar efficacy. Compared to no maintenance therapy, maintenance BCG significantly reduced the risk of recurrence, progression and death, both overall, and disease specific, for TICE, but not for Connaught.

Conclusions: We found that BCG Connaught results in a lower recurrence rate as compared with BCG TICE when no maintenance is used. However, the opposite is true when maintenance is given.

Patient Summary: As there is currently a BCG shortage, information on the efficacy of different BCG strains is important. In this nonrandomized retrospective comparison in over 2,000 patients, we found that BCG Connaught reduces the recurrence rate compared to BCG TICE when no maintenance is used, but the opposite is true when maintenance is given.
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http://dx.doi.org/10.1016/j.urolonc.2016.05.033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5515280PMC
November 2016

DNA-PKcs Expression Is a Predictor of Biochemical Recurrence After Permanent Iodine 125 Interstitial Brachytherapy for Prostate Cancer.

Int J Radiat Oncol Biol Phys 2016 07 11;95(3):965-972. Epub 2016 Feb 11.

Department of Pathology, INSERM UMR1069, CHU/Université de Tours, Tours, France. Electronic address:

Purpose: Predictive factors for biochemical recurrence (BCR) in localized prostate cancer (PCa) after brachytherapy are insufficient to date. Cellular radiosensitivity depends on DNA double-strand breaks, mainly repaired by the nonhomologous end-joining (NHEJ) system. We analyzed whether the expression of NHEJ proteins can predict BCR in patients treated by brachytherapy for localized PCa.

Methods And Materials: From 983 PCa cases treated by brachytherapy between March 2000 and March 2012, 167 patients with available biopsy material suitable for in situ analysis were included in the study. The median follow-up time was 47 months. Twenty-nine patients experienced BCR. All slides were reviewed to reassess the Gleason score. Expression of the key NHEJ proteins DNA-PKcs, Ku70, and Ku80, and the proliferation marker Ki67, was studied by immunohistochemistry performed on tissue microarrays.

Results: The Gleason scores after review (P=.06) tended to be associated with BCR when compared with the score initially reported (P=.74). Both the clinical stage (P=.02) and the pretreatment prostate-specific antigen level (P=.01) were associated with biochemical failure. Whereas the expression of Ku80 and Ki67 were not predictive of relapse, positive DNA-PKcs nuclear staining (P=.003) and higher Ku70 expression (P=.05) were associated with BCR. On multivariate analysis, among pretreatment variables, only DNA-PKcs (P=.03) and clinical stage (P=.02) remained predictive of recurrence. None of the patients without palpable PCa and negative DNA-PKcs expression experienced biochemical failure, compared with 32% of men with palpable and positive DNA-PKcs staining that recurred.

Conclusions: Our results suggest that DNA-PKcs could be a predictive marker of BCR after brachytherapy, and this might be a useful tool for optimizing the choice of treatment in low-risk PCa patients.
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http://dx.doi.org/10.1016/j.ijrobp.2016.02.015DOI Listing
July 2016

[Metastatic lymph node collision of a prostatic adenocarcinoma and an urothelial carcinoma and review of the literature].

Ann Pathol 2015 Dec 17;35(6):496-501. Epub 2015 Nov 17.

Service d'anatomie et de cytologie pathologiques, CHU de Poitiers, 2, rue de la Milétrie, 86021 Poitiers cedex, France.

Introduction: Tumor collision is the encounter of two tumors from two different topographical sites. Cases of metastatic lymph node collision are exceptional. We report the case of a metastatic lymph node collision of an urothelial carcinoma and a prostatic adenocarcinoma.

Observation: A 61-year-old man was hospitalized for a right nephroureterectomy with peri-ureteral lymph node dissection. He was followed since 2004 for prostatic adenocarcinoma and treated with radical prostatectomy then radiation therapy 4 years later due to a new increase of PSA. In the follow-up, an urothelial carcinoma of the lower right ureter was discovered in 2014. Histological analysis of a peri-ureteral lymph node showed a double metastasis of urothelial and prostatic origin. The prostatic adenocarcinoma was composed of acinar and ductal subtypes. Immunohistochemical study including CK7, CK20, PSA, GATA3, P63 antibodies confirmed the distinct phenotype of the 2 tumors.

Discussion: Metastatic collision of urothelial carcinoma and prostatic adenocarcinoma has been reported in 4 cases only. Our review of literature shows that prostatic adenocarcinoma always precedes the urothelial carcinoma. Immunohistochemical study, when carried out for distinguishing both tumors, should include CK7, CK20 and PSA. GATA3, androgen receptor and P63 could be added in a second time.
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http://dx.doi.org/10.1016/j.annpat.2015.09.005DOI Listing
December 2015

The impact of re-transurethral resection on clinical outcomes in a large multicentre cohort of patients with T1 high-grade/Grade 3 bladder cancer treated with bacille Calmette-Guérin.

BJU Int 2016 Jul 6;118(1):44-52. Epub 2015 Nov 6.

Department of Urology, Fundacio Puigvert, University of Barcelona, Barcelona, Spain.

Objectives: To determine if a re-transurethral resection (TUR), in the presence or absence of muscle at the first TUR in patients with T1-high grade (HG)/Grade 3 (G3) bladder cancer, makes a difference in recurrence, progression, cancer specific (CSS) and overall survival (OS).

Patients And Methods: In a large retrospective multicentre cohort of 2451 patients with T1-HG/G3 initially treated with bacille Calmette-Guérin, 935 (38%) had a re-TUR. According to the presence or absence of muscle in the specimen of the primary TUR, patients were divided in four groups: group 1 (no muscle, no re-TUR), group 2 (no muscle, re-TUR), group 3 (muscle, no re-TUR) and group 4 (muscle, re-TUR). Clinical outcomes were compared across the four groups.

Results: Re-TUR had a positive impact on recurrence, progression, CSS and OS only if muscle was not present in the primary TUR specimen. Adjusting for the most important prognostic factors, re-TUR in the absence of muscle had a borderline significant effect on time to recurrence [hazard ratio (HR) 0.67, P = 0.08], progression (HR 0.46, P = 0.06), CSS (HR 0.31, P = 0.07) and OS (HR 0.48, P = 0.05). Re-TUR in the presence of muscle in the primary TUR specimen did not improve the outcome for any of the endpoints.

Conclusions: Our retrospective analysis suggests that re-TUR may not be necessary in patients with T1-HG/G3, if muscle is present in the specimen of the primary TUR.
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http://dx.doi.org/10.1111/bju.13354DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5502757PMC
July 2016

[Non-muscle invasive bladder cancer].

Authors:
Jacques Irani

Rev Prat 2014 Dec;64(10):1382-5

Non-muscle invasive bladder cancers (NMIBC) represent a heterogeneous group as regards their biology and their seriousness. NMIBC management should be adapted to the acknowledged prognostic factors. First line treatment of NMIBC includes a transurethral resection of the bladder (TURB). Recurrence and progression risks following TURB are significantly high. Acknowledged factors are T stage, grade, number and size of tumors, recurrence modalities and associated carcinoma in situ. The benefit of adjuvant therapy using chemotherapy or BCG intravesical instillations has been demonstrated particularly on recurrence risk. Progression is very likely reduced by maintenance BCG. However, when high grade tumours do not respond to BCG, radical cystectomy is the mainstay treatment.
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December 2014

Efficacy and tolerance of one-third full dose bacillus Calmette-Guérin maintenance therapy every 3 months or 6 months: two-year results of URO-BCG-4 multicenter study.

Int J Urol 2015 Jan 25;22(1):53-60. Epub 2014 Sep 25.

Urology Department, Charles Nicolle University Hospital, Rouen, France; Clinical Investigation Center, Inserm 6204, Onco-Urology Group, Rouen, France.

Objectives: To assess bacillus Calmette-Guérin maintenance treatment schedule for non-muscle invasive bladder cancer at 2 years, using one-third of the full dose and fewer instillations every 3 months or 6 months.

Methods: This was a prospective, randomized, multicenter study. All patients had an intermediate- or high-risk non-muscle invasive bladder cancer. They received three weekly instillations of one-third dose bacillus Calmette-Guérin every 6 months (group I) and two weekly instillations every 3 months (group II) during 3 years. In the two schedules we assessed efficacy, tolerance, leukocyturia and prostate-specific antigen.

Results: No significant difference was observed between the two groups for recurrence at 6, 12 or 18 months. At 2 years, tumor recurrence was observed in 10.9% and muscle invasion in 2.9% of cases. Bacillus Calmette-Guérin tolerance was comparable - the adverse events score was 0.8 in group I and 1 in group II (P = 0.242). No statistical correlation was observed between the adverse events score over 2 years, either for leukocyturia (P = 0.8891) or prostate-specific antigen level (P = 0.7155). Leukocyturia level was not significantly associated with tumor recurrence or progression.

Conclusion: One-third dose maintenance bacillus Calmette-Guérin is effective with no impact on tumor recurrence or muscle invasion. Furthermore, there seems to be no difference in tumor response or side-effects between patients receiving two or three maintenance instillations every 3 months or 6 months. In clinical practice, the use of leukocyturia or total prostate-specific antigen levels do not appear to be useful in predicting bacillus Calmette-Guérin toxicity.
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http://dx.doi.org/10.1111/iju.12609DOI Listing
January 2015

ERG expression in prostate cancer: the prognostic paradox.

Prostate 2014 Nov 29;74(15):1481-7. Epub 2014 Aug 29.

Department of Pathology, CHU-Universite de Poitiers, Poitiers, France.

Background: TMPRSS2/ERG fusion resulting in ERG overexpression occurs in 30 to 50% of prostate cancer (PCa) in Caucasian patients, but its prognostic relevance remains controversial. In the present study, we investigated ERG expression in all stages of PCa progression, and evaluated the prognostic impact of ERG status in clinically localized PCa (CLC) and in castration resistant disease (CRPC).

Methods: ERG and AR expressions were evaluated by immunohistochemistry on tissue microarrays containing samples of high grade PIN (n = 57), CLC surgically treated (n = 299, including 185 Caucasians and 114 African-Caribbeans), metastases (n = 17), and CRPC (n = 41).

Results: In Caucasians, ERG expression significantly increased from high grade PIN (17.5%) to pT2 (27%) and pT3 CLC (43%), then to metastases (53%). In CLC, stainings for ERG and AR were correlated, and ERG expression was less frequent in African-Caribbeans compared to Caucasians (11.5% vs. 33%). In Caucasians CLC, ERG was associated with longer recurrence free survival, after adjusting for classical prognostic markers. In CRPC, ERG was expressed in 29% of cases, and was associated with a longer overall survival.

Conclusions: Our results confirm that ERG expression is less frequent in PCa from patients of African descent. Although ERG expression increases during PCa natural history, positive ERG status is associated with better outcome in both CLC and CRPC. This paradox could be explained in part by the fact that ERG expression is AR dependant, then ERG positive cancers are likely to progress in a rich androgen environment, with a better response to androgen suppression.
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http://dx.doi.org/10.1002/pros.22863DOI Listing
November 2014

Prognostic factors and risk groups in T1G3 non-muscle-invasive bladder cancer patients initially treated with Bacillus Calmette-Guérin: results of a retrospective multicenter study of 2451 patients.

Eur Urol 2015 Jan 16;67(1):74-82. Epub 2014 Jul 16.

Department of Urology, General Teaching Hospital and 1st Faculty of Medicine, Charles University in Praha, Praha, Czech Republic.

Background: The impact of prognostic factors in T1G3 non-muscle-invasive bladder cancer (BCa) patients is critical for proper treatment decision making.

Objective: To assess prognostic factors in patients who received bacillus Calmette-Guérin (BCG) as initial intravesical treatment of T1G3 tumors and to identify a subgroup of high-risk patients who should be considered for more aggressive treatment.

Design, Setting, And Participants: Individual patient data were collected for 2451 T1G3 patients from 23 centers who received BCG between 1990 and 2011.

Outcome Measurements And Statistical Analysis: Using Cox multivariable regression, the prognostic importance of several clinical variables was assessed for time to recurrence, progression, BCa-specific survival, and overall survival (OS).

Results And Limitations: With a median follow-up of 5.2 yr, 465 patients (19%) progressed, 509 (21%) underwent cystectomy, and 221 (9%) died because of BCa. In multivariable analyses, the most important prognostic factors for progression were age, tumor size, and concomitant carcinoma in situ (CIS); the most important prognostic factors for BCa-specific survival and OS were age and tumor size. Patients were divided into four risk groups for progression according to the number of adverse factors among age ≥ 70 yr, size ≥ 3 cm, and presence of CIS. Progression rates at 10 yr ranged from 17% to 52%. BCa-specific death rates at 10 yr were 32% in patients ≥ 70 yr with tumor size ≥ 3 cm and 13% otherwise.

Conclusions: T1G3 patients ≥ 70 yr with tumors ≥ 3 cm and concomitant CIS should be treated more aggressively because of the high risk of progression.

Patient Summary: Although the majority of T1G3 patients can be safely treated with intravesical bacillus Calmette-Guérin, there is a subgroup of T1G3 patients with age ≥ 70 yr, tumor size ≥ 3 cm, and concomitant CIS who have a high risk of progression and thus require aggressive treatment.
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http://dx.doi.org/10.1016/j.eururo.2014.06.040DOI Listing
January 2015
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