Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project†.

BACKGROUND: In clinical trials, the use of intermediate time-to-event end points (TEEs) is increasingly common, yet their choice and definitions are not standardized. This limits the usefulness for comparing treatment effects between studies. The aim of the DATECAN Kidney project is to clarify and recommend definitions of TEE in renal cell cancer (RCC) through a formal consensus method for end point definitions. MATERIALS AND METHODS: A formal modified Delphi method was used for establishing consensus. From a 2006-2009 literature review, the Steering Committee (SC) selected 9 TEE and 15 events in the nonmetastatic (NM) and metastatic/advanced (MA) RCC disease settings. Events were scored on the range of 1 (totally disagree to include) to 9 (totally agree to include) in the definition of each end point. Rating Committee (RC) experts were contacted for the scoring rounds. From these results, final recommendations were established for selecting pertinent end points and the associated events. RESULTS: Thirty-four experts scored 121 events for 9 end points. Consensus was reached for 31%, 43% and 85% events during the first, second and third rounds, respectively. The expert recommend the use of three and two endpoints in NM and MA setting, respectively. In the NM setting: disease-free survival (contralateral RCC, appearance of metastases, local or regional recurrence, death from RCC or protocol treatment), metastasis-free survival (appearance of metastases, regional recurrence, death from RCC); and local-regional-free survival (local or regional recurrence, death from RCC). In the MA setting: kidney cancer-specific survival (death from RCC or protocol treatment) and progression-free survival (death from RCC, local, regional, or metastatic progression). CONCLUSIONS: The consensus method revealed that intermediate end points have not been well defined, because all of the selected end points had at least one event definition for which no consensus was obtained. These clarified definitions of TEE should become standard practice in all RCC clinical trials, thus facilitating reporting and increasing precision in between trial comparisons.

[Laparoscopic cystectomy and ileal conduit urinary diversion for neurogenic bladders and related conditions. Morbidity and better quality of life]. / Cystectomie cœlioscopique et urétérostomie transiléale pour vessies neurologiques et assimilées. Morbidité et amélioration de la qualité de vie des patients.

OBJECTIVES: To assess morbidity and functional consequences of laparoscopic cystectomy with ileal conduit urinary diversion: in neurologic patients. MATERIALS: We reviewed the records of forty-two patients (ten men and thirty-two women) who underwent surgery between August 2007 and October 2013. The median age of the patient was 54 years old (range between 21-79 years). A laparoscopic cystectomy was performed followed by a short laparotomy to perform the ileal conduit urinary diversion. Records were reviewed to retrieve the indications and describe the postoperative and functional course. Patients and GPs were interviewed during phone calls to appreciate the quality of life by the PGII scale in order to assess the functional outcome. RESULTS: The operation was performed on 42 patients, of whom 18 had multiple sclerosis, nine a post-traumatic neurogenic bladder. Among the total population, 10 patients (23.81%) required a transfusion of at least one packed red blood cells (1-7). The overall rate of early complications was 35.71%. Belated complications were seen in 52.38% of the population. The median duration of hospital stay was 16 days (range between 9-70 days). The median follow up was 34 months (range between 1-76 months). For patients, the PGII scale rating had a median value of 6 (2-7). All referring physicians described a better functional status. CONCLUSION: The laparoscopic cystectomy can make postoperative course smoother for the neurological patients. However, the surgeon must weigh individually the benefit of performing the operation.

[Surveillance of stage I testicular seminoma: 20 years oncological results]. / Surveillance des séminomes testiculaires de stade I: résultats oncologiques sur 20ans.

INTRODUCTION AND OBJECTIVE: The objective of this study was to assess the oncological results of a population of patients which undergo surveillance after diagnosis of stage I testicular seminoma (2, 5 and 8 years overall, specific and recurrence free survival). We also research recurrence risk factors. PATIENTS AND METHODS: We have looked at the data of all patients treated in our center since 1993 for a grade I testicular seminoma. We focused on age at diagnosis, biological (tumoral markers) and pathological (tumor size, rete testis, lymphovascular, tunica albuginea or spermatic cord invasion) data. During surveillance, we noted the number, the localization and the interval until recurrence and death. We calculated 2, 5 and 8 years overall, specific and recurrence-free survival and searched recurrence risk factors. RESULTS: Sixty-nine patients (mean age: 37) were followed during a mean time of 97 months. Sixty-three per cent of the tumours were less than 4 cm (50 lesions). Lymphovascular, rete testis, spermatic cord and tunica albuginea invasion were present in respectively 21%, 33%, 4% and 29% of the cases. LDH and HCG were above normal rate in respectively 44 and 27% of the cases. Eighteen patients (23%) relapsed at a mean time of 12 months. Recurrence-free survival was respectively 81%, 77% and 77% at 2, 5 and 8 years. Tumor size<4 cm (P = 0.002), rete testis invasion (P = 0.03) and stage ≥ pT2 (P = 0.012) were associated with recurrence in univariate analysis. Using multivariate analysis, only tumor size >4 cm was a recurrence risk factor (risk multiplied by 3). At the end of the study, 77 patients are alive (97.5%). Overall and specific survival was 97.5% at 2, 5 and 8 years. CONCLUSION: We show here the interest of surveillance in case of stage 1 testicular seminoma. The overall and specific survivals are the same as after chemotherapy or radiotherapy. Furthermore, we confirm the role of tumor size to stratify recurrence risk.

[Salvage radical prostatectomy for brachytherapy failure: preliminary results]. / Prostatectomie radicale de sauvetage après échec de curiethérapie: étude préliminaire.

OBJECTIVES: Analysis of preliminary results in six patients operated by second-line (salvage) radical prostatectomy for local recurrence after low-dose brachytherapy. PATIENTS AND METHODS: Since January 2009, six patients had an open salvage radical prostatectomy with a lymph node dissection and without neurovascular bundles preservation for a low-dose I125 brachytherapy failure. Local recurrence was confirmed by trans-rectal biopsy or TURP. All the patients had PSA increase or lower urinary tract symptoms. Bone scan and pelvis MRI were performed to detect a locally advanced disease, a lymph node involvement or the presence of bone metastasis. Pathology reports and PSA level at 1, 3, 6 and 12 months were analyzed. RESULTS: Salvage radical prostatectomy with lymph node dissection was performed in all patients without major complications. The PSA level was below 0.1 ng/mL in five out of six patients at 1 and 3 months. The only case of persistent PSA is treated by androgen deprivation in a pT3b N1 patient. CONCLUSION: Salvage radical prostatectomy after brachytherapy failure was feasible with a limited perioperative morbidity. This second-line curative treatment in a selected group of patients should be kept in mind. Our early results looked promising.

[Postoperative male stress urinary incontinence: outcomes of treatment by I-STOP TOMS® transobturator sling]. / Incontinence urinaire d'effort postopératoire chez l'homme: résultats du traitement par bandelette transobturatrice I-STOP TOMS®.

OBJECTIVE: To evaluate the outcome of postoperative male stress urinary incontinence surgery using the I-STOP TOMS(®) sub-urethral sling. MATERIAL AND METHOD: Between April 2007 and August 2012, 29 patients had been treated by sub-urethral sling. Stress urinary incontinence was classified as mild, moderate or severe according to the number of pads per day. Patients were also assessed thanks to IQOL, MHU and Ditrovie self-administered questionnaires. RESULTS: Before surgery, 16 patients (55.2%) had mild incontinence, 12 (41.4%) had moderate incontinence and one (3.4%) had severe incontinence. Preoperative median MHU was 9 (5-12); median IQOL was 73 (58-88); and median Ditrovie was 2.7 (2.1-3.3). Three months after surgery, median MHU was 7 (4-9); median IQOL was 85 (75-99); and median Ditrovie was 2.1 (1.6-2.4). Pre- and postoperative questionnaires scores show a significant improvement for IQOL (P=0.014) and Ditrovie (P<0.001). After 3 months, six patients were dry (20.7%), 19 patients had mild incontinence (65.5%) and four had moderate incontinence (13.8%); in résumé 17 patients (58.6%) showed a significant improvement in the number of pads (20.7% dry, 37.9% improved). After a mean follow-up of 24 ± 19.9 months, five patients were dry (17.2%), 20 patients (69%) had mild incontinence and four had moderate incontinence (13.8%). CONCLUSION: I-STOP TOMS(®) sub-urethral sling improved the level of postoperative stress urinary incontinence. However, the continence rate was weak.

[Laparoscopic approach for artificial urinary sphincter implantation in women with severe urinary stress incontinence]. / Implantation de sphincter artificiel urinaire par voie laparoscopique chez des femmes avec incontinence urinaire d'effort sévère.

INTRODUCTION: To evaluate, feasibility, efficacy and morbidity of laparoscopic artificial urinary sphincter (AUS) implantation in women with severe stress urinary incontinence. PATIENTS AND METHODS: Twenty-six women with severe stress urinary incontinence were treated between October 2007 and January 2012 by laparoscopic implantation of an AUS AMS 800 (American medical Systems, Inc., Minnetonka, Minnesota). For 18 patients AUS was primary implanted and, for eight, AUS was revised for a mechanical failure. Three patients had a concomitant laparoscopic vaginal prolapse repair. Mean value was for age 64 years, BMI 27.8kg/m2, and mean maximal urethral closure pressure was 26.75cm of water. Most of the patients (88%) had a history of pelvic or incontinence surgery. The study was a retrospective analysis of operative parameters, complications and functional results. RESULTS: Three conversions in open surgery and five bladder injuries were described. Mean operative time was 149 minutes. Bladder catheter was removed at a mean of day 3.8. Mean post-operative stay was 5 days. Early postoperative complications consist in eight acute transient urinary retentions, two pump migrations, and one vaginal injury. Late post-operative complications consist in one vaginal erosion. Explantation of AUS was performed for these last two patients. Mean follow-up was 20 months. Sixteen patients are totally continent, five have a social continence (1 pad/day) and three need more than one pad/day. ANALYSIS: Our results compare favorably to literature either for laparoscopic or conventional approach with a limited learning curve. CONCLUSION: Laparoscopic implantation of AUS in women with severe stress urinary incontinence was feasible and efficient.

[Vaginal prolapse. What dynamic pelvic MRI adds to clinical examination?]. / Prolapsus vaginal. Comment l'IRM pelvienne dynamique vient-elle compléter l'examen clinique ?

OBJECTIVE: We wanted to study the role of dynamic pelvic MRI (D-MRI) in the surgical management of patients with genito-urinary prolapse. PATIENTS: A routine D-MRI examination before and after laparoscopic double promontofixation was performed in 15 cases with symptomatic vaginal prolapse in need of surgical treatment. The review included also three self-administered questionnaires of symptoms and quality of life. We compared the preoperative clinical evaluation of the studied cases with D-MRI data. Changes after the surgical treatment were also studied. RESULTS: The D-MRI provides an accurate diagnostic evaluation of the pelvis, which is both objective and reproducible. The correlation between clinical scores and radiological magnetic resonance was 53.3% only. In cases with absence of previous pelvic surgery, there was a radio-clinical discrepancy of 40% of cases, while in cases with history of a previous pelvic surgery we found a discrepancy of 60% of cases. This was due to clinical difficulty in differentiating between peritoneocele and rectocele, or due to under-diagnosis of complex prolapse. The sensitivity of MRI in the diagnosis of cystocele, hysterocele and rectocele were respectively 100, 100 and 83%. The gain in sensitivity provided by the MRI was significant for the diagnosis of peritoneocele: 100% against 33%. The specificity was 100%. Static images allowed a detailed study of damaged connective tissues and pelvic muscles. CONCLUSION: The D-MRI seems an appropriate tool in pre-operative assessment of cases with vaginal prolapse. It will help in focusing our surgical strategy, especially in cases that present post-hysterectomy and in cases with residual or recurrent prolapse.

[Hexaminolevulinate fluorescence cystoscopy in 2009]. / Le point sur les indications de l'Hexvix en 2009.

Fluorescence cystoscopy improves the detection of non-muscle-invasive bladder cancer, particularly carcinoma in situ, and reduces recurrence. The technique is well tolerated with few side effects. Guidelines recommend fluorescence cystoscopy in multifocal tumors, tumors >3cm, early recurrence, High grade cytology, follow-up of high-risk bladder cancer (T1G3 and CIS).

[External validation of the University of Los Angeles Integrated Staging System (UISS) in localized renal cell carcinoma: single center study]. / Validation externe du modèle pronostique de l'University of Los Angeles Integrated Staging System (UISS) dans le cancer du rein localisé: étude monocentrique.

OBJECTIVE: To assess the ability of the University of Los Angeles Integrated Staging System (UISS) to stratify patients with a renal cell carcinoma (RCC) in one single French centre. PATIENTS AND METHODS: Four hundred and forty-three patients operated for a RCC in the Urological Department of Strasbourg University Hospital between January 1989 and December 2000 were classified according to the UISS, which combines TNM stage, Fuhrman grade and Eastern cooperative oncology group performance status. Two groups were created: 362 patients with localized and 81 patients with metastatic RCC. RESULTS: The UISS stratified the localized RCC into three different risk groups (p<0.0001). The 5-year survival rates were 75, 61 and 29% for low-, intermediate- and high-risk groups, respectively. For the metastatic RCC, the UISS couldn't well discriminate (p=0.092), with the 5-year survival rates of 18, 9 and 12% for low-, intermediate- and high-risk groups, respectively. CONCLUSION: This study validates the UISS for predicting survival in patients with localised RCC in our centre and, therefore, qualifies us to participate in clinical trials using this model. In metastatic RCC, the UISS was less accurate due to the small number of patients and the heterogeneity of treatments.

[The role of introital ultrasonography in treating low urinary tract symptoms complicating sub-urethral tape placement]. / Rôle de l'échographie translabiale dans la prise en charge des troubles urinaires du bas appareil compliquant la mise en place d'une bandelette sous-urétrale.

OBJECTIVE: To assess the role of the introital ultrasound in the evaluation of patients with low urinary tract symptoms after sling placement. MATERIAL AND METHOD: From 2000 till 2007, a total of 31 patients underwent sub-urethral tape placement for a stress urinary incontinence and developed thereafter a low urinary tract symptoms. The urological evaluation consisted of a detailed medical history, a urogynecologic examination, a complete urodynamic exam, a measurement of the postvoiding residue and a introital ultrasound. All patients filled the mesure du handicap urinaire (MHU) questionnaire. These patients had a transvaginal tape lysis under local anesthesia. We correlated the ultrasound findings with postoperative clinical success and failure. RESULTS: Thirty-one patients with low urinary tract symptoms secondary to sling placement underwent a tape lysis. Median age was 63.1+/-10.9 years, the median time between the anti-incontinence surgery and the tape lysis was 21.5+/-16.2 months. Seven patients had only obstructive symptoms, 15 patients had obstructive and bladder overactivity symptoms and nine patients had bladder overactivity symptoms. Introital ultrasound revealed an abnormality of the tape in 26 patients. Ten patients had a position abnormality of the tape, five patients had urethral angulation abnormality and 11 patients had the previous two abnormalities. After tape lysis, the obstructive symptoms disappeared in 19 out of 22 patients (86%), the bladder overactivity symptoms disappeared in 16 out of 24 patients (66%). In case of introital ultrasound abnormalities, the tape lysis was efficient in 23 out of 26 patients (89%), while in the absence of ultrasound abnormalities (five patients), the tape lysis was not useful in treating LUTS in all patients. CONCLUSION: Ultrasonography is a useful tool in investigating postoperative low urinary tract symptoms and in the selection of patients who will benefit from tape lysis.

[Metastatic renal cell carcinoma: pretherapeutic approach before antiangiogenic treatment. A case report]. / Cancer du rein métastatique: bilan préthérapeutique, instauration et suivi d'un traitement anti-angiogénique. A propos d'un cas.

Antiangiogenic treatment initiation justifies a clinical and biological pretherapeutic assessment and a close follow-up of side effects according to each drug. Because of potential healing complications, a deadline of 4 weeks after surgery is recommended before starting antiangiogenic treatment. The optimal sequence and the potential role of neo-adjuvant therapies remain to define. In the absence of prospective data, nephrectomy is still recommended in renal cell carcinoma management.

[Can candidates for reimplantation of suburethral sling after sling removal due to chronic obstruction be identified intraoperatively?]. / Peut-on déterminer en peropératoire les candidates à une réimplantation immédiate d'une bandelette sous-urétrale après résection d'une première bandelette pour obstruction chronique?

OBJECTIVE: To intraoperatively identify candidates for immediate reimplantation of a suburethral sling after sling removal due to chronic obstruction. MATERIAL AND METHOD: Clinical study of 22 women, operated by suburethral sling for stress urinary incontinence between 2000 and 2007, who subsequently developed lower urinary tract obstructive symptoms. The suburethral sling was removed in all patients under local anaesthesia and fentanyl/midazolam sedation. Immediate replacement of the suburethral sling was performed in patients with cough incontinence demonstrated intraoperatively after sling removal. The measure of handicap urinary (MHU) questionnaire, UDI-6/IIQ-7 score and uroflowmetry with determination of the post-voiding residual volume were performed before and three months after the operation. RESULT: Twelve patients (group 1) underwent removal and reimplantation of a new sling and 10 patients (group 2) underwent simple sling removal. The two groups were comparable. In each group, a significant difference was observed between preoperative and postoperative post-voiding residual volume, peak flow rate and MHU score and a non-significant difference was observed for the UDI-6/IIQ-7 score in group 2, in contrast to group 1. The urinary continence rate was 100% in both groups. The success rate, defined urodynamically, was 75% in group 1 and 80% in group 2. The success rate, defined by resolution of the initial urinary symptoms and improvement of the questionnaire score, was 75% in group 1 and 90% in group 2. CONCLUSION: Candidates for immediate replacement of suburethral sling after sling removal due to obstructive symptoms can be identified intraoperatively. The cough test under local anaesthesia and fentanyl/midazolam sedation allows selection of these patients. Immediate sling replacement is accompanied by good results on continence without inducing a new obstruction.

[Using the intersitital cystitis new diagnostic criteria in daily practice: about 156 patients]. / Utilisation des nouveaux critères diagnostiques de la cystite interstitielle dans la pratique quotidienne : à propos de 156 cas.

OBJECTIVES: To describe the characteristics of patients with interstitial cystitis and to determine what proportion of those patients met the European Society for the Study of interstitial cystitis/painful bladder syndrome 2005 (ESSIC IC/PBS) definition and how those who met the definition differed from those who did not. MATERIAL AND METHOD: A total of 156 patients diagnosed as having an interstitial cystitis were followed in our institution between 1997 and 2007. The diagnosis was suggested by the clinical history and confirmed on the basis of clinical symptoms, voiding diary findings, Pearson's test, O'Leary-Sant questionnaire, cystoscopy and hydrodistension and by the exclusion of other significant pathologies. The patients were evaluated in a prospective manner. We studied the demographics of our patients, described the common clinical presentation. We applied the ESSIC 2005 definition of CI/PBS on this population and found the proportion that meets this definition. RESULTS: The sex ratio F/M was 8:1. The patients were symptomatic for a median of 7.3 years before IC is diagnosed. The most common symptom was pain which was found in 100% of patients, frequency was found in 82% and nocturia in 62%. The common sites where pain was localized were suprapubic in 80%, perineal in 70% and genital in 40%. A burning sensation was found in 55% of patients. Hunner's lesion was found in three patients. The cystoscopy and hydrodistension revealed glomerulations in 88.4% of patients. The ESSIC 2005 definition identified only 74% of the 156 patients diagnosed as having IC/PBS. CONCLUSION: The symptoms in interstitial cystitis are variable. The ESSIC 2005 definition may not be sufficiently sensitive excluding over 26% of patients diagnosed as having IC. Minor modifications (pain type and location) of the definition appeared to increase its sensitivity.

[Treatment of postoperative male urinary incontinence by bone-anchored male sling]. / Le traitement de l'incontinence urinaire postopératoire de l'homme par la bandelette sous-urétrale à ancrage osseux.

OBJECTIVE: To evaluate the results of treatment of postoperative male stress urinary incontinence by placement of an AMS Invance bone-anchored male sling (BAMS). MATERIAL AND METHOD: Between February 2005 and May 2007, 29 patients with stress urinary incontinence secondary to prostatic surgery were treated by Invance bone-anchored male sling. This BAMS consists of a silicone-coated polyester sling placed around the bulbar urethra and anchored to the ischiopubic rami by six titanium screws. According to the number of protections used per 24 hour, patients were considered to present mild (one to two), moderate (three to four) or severe (five or more, or penile sheath) incontinence. The number of protections, the continence rate and early and late complications were reported. Success or continence was defined by the absence of urine leaks and protections. RESULTS: The mean age of the patients of this series was 67.5 years. Incontinence was mild for 12 patients (41.4%), moderate for six patients (20.7%) and severe for 11 patients (37.9%). The mean interval between prostatic surgery and BAMS placement was 47.9 months. The mean operating time was 65.8 minutes. There were no intraoperative complications. Two cases (7%) of spontaneously resolving acute urinary retention were observed. Explantation of the BAMS for chronic perineal pain or operative site infection was performed in five patients (17%) after a mean interval of 4.1 months (range: 1-8.5 months). The revision rate for repositioning of the screws was 10.3% (three patients). The continence rate at three months was 62.5%. After a mean follow-up of 11.5 months, this rate was 37.5%, corresponding to 77.8% of patients with initially mild or moderate incontinence and 22.2% with severe incontinence. Residual incontinence was mild in 41.7%, moderate in 8.3% and severe in 12.5%. Four patients with persistent urinary incontinence after BAMS placement were treated by artificial urinary sphincter. CONCLUSION: Bone-anchored male sling is a minimally invasive treatment for postoperative male urinary incontinence, but is associated with significant morbidity (five explanations in a series of 29 patients). Better results were obtained for mild to moderate incontinence.

[Is nephron-sparing surgery relevant for unilateral Wilms tumors?] / Néphrectomie partielle pour tumeur de Wilms unilatérale chez l'enfant : est-ce pertinent ?

BACKGROUND: Wilms tumors (WTs) are the most frequent renal tumors in children. Radical nephrectomy (RN) remains the gold-standard surgical treatment for this type of cancer. Excellent results in overall survival (>90%) make it possible to consider nephronic preservation. The objective of this systematic review is to evaluate the relevance of nephron-sparing surgery (NSS) for the treatment of nonsyndromic unilateral Wilms tumor (UWT) in children. METHODS: Articles in English related to "unilateral Wilms tumor, unilateral nephroblastoma, partial nephrectomy, nephron-sparing surgery, renal function" identified in the Medline library were screened and data were extracted to perform a qualitative systematic review. RESULTS: We identified 377 articles, 14 of which were integrated into the analysis. Data on 4288 children were included, 3994 (93.1%) underwent RN, whereas 294 (6.8%) underwent NSS. Stage I anatomopathology resulted in 55.1% RN and 79% NSS. Overall survival and event-free survival were similar: respectively 95.7% and 92.8% after RN and 96 and 90.5% after NSS. Positive margin status was higher after NSS (8.5% vs 0.5%), but tumor rupture and local tumor recurrences were similar. The rate of mild to moderate renal function was higher after RN (42% vs 10% after NSS). DISCUSSION: NSS is regularly performed for WT in case of bilateral or syndromic tumors, but the literature considering UWT does not show consensus. The superiority of NSS for renal outcomes has now been fully evaluated, but the main problem of this surgery in case of UWT is to ensure oncologic outcomes as good as outcomes after RN. WTs are usually massive tumors for which partial nephrectomy is contraindicated, but studies showed that chemotherapy before surgery could reduce tumor volume and make NSS possible. This review shows that NSS results seem to be as good as RN results and that preoperative chemotherapy should be highlighted for its participation in the reduction of the positive margin status. Although radiotherapy is used with caution because of its side effects, some studies showed that it gave excellent results for oncologic salvage after local recurrence. Constant progress in medical imaging and detection systems has led to the emergence of a new type of assistance for surgeons such as image reconstruction and vessel or urinary tract system segmentation. Virtual simulation of the operation based on a real case should help evaluate the feasibility of complex procedures in the near future. CONCLUSION: NSS for UWT seems to be a credible therapeutic alternative. New technologies such as 3D reconstruction should help surgeons define the best parameters to select ideal tumors for this surgery in the near future. For the moment, small tumors (<4cm), distant from the renal hilum (ideally on the upper pole) that respect at least 50% of the renal parenchyma (ideally superficial with exophytic development) seem to be the perfect indication for NSS.

Evaluation of microsatellite analysis in urine sediment for diagnosis of bladder cancer.

Alterations at microsatellite DNA markers in cells exfoliated in urine have been correlated to the presence of bladder cancer. To check the feasibility of such noninvasive analysis to routinely diagnose bladder cancers, we have developed a highly sensitive method using fluorescent PCR to search for DNA microsatellite alterations in urine sediment compared with a blood paired sample. One hundred eighty-three patients were included in our study. This population comprised 103 bladder cancers (64 pTa stages), the complement representing controls and other benign or malignant diseases. Results of the analysis at 17 loci in a blinded study were compared with cystoscopy and/or pathology. The high reproducibility of this technique and the analysis of 26 control patients allowed us to determine for each microsatellite a cutoff characterizing a significant allelic imbalance. For bladder cancer detection, the overall sensitivity of the test was 84%. Using this procedure, we identified alterations in 81%, 84%, 91%, and 100% of pTa, pT1, pT2, and >pT2 stages, respectively. This corresponds to 79%, 82%, and 96% sensitivity for grades I, II, and III, respectively. Interestingly, for routine purposes, we observed an overall sensitivity of 80% (76% for pTa stages) when only the eight most rearranged microsatellites were considered. In conclusion, the noninvasive feature combined with the rapidity of this fluorescent and highly sensitive technique for the detection of early stages provides us with a useful help for the diagnosis of bladder cancer.

Genitourinary group phase II study of chemotherapy in stage T3-4 N0-X M0 transitional cell cancer of the bladder: prognostic factor analysis.

The aim of this study was to examine prognostic factors for survival of patients with invasive bladder cancer who had received neoadjuvant chemotherapy followed by further treatment. From 1986 to 1990, 149 eligible patients with T3-4 N0-X M0 bladder cancer were entered into a phase II trial of neoadjuvant chemotherapy, consisting of cisplatin and methotrexate. Patients received two or four courses of chemotherapy, depending on the absence or presence, respectively, of a major clinical response after two courses. 136 patients were evaluable for clinical response after two courses of chemotherapy, and 75 patients were evaluable for pathological response after two or four courses. A multivariate analysis, based on pretreatment variables and the post-treatment variables, clinical response and pathological response, showed that performance status, tumour size and clinical response after two courses of chemotherapy were the only independent prognostic factors for all eligible patients. A second multivariate analysis in the selected subgroup of patients, who underwent a cystectomy, showed that the G-cagetory and pathological response were the only independent prognostic factors. In conclusion, in this group of patients, the response to chemotherapy was a strong and independent prognostic factor in addition to other independent variables. However, it was not accurate or strong enough to allow an impact on the choice of locoregional therapy.

Fast imaging MR assessment of ureterohydronephrosis during pregnancy.

PURPOSE: to assess the value of the fast imaging sequence called RARE-MR-Urography (RMU) for the diagnosis of pathologic ureterohydronephrosis during pregnancy. MATERIALS AND METHODS: 15 pregnant women with an acute flank pain were examined with RMU. Results were compared with those of ultrasonography (US), X-rays, and the evolution of symptoms. RESULTS: the accuracy of RMU in the detection of urinary tract dilatation and the localization of the level of obstruction was excellent (100%). The determination of the type of obstruction, intrinsic vs. extrinsic, was always exact. RMU alone cannot specify the exact nature of the intrinsic obstruction. Ultrasonography gave less sensitive information in terms of level (60%) and type of obstruction (53%). CONCLUSION: RMU is able to differentiate a physiological from a pathologic ureterohydronephrosis during pregnancy. It could be considered as a procedure of choice for special cases when US failed to establish this differential diagnosis.