INTRODUCTION AND OBJECTIVES: The goals of transurethral resection of a bladder tumor (TUR) are to completely resect the lesions and to make a correct diagnosis in order to adequately stage the patient. It is well known that the presence of detrusor muscle in the specimen is a prerequisite to minimize the risk of under staging. Persistent disease after resection of bladder tumors is not uncommon and is the reason why the European Guidelines recommended a re-TUR for all T1 tumors. It was recently published that when there is muscle in the specimen, re-TUR does not influence progression or cancer specific survival. We present here the patient and tumor factors that may influence the presence of residual disease at re-TUR. MATERIAL AND METHODS: In our retrospective cohort of 2451 primary T1G3 patients initially treated with BCG, pathology results for 934 patients (38.1%) who underwent re-TUR are available. 74% had multifocal tumors, 20% of tumors were more than 3 cm in diameter and 26% had concomitant CIS. In this subgroup of patients who underwent re-TUR, there was no residual disease in 267 patients (29%) and residual disease in 667 patients (71%): Ta in 378 (40%) and T1 in 289 (31%) patients. Age, gender, tumor status (primary/recurrent), previous intravesical therapy, tumor size, tumor multi-focality, presence of concomitant CIS, and muscle in the specimen were analyzed in order to evaluate risk factors of residual disease at re-TUR, both in univariate analyses and multivariate logistic regressions. RESULTS: The following were not risk factors for residual disease: age, gender, tumor status and previous intravesical chemotherapy. The following were univariate risk factors for presence of residual disease: no muscle in TUR, multiple tumors, tumors > 3 cm, and presence of concomitant CIS. Due to the correlation between tumor multi-focality and tumor size, the multivariate model retained either the number of tumors or the tumor diameter (but not both), p < 0.001. The presence of muscle in the specimen was no longer significant, while the presence of CIS only remained significant in the model with tumor size, p < 0.001. CONCLUSIONS: The most significant factors for a higher risk of residual disease at re-TUR in T1G3 patients are multifocal tumors and tumors more than 3 cm. Patients with concomitant CIS and those without muscle in the specimen also have a higher risk of residual disease.

• MeSH
• Carcinoma, Transitional Cell * pathology   MeSH
• Humans MeSH
• Urinary Bladder Neoplasms * surgery   MeSH
• Retrospective Studies MeSH
• Risk Factors MeSH
• Neoplasm Staging MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH

PURPOSE: To evaluate the oncological impact of postponing radical cystectomy (RC) to allow further conservative therapies prior to progression in a large multicentre retrospective cohort of T1-HG/G3 patients initially treated with BCG. METHODS: According to the time of RC, the population was divided into 3 groups: patients who did not progress to muscle-invasive disease, patients who progressed before radical cystectomy and patients who experienced progression at the time of radical cystectomy. Clinical and pathological outcomes were compared across the three groups. RESULTS: Of 2451 patients, 509 (20.8%) underwent RC. Patients with tumors > 3 cm or with CIS had earlier cystectomies (HR = 1.79, p = 0.001 and HR = 1.53, p = 0.02, respectively). Patients with tumors > 3 cm, multiple tumors or CIS had earlier T3/T4 or N + cystectomies. In patients who progressed, the timing of cystectomy did not affect the risk of T3/T4 or N + disease at RC. Patients with T3/T4 or N + disease at RC had a shorter disease-specific survival (HR = 4.38, p < 0.001), as did patients with CIS at cystectomy (HR = 2.39, p < 0.001). Patients who progressed prior to cystectomy had a shorter disease-specific survival than patients for whom progression was only detected at cystectomy (HR = 0.58, p = 0.024) CONCLUSIONS: Patients treated with RC before experiencing progression to muscle-invasive disease harbor better oncological and survival outcomes compared to those who progressed before RC and to those upstaged at surgery. Tumor size and concomitant CIS at diagnosis are the main predictors of surgical treatment while tumor size, CIS and tumor multiplicity are associated with extravesical disease at surgery.

• MeSH
• Survival Analysis MeSH
• BCG Vaccine therapeutic use   MeSH
• Cystectomy methods   MeSH
• Risk Assessment MeSH
• Neoplasm Invasiveness pathology   MeSH
• Kaplan-Meier Estimate MeSH
• Carcinoma, Transitional Cell drug therapy   mortality   pathology   surgery   MeSH
• Cohort Studies MeSH
• Middle Aged MeSH
• Humans MeSH
• Neoplasm Recurrence, Local mortality   pathology   therapy   MeSH
• Multivariate Analysis MeSH
• Urinary Bladder Neoplasms drug therapy   mortality   pathology   surgery   MeSH
• Disease-Free Survival MeSH
• Prognosis MeSH
• Proportional Hazards Models MeSH
• Retrospective Studies MeSH
• Aged MeSH
• Neoplasm Staging MeSH
• Treatment Outcome MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH

PURPOSE: The goals of transurethral resection of a bladder tumor (TUR) are to completely resect the lesions and to make a correct diagnosis to adequately stage and treat the patient. Persistent disease after TUR is not uncommon and is why re-TUR is recommended in T1G3 patients. When there is T1 tumor in the re-TUR specimen, very high risks of progression (82%) have been reported. We analyze the risks of recurrence, progression to muscle-invasive disease and cancer-specific mortality (CSM) according to tumor stage at re-TUR in T1G3 patients treated with BCG. METHODS: In our retrospective cohort of 2451 T1G3 patients, 934 patients (38.1%) underwent re-TUR. 667 patients had residual disease (71.4%): Ta in 378 (40.5%), T1 in 289 (30.9%) patients. Times to recurrence, progression and CSM in the three groups were estimated using cumulative incidence functions and compared using the Cox regression model. RESULTS: During a median follow-up of 5.2 years, 512 patients recurred. The recurrence rate was significantly higher in patients with a T1 at re-TUR (P < 0.001). Progression rates differed according to the pathology at re-TUR, 25.3% in T1, 14.6% in Ta and 14.2% in case of no residual tumor (P < 0.001). Similar trends were seen in both patients with and without muscle in the original TUR specimen. CONCLUSIONS: Patients with T1G3 tumors and no residual disease or Ta at re-TUR have better recurrence, progression and CSM rates than previously reported, with a CSM rate of 13.1 and a 25.3% progression rate in re-TUR T1 disease.

• MeSH
• Adjuvants, Immunologic therapeutic use   MeSH
• Administration, Intravesical MeSH
• BCG Vaccine therapeutic use   MeSH
• Cystectomy methods   MeSH
• Humans MeSH
• Neoplasm Recurrence, Local mortality   MeSH
• Urinary Bladder Neoplasms * mortality   pathology   therapy   MeSH
• Follow-Up Studies MeSH
• Cause of Death MeSH
• Disease Progression MeSH
• Proportional Hazards Models MeSH
• Reoperation MeSH
• Retrospective Studies MeSH
• Aged MeSH
• Neoplasm Staging MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

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.

• MeSH
• Delphi Technique MeSH
• Guideline Adherence standards   MeSH
• Carcinoma, Renal Cell mortality   therapy   MeSH
• Humans MeSH
• Neoplasm Recurrence, Local mortality   therapy   MeSH
• Kidney Neoplasms mortality   therapy   MeSH
• Disease-Free Survival MeSH
• Randomized Controlled Trials as Topic methods   standards   MeSH
• Endpoint Determination methods   standards   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Review MeSH

• MeSH
• Androgen Antagonists adverse effects   therapeutic use   MeSH
• Antineoplastic Agents, Hormonal adverse effects   therapeutic use   MeSH
• Radiotherapy Dosage MeSH
• Long-Term Care * MeSH
• Humans MeSH
• Neoplasm Recurrence, Local diagnosis   therapy   MeSH
• Magnetic Resonance Imaging MeSH
• Neoplasm Metastasis diagnosis   therapy   MeSH
• Biomarkers, Tumor blood   MeSH
• Bone Neoplasms secondary   therapy   MeSH
• Prostatic Neoplasms * diagnosis   therapy   MeSH
• Tomography, X-Ray Computed MeSH
• Positron-Emission Tomography MeSH
• Disease Progression MeSH
• Prostate-Specific Antigen blood   MeSH
• Antineoplastic Combined Chemotherapy Protocols MeSH
• Radiotherapy methods   MeSH
• Testosterone blood   MeSH
• Salvage Therapy * methods   MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Publication type
• Practice Guideline MeSH

• MeSH
• Clinical Trials, Phase III as Topic MeSH
• Middle Aged MeSH
• Humans MeSH
• Prostatic Neoplasms * diagnosis   physiopathology   therapy   MeSH
• Survival MeSH
• Prospective Studies MeSH
• Prostatectomy MeSH
• Radiotherapy MeSH
• Randomized Controlled Trials as Topic MeSH
• Risk MeSH
• Aged MeSH
• Neoplasm Staging MeSH
• Statistics as Topic MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Publication type
• Practice Guideline MeSH

• MeSH
• Adenocarcinoma diagnosis   blood   pathology   ultrasonography   MeSH
• Alkaline Phosphatase blood   MeSH
• Biopsy * methods   MeSH
• Early Detection of Cancer MeSH
• Histological Techniques methods   MeSH
• Risk Assessment MeSH
• Humans MeSH
• Magnetic Resonance Imaging MeSH
• Bone Neoplasms blood   secondary   MeSH
• Prostatic Neoplasms * diagnosis   blood   pathology   ultrasonography   MeSH
• Specimen Handling methods   MeSH
• Digital Rectal Examination MeSH
• Mass Screening MeSH
• Prostate-Specific Antigen * blood   MeSH
• Risk Factors MeSH
• Neoplasm Staging * classification   methods   MeSH
• Ultrasonography MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Publication type
• Practice Guideline MeSH

• MeSH
• Androgen Antagonists MeSH
• Diphosphonates MeSH
• Antibodies, Monoclonal, Humanized pharmacology   MeSH
• Castration MeSH
• Clinical Trials, Phase II as Topic MeSH
• Clinical Trials, Phase III as Topic MeSH
• Cryosurgery methods   MeSH
• Quality of Life MeSH
• Humans MeSH
• Neoplasm Metastasis MeSH
• Multicenter Studies as Topic MeSH
• Prostatic Neoplasms * therapy   MeSH
• Drug Costs MeSH
• Oligopeptides pharmacology   MeSH
• Survival MeSH
• Prognosis MeSH
• Prospective Studies MeSH
• Prostate * physiopathology   drug effects   MeSH
• Receptors, LHRH drug effects   MeSH
• Retrospective Studies MeSH
• Risk MeSH
• Testosterone secretion   MeSH
• Ultrasound, High-Intensity Focused, Transrectal MeSH
• Patient Selection MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Publication type
• Practice Guideline MeSH

• Publication type
• Abstracts MeSH