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 Abstracts (13111)

P077: Real-world outcomes of enzalutamide treatment in men with metastatic castration-resistant prostate cancer following chemotherapy: A retrospective, multicenter study in Korea

By:

Kang M., Kim J.K., Tae B.S., Ku J.H., Kwak C., Kim H.H., Jeong C.W.

Institutes:

Seoul National University Hospital, Dept. of Urology, Seol, South Korea

Introduction & Objectives

Enzalutamide significantly suppress the growth of prostate cancer, particularly metastatic Castration-Resistant Prostate Cancer (mCRPC), by targeting androgen receptor signaling pathway. However, there are paucity of evidences on the clinical benefits of enzalutamide in Korea. Here, we analyzed the real-world outcomes of enzalutamide treatment in Korean men with mCRPC following chemotherapy.

Material & Methods

We retrospectively reviewed the medical records of 110 mCRPC patients who received oral enzalutamide at a dose of 160 mg per day following chemotherapy in three tertiary centers in Korea between 2014 and 2016. Primary endpoint was Overall Survival (OS). Secondary endpoints were time-to first Skeletal-Related Event (SRE), time-to PSA progression and the PSA responsiveness. Kaplan-Meier analysis and log-rank tests were adopted to compare these oncological outcomes according to the various clinicopathological variables. Multivariate Cox regression model was used to identify the predictors for OS.

Results

All-cause mortality rate was 18.4% (N=18). The median overall and PSA progression-free were 18.2 months (95% confidence interval [CI], not yet reached) and 9.5 months (95% CI, 6.4 – 12.5), respectively. Notably, patients with poor ECOG scores (≥ 2), visceral metastasis, prior abiraterone treatment, and no concomitant hormonal therapy showed significant worse OS outcomes in Kaplan-Meier analysis (Fig.1). Conversely, there were comparable PSA responses in these subgroups. After adjusting confounding factors among various clinicopathological factors, we finally identified ECOG scores (≥ 2) [hazard ratio (HR), 3.28; 95% CI, 1.11 – 9.68], prior abiraterone treatment (HR, 5.29; 95% CI, 1.68 – 16.67), and concomitant androgen deprivation therapy (HR, 0.19; 95% CI, 0.05 – 0.76) as the independent predictors for OS.

Conclusions

In sum, this is the first report for the real-world outcomes of the post-chemotherapeutic enzalutamide in Korean men with mCRPC. Although our study included a small number of patients, it suggests the valuable information for the treatment of mCPRC in a Korean population.

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  • Event: 8th European Multidisciplinary Meeting on Urological Cancers
  • Medium: Abstract
  • Date: 26-11-2016
  • Views: 153
  • Nr: P077

P012: Urotensin II receptor predicts the upgrading of prostate cancer from biopsy to radical prostatectomy

By:

Giulianelli R.1, Nardoni S.2, Mirabile G.1, Manini C.3, Bruzzese M.4

Institutes:

1Nuova Villa Claudia Clinic, Dept. of Urology, Rome, Italy, 2Centro Medico Samar, Dept. of Histology, Rome, Italy, 3San Giovanno Bosco Hospital, Dept. of Anatomy Pathology, Turin, Italy, 4Universita'Federico II, Dept. of Public Health, Naples, Italy

Introduction & Objectives

Urotensin II (UT-II) is a potent vasoconstrictor peptide and its receptor (UTR) was correlated with human cortico-adrenal carcinoma proliferation. In this retrospective study, we have evaluated the correlation between UTR expression and Gleason score of human prostate adenocarcinoma.

Material & Methods

We have evaluated the expression of UTR in 143 human prostate tissue samples of patients affected by prostate adenocarcinoma. All patients underwent prostate biopsy prior Radical Prostatectomy between 2009 and 2011. The mean age was 66,2 years (range from 50 to 74 years). Univariate associations between Gleason Score upgrading and clinical and tumour characteristics were assessed using either the chi square test or the Mann-Whitney U test. Multivariable logistic regression models were used to explore the independent role of UTR expression in predicting Gleason upgrading with respect to a set of base prognostic factors including PSA, primary and secondary Gleason score and muscle invasion. The predictive accuracy of the models was evaluated by ROC curve analysis and measured using the Area Under the Curve (AUC). Comparison among the different AUCs was carried out computing the bootstrap sampling distribution of the difference in the two AUCs.

Results

55 (38.5%) patients showed a Gleason score upgrading from biopsy on final pathology. The most frequent pattern (n=20, 36.4%) of upgrading was from a biopsy score of 3+4 to a RPP score of 4+3. At univariate analysis, lower primary Gleason, presence of muscle invasion ad higher UTR expression showed a significant association (p<0.001) with Gleason upgrading. Although patients with GS upgrading were characterized by higher PSA values (median [range] PSA: 6.6 [4.8 to 9.5] vs 5.8 [4.4 7.8]), this difference did not reach statistical significance (p=0.215). In a multivariable logistic model including both primary and secondary Gleason score, PSA, muscle invasion and UTR expression levels, patients with an high UTR expression showed a more than ten-fold increase in the odds of upgrading (O.R. 13.77, C.I. 3.1 to 62.5, p<0.001) with respect to patients with low UTR expression. In ROC analysis, this model predicted Gleason Upgrading with an AUC equal to 0.88 (95% C.I. 0.79 to 0.96, p<0.001). With respect to base model not including UTR, the absolute gain in predictive accuracy of the complete model was equal to 9% (p=0.042).

Conclusions

These data suggest that the dosage of UTR could be useful to identify a group of patients with a statistically significant high risk of upgrading from biopsy to radical prostatectomy.

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  • Event: 8th European Multidisciplinary Meeting on Urological Cancers
  • Medium: Abstract
  • Date: 26-11-2016
  • Views: 95
  • Nr: P012

O1: RESIRT: A phase 1 study of Selective Internal Radiation Therapy (SIRT) using Yttrium-90 (Y-90) resin microspheres in patients with primary Renal Cell Carcinoma (RCC)

By:

De Souza P.1, Aslan P.3, Clark W.4, Patel M.2, Vass J.5, Cade D.6, De Silva S.7

Institutes:

1Western Sydney University School of Medicine, Dept. of Medical Oncology, Sydney, Australia, 2Westmead Hospital, Dept. of Urology, Sydney, Australia, 3Waratah Private Hospital, The Urology Practice, Sydney, Australia, 4St George Private Hospital, Dept. of Radiology, Sydney, Australia, 5Royal North Shore Hospital, Dept. of Urology, Sydney, Australia, 6Sirtex Medical Limited, Medical Affairs, Sydney, Australia, 7Sutherland Hospital, Dept. of Radiology, Sydney, Australia

Introduction & Objectives

Selective Internal Radiation Therapy (SIRT) is an interventional procedure used for unresectable liver tumours, and has properties that make it potentially useful for primary Renal Cell Carcinoma (RCC) that is unsuitable for nephrectomy. RESIRT is the first-in-human study to evaluate safety and feasibility of SIRT for primary RCC.

Material & Methods

Patients (pts) not amenable for or who declined conventional therapy were eligible. A single transfemoral microcatheter administration of Yttrium-90 (Y-90) resin microspheres (SIR-Spheres; Sirtex, Australia) was delivered super-selectively via the renal artery to the tumour at intended radiation doses of 75, 100, 150, 200, 300 Gray and a final cohort with a procedural endpoint of imminent stasis, in a dose-escalation design. Post-SIRT follow-up was 12 months. The primary endpoint was safety and toxicity 30 days post-SIRT. Secondary endpoints included tumour response (RECIST v1.1).

Results

The study enrolled 21 pts with RCC (33% left and 67% right kidney), mean age 75.0 years (SD: 9.3; range 48–86) and WHO performance status of 0 (81%) or 1 (19%); gender was 6 (29%) female and 15 (71%) male. Eight pts (38%) had metastatic RCC. Seven pts (33%) had previously undergone total nephrectomy of the contralateral kidney, 1 (5%) received prior chemotherapy and 1 (5%) progressed after cryotherapy to the target organ. Three patients were re-treated within the RESIRT study at a higher Y-90 dose, after at least a 12-month interval from their previous SIRT treatment. Median follow-up was 12.0 months (95% CI 11.9–12.1). Sum of longest diameters for the target lesion was median 45 mm (range 23‒123 mm). The intended Y-90 doses were delivered without any dose-limiting toxicity.  Imminent stasis was reached in 11 (52%) pts. 18 (86%) pts experienced 70 adverse events (AEs) at any time to 12 months, with 8 (38%) pts experiencing 18 SAEs; 4 (19%) pts experienced 5 SAEs within 30 days post-SIRT, all determined as not related to SIRT. Ten (48%) pts had 24 AEs grade ≥3 at any time point to 12 months and all were considered unrelated to SIRT; 9 pts (43%) had 16 AEs that were related to SIRT (all grade 1–2, no SAEs), of which 2 occurred pre SIRT. Treatment-related AEs were fatigue/tiredness/lethargy, pain, hypertension, lack of appetite, nausea, ‘heaviness’, bruised groin andhypomagnesemia. Best overall tumour responses were Partial Response [PR] 1/18 (6%), stable disease [SD] 16/18 (89%) and progressive disease 1/18 (6%), with SD in 2 further patients with on-going follow-up.

Conclusions

This pilot study demonstrates good tolerability of SIRT at all dose levels including imminent stasis in treating primary tumours in RCC pts otherwise unsuitable for conventional therapy.

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  • Event: 8th European Multidisciplinary Meeting on Urological Cancers
  • Medium: Abstract
  • Date: 26-11-2016
  • Views: 122
  • Nr: O1

P130: Clinical characteristics of long-term recurrence free survivors after radical cystectomy with pelvic lymphadenectomy in muscle invasive bladder cancer with lymph nodes metastasis

By:

Nam J.1, Choi Y.H.2, Lee D.H.1, Kim T.N.2, Park S.W.3, Chung M.K.2

Institutes:

1Pusanl National University Yangsan Hospital, Yangsan, South Korea, 2Pusanl National University Hospital, Busan, South Korea, 3Pusanl National University Hospital, Yangsan, South Korea

Introduction & Objectives

This study aims to clarify the clinicopathologic features of long-term survivors after radical cystectomy in muscle invasive bladder cancer patients with lymph nodes metastasis.

Material & Methods

We analyzed data on 269 patients at two institutions who underwent radical cystectomy and urinary diversion for bladder cancer between 2006 and 2015 and were observed at least 2 year postoperatively.

Results

The incidence of lymph nodes metastasis was 25.2% (68 patients). Urinary diversion was orthotopic bladder substitutions in 16, ileal conduit in 22, ureterocutaneoustomy in 30 patients. Clinicopathologic features associated with above 2-year recurrence free survivors included low grade (p=0.001), no ureteral invasion (p=0.001), adjuvant chemotherapy (p=0.010) (Table 1).

Conclusions

This study shows that long-term recurrence-free survival above 2-years after radical cystectomy with pelvic lymphadenectomy can be achieved in patients with favorable tumor characteristics. In addition, ureteral status and adjuvant chemotherapy was reliable predictor of above 2-year recurrence free survivors.

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  • Event: 8th European Multidisciplinary Meeting on Urological Cancers
  • Medium: Abstract
  • Date: 26-11-2016
  • Views: 80
  • Nr: P130

P061: Circulating tumor cells as liquid biopsies of skeletal metastases

By:

Josefsson A., Larsson K., Damber J-E., Welén K.

Institutes:

University of Gothenburg, Dept. of Urology, Gothenburg, Sweden

Introduction & Objectives

Circulating Tumor Cells (CTC) are promising biomarkers in advanced prostate cancer. Since they are seeded from metastases they may also serve as liquid biopsies for skeletal metastases that are difficult to sample. The aim of the present study was to evaluate to which extent CTCs reflect the phenotype of skeletal metastases, and thereby their potential to serve as a clinical tool in individualizing treatment of metastatic prostate cancer.

Material & Methods

CTC and tissue from skeletal metastases were sampled from 17 patients (5 castration naïve and 12 castration resistant) during surgery for spinal cord compression symptoms. CTCs were sampled prior to removal of metastatic tissue, and isolated with AdnaTest ProstateCancerSelect/Detect (Qiagen). Resulting cDNA was pre-amplified in a multiplex reaction and analysed for expression of 48 genes related to prostate cancer progression and metastasis with qPCR. RNA was extracted from the metastatic tissue with RNeasy Plus Universal Mini kit (Qiagen), and gene expression was assessed in the same way as for CTCs. EpCAM expression level was used as internal control to enable normalization to epithelial content (CTCs or tumor tissue) of the samples. Correlation of detected signals between matched CTC and tissue was calculated with Pearson correlations.

Results

In 10 of the 17 patient samples (59%) there was a statistically significant correlation between the gene expression profile of CTCs and the sampled metastatic tissue. In the castration naïve group, 80% of the patients had correlating gene expression in CTC and the metastatic sample, while only 50 % of CRPC patients displayed such correlation. The genes that contributed most to the correlations were AGR2, AKR1C3, FOLH1 (PSMA), CDH1 (E-cadherin) and TACSTD2 (TROP2).

Conclusions

This study shows that gene expression patterns in CTC can reflect those of metastases. The high ratio of correlation between CTC and a single metastatic sample in the castration naïve patients may be due to a limited metastatic heterogeneity. Thus, one interpretation of the decreased correlation ratio in CRPC patients is that CTCs reflect the total heterogenic tumor burden rather than the single sample used the present study. Taken together, the results imply that CTC phenotyping is a promising tool for individualized therapy in metastatic prostate cancer.

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  • Event: 8th European Multidisciplinary Meeting on Urological Cancers
  • Medium: Abstract
  • Date: 26-11-2016
  • Views: 82
  • Nr: P061

 Outline Lecture (42)