178 Abstracts

• P126: Efficacy of treatment with post-TUR single dose of Mitomycin C in patients with Non Muscle Invasive Bladder Cancer (NMIBC)Baena Villamarín C.¹, Beardo Villar P.², Pérez Pérez A.B.², Castro Dorantes M.J.², Gamaza Martínez R.², Gavira Moreno R.³

  12 Nov 2015

  952

  Introduction & Objectives

  1. Compare the recurrence and progression-free survival  among patients treated and untreated with post-TUR chemotherapy.
  2. Determine the target population with NMIBC potentially beneficiary of MMC post-TUR.

  Material & Methods

  Non experimental longitudinal prospective study of 349 consecutive patients with NMIBC subsidiary of MMC post-TUR in the Jerez Hospital between 2010-2013. Potential predictors of efficacy of MMC post-TUR in our series were analysed: Age, gender, smoking quit at the time of diagnosis, early recurrence.

  Results

  The average rate of patients included in the program is 53.9%, an increase of 79.3% (p <0.001)
  at 3 years.  Mean follow-up 26.3 ± 0.7 months. Mean time to first recurrence significantly higher in the
  MMC post-TUR group receiving [43.5 months (95% CI, 40.7 to 46.3) vs 38.5 months (95% CI, 35.5 to 41.6); p <0.05].  The absolute risk reduction of recurrence with MMC post-TUR is 14.5% (95% CI, 5.9 to 23.5%, p <0.001), and the number of patients needed to be treated (NNT) of 6.9 (95% CI, 4.3 to 17.9 P <0.001).  The statistical analysis of the exposed cohort to MMC post-TUR (n = 164) and unexposed (n = 185) results that the MMC post-TUR is effective in reducing the risk of recurrence in tumours PTa-1, low-high grade, single-multiple, ≤ 3cm maximum diameter, with no history of bladder tumours in the 12 months prior, with a sample of muscle layer in the TUR, and  without pretreatment with MMC.

  Conclusions

  MMC decreases the percentage of tumour recurrence in NMIBC, and increases disease-free time. The MMC increases disease-free time in all prognosis recurrence groups. The effectiveness of MMC post-TUR in our country is similar to that reported by other groups. Our findings suggest a potential benefit of MMC post-TUR in all patients with primary NMIBC or without early relapse, ≤ 3cm without prior treatment with intravesical MMC.

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• P155: Patients (pts) with metastatic chromophobe renal cell carcinoma (mchRCC) treated with sunitinib (Su) therapy (tx): Analysis of an international database regarding outcome and comparison to clear cell histology (mccRCC)Keizman D.¹, Sarid D.², Lee J.³, Chish A.¹, Sella A.⁴, Gottfried M.¹, Hammers H.⁵, Eisenberger M.⁵, Carducci M.⁵, Sinibaldi V.⁵, Neiman V.⁶, Rosenbaum E.⁶, Gez E.², Peer A.⁷, Neumann A.⁷, Kovel S.⁴, Mermershtain W.⁸, Rouvinov K.⁸, Berger R.⁹

  12 Nov 2015

  892

  Introduction & Objectives

  Su is a standard tx for mccRCC. Data on its activity in the rare variant of mchRCC, is limited by very small or heterogeneous (mixed histology with papillary type, or mixed targeted therapies) studies. We analysed the activity of Su in a relatively large and homogenous international cohort of mchRCC pts, in terms of outcome and comparison to mccRCC.

  Material & Methods

  Records from mchRCC pts treated with 1st line Su in 9 centers across 4 countries were retrospectively reviewed. Univariate and multivariate analyses of association between clinicopathologic factors and outcome were performed. Subsequently, mchRCC pts were individually matched to mccRCC pts. We compared the response rate (RR), progression free survival (PFS), and overall survival (OS) between the groups.

  Results

  Between 2004-2014, 33 pts (median age 64, 45% male) with mchRCC were treated with Su as 1^st line tx. 76% had a prior nephrectomy. HENG risk was good 27%, intermediate 55%, and poor 18%. 33% were active smokers, and 30% users of angiotensin system inhibitors (ASIs). 55%, 27%, and 33% had lung, liver and bone metastases, respectively. 48% had a pre-tx neutrophil to lymphocyte ratio (NLR) >3. 42% had dose reduction/tx interruption (DR/TI). Su induced hypertension (HTN) occurred in 48%. 75% achieved a clinical benefit (partial response + stable disease), while 25% had disease progression within the first 3 months of tx. Median PFS and OS were 10 and 26 months, respectively. Factors associated with PFS were the HENG risk (HR 3.8, p=0.025) and pre-tx NLR >3 (HR 0.6, p=0.012). Factors associated with OS were the HENG risk (HR 4.27, p=0.027), liver metastases (HR 4.6, p=0.029), and pre-treatment NLR < 3 (HR 0.5, p=0.04). Tx outcome was not significantly different between mchRCC pts and mccRCC pts, who were individually matched by HENG risk, nephrectomy/smoking status, pre-tx NLR, use of ASIs, DR/TI, and Su induced HTN. In mccRCC pts (p value versus mchRCC), 70% achieved a clinical benefit (p=0.58), and median PFS and OS were  9 (p=0.7) and 24 (p=0.6) months, respectively.

  Conclusions

  In mchRCC pts, Su tx may have similar outcome to mccRCC pts.

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• P068: Survival data from an IQUO register study on the treatment of patients with prostate cancer with Degarelix in daily clinical practiceGeiges G.¹, Eckert R.², Eichenauer R.³, Harms T.⁴, König F.⁵, Rodemer G.⁶, Thösen C.⁷

  12 Nov 2015

  842

  Introduction & Objectives

  Collection of data in daily clinical practice on the efficacy and safety of Degarelix in the treatment of patients with prostate cancer (PCa).

  Material & Methods

  Data of 1,010 Degarelix patients were collected. During the assessment, previous treatment, concomitant medication, stage and grade of tumour as well as alkaline phosphatase, testosterone and PSA-value, side-effects, and overall survival were documented. At the time of this assessment the maximum follow-up was 48 months.

  Results

  The median overall survival was not yet reached. The 75% threshold for overall survival was reached for all patients after 149 weeks (176 vs. 132 weeks in the sub-groups of hormone-naive patients and patients with previous hormone treatment, respectively, Fig. 1).

  In the sub-group of patients with previous LHRH agonist therapy, the median time to PSA progression was shorter (30 weeks, 75% threshold) than in the group without previous LHRH therapy (88 weeks, 75% threshold, Fig. 2). A higher proportion of patients with previous LHRH therapy experienced PSA progression (25%, n=114) as compared to patients without previous LHRH therapy (15%, n=86).

  In the sub-group of metastatic patients, the median progression-free survival was 141 weeks. The median follow-up of the whole patient population was 128 weeks (32 months).

  The mean prostate volume decreased from 37 ml at the beginning (n=85) to 30 ml after 3 months (19% decrease, n=25) and 26 ml after 6 months (30% decrease, n=16).

  The most frequent side-effects were hot flushes (12.87%), erythema at the injection site (8.5%) and fatigue (5.25%).

   

  Conclusions

  Efficacy and safety of Degarelix were confirmed in routine daily practice. The median survival was not yet reached. The 75% threshold for the overall survival was reached after 37 months. Thus, these values are already above those reported in scientific literature for LHRH agonists at 25-31 months.

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• EP173: Diagnostics and monitoring of disease course of the induratio penis plastica using three dimensional ultrasound examination – Nine years’ experienceTyloch J., Tyloch D., Wolski Z.

  12 Nov 2015

  822

  Introduction & Objectives

  Peyronie's disease is characterized by formation of hardened scar and fibrous tissue in the tunica albuginea, septum and corpora cavernosa of the penis. Its typical symptoms are the painful bend during erection, which makes sexual intercourse difficult and palpable plaque or tough "cord"  on the dorsal side of the penis. Proper evaluation of the plaque's location and size is important in the choice of treatment method and in the evaluation of the effects of instituted treatment.
  3D ultrasound transducers enable to obtain three-dimensional images and make the evaluation of the examined organ more accurate.
  The aim of this study was to present the examination methods, indications and advantages of three-dimensional ultrasound in the diagnosis of induratio penis plastica (Peironie' s disease) and assessment of the effects of treatment.

  Material & Methods

  3D ultrasound scanning was performed in twelve patients with Peyronie's disease with palpable plaques in the tunica albuginea of the penis. The scanning was carried out with a linear transducer (ultrasonic wave frequency of 12 MHz) positioned transversely to the long axis of the penis and then moved from the root of the penis towards the glans penis. During movement of the transducer, single ultrasound images are obtained and arranged to give an appearance of a three-dimensional image.

  Results

  We obtained the ultrasound images, encoded as "volumetric units", or voxels, and arranged to form a cube, which was later computer-processed, using a specially designed computer program. In addition to traditional longitudinal and transverse views, it enabled to obtain also a coronal view. In patients with Peyronie's disease, this third view is of great importance since it allows for visualization of the whole plaque. Careful image analysis performed after the examination (not in the patient's presence) allowed to identify other, smaller plaques which were not observed prior to examination.

  Conclusions

  l. 3D ultrasound diagnosis allows for more accurate evaluation of pathologic changes in the tunica albuginea of the penis in Peyronie's disease.
  2. Final evaluation involving analysis of obtained images is done after the examination and not in the patient's presence.
  3. Examination time is shortened when compared with two-dimensional ultrasound.

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• P130: Differences in mortality and patient characteristics between national health service patients and those with private health insurance post radical cystectomyRobinson S., Rao A.

  12 Nov 2015

  775

  Introduction & Objectives

  Mortality from cancer appears to be due to a complex of demographic and clinical factors of which insurance is a part.
  We looked at 257 patients undergoing radical cystectomy and compared their presenting characteristics and their mortality rates, all cause, disease specific and progression rates between those treated in the national health service (NHS) and those with private health insurance (PHI).

  Material & Methods

  Various characteristics were compared using Fishers and t tests.
  Kaplan Meier curves were generated for the two cohorts for progression and mortality and logistic regression applied to generate significant predictors. The operations were all performed by the same surgeon.

  Results

  Characteristic	NHS n = 225	PHI n = 32	P
  Age years	68	64	0.026
  Tumour volume cc	22	11	0.18
  Positive surgical margins	32 (14%)	2 (6%)	0.27
  Stage localised           Locally advanced	146 (56%) 99 (44%)	20 (62%) 12 (38%)	0.84
  Carcinoma in situ	92 (41%)	19 (59%)	0.057
  Mean number of nodes dissected	9	13	0.006
  Patients with nodal involvement	43 (19%)	7 (22%)	0.811
  Nodal extracapsular extension	24/43	4/7	1.0
  Complications	89 (40%)	4 (13%)	0.002
  Additional treatment given	38 (17%)	4 (13%)	0.79
  Neobladder	40 (18%)	12 (38%)	0.16

   
   

  All cause mortality
  	coefficient	P	Odds ratio
  Neobladder	-0.8	0.0154	0.42
  Private patient	-1.4	0.0013	0.24
  T3	1.007	0.0008	2.7
  T4	1.97	<0.0001	7.18
  Disease specific mortality
  Additional treatment	0.77	0.021	2.17
  Complication	0.73	0.013	2.08
  Neobladder	-0.95	0.015	0.38
  Node density	2.26	0.014	9.67
  Private patient	-1.08	0.035	0.33
  Progression
  Additional treatment	0.74	0.029	2.11
  Private patient	-1.92	0.002	0.14
  T2	1.18	0.010	3.28
  T3	1.99	<0.0001	7.3
  T4	1.89	0.0001	6.6

  Conclusions

  The PHI cohort generated negative protective coefficents on all three survival analyses.
  PHI younger, with more nodes taken during nodal dissection and have less complications.
  Regarding prognosis, PHI was a significant protective risk variable for ACM (OR 0.24),  DSM (OR 0.33) and PFM (0.14).
   
  Also (but not statistically significant), those with PHI had smaller tumours, less PSM, less locally advanced disease, less additional treatments (adjuvant, neoadjuvant, radiotherapy and chemotherapy), more neobladders and more CIS.
  However, stage, additional treatment and neobladder were all significant predictors of survival. These were all favourable in those with PHI.
   
  The higher ACM may be due to overall poorer health, more comorbidities, unhealthy behaviour? Inadequate preventive health care, poor management of chronic conditions, barriers to receiving treatment, inability to navigate health care system, high cost, misinformation and distrust of healthcare system, lack of transport, lack of time off work. Lower quality of treatment offered by providers  serving Medicaid and uninsured. Further, there is no lead time bias (perceived increased survival time with no effect on course of cancer) with bladder cancer as there is no screening protocol, unlike prostate.
   
  This study shows significant differences in prognosis post cystectomy to those treated in the NHS and those treated privately.

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