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178 Abstracts

  • Introduction & Objectives

    Complete metastasectomy in patients with potentially surgically resectable metastases have an important role in the management of metastatic renal cell carcinoma (mRCC). Clinical benefits of incomplete or Partial Metastasectomy (PME) can be assessed in the era of targeted therapy. The aim of present retrospective study was to evaluate the preliminary efficacy of PME and following targeted therapy.

    Material & Methods

    Data was collected from single center for patients with clear cell mRCC and metastases at presentation treated surgically with following therapy or medical treatment alone from 2008-2015. Resection of metastases was incomplete (patients had at least 1 but not all metastases resected). All patients had prior nephrectomy. Kaplan Meier analysis was used to estimate Progression-Free (PFS) and Overall (OS) survival.

    Results

    Median follow-up was 31.2 months (3–82). In total, 47 of 147 patients (32.0%) received PME with systemic therapy, and 100 (68.0%) patients were treated with systemic therapy alone. These treatments included sunitinib (n=53), bevacizumab+IFN (n=11), pazopanib (n=21), sorafenib (n=73), axitinib (n=11), everolimus (n=22), and immunotherapy (n=56). 80 (54.4%) patients received more than 2 treatment lines. Most common metastatic sites were lungs (70%) and bones (28%). MSKCC, Age and Rare metastatic sites were significant prognosic predictors od Survival and PFS (р<0.01) but did not differed between patients who did and did not undergo PME (P>0.05). OS rate was higher in group of combined treatment (PME+ST) compare to Systemic Treatment (ST): 32 and 29 months, respectively (р=0.08). There was associated with a trend of improvement in survival in patients who underwent  treatment of PME and ST sequentially, then it was provided concurrently, with  OS of 46 months (95% CI1,67 (0,8 – 3,1) compared with 31 months (95% CI 0.59 (0,3-1,1)) in favour of sequential scheme (P=0.09). Also, PME significantly increased PFS in first-line therapy (P=0.018), and did not cause a significant impact on PFS in second- or third- lines (P>0.1).

    Conclusions

    The current results supposed that partial metastasectomy of RCC lesions may be associated with increased efficacy of first-line targeted therapy and long-term survival of selected mRCC patients. Prospective trials are needed to better establish the role of iME in this group of patients.

  • Introduction & Objectives

    Laparoscopic Radical Cystectomy (LRC) is a technically high-demanding procedure requiring advanced laparoscopic skills. LRC offers a complete minimally invasive alternative with equivalent oncologic outcomes compared to open surgery. One of the time-consuming steps in LRC is the transection of the vascular pedicle from the bladder (and prostate). In this study we investigated the use of an endoscopic stapling device for this step, looking at the peri- and postoperative outcome.

    Material & Methods

    From December 2015 till October 2016, 21 patients underwent LRC using the new stapling technique: the vascular bladder (and prostate) pedicle was transected using a laparoscopic stapling device (Echelon® 60mm). The same stapling device was used later in the procedure for the side-to-side anastomosis of the small intestine, creating the Bricker-loop or neobladder. We compared this group with our control-group of 122 patients who underwent LRC from January 2005 till October 2014. In the previous procedures we used Hemolock® clips and ultrasonic sealing (Ultracision®) for the transection of the vascular bladder (and prostate) pedicle. The indication for surgery in both groups was Muscle Invasive Bladder Carcinoma (MIBC) or BCG-resistant high-risk non-MIBC. All procedures were performed by the same urologist. Patient characteristics and peri-operative data are reported. All data were prospectively collected.

    Variables LRC (n=122) LRC stapling (n=21)
    Age Mean 68,5 69,4
    Median 69,3 71
    Gender Male - n (%) 96 (78,7%) 8 (38,1%)
    Female - n (%) 26 (21,3%) 13 (61,9%)
    BMI Mean 24,9 26,2
    Median 24,1 26,6
    Clinical Stage
    - n (%)
    CIS, BCG-resistant 7 (5,7%)  
    pTa-1 GrIII, BCG-resistant 22 (18,0%) 6 (28,6%)
    pT2 82 (67,2%) 12 (57,1%)
    cT3 4 (3,3%)  3 (14,3%)
    cT4 5 (4,1%)  
    Table 1. Pre-operative characteristics

    Results

    In our study we found that LRC + stapling compared to LRC without stapling showed a highly significant decrease in operation time and a decrease in blood loss. The postoperative hospital stay in the LRC + stapling group was significantly decreased with six days on average. The transfer to the ICU was also lower in the LRC+stapling group.

    Variables LRC (n=122) LRC stapling (n=21) P-value
    Urinary    derivations Bricker 111 (90,1%) 18 (85,7%)  
    Neobladder 9 (7,3%) 3 (14,3%)  
    Indiana Pouch 2 (1,6%)    
    Operation time (min) Mean 358 290 <0,001
    Median 343 275  
    Blood loss (ml) Mean 630 432 0,065
    Median 400 350  
    Hospital stay (days) Mean 17 11 <0,001
    Median 13 10  
    Transfer IC 19 (15,7%) 0 0,012
    MC 18 (14,9%) 2 (9,5%) 0,523
    Ward 84 (69,4%) 19 (90,5%) 0,010
     Table 2. Per- and postoperative results

    Conclusions

    This study shows promising results in the use of a stapling device in LRC: lower perioperative blood loss, reduction in operating time and admission stay. The biases in this study were the small series in LRC + stapling, a difference in experience of the surgeon and a difference in gender between the both groups. Despite of these biases we think we have proved the feasibility of this new technique with this study. Future research and data analysis is necessary to further investigate this subject, looking at cost-effectiveness and long-term follow-up.

  • Introduction & Objectives

    Radium-223 (Ra223) is a registered therapy for bone metastatic castration-resistant prostate cancer (CRPC), with a proven overall survival (OS) benefit of 3.6 months. There is a need for more clinical data to define which variables are associated with the OS benefit of Ra223 therapy. The aim of this study was to identify pre-therapeutic variables associated with OS in patients treated with Ra223.

    Material & Methods

    Data from 45 CRPC patients treated with Ra223 were retrospectively analyzed. All patients who received at least one Ra223 injection were included in the study. Cox proportional hazard regression models were used to estimate hazard ratio’s (HR) and to test for association.

    Results

    Median age at start of Ra223 therapy was 71 years (range 51-84) and median follow-up was 13 months (range 1-38). At time of analysis, 38 (84%) patients had died. Median OS since start of Ra223 was 13.0 months (95% CI 8.2-17.8).
    Univariable analysis showed poor baseline ECOG performance status (PS), baseline opioid use, lowered baseline hemoglobin, and elevated prostate-specific antigen, alkaline phosphatase and lactate dehydrogenase (LD) levels were significantly associated with OS. Multivariable Cox regression analysis demonstrated that poor baseline ECOG PS (HR 10.6) and high LD levels (HR 7.7) were pre-therapeutic variables that predicted poor OS (table 1).
    The median number of injections was five; 21 patients (47%) received 6 injections, 24 patients (53%) received 1-5 injections. Patients who completed Ra223 therapy had a median OS of 19.7 months (95% CI 14.9-24.6), while patients who received one to five injections had a median OS of 5.9 months (95% CI 3.8-8.1; P < 0.001; figure 1). We found significant differences between patients who received 1-5 injections and those who completed therapy regarding baseline LD levels, baseline opioid use and prior use of abiraterone or enzalutamide. 

    Table 1. Multivariable Cox regression analysis

    Variable n Hazard Ratio 95% CI p
    Prior abiraterone or enzalutamide (yes vs no) 32 2.38 0.91-6.23 0.08
    ECOG performance score (0 vs 1) 26 10.62 3.07-36.73 <0.01
    ECOG performance score (0 vs 2-3) 23 5.67 1.74-18.47 <0.01
    Log lactace dehydrogenase 32 7.67 1.75-33.53 <0.01


    Figure 1.

    Conclusions

    In a multivariable Cox regression model, good baseline ECOG PS and low LD levels were significantly associated with longer OS in patients treated with Ra223. These variables may be used for stratification of CRPC patients for Ra223 therapy. Prospective studies to evaluate these variables are warranted, to develop a nomogram to select patients properly.

  • Introduction & Objectives

    Urinary Toxicity (UT) still represents a crucial issue in the Radiation Treatment (RT) of Prostate Cancer (PCa), owing to both the unchanged need over time, despite the widespread availability of modern IMRT techniques, to include the bladder neck/vesico-urethral anastomosis in the “high-dose” region and, more importantly, to the unpredictability of late events. Stool calprotectin has a well-established role in the monitoring of intestinal inflammation in patients (pts) with inflammatory bowel diseases. In this preliminary study, urinary calprotectine (UrCALPRO) was used as a potential marker of UT.

    Material & Methods

    Twenty pts were treated by RT with either radical, adjuvant or salvage intent. An IPSS (International Prostate Symptoms Score) questionnaire was filled-in by pts at baseline, at RT mid-point, end, and 90 days after RT end. With the same schedule, a urine sample was collected and diluted 1:10 in the Diluent Buffer, mixed by vortex (10 sec), and incubated at room temperature for 20 minutes. Levels of UrCALPRO were measured by means of fast immunochromatography assay (Calfast Reader) and the results expressed as mg/kg. The agreement between Calfast and subsequent ELISA assays was good.

    Results

    An increase in UrCALPRO levels with respect to baseline (Fig. 1) was recorded at RT mid-point, end, and 3 months after RT conclusion (p=0.001, 0.004 and 0.11, respectively, ANOVA test). A similar trend was observed (Fig. 1) for the overall IPSS score: p=0.002, <0.0001 and 0.13, respectively. At Wilcoxon paired samples test, the association between the variations of UrCALPRO levels and IPSS scores (both the 8 single items and the overall sum score) with respect to baseline was always significant (p≤0.0003) at RT mid-point and end, and of borderline significance at 3 months (p=0.08-0.13). 

    Conclusions

    Although preliminary, these findings suggest UrCALPRO as a potentially robust and easy to use tool for the timely assessment of RT-induced UT. If confirmed on a larger population, its role could be of potentially enormous importance in the timely detection and management of late events, often consequent to severe acute UT.
    This study was supported by a grant from the Associazione Italiana Ricerca Cancro (Investigational Grant 14603) - ClinicalTrials.gov Identifier NCT02803086.

  • Introduction & Objectives

    To assess therapeutic approaches to muscle-invasive bladder cancer at Radiation Oncology Services in Spain.

    Material & Methods

    A specifically-designed questionnaire was submitted to Radiation Oncology Services in Spain via e-mail, to assess their therapeutic approach to bladder cancer over five years.

    Results

    A total of 26 centers (30.5% of the total, of which 96% were public and 81% were university hospitals) answered the questionnaire. Of these, 92% reported to have a Urology Tumor Board that makes consensual decisions. 96%  of these boards are composed of  urologist, medical oncologist and radiation oncologist, and 62% have also  pathologist and radiologist. Additionally, 77% of the respondent hospitals had designed a specific treatment protocol. Treatment approaches was reported to be systematically determined by the Board at 92% of hospitals. Treatments provided at hospitals for muscle invasive bladder cancer: A total of 100% of hospitals provide radical 3D conformal radiation therapy and three hospitals also performed IRMT and one Tomotherapy. The radiation therapy scheme designed for “bladder preservation” was reported to include both options: single-dose series (continuous irradiation without response evaluation after 40-45 Gy) or fractionated series (irradiation with response evaluation by cystoscopy and by radical transurethral resection after 40-45 Gy). A total of 64% of hospitals “always” perform single-dose series, of which 19% “sometimes” perform fractionated series. The average of patients on radical radiation therapy in  2010 was 51%, in 2013  was 47%, and in 2014 was 43%, with a statistically significant decreasing tendency (p=0.02).

    Conclusions

    At public hospitals in Spain, there are multidisciplinary urology tumor boards where urologists, radiation oncologists and medical oncologists collaborate to systematically make consensual decisions. In this period there is a significant downward trend in the use of radiotherapy for bladder sparing.

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