Stefania Zamboni

Evaluating the role of neoadjuvant chemotherapy in bladder cancer patients with occult lymph node metastases

Bladder cancer (BCa) is the second most common genitourinary malignancy with 81,190 estimated new diagnosis in the 2018 in the United States only (1). Radical cystectomy (RC) with bilateral pelvic node dissection (PLND) represents the gold standard for very recurrent high risk non-muscle invasive tumors and for muscle invasive BCa (2).

MP11-02 OUTCOMES OF A PHASE III RANDOMIZED CONTROLLED TRIAL COMPARING PREVENTIVE VERSUS DELAYED LIGATION OF DORSAL VASCULAR COMPLEX DURING ROBOT-ASSISTED RADICAL PROSTATECTOMY

Primary endpoint was estimated blood loss (EBL); considering significant a difference 330 ml, a sample size of 226 patients were calculated (two-sided α of 0.05 and 80% power). Secondary endpoints were: transfusion rate, positive surgical margins (PSMs), apical PSMs and 1-month PSA and continence (0-1 security pad/day). Differences were compared using Pearson chi-square test or MannWhitney test as appropriate (p<0.05 was considered statistically significant).

A Novel Nomogram to Identify Candidates for Extended Pelvic Lymph Node Dissection Among Patients with Clinically Localized Prostate Cancer Diagnosed with Magnetic Resonance Imaging-targeted and Systematic Biopsies

BACKGROUND Available models for predicting lymph node invasion (LNI) in prostate cancer (PCa) patients undergoing radical prostatectomy (RP) might not be applicable to men diagnosed via magnetic resonance imaging (MRI)-targeted biopsies. OBJECTIVE To assess the accuracy of available tools to predict LNI and to develop a novel model for men diagnosed via MRI-targeted biopsies. DESIGN, SETTING, AND PARTICIPANTS A total of 497 patients diagnosed via MRI-targeted biopsies and treated with RP and extended pelvic lymph node dissection (ePLND) at five institutions were retrospectively identified. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES Three available models predicting LNI were evaluated using the area under the receiver operating characteristic curve (AUC), calibration plots, and decision curve analyses. A nomogram predicting LNI was developed and internally validated. RESULTS AND LIMITATIONS Overall, 62 patients (12.5%) had LNI. The median number of nodes removed was 15. The AUC for the Briganti 2012, Briganti 2017, and MSKCC nomograms was 82%, 82%, and 81%, respectively, and their calibration characteristics were suboptimal. A model including PSA, clinical stage and maximum diameter of the index lesion on multiparametric MRI (mpMRI), grade group on targeted biopsy, and the presence of clinically significant PCa on concomitant systematic biopsy had an AUC of 86% and represented the basis for a coefficient-based nomogram. This tool exhibited a higher AUC and higher net benefit compared to available models developed using standard biopsies. Using a cutoff of 7%, 244 ePLNDs (57%) would be spared and a lower number of LNIs would be missed compared to available nomograms (1.6% vs 4.6% vs 4.5% vs 4.2% for the new nomogram vs Briganti 2012 vs Briganti 2017 vs MSKCC). CONCLUSIONS Available models predicting LNI are characterized by suboptimal accuracy and clinical net benefit for patients diagnosed via MRI-targeted biopsies. A novel nomogram including mpMRI and MRI-targeted biopsy data should be used to identify candidates for ePLND in this setting. PATIENT SUMMARY We developed the first nomogram to predict lymph node invasion (LNI) in prostate cancer patients diagnosed via magnetic resonance imaging-targeted biopsy undergoing radical prostatectomy. Adoption of this model to identify candidates for extended pelvic lymph node dissection could avoid up to 60% of these procedures at the cost of missing only 1.6% patients with LNI.

MP05-01 MANAGEMENT AND PROGNOSIS OF POSITIVE SURGICAL MARGINS AFTER RADICAL PROSTATECTOMY: RETROSPECTIVE ANALYSIS OF A CONTEMPORARY COHORT

INTRODUCTION AND OBJECTIVES: Positive surgical margins (PSM) after RP are a known factor associated with BCR. Radiation therapy (RT) currently represents an established option for metastasis-free patients. However, the timing of administration is not univocal. The aim of this study is to identify factors related to the indication to adjuvant radiation therapy (aRT) vs salvage (sRT), taking a picture of the contemporary management and prognosis of patients with PSM after radical prostatectomy (RP) at an academic tertiary institution. METHODS: We retrospectively reviewed our perspectivelymaintained database. RP has been performed with an open retropubic approach until 2010, then with a robotic transperitoneal one.All the cases with PSM and adverse pathological features (stage pT3, GS 8) were submitted to a multidisciplinary discussion. The indication to sRT was given if biochemical recurrence (BCR, PSA 0.2 ng/ml), preferably before PSA >0.5 ng/ml. Logistic regression models were used to determine the factors associated with RT indication and BCR in univariate and multivariate analysis. The BCR-free survival was calculated using KaplanMeier method. RESULTS: Out of 789 patients, 197 had PSM (overall prevalence 25,2%), with monofocal involvement in 121 (60.8%) and multifocal in 78 (39.2%). An aRT was indicated in 40 patients (20.3%). Findings are summarized in table 1. Factors independently related to aRT indication were: pathological stage, number of sites of PSM and post-operative PSA. The median follow-up time was 51.1 months (IQR 30.9-69.3). Among the 157 patients for whom aRT was not indicated, 39 experienced a relapse of PSA (prevalence of BCR 24.8%, p not significant). 26 were then treated by sRT, 8 by androgen deprivation therapy, 5 underwent surveillance. Overall, a BCR was found in 46 patients (23.4%) after a median time of 24.0 months (IQR 18.0-36.0). At the last available control 176 patients (89.3%) had a PSA < 0.2 ng/ml (median value 0.02). Only pathological stage was significantly related to the risk of BCR. CONCLUSIONS: In a real-life scenario, the indication to aRT is more restrictive than what recommended by guidelines and is driven by the amount of PSM and a detectable post-operative PSA. No differences in BCR free survival are evident in patients with PSM submitted to aRT vs sRT. Source of Funding: none

MP34-09 IS A DELAY IN THE TIMING OF RADICAL CYSTECTOMY REALLY DETRIMENTAL? A RETROSPECTIVE STUDY ON A SINGLE CENTRE COHORT

INTRODUCTION AND OBJECTIVES: EAU guidelines recommends radical cystectomy (RC) within a time span of 90 days from the diagnosis, to avoid an impairment in the prognosis, but the literature on this issue is not univocal. This study aims to evaluate if the latency between the diagnosis and cystectomy (LDC) could affect oncological outcomes. METHODS: Retrospective analysis of a perspectivelymaintained database that stores data of all the patients submitted to RC since 2009 at a tertiary academic institution. LDC was defined as the days between RC and the last TURBT. The primary outcome was overall survival (OS), the secondary were: relationship between clinical and pathological features and a LDC >90 days and relationship between LDC and pathological upstaging (pUS) (shift from cT1-2 to pT3-4). Statistical correlations were evaluated by univariate and multivariate Cox regression and binary logistic models, considering as significant p values <0.05. RESULTS: Overall, 226 patients were included from January 2009 to June 2016 (mean/median LDC 89/79 days). A LDC>90 days was observed for 84 patients (37.2%), while pUS in 48 patients (25.7%). After a median follow up time of 17 months, the overall mortality rate was 47.3% (98/226). Table 1 summarizes results. Factors independently related to LDC >90 days were: age (OR1⁄41.047), Charlson Comorbidity Index (CCI)1⁄40 (OR1⁄4 0.428), diagnosis of recurrent BC (OR1⁄4 3.390) and lack of detrusor infiltration at TURBT (OR1⁄4 0.490). Factors related to pUS were: age (RR1⁄41.045) and detrusor infiltration at TURBT (OR1⁄40.307), whereas no relationship was found with LDC (upstaging rate LDC<90 vs >90 days 25.5% vs 26%). OS was independently related to female gender (RR1⁄40.597), CCI>0 (OR1⁄41.377), advanced clinical and pathological staging, and lymph node invasion (OR1⁄42.096), but not to LDC (estimated 2 years OS rate LDC<90 vs >90 days 55% vs 59%). CONCLUSIONS: Elderly and healthier patients with recurrent or clinically NMIBC are more frequently submitted to RC after a longer interval. In daily practice at referral institutions a comprehensive evaluation of the patient could balance known and unknown prognostic factors making negligible the impact of a delay in RC. A threshold of LDC of 90 days seems to affect neither the risk of pUS nor OS and should be discussed in further editions of Guidelines. Source of Funding: None