Compared Efficacy of Adjuvant Intravesical BCG-TICE vs. BCG-RIVM for High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC): A Propensity Score Matched Analysis

Background: Intravesical immunotherapy with bacillus Calmette-Guerin (BCG) is the standard therapy for high-risk non-muscle invasive bladder cancer (NMIBC). The superiority of any BCG strain over another could not be demonstrated yet. Methods: Patients with NMIBCs underwent adjuvant induction ± maintenance schedule of intravesical immunotherapy with either BCG TICE or RIVM at two high-volume tertiary institutions. Only BCG-naïve patients and those treated with the same strain over the course of follow-up were included. One-to-one (1:1) propensity score matching (PSM) between the two cohorts was utilized to adjust for baseline demographic and tumor characteristics imbalances. Kaplan-Meier estimates and multivariable Cox regression models according to high-risk NMIBC prognostic factors were implemented to address survival differences between the strains. Sub-group analysis modeling of the influence of routine secondary resection (re-TUR) in the setting of the sole maintenance adjuvant schedule for the two strains was further performed. Results: 852 Ta-T1 NMIBCs (n = 719, 84.4% on TICE; n = 133, 15.6% on RIVM) with a median of 53 (24-77) months of follow-up were reviewed. After PSM, no differences at 5-years RFS, PFS, and CSS at both Kaplan-Meier and Cox regression analyses were detected for the whole cohort. In the sub-group setting of full adherence to European/American Urology Guidelines (EAU/NCCN), BCG TICE demonstrated longer 5-years RFS compared to RIVM (68% vs. 43%, p = 0.008; HR: 0.45 95% CI 0.25-0.81). Conclusion: When routinely performing re-TUR followed by a maintenance BCG schedule, TICE was superior to RIVM for RFS outcomes. However, no significant differences were detected for PFS and CSS, respectively

Development of a nomogram to predict achievement of trifecta outcomes in patients receving robot-assisted radical cystectomy with intracorporeal orthotopic neobladder

INTRODUCTION AND OBJECTIVE: Robot-assisted radical cystectomy (RARC) with orthotopic neobladder (ON) is associated with heterogeneous surgical, functional and oncological outcomes. We propose a combination of three standardized and reproducible postoperative criteria (Trifecta) to optimize outcomes reporting after RARC with ON and we developed a nomogram to predict probability of achieving trifecta. METHODS: We defined the "trifecta" as the combination of daily urinary continence, no reoperations (meaning neither post-operative complications Clavien-Dindo ≥ 3 nor other surgical interventions related to RARC/ON, after discharge) and recurrence-free status, all assessed at one year. A total of 137 consecutive patients who underwent RARC with intracorporeal ON for bladder cancer were used to generate a nomogram predicting probability of achieving trifecta outcomes. The discrimination accuracy was measured by concordance index (CI). Calibration plot was generated with 200 bootstrap resampling. A decision curve analysis was performed to assess the net benefit of the model. RESULTS: Overall, 137 patients were included in the analysis (Table 1). The trifecta was achieved by 72 (53%) patients. On multivariable logistic regression analysis, age, ASA score, body mass index and neoadjuvant chemotherapy were significant predictors of trifecta achievement. The developed nomogram had a 0.71 CI (Figure 1A) and was well calibrated (Figure 1B); on decision curve analysis, the net benefit of using the model was evident for probabilities ranging between 25% and 70% (Figure 1C). The small sample size and the lack of external validation are the main limitations of this study. CONCLUSIONS: This newly defined trifecta is the first standardized and reproducible system specifically designed to provide a comprehensive summary of global results after RARC-iN. The developed nomogram is an easy clinical tool to predict probability of trifecta achievement at 12-mo follow-up evaluation

Software Product Management

Software organizations evolve and maintain software solutions with more than a single development project. The delta specifications and artefacts that result from each project make reuse difficult and challenge a company’s ability to innovate. Software product management is a growing discipline for understanding how to productise and align software with company strategy, how to evolve software, and how to coordinate product stakeholders. With product focus, in addition to project focus, planning accuracy can be improved, time-to-market reduced, product quality enhanced, and economic success sustained. This chapter provides an overview on software product management and discusses what today is known about this discipline