Urinary bother, Urinalysis, and Two-Year Efficacy Follow-Up Results of Phase I Trial of Intravesical Bacillus Calmette-Guérin Combined with Intravenous Pembrolizumab in Recurrent or Persistent High-Grade Non-Muscle-Invasive Bladder Cancer after Previous Bacillus Calmette-Guérin Treatment.

OBJECTIVE: To report urinary bother, urinalysis changes, disease-free survival (DFS), and overall survival (OS) over 2 years for subjects enrolled in a phase I dose-escalation trial (NCT02324582) of intravesical Bacillus Calmette-Guérin (BCG) in combination with systemic pembrolizumab for recurrent or persistent high-grade non-muscle invasive bladder cancer (HGNMIBC). METHODS: Eighteen patients consented to the study. Five were screen failures. Clinical activity was determined using cystoscopy and cytology with a biopsy of suspicious lesions. Urinalysis and International Prostate symptom score were assessed at pre-treatment, Week 10 (during combined BCG and pembrolizumab treatment), and 3 and 6 months from treatment completion. IPSS was analyzed using a mixed-model repeated measures analysis. A Chi-square test was used to compare urinalysis results at each interval. RESULTS: The pathologic disease stage after restaging transurethral resection and before treatment was pTa in 6 (46.2%), CIS in 6 (46.2%), and pT1 in 1 (7.7%). There was no increase in reported urinary bother throughout treatment. Quality of life measurements demonstrated no change in subjective burden. On urinalysis, we did not observe significant differences at 3 months compared to baseline evaluation. At 12 months, the DFS and OS were 69.23% and 92.31%, respectively. At 24 months, the DFS and OS were 38.46% and 92.31%, respectively. CONCLUSIONS: Treatment with BCG combined with intravenous pembrolizumab is not showing increased urinary bother or adverse urinalysis changes. Two-year response data is promising and await confirmation in the phase III study (Keynote 676).

Intermediate-Term Oncologic Outcome Assessment for Robot-Assisted Radical Prostatectomy: Comparing Retzius-Sparing with Standard Approach in a Randomized Control Cohort.

Introduction: Retzius-sparing prostatectomy was promoted with the early continence result. The long-term oncologic outcome is still unknown. In this study, we aimed to compare the intermediate-term oncologic outcomes of these two approaches in patients' cohort who were treated as part of a randomized controlled trial. Methods: A total of 120 patients were previously randomized equally to receive Retzius-sparing robot-assisted laparoscopic radical prostatectomy (RS-RARP) vs standard robot-assisted laparoscopic radical prostatectomy (S-RARP) between January 2015 and April 2016. Baseline, surgical, and pathologic characteristics as well as oncologic outcomes were assessed. The analysis was done based on the treatment received. Result: Sixty-three patients underwent S-RARP, whereas 57 patients underwent RS-RARP. There was no statistically significant difference in the baseline nor surgical characteristics. The median follow-up was 71.24 (interquartile range: 59.75-75.75) months. There were more pathologic T3 diseases in RS-RARP. There was no significant difference in the positive margin status nor in the biochemical recurrence (BCR) rate among both groups. After S-RARP and RS-RARP, 6 and 10 patients had BCR, and the 5 years BCR-free survival was 91% and 85%, respectively (p = 0.21). Conclusion: In this cohort, there was no difference in BCR in the patients who received either technique. Further multi-institutional studies with a larger sample size and longer follow-up are required.

Admission Rates, Healthcare Utilization, and Inpatient Cost of Radiation Cystitis in the United States.

OBJECTIVE: To assess the incidence, cumulative healthcare burden, and financial impact of inpatient admissions for radiation cystitis (RC), while exploring practice differences in RC management between teaching and nonteaching hospitals. METHODS: We focused on 19,613 patients with a diagnosis of RC within the National Inpatient Sample (NIS) from 2008 to 2014. ICD-9 diagnosis and procedure codes were used. Complex-survey procedures were used to study the descriptive characteristics of RC patients and the procedures received during admission, stratified by hospital teaching status. Inflation-adjusted cost and cumulative annual cost were calculated for the study period. Multivariable logistic regression was used to study the impact of teaching status on the high total cost of admission. RESULTS: Median age was 76 (interquartile range 67-82) years. Most of the patients were males (73%; P < .001). 59,571 (61%) patients received at least one procedure, of which, 24,816 (25.5%) received more than one procedure. Median length of stay was 5days (interquartile range 2-9). Female patients and patients with a higher comorbidity score were more frequently treated at teaching hospitals. A higher proportion of patients received a procedure at a teaching hospital (64% vs 59%; P < .001). The inflation-adjusted cost was 9207 USD and was higher in teaching hospitals. The cumulative cost of inpatient treatment of RC was 63.5 million USD per year and 952.2 million USD over the study period. CONCLUSION: The incidence of RC-associated admissions is rising in the US. This disease is a major burden to US healthcare. The awareness of the inpatient economic burden and healthcare utilization associated with RC may have funding implications.

Robot-assisted vs. Laparoscopic Partial Nephrectomy: utilization rates and perioperative outcomes

Objectives To examine the effect of surgical approach on perioperative morbidity and mortality after partial nephrectomy. Materials and Methods Within the Nationwide Inpatient Sample, patients who underwent RAPN or LPN between October 2008 and December 2009 were identified. Propensity-based matching was performed to adjust for potential baseline differences between the two groups. The rates of intraoperative and postoperative complications, blood transfusions, prolonged length of stay, and in-hospital mortality, stratified according to RAPN vs. LPN, were compared. Results Overall, 851 (72.5%) patients underwent RAPN and 323 (27.5%) underwent LPN. For RAPN and LPN respectively, the following rates were recorded in the propensity-score matched cohort: blood transfusions, 4.5 vs. 6.8% (p = 0.223); intraoperative complications, 5.2 vs. 2.6% (p = 0.096); postoperative complications, 10.6 vs. 13.5% (p = 0.268); prolonged length of stay, 6.8 vs. 9.4% (p = 0.238); in-hospital mortality, 0.0 vs. 0.0%. Conclusions RAPN has supplanted LPN as the predominant minimally invasive surgical approach for renal masses. Perioperative outcomes after RAPN and LPN are comparable. Interpretation of these findings needs to take into account the lack of adjustment for case complexity and surgical expertise. .