Quality of Life in the Phase 2/3 Trial of N-803 Plus Bacillus Calmette-Guérin in Bacillus Calmette-Guérin‒Unresponsive Nonmuscle-Invasive Bladder Cancer.

INTRODUCTION: In the phase 2/3 study QUILT-3.032 (NCT03022825), the ability of the IL-15RαFc superagonist N-803 (nogapendekin alfa inbakicept) plus bacillus Calmette-Guérin (BCG) to elicit durable complete responses in patients with BCG-unresponsive nonmuscle-invasive bladder cancer (NMIBC) was demonstrated. As a secondary end point, patient-reported outcomes (PROs) were assessed. METHODS: Both cohort A patients with carcinoma in situ with or without Ta/T1 disease and cohort B patients with high-grade Ta/T1 papillary disease who received N-803 plus BCG therapy completed the EORTC (European Organization for Research and Treatment of Cancer) Core 30 and Quality of Life NMIBC-Specific 24 questionnaires at baseline and months 6, 12, 18, and 24 on study. Scores were analyzed using descriptive statistics, and multivariable analyses were performed to identify baseline variables associated with PROs. RESULTS: On study, mean physical function (PF) and global health (GH) scores remained relatively stable from baseline for cohorts A (n = 86) and B (n = 78). At month 6, cohort A patients with a complete response reported higher PF scores than those without (P = .0659); at month 12, > 3 as compared with ≤ 3 prior transurethral resections of bladder tumor was associated (P = .0729) with lower GH scores. In cohort B, baseline disease type was associated (P = .0738) with PF and race was significantly associated (P = .0478) with GH at month 6. NMIBC-Specific 24 summary scores also remained stable on study for both cohorts. CONCLUSIONS: The overall stability of PROs scores, taken together with the efficacy findings, indicates a favorable risk-benefit ratio and quality of life following N-803 plus BCG.

Providing Access to Care through a 24-Hour Dedicated Stone Line.

INTRODUCTION: Many patients with urolithiasis are seen acutely in the emergency department for initial treatment. In an effort to improve cost and quality of care increasing focus has been placed on shifting management of low acuity conditions from emergency departments to outpatient settings. One barrier to such initiatives is timely access to outpatient services. We established a telephone stone line to provide access to outpatient urological care of kidney stones and we report our initial experience. METHODS: A 24-hour dedicated telephone stone line was created with calls answered by dedicated staff. A computer program was created to track stone line calls and post-call care. We retrospectively analyzed all stone line calls received in a 4-year period with the focus on utilization and cost. An e-mail survey was performed to assess patient satisfaction. RESULTS: Between January 2009 and July 2013 the mean call volume was 2,107 per year. A significant distribution of calls was seen across all days and hours. Duration was less than 15 minutes in 7,761 calls (82%). Patients or family members placed 77% of calls and physicians placed 16%. As a result of a stone line call, 4,173 patients (76%) were seen by a urologist within 48 hours. Of the patients 88% reported satisfaction with the stone line. The mean annual cost of providing the telephone stone line was $51,873. CONCLUSIONS: Our experience demonstrates sustained utilization of and satisfaction with the telephone stone line. Further, stone line use results in timely outpatient evaluation in the majority of patients. Further analysis to assess for a cost benefit is ongoing.

Clinical variables and stone detection in patients with flank pain.

INTRODUCTION: Non-contrast CT (NCT) is commonly used to evaluate flank pain (FP). We sought to evaluate incidence of ureteral calculi on NCT in patients with FP, and to determine if clinical variables are associated with higher detection rates. MATERIALS AND METHODS: Retrospective review identified 613 patients undergoing NCT for FP. Patient clinical data, NCT findings, and intervention were analyzed. Focus was placed on variables commonly associated with urolithiasis (Vstone), comprising hematuria, nausea/vomiting, and prior stone history. Statistical analysis was performed to identify risk of ureteral stones based on number and type of Vstone. RESULTS: No stone disease was identified on NCT in 175 patients (28.5%). NCT demonstrated 214 (35%), 72 (12%), and 152 (25%) patients with stones located in the kidney, ureter, or both, respectively. Only 33 (5%) patients had FP as their sole Vstone, with ureteral calculi identified in 6% of this cohort. The rate of ureteral calculi increased with more Vstone. Patients having all four Vstone were found to have the highest rate of ureteral stones (59%). Statistical analysis demonstrated a statistically significantly increased relative risk of stone formation given three or four Vstone when compared with FP alone. CONCLUSIONS: Whereas isolated FP is associated with a lower rate of ureteral calculus detection, a significant increased relative risk of ureteral calculus is seen in patients with additional clinical variables associated with stone disease. Accordingly, it may be possible to improve detection rates of ureteral stones through the use of additional clinical variables to guide NCT selection.

Clinical and economic impact of implementation of slow shockwave lithotripsy for the treatment of urinary calculi.

AIM: To analyze the impact of slowing the shockwave delivery during extracorporeal shockwave lithotripsy (SWL) on the clinical patient outcome and the cost of delivering this service in a community practice. PATIENTS AND METHODS: The data from 1745 consecutive SWL procedures were analyzed at a freestanding surgery center. About 872 treatments were performed at 120 shocks per minute (fast rate [FR]) and 873 were performed at 60 shocks per minute (slow rate [SR]) using a Lithotron machine. Ninety-nine percent of the patients received 3000 shocks. The location and stone size were similar in both groups. Stone-free rate was determined by a plain film of the abdomen at follow-up. RESULTS: The clinical outcome of SR shows a statistically significant improvement in stone-free rate on all stone locations and stone sizes except for those smaller than 25 mm(2). The need for additional secondary treatment decreased from 35.4% to 18.2%. The anesthesia time increased from 26 to 50 minutes per treatment. On the basis of Medicare reimbursement, there was an increase of $28,294 for anesthesia services by going SR. However, the savings realized as a result of decrease in secondary procedures was $264,989, resulting in a total savings of $236,695 during the study period. The cost savings was $271.13 per SWL treatment. CONCLUSION: The slowing of SWL treatment results in a longer procedure decreasing the time available for treatment; however, the clinical outcome results in improved patient quality of care and decreased cost. Slowing SWL both benefits the patient and decreases the cost of SWL in the community setting.