IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer.

IL-15 Superagonist NAI in BCG-Unresponsive NMIBCIn this trial, patients with BCG-unresponsive bladder CIS with or without Ta/T1 papillary disease or BCG-unresponsive high-grade Ta/T1 papillary NMIBC were treated with intravesical NAI, an IL-15 superagonist, plus BCG. Primary end points were CR at 3 or 6 months for patients with CIS disease and DFS rate at 12 months for those with high-grade Ta/T1 disease. CR rate was 71% (58 of 82 patients), and the DFS rate was 55.4%.

Validation of an mRNA-based Urine Test for the Detection of Bladder Cancer in Patients with Haematuria.

BACKGROUND: In patients with haematuria, a fast, noninvasive test with high sensitivity (SN) and negative predictive value (NPV), which is able to detect or exclude bladder cancer (BC), is needed. A newly developed urine assay, Xpert Bladder Cancer Detection (Xpert), measures five mRNA targets (ABL1, CRH, IGF2, UPK1B, and ANXA10) that are frequently overexpressed in BC. OBJECTIVE: To validate the performance of Xpert in patients with haematuria. DESIGN, SETTING, AND PARTICIPANTS: Voided precystoscopy urine specimens were prospectively collected at 22 sites from patients without prior BC undergoing cystoscopy for haematuria. Xpert, cytology, and UroVysion procedures were performed. Technical validation was performed and specificity (SP) was determined in patients without BC. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Test characteristics were calculated based on cystoscopy and histology results, and compared between Xpert, cytology, and UroVysion. RESULTS AND LIMITATIONS: We included 828 patients (mean age 64.5 yr, 467 males, 401 never smoked). Xpert had an SN of 78% (95% confidence interval [CI]: 66-87) overall and 90% (95% CI: 76-96) for high-grade (HG) tumours. The NPV was 98% (95% CI: 97-99) overall. The SP was 84% (95% CI: 81-86). In patients with microhaematuria, only one HG patient was missed (NPV 99%). Xpert had higher SN and NPV than cytology and UroVysion. Cytology had the highest SP (97%). In a separate SP study, Xpert had an SP of 89% in patients with benign prostate hypertrophy and 92% in prostate cancer patients. CONCLUSIONS: Xpert is an easy-to-use, noninvasive test with improved SN and NPV compared with cytology and UroVysion, representing a promising tool for identifying haematuric patients with a low likelihood of BC who might not need to undergo cystoscopy. PATIENT SUMMARY: Xpert is an easy-to-perform urine test with good performance compared with standard urine tests. It should help identify (micro)haematuria patients with a very low likelihood to have bladder cancer.

Prospective Validation of an mRNA-based Urine Test for Surveillance of Patients with Bladder Cancer.

BACKGROUND: A fast, noninvasive test with high sensitivity (SN) and a negative predictive value (NPV), which is able to detect recurrences in bladder cancer (BC) patients, is needed. A newly developed urine assay, Xpert Bladder Cancer Monitor (Xpert), measures five mRNA targets (ABL1, CRH, IGF2, UPK1B, and ANXA10) that are frequently overexpressed in BC. OBJECTIVE: To validate Xpert characteristics in patients previously diagnosed with non-muscle-invasive BC. DESIGN, SETTING, AND PARTICIPANTS: Voided precystoscopy urine samples were prospectively collected at 22 sites. Xpert, cytology, and UroVysion were performed. If cystoscopy was suspicious for BC, a histologic examination was performed. Additionally, technical validation was performed and specificity was determined in patients without a history or clinical evidence of BC. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Test characteristics were calculated based on cystoscopy and histology results, and compared between Xpert, cytology, and UroVysion. RESULTS AND LIMITATIONS: Of the eligible patients, 239 with a history of BC had results for all assays. The mean age was 71 yr; 190 patients were male, 53 never smoked, and 64% had previous intravesical immunotherapy (35%) or chemotherapy (29%). Forty-three cases of recurrences occurred. Xpert had overall SN of 74% (95% confidence interval [CI]: 60-85) and 83% (95% CI: 64-93) for high-grade (HG) tumors. The NPV was 93% (95% CI: 89-96) overall and 98% (95% CI: 94-99) for HG tumors. Specificity was 80% (95% CI: 73-85). Xpert SN and NPV were superior to those of cytology and UroVysion. Specificity in non-BC individuals (n=508) was 95% (95% CI: 93-97). CONCLUSIONS: Xpert has an improved NPV compared with UroVysion and cytology in patients under follow-up for BC. It represents a promising tool for excluding BC in these patients, reducing the need for cystoscopy. PATIENT SUMMARY: Xpert is an easy-to-perform urine test with good performance compared with standard urine tests. It should help optimize the follow-up of recurrent bladder cancer patients.

Laparoscopic radical prostatectomy: initial 70 cases at a U.S. university medical center.

OBJECTIVES: To report our experience with the first 70 cases of laparoscopic radical prostatectomy. Radical retropubic prostatectomy is an accepted therapy for the management of locally confined prostate cancer. Recently, laparoscopic prostatectomy has been introduced as a minimally invasive alternative to open radical prostatectomy. Several published series from Europe have demonstrated that laparoscopic radical prostatectomy is a safe and feasible approach to the management of localized prostate cancer. METHODS: From May 2000 to May 2001, transperitoneal laparoscopic radical prostatectomy was performed on 70 men, aged 40 to 76 years, who were appropriate candidates for radical retropubic prostatectomy. Patient characteristics, surgical statistics, and pathologic results were prospectively collected. RESULTS: The mean preoperative prostate-specific antigen level was 6.6 ng/mL (range 1.5 to 20.7). The preoperative Gleason sum was 6 in 53 patients (75.7%), 7 in 16 (22.9%), and 8 in 1 patient (1.4%). The mean operating time was 274 minutes (range 165 to 495). The estimated blood loss averaged 449 mL (range 50 to 2750), and 4 patients (5.7%) required blood transfusions. In 1 case, we converted to a standard retropubic approach. Two intraoperative (2.9%) and 14 (20%) overall postoperative complications occurred. Positive surgical margins were reported in 8 specimens (11.4%). At a minimum of 3 months' follow-up, 85% reported use of 0 or 1 pad per day. The operative times, amount of blood loss, and complication rate decreased dramatically with experience. CONCLUSIONS: Laparoscopic radical prostatectomy is a technically demanding procedure that is a feasible option for the surgical treatment of localized prostate cancer. The morbidity of this operation is significantly less than that of radical retropubic prostatectomy. The laparoscopic approach shows significant promise for reducing surgical morbidity and improving the anatomic radical prostatectomy.