Lawrence Karsh

Safety and efficacy of a patient‐controlled bladder management system for treating urinary retention in men

The CymActive™ Bladder Management System (BMS) is a self‐retaining, intraurethral catheter with a patient‐controlled magnetic valve that allows cyclical bladder filling and emptying, without external appliances. We determined the safety and efficacy of the BMS in men with urinary retention who required catheterization for more than 7 days.

Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials

BackgroundThis analysis estimated the number needed to treat with enzalutamide versus bicalutamide to achieve one additional patient with chemotherapy-naïve metastatic castration-resistant prostate cancer who would obtain clinical benefit regarding progression-free survival, radiographic progression-free survival, or no prostate-specific antigen progression at 1 and 2xa0years following treatment initiation.MethodsClinical event rates were obtained from the STRIVE (NCT01664923) and TERRAIN (NCT01288911) trials, and the number needed to treat was the inverse of the absolute rate difference between the event rates of enzalutamide and bicalutamide. The 95% Confidence Interval of the number needed to treat was derived from the 95% Confidence Interval of the event rate difference.ResultsUsing STRIVE data (patients with metastatic disease: nu2009=u2009128 enzalutamide; nu2009=u2009129 bicalutamide) comparing enzalutamide with bicalutamide at 1 and 2xa0years, the numbers needed to treat to achieve one additional patient with chemotherapy-naïve metastatic castration-resistant prostate cancer with progression-free survival were 2.0 and 2.8, respectively; with radiographic progression-free survival, 2.6 and 3.0, respectively; and without prostate-specific antigen progression, 1.8 and 2.4, respectively. Using TERRAIN data (nu2009=u2009184 enzalutamide; nu2009=u2009191 bicalutamide) comparing enzalutamide with bicalutamide at 1 and 2xa0years, the numbers needed to treat to achieve one additional patient with progression-free survival were 4.3 and 3.7, respectively; with radiographic progression-free survival, 10.0 and 2.8, respectively; and without prostate-specific antigen progression, 2.1 and 3.2, respectively.ConclusionsThe combined data from TERRAIN and STRIVE demonstrated that treating chemotherapy-naïve metastatic castration-resistant prostate cancer with enzalutamide leads to more patients without clinical progression at 1 and 2xa0years than with bicalutamide.Trial registrationSTRIVE (NCT01664923; registration date: August 10, 2012) and TERRAIN (NCT01288911; registration date: February 1, 2011).

PNFLBA-10 A PHASE III BLINDED STUDY OF IMMEDIATE POST-TURBT INSTILLATION OF GEMCITABINE VERSUS SALINE IN PATIENTS WITH NEWLY DIAGNOSED OR OCCASIONALLY RECURRING GRADE I/II NON-MUSCLE INVASIVE BLADDER CANCER: SWOG S0337

following genes were queried: VHL, PBRM1, SETD2, BAP1, KDM5C, KIT, NFE2L2, MET, TP53, CDKN2A, FGFR3, PIK3CA, BRAF, MUC4. Criteria for calling mutations included adequate frequency by overall count and percentage of reads, identification in all overlapping sequences, and presence of buffy coat for comparison with <0.5% containing the mutation. RESULTS: Thirty preoperative test patients with RCC and 32 healthy controls were analyzed using the gene panel. Of the 32 patients analyzed in the healthy control cohort, 27 (84%) failed to yield sequence of the genes of interest. Of the pre operative RCC patients, 20/30 (67%) had detectable somatic mutations, resulting in nonsynonymous, frameshift, stopgain, or splice site mutations, compared to 1/32 (3.1%) controls. Mutations were detected in both early and advanced stage disease, including a patient with a 1.1 x 0.7 x 0.5 cm tumor. Mutations were seen in all genes assayed. CONCLUSIONS: These data demonstrate feasibility of genespecific whole exome sequencing of ctDNA for diagnosis of RCC in patients with solid renal tumors. The majority of RCC patients of various stages and histology had ctDNA detected in a single preoperative blood sample. A single control gave a positive test. Non invasive detection of RCC shows promise for not only initial diagnosis but also disease monitoring and guidance of targeted therapies throughout a wide spectrum of disease severity, including small lesions.