Systematic Literature Review and Meta-Analysis of Response to First-Line Therapies for Advanced/Metastatic Urothelial Cancer Patients Who Are Cisplatin Ineligible.

OBJECTIVE: The purpose of this systematic literature review (SLR) and meta-analysis was to compile the response of historic treatment options in first-line settings for patient populations who are cisplatin ineligible. MATERIALS AND METHODS: SLR was conducted to compile objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) of historic therapies for this population based on stringent criteria. Clinical trials published in English from January 1991 to June 2016 were identified by searching the PubMed (Medline), Cochrane, and Embase databases. RESULTS: Eighteen studies (21 arms; N=810) were identified and used for this meta-analysis. For all treatments included in these studies, the pooled ORR was 0.36 (95% confidence interval [CI], 0.30-0.42). The ORR for the carboplatin+gemcitabine arms (6 arms; N=259), which is the National Comprehensive Cancer Network's recommended first-line treatment (before approval of atezolizumab and pembrolizumab) for this population was 0.36 (95% CI, 0.30-0.42), the median DOR (4 arms) was 7.00 months (95% CI, 4.34-11.29), and the median OS was 8.39 months (95% CI, 7.05-9.98). CONCLUSIONS: The results of this SLR clearly demonstrate the paucity of clinical studies that assess therapeutic intervention in truly cisplatin-ineligible advanced/metastatic urothelial carcinoma subjects and highlight the development of novel therapies that can create real improvement in long-term outcomes. The recent approval of 2 checkpoint inhibitors, atezolizumab and pembrolizumab, were added in the National Comprehensive Cancer Network guidance as recommended first-line treatment for cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma and has provided alternatives for this patient population.

Office based transurethral needle ablation of the prostate with analgesia and local anesthesia.

PURPOSE: We evaluated the efficacy and feasibility of performing office based transurethral needle ablation of the prostate with analgesia and local anesthesia. MATERIALS AND METHODS: A total of 56 consecutive patients underwent transurethral needle ablation of the prostate for symptomatic benign prostatic hyperplasia. Oral rofecoxib (50 mg) and ciprofloxacin (250 mg) were administered before the procedure with 25 mg hydroxyzine and 50 to 100 mg meperidine intramuscularly. A combination of 2% lidocaine solution and jelly was used for anesthesia. Patients rated discomfort during anesthesia administration and the procedure using a 10-point scale of 0--no discomfort to 10--the worst pain/discomfort ever experienced in the patient life. Overall satisfaction with the procedure was assessed with a 4-point scale of 1--very satisfactory to 4--very unsatisfactory. Followup was 12 months for uroflow and 36 months for International Prostate Symptom Score. RESULTS: The mean age of 47 patients was 65.4 years. Mean discomfort ratings were 3.6 and 4.9 for anesthesia administration and the procedure, respectively. Average operative time was 34.4 minutes, excluding anesthesia administration. The mean overall satisfaction score was 1.5. The mean preoperative International Prostate Symptom Score was 23.1, which improved to 10.9, 11.2, 12.3, 13.8 and 11.3 at 3, 6, 12, 24 and 36 months, respectively. Mean maximum uroflow improved from 8.2 ml/sec at baseline to 12.8, 13.9 and 13.3 ml/sec at 3, 6 and 12 months, respectively. CONCLUSIONS: Administration of an intramuscular narcotic combined with oral analgesic and topical lidocaine provided adequate pain control for transurethral needle ablation of the prostate, making it a feasible office procedure.