A phase II clinical trial of neoadjuvant ketoconazole and docetaxel chemotherapy before radical prostatectomy in high risk patients.

PURPOSE: Patients with high risk prostate cancer (prostate specific antigen greater than 20 ng/ml, Gleason score greater than 7, or clinical stage T2b or greater) have been shown to have a 30% to 40% biochemical recurrence rate after definitive local therapy. Looking for improvement on these outcomes, we conducted a phase II clinical trial examining the combination of ketoconazole and docetaxel in the neoadjuvant setting before radical prostatectomy. MATERIALS AND METHODS: A total of 22 patients with clinically localized, high risk prostate cancer were enrolled in the study. For 12 weeks they were treated with neoadjuvant docetaxel and ketoconazole, with dosing based on phase I data. Patients were monitored for tolerance of therapy and dosing adjustments were made for significant toxicities. Radical prostatectomy with extended lymph node dissection was subsequently performed and patients were followed postoperatively for biochemical recurrence. RESULTS: At a median followup of 18 months 8 patients remained biochemically free of recurrence after surgery alone. An additional 6 patients received salvage therapy and had an undetectable prostate specific antigen. Of the 22 patients 16 experienced National Cancer Institute grade 3 or 4 toxicity at some point during the therapy. However, 16 patients completed all 4 cycles of chemotherapy. CONCLUSIONS: Neoadjuvant ketoconazole combined with docetaxel has appreciable but acceptable toxicity with 73% of the patients completing all 4 courses of therapy. Of those who underwent radical prostatectomy 36% remained continuously biochemically free of recurrence at a median followup of 18 months.

Differences in left and right laparoscopic adrenalectomy.

BACKGROUND AND OBJECTIVES: The classic belief is that right-sided laparoscopic adrenalectomy is technically more difficult to perform than left-sided. The purpose of this study was to determine whether objective outcomes are different for the right- versus left- sided operation. METHODS: A retrospective review of 163 laparoscopic adrenalectomies was performed to compare outcomes. Variables extracted included age, demographics, body mass index (BMI), laterality, indication, operative time, estimated blood loss (EBL), gland size, complications, open conversion rates, and length of stay. RESULTS: Of the adrenalectomies performed, 109 were on the left and 54 on the right. Age, BMI, and indication were similar for each group. The mean EBL on the left side was 113 mL (range, 2 to 3000) and 84 mL (range, 10 to 700) for the right (P=0.85). The mean operative time on the left side was 187 minutes (range, 62 to 475) and on the right was 156 minutes (range, 50 to 365) (P=0.02). There was no difference in complication or conversion rate. CONCLUSIONS: There was no difference in complication or conversion rates between each side, and we observed a trend toward lower blood loss for the right side. Although we report generally similar outcomes, the mean operative time for a right-sided laparoscopic adrenalectomy was significantly less (31 minutes) than the left side.

Decision tree for laparoscopic partial nephrectomy versus laparoscopic renal cryoablation for small renal masses.

PURPOSE: We propose an algorithm to help guide surgeons' decisions between laparoscopic partial nephrectomy (LPN) and renal laparoscopic cryoablation (LCA) based on preoperative parameters and outcomes defined in the literature. PATIENTS AND METHODS: From July 2004 to December of 2007, we performed 51 LPNs and 22 LCAs. We formulated an algorithm between LPN and LCA based on outcomes from published series. Candidates for LPN are younger than 70 years; have few comorbidities; masses < or = 7 cm; and solitary, solid, and or cystic masses with an exophytic or mesophytic location. Candidates for LCA are 70 years old or older, with multiple comorbidities, masses < or = 3.5 cm, multiple masses, solid masses only, and include endophytic or hilar tumors. We then applied this decision tree to our series. RESULTS: Our results for LPN are statistically similar to the published series except there was a higher positive margin rate in our series (11.8 v 3.5%). Our LCA series had older patients (71 v 65 y), larger masses (3.2 v 2.5 cm), and a higher rate of bleeding necessitating transfusion (18%). We applied the algorithm to all 73 patients in our series. It estimated that 45 patients should undergo LPN and 28 should undergo LCA. A correlation between the predicted surgery and the surgery performed was seen, but approximately one in five patients would have a change in the surgery performed. CONCLUSIONS: This algorithm validates decisions surgeons are already making between LPN and LCA. While not a perfect model, it can be used to help simplify decisions between these two minimally invasive procedures to achieve optimal outcomes.

IL-6 does not predict current urolithiasis in stone formers.

INTRODUCTION: Interleukin-6 (IL-6), an inflammatory marker, has previously been found to be elevated in the urine of patients with urolithiasis. Oxalate and other stone precursors have been shown to increase IL-6 production in proximal tubular epithelial cells in vitro. We examined whether urinary IL-6 could be used as a screening test to determine current urolithiasis in individuals who are known to form urinary stones. METHODS: Thirty-five adult patients with current urolithiasis demonstrated on imaging were enrolled in the study. Exclusion criteria included disease known to elevate IL-6. Each patient provided a pre-treatment urine specimen and one month after proven to be stone-free an additional urine specimen was obtained. The urinary IL-6/creatinine ratio was determined for both specimens and compared. RESULTS: Ten patients provided both specimens. The mean pre-operative urinary IL-6/creatinine ratio before the procedure was 1.63 pg/mL. The mean post procedure urinary IL-6/creatinine ratio after the patient was confirmed to be stone-free was 1.81 pg/mL. These were not significantly different (p=0.38). Preoperative urinary IL-6/creatinine ratio did not correlate to stone size (r=0.15) and no correlation was seen between time from treatment and stone free IL-6/creatinine ratio (r=0.48). CONCLUSION: Urinary IL-6 is not a good screening test for current urolithiasis in stone-forming individuals. It is elevated whether the stone is present or not.

Impact of diabetes mellitus on the presentation and outcomes of Fournier's gangrene.

OBJECTIVES: To evaluate, in a population of patients with very high risk of diabetes, the natural history of Fournier's gangrene (FG) and to characterize the differences in presentation and outcome. METHODS: Patients with FG were identified during a 6-year period at two tertiary care institutions in San Antonio, Texas. The impact of diabetes on presentation and outcome were evaluated and compared with previous series. RESULTS: We identified 26 patients with FG, of whom 20 (76.9%) had diabetes. Diabetes was the most common risk factor identified and was associated with a younger age. The average hospital stay was not affected by the diagnosis of diabetes. Of 26 patients treated for FG, 3 (11%) died, 1 of whom had diabetes. Although the extent of debridement required was greater among diabetics, the average number of debridements required was not increased (2.55 in diabetic and 2.4 in nondiabetic patients). CONCLUSIONS: Although diabetes is a risk factor for FG, the outcome is not affected by this diagnosis.