Abiraterone in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: a systematic review of 'real-life' studies.

BACKGROUND: To assess the efficacy and safety of treatment with abiraterone acetate (AA) in chemotherapy-naïve men with metastatic castration-resistant prostate cancer (mCRPC) in the 'real-life' setting. METHODS: Data acquisition on the outcomes of the use of AA in chemotherapy-naive patients with mCRPC was performed by a MEDLINE comprehensive systematic literature search using combinations of the following key words: 'prostate cancer', 'metastatic', 'castration resistant', 'abiraterone', 'real life', and excluding controlled clinical trials (phase II and III studies). Identification and selection of the studies was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) criteria. Outcomes of interest were overall survival (OS), progression-free survival (PFS), 12-week 50% reduction in prostate-specific antigen (PSA), and grade 3 and higher adverse events. Data were narratively synthesized in light of methodological and clinical heterogeneity. RESULTS: Within the eight identified studies that fulfilled the criteria, a total of 801 patients were included in the meta-analysis. Baseline PSA ranged between 9.5 and 212.0 ng/ml. Most of the patients had bone metastases. Duration of treatment with AA was longer in the studies with lower baseline PSA levels. The median OS ranged between 14 and 36.4 months. The PFS, assessed according to different definitions, ranged from 3.9 to 18.5 months. A 50% PSA reduction at 12 weeks was reached by a variable percentage of patients ranging from 36.0% to 62.1%. Finally, the rate of grade 3 and higher adverse events was reported in three studies and ranged from 4.4% to 15.5%. CONCLUSIONS: Despite the high grade of heterogeneity among studies, treatment with AA seems to ensure good survival outcomes in the 'real-life' setting. However, prospective studies based on patients' characteristics being more similar to 'real-life' patients are necessary.

Monocenter Experience with 532 Nm-Laser Photoselective-Vaporization of the Prostate by GreenLight XPS™ Laser: Is It Really an Endourological Joker Card?

INTRODUCTION: In our study, we reported on our monocenter experience with GreenLight (GL) Xcelerated Performance System (XPS)™ /MoXy™ laser fiber (American Medical Systems Inc., Minnetonka, Minnesota), examining its efficacy, safety, and its ability to effectively treat lower urinary tract symptoms (LUTS) in benign prostate obstruction (BPO). We also explored and compared the three different endoscopic approaches used for GL treatment of benign prostatic hyperplasia (BPH), standard photovaporization (PVP), anatomical PVP, and GreenLight XPS™ enucleation of the prostate. MATERIALS AND METHODS: Between February 2013 and April 2017, 140 patients, with an average age of 67.7 years (range 47-85), were treated using the XPS™/MoXy™ system in a single-operative urologic center. The data were retrospectively analyzed with an assessment of the main intra- and postoperative outcomes at three, six, 12, and 18 months comparing both subjective (international prostate symptom score [IPSS]) and objective (uroflow [Qmax] parameters and prostate volume) parameters to the preoperative data. Patients underwent standard PVP, anatomical PVP, or prostate photo-selective en-bloc enucleation (PEBE) according to surgeon preferences. RESULTS: Median prostate volume (MPV) and prostate-specific antigen (PSA) were 69cc and 3.24 ng/dl, respectively. An indwelling catheter, at the time of surgery, was observed in 15% of men. Median operative-laser time and energy applied were 56.4 minutes, 26.5 minutes, and 245813 kJ. Outpatient surgery was feasible with median length of stay at 48 hours. Significant improvement in IPSS and Qmax are observed at all endpoints. No significant intraoperative complications were reported. When stratifying postoperative complications according to the Cavien-Dindo classification, only two cases of high-degree emerged (grades III-IV). CONCLUSION: Our data confirm that in treating men with symptomatic benign prostate disease, the GreenLight XPS™/MoXy™ laser fiber is safe and able to achieve challenging results in terms of clinical outcomes and prostate volume reduction. Balance between functional outcomes and complications was great without statistically significant differences, in terms of outcomes, between the different surgical techniques.

Laparoendoscopic single-site partial nephrectomy without ischemia for very small, exophytic renal masses: surgical details and functional outcomes.

BACKGROUND: Laparoendoscopic single-site surgery (LESS) has emerged as a natural progression from standard laparoscopy aiming to further minimize the morbidity of urologic procedures. OBJECTIVE: To describe our technique and report the surgical and functional outcomes of unclamped LESS partial nephrectomy (PN) in the treatment of small renal masses (SRMs). DESIGN, SETTING, AND PARTICIPANTS: Prospective evaluation of pre- and postoperative variables of patients undergoing the LESS-PN without ischemia between 2009 and 2012. The indications were single exophytic SRMs. SURGICAL PROCEDURE: Unclamped LESS-PN was performed through a transperitoneal approach. A pararectal Hasson access technique was preferred. Single-port access was achieved via different single-port devices. A combination of straight and articulating laparoscopic instruments was used. The tumor was excised using bipolar scissors during normal renal perfusion. Hemostasis was achieved by bipolar electrocautery, parenchymal stitches, and hemostatic agents. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Demographic, operative, postoperative, and pathologic outcomes data were recorded and analyzed. RESULTS AND LIMITATIONS: A total of 21 LESS-PN were performed (operative time: 111 ± 41 min; blood loss: 196 ± 195 ml: tumor size: 2.0 ± 0.3 cm). Neither conversion to open surgery nor transfusions occurred. Three patients required conversion to standard laparoscopy. Postoperatively, three complications (Clavien grades 2, 3a, and 4) were recorded. Pathologic examination revealed 14 clear cell carcinomas, four renal cysts, two oncocytomas, and one angiomyolipoma. Hospital stay was 4.4 ± 1.9 d. At the last follow-up (mean: 17±11.5 mo), no port-site, local, or distant recurrences were detected. No significant variation in serum creatinine and estimated glomerular filtration rate was observed. Subjective scar evaluation indicated 66% of patients were very satisfied/enthusiastic. Study limitations include the small sample size, the lack of a control group, the short follow-up period, and the arbitrary measure of patient's scar perception. CONCLUSIONS: Unclamped LESS-PN for selected SRMs is a safe and feasible procedure providing favorable postoperative outcomes and ensuring high levels of subjective, cosmetic satisfaction.

Clinical effects and economical impact of dutasteride and finasteride therapy in Italian men with LUTS.

OBJECTIVES: To investigate differences in the risk of benign prostatic hyperplasia (BPH)- related hospitalization, for surgical and non-surgical reasons, and of new prostate cancer (PCa) diagnosis between patients under dutasteride or finasteride treatment. MATERIAL AND METHODS: A retrospective cohort study was conducted using data from record-linkage of administrative databases. Men aged ≥ 40 years old who had received a prescription for at least 10 boxes/year (index years: 2004-06) were included. The association of the outcomes was assessed using a multiple Cox proportional hazard model. Propensity score matched analysis and a 5-to-1, greedy 1:1 matching algorithm were performed. The budget impact analysis of dutasteride vs finasteride in BPH-treated patient was performed. RESULTS: From an initial cohort of about 1.5 million of Italian men, 19620 were selected. The overall hospitalization for BPH-non surgical reasons, for BPH-related surgery and for new detection of PCa incidence rates (IRs) were 8.20 (95% CI, 7.62-8.23), 18.0 (95% CI, 17.12-18.93) and 8.62 (95% CI, 8.03-9.26) per 1000 person-years, respectively. The multivariate analysis after the propensity score-matching showed that dutasteride was associated with an independent reduced likelihood of hospitalization for BPH-related surgery (HR 0.82; 95% CI 0.73-0.93; p = 0.0025) and of newly detected PCa (HR: 0.76,95% CI, 0.65-0.85; p = 0.0116). The IR for BPH-non surgical reasons was 8.07 (95% CI, 7.10-9.17) and 9.25 (95% CI, 8.19-10.44) per 1000 person-years, respectively. The IR for BPH-related surgery was 18.28 (95% CI, 17.17-20.32) and 21.28 (95% CI, 19.24-23.06) per 1000 person-years among patients under dutasteride compared with those under finasteride, respectively. For new-onset PCa, the IR was 8.01 (95% CI, 7.07-9.08) and 9.38 (95% CI, 8.32-10.58) per 1000 person-years The pharmacoeconomical evaluation showed that the net budget impact of the use of dutasteride vs. finasteride in 1000 BPH-treated patient for 1 year induces a saving of 3933 €. CONCLUSIONS: The clinical effects of dutasteride and finasteride are slightly different. The likelihood of hospitalization for BPH-related surgery and of newly detected PCa seems to be in favor of dutasteride. The budget impact analyses showed a slightly benefit for dutasteride. Comparative prospective studies are necessary to confirm these results.

First Italian experience in single-incision laparoscopic nephrectomy.

We describe our laparoscopic nephrectomy technique of placing trocars directly on the fascia once the skin and the subcutaneous layers are prepared. A series of 10 consecutive patients were operated on by single-incision laparoscopic nephrectomy (SILN). With a 5-cm mean skin incision, the fascia was prepared and 3/4 trocars inserted separately directly on the fascia. Surgical strategy followed the standard technique, except for the use of articulating instruments and 5-mm optic. Demographics, body mass index (BMI), operative time, blood loss, perioperative complications, transfusions, hemoglobin decrease, analgesic requirement, length of stay, and final pathology were recorded. Postoperative and prior-to-discharge visual analogue scale (VAS) pain evaluations were also collected, together with the limitations inherent in the instruments' placement and parallel driving during the procedure. The procedures were successfully completed in all but one case. The mean operative time was 169 min. (mean blood loss 113 ml). Without major perioperative complications, the patients were discharged early (mean 5.3 days). Four patients had a BMI>30. For specimen retrieval (neoplasms) two trocar holes were joined. One patient required analgesics; the mean post-operative and prior-to-discharge VAS scores were 5.7 and 1.4, respectively. Pathology examination confirmed 4 pyelonephritic kidneys, 4 renal carcinomas, and 2 upper-urinary tract carcinomas. The laparoscopic nephrectomy via a single incision is feasible and safe, with favorable perioperative and short-term outcomes. It's technically more challenging than standard laparoscopy requiring advanced surgical skills.

First Italian experience in single incision laparoscopic nephrectomy. Assessing and overcoming new challenges.

BACKGROUND: The need to enlarge one of laparoscopic holes for specimen retrieval at the end of a laparoscopic nephrectomy, suggested us to use this final access for the entire procedure. We describe our technique placing trocars directly on the fascia once the skin and the subcutaneous layers were prepared. MATERIAL AND METHODS: A 10 consecutive patients series operated by Single Incision Laparoscopic Nephrectomy (SILN) is presented. With a 5 cm mean skin incision, the fascia was prepared and 3/4 trocars inserted separately directly on the fascia. Surgical strategy followed the standard technique, except for the use of articulating instruments and 5 mm optic. Demographics, Body Mass Index (BMI), operative time, blood loss, perioperative complications, transfusions, hemoglobin decrease, analgesic requirement, length of stay, final pathology were recorded. Postoperative and prior-to-discharge Video Analogue Scale Pain (VAS) evaluation were also collected, together with the limitations inherent to the instruments placing and parallel driving during the procedure. RESULTS: SILN was successfully completed in all but one cases. The mean operative time was 169 min (mean blood loss 113 ml). Without major perioperative complications, the patients were discharged early (mean 5.3 days). Four patients had a BMI > 30. For specimen retrieval (neoplasms) two trocars holes were joined. One patient required analgesics; the mean post-operative and prior-to-discharge VAS scores were 5.7 and 1.4, respectively. Pathology examination confirmed 4 pyelonephritic kidneys, 4 renal carcinoma and 2 upper-urinary tract carcinoma. CONCLUSION: SILN is feasible, safe, with favourable perioperative and short-term outcomes. It's technically more challenging than standard laparoscopy requiring advanced surgical skills.