Real-World Clinical Outcomes of Ribociclib in Combination with a Non-Steroidal Aromatase Inhibitor and a Luteinizing Hormone-Releasing Hormone Agonist in Premenopausal HR+/HER2- Advanced Breast Cancer Patients: An Italian Managed Access Program.

Ribociclib plus an aromatase inhibitor and ovarian function suppression is the preferred first-line option for pre-/perimenopausal women with hormone receptor-positive/human epidermal growth factor receptor-2-negative advanced or metastatic breast cancer. We opened an italian managed access program (MAP) that permitted access to ribociclib to selected patients and allowed to collect informative results on the clinical impact of the therapy. The MAP (April 2018-May 2020) included 64 premenopausal patients, with characteristics similar to those of the MONALEESA-7 trial. Of 57 patients with a known response, 48 (84.2%) achieved a clinical benefit (i.e., complete response, N = 7 (12.3%); partial response, N = 17 (29.8%); stable disease, N = 24 (42.1%)), while 9 (15.8%) experienced tumor progression. Some patients (N = 15-23.4%) needed ribociclib dose reduction because of adverse events. Thereafter, the treatment was well tolerated, and no new safety signals emerged. Our study is the first reported Italian real-world evidence of ribociclib effectiveness in premenopausal HR+/HER2- advanced breast cancer patients. Response and clinical benefit rates were particularly encouraging compared with those of the ribociclib group of MONALEESA-7. Our work confirms that ribociclib in combination with endocrine therapy is highly effective in the treatment of premenopausal HR+/HER2- advanced breast cancer patients with an expected safety profile.

Randomised controlled trial comparing laparoscopic and robot-assisted radical prostatectomy.

BACKGROUND: The advantages of robot-assisted radical prostatectomy (RARP) over laparoscopic radical prostatectomy (LRP) have rarely been investigated in randomised controlled trials. OBJECTIVE: To compare RARP and LRP in terms of the functional, perioperative, and oncologic outcomes. The main end point of the study was changes in continence 3 mo after surgery. DESIGN, SETTING, AND PARTICIPANTS: From January 2010 to January 2011, 120 patients with organ-confined prostate cancer were enrolled and randomly assigned (using a randomisation plan) to one of two groups based on surgical approach: the RARP group and the LRP group. INTERVENTION: All RARP and LRP interventions were performed with the same technique by the same single surgeon. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The demographic, perioperative, and pathologic results, such as the complications and prostate-specific antigen (PSA) measurements, were recorded and compared. Continence was evaluated at the time of catheter removal and 48 h later, and continence and potency were evaluated after 1, 3, 6, and 12 mo. The student t test, Mann-Whitney test, χ(2) test, Pearson χ(2) test, and multiple regression analysis were used for statistics. RESULTS AND LIMITATIONS: The two groups (RARP: n=60; LRP: n=60) were comparable in terms of demographic data. No differences were recorded in terms of perioperative and pathologic results, complication rate, or PSA measurements. The continence rate was higher in the RARP group at every time point: Continence after 3 mo was 80% in the RARP group and 61.6% in the LRP group (p=0.044), and after 1 yr, the continence rate was 95.0% and 83.3%, respectively (p=0.042). Among preoperative potent patients treated with nerve-sparing techniques, the rate of erection recovery was 80.0% and 54.2%, respectively (p=0.020). The limitations included the small number of patients. CONCLUSIONS: RARP provided better functional results in terms of the recovery of continence and potency. Further studies are needed to confirm our results.

The clinical and imaging presentation of acute "non complicated" pyelonephritis: a new profile for an ancient disease.

BACKGROUND: Acute pyelonephritis (APN) is differently defined according to imaging or clinical criteria. In adults information on the relationship between imaging and clinical data is lacking.Our study was aimed at analysing the relationship between the clinical and imaging presentation of APN, defined according to imaging criteria (parenchymal involvement at MR or CT scan). METHODS: All consecutive patients hospitalized for "non-complicated" APN were considered (June 2005-December 2009). Clinical, biochemical and imaging data at hospitalization were analyzed by univariate and logistic regression analysis. RESULTS: There were 119 patients, all females, median age 32 years (15-72). At hospitalization, inflammatory markers were elevated (CRP median: 12.1 mg/dL, normal < 0.8). Incomplete presentations were frequent: fever was absent in 6.7%, pain in 17.8%, lower urinary tract symptoms in 52.9%. At CT or MR scan the lesions were bilateral in 12.6%, multiple in 79.8%; abscesses were present in 39.5%. Renal scars were found in 15.1%. Positive cultures were correlated with multiple foci (multivariate OR 4.2; CI 1.139-15.515). No other sign/symptom discriminated between small lesions, abscesses or multifocal involvement. CONCLUSIONS: APN is a protean disease. In the absence of strict correlation with clinical or biochemical markers, imaging studies are required to assess the severity of kidney involvement.

Positron emission tomography as a tool for the 'tailored' management of retroperitoneal fibrosis: a nephro-urological experience.

BACKGROUND: Retroperitoneal fibrosis (RF) is a complex clinical entity characterized by a fibro-inflammatory reaction around the abdominal aorta and iliac arteries extended into the retroperitoneum. No biochemical marker correlates with the disease severity and progression, and imaging data fail to discriminate between fibrotic and florid lesions. Positron emission tomography (PET) was recently suggested as a promising tool to detect the disease. METHODS: We report on seven consecutive cases of RF managed by tailoring therapeutic interventions to the metabolic activity detected by PET. In 2006-09, seven patients with RF (five new diagnoses) were referred to the same nephro-urological facility. There were six males and one female aged 41-79. RF was associated with autoimmune diseases in three patients, with an aortic aneurysm in another three, and was 'idiopathic' in one. The diagnoses were made by imaging techniques [computed tomography (CT) or nuclear magnetic resonance (NMR)]; PET scan was performed in all patients in the same setting at referral and during follow-up. RESULTS: Patients were followed up with tailored interventions (medical therapy: tamoxifen, steroids, and immunosuppressors according to disease activity, side effects and tolerance). Six patients needed ureteral stenting for obstruction. PET imaging was used as a guide for the tapering of immunosuppressors and for stent removal. In this way, stents were safely removed when a negativization of disease activity was revealed by PET. Only one relapse was recorded over 163 months of follow-up (median 24 months) detected in time by PET. CONCLUSION: PET is a promising tool for surveillance of disease activity and for planning the removal of ureteral stents in RF.

Laparoscopic vesico-vaginal fistula repair: our experience and review of the literature.

PURPOSE: To describe our experience with laparoscopic transperitoneal vesico-vaginal fistula (VVF) repair and we review current literature. METHODS: Four patients with VVF underwent transperitoneal transvesical laparoscopic repair, with the same principles of open abdominal approach. We considered: operation time, complications, hospital stay, Foley catheter duration, and recurrence during the follow-up. RESULTS: Mean operative time was 103 minutes and no complications were recorded. Average length of hospital stay was 3 days, Foley catheter remained indwelling on an average of 8 days. All patients were cured, after a mean of 14.5 months no recurrence was recorded and no patient referred urinary symptoms. CONCLUSIONS: On the basis of our and literature data, we believe that laparoscopic VVF repair is feasible, safe and effective and it is a viable alternative to the traditional open procedure.

A second cycle of tamsulosin in patients with distal ureteric stones: a prospective randomized trial.

OBJECTIVE: To evaluate, in a prospective randomized pilot study, the effectiveness and safety of tamsulosin, administered in patients with distal ureteric stones and who have already undergone an unsuccessful first cycle of medical expulsive therapy (MET). PATIENTS AND METHODS: We evaluated the effectiveness and safety of tamsulosin, administered as a further therapy, in patients previously unsuccessfully treated with combined expulsive 10-day therapy (tamsulosin + deflazacort) for distal ureteric stones. Ninety-one patients were enrolled and randomized into two groups, each receiving a different therapy for 10 days. Group A (46 patients) received a further cycle of tamsulosin (0.4 mg daily), and group B (45) did not. Age, gender, stone size, time to expulsion, number of acute episodes of colic during treatment and analgesic consumption were recorded. Patients who were not stone-free after the study period had ureteroscopy. The results were compared statistically using Student's t-, chi-square test and Fisher's exact test. RESULTS: The groups were comparable in age, gender and stone size (5.93 mm for group A and 6.03 mm for group B). The expulsion rate was significantly higher in group A (80%) than in group B (49%) (P < 0.01), whilst there were no differences between the groups in the number of colic episodes and analgesic use. There were no reported side-effects of medical therapy. CONCLUSIONS: A second cycle of 10 days of MET with tamsulosin in nonresponders to a 10-day first cycle of MET with tamsulosin and deflazacort is safe and effective, and therefore should be considered as an option in the management of uncomplicated distal ureteric stones.

The clinical spectrum of acute 'uncomplicated' pyelonephritis from an emergency medicine perspective.

Acute uncomplicated pyelonephritis (APN) is a complex clinical entity, which is defined differently based on clinical or imaging criteria. The aim of this study was to describe the clinical and radiological presentation of APN-upper urinary tract infection (UTI) cases observed between May 2005 and June 2006 and hospitalised in the Emergency Medicine ward of San Luigi Hospital, Orbassano, Turin, Italy. All patients underwent imaging scans and were differentiated on the basis of parenchymal involvement. Of around 45000 patient visits to the emergency room between May 2005 and June 2006, 23 patients were diagnosed as having uncomplicated upper UTI (all female, age 15-57 years). Renal parenchymal involvement was confirmed by imaging in 16 cases (69.6%). The imaging spectrum ranged from a small single lesion to large multiple defects; on admission, 2 cases had no pain and 2 had no fever; lower urinary tract symptoms were present in only 13 patients (7 with parenchymal involvement). All patients with parenchymal involvement had at least one sign of systemic inflammation-infection. Most patients (15) had taken antibiotics before hospitalisation; consequently, urine cultures were negative in 21 cases (14 cases with positive imaging (87.5%)). The data from patients with and without parenchymal involvement overlapped, the only difference being a higher prevalence of high CRP levels in cases with parenchymal involvement.

Is laparoscopic unilateral sural nerve grafting during radical prostatectomy effective in retaining sexual potency?

OBJECTIVES: To present a pilot study of laparoscopic unilateral sural nerve grafting during radical prostatectomy, with the aim of preserving sexual potency. PATIENTS AND METHODS: Because they had localized prostate cancer, 29 men had a laparoscopic radical prostatectomy with deliberate wide unilateral neurovascular bundle resection and preservation of the contralateral bundle. Fifteen men (group A) had an interposition sural nerve graft on the sectioned bundle, and 14 (group B) had laparoscopic radical prostatectomy with preservation of the unilateral bundle only. The men were also involved in a rehabilitation programme, and erectile function was evaluated after surgery, and at 3, 8, 12 and 18 months, using the five-item version of the International Index of Erectile Function (IIEF-5) questionnaire. RESULTS: The two groups had similar clinical characteristics (age, prostate-specific antigen level, body mass index, prostate volume, clinical stage, Gleason score before and after surgery, postoperative stage). The follow-up was complete for 12 men in group A and 10 in group B. Group A had significantly higher erectile function scores on the IIEF-5 at 12 and 18 months than immediately after surgery (P < 0.01), whereas in group B the improvement was not statistically significant. Overall, by 18 months after surgery five of 12 men in group A had achieved spontaneous unassisted erection or erection assisted with sildenafil, while three of 10 in group B achieved an erection assisted with sildenafil (not significant). CONCLUSIONS: These data suggests that laparoscopic sural nerve grafting during radical prostatectomy is feasible and safe; nevertheless we cannot conclude that sural nerve grafting is more effective than preserving the neurovascular bundle alone in retaining sexual potency. More research is required to validate the effectiveness of this technique.