0000000000087702
AUTHOR
Mario Falsaperla
Management of bicalutamide induced gynaecomastia. A randomized study comparing therapy versus prophylaxis with tamoxifen.
Introduction and Objective: Gynaecomastia is a potentially treatment limiting adverse event of antiandrogen monotherapy for prostate cancer. Tamoxifen has shown to be effective in therapy and prophylaxis of gynecomastia and breast pain. However, tamoxifene dosage and treatment duration are not established and debate still exists if prophylaxis is more effective than therapy at the early onset. This randomized study compared the prophylactic activity of tamoxifene at the dose of 10 mg with its therapeutic activity when given at the dose of 20 mg at the early appearance of gynecomastia in patients receiving bicalutamide 150 mg/d for prostate cancer. Methods: Between June 2005 and June 2007, 1…
Prediction of significant renal function decline after open, laparoscopic, and robotic partial nephrectomy: External validation of the Martini’s nomogram on the RECORD2 project cohort
Objectives: Martini et al. developed a nomogram to predict significant (>25%) renal function loss after robot-assisted partial nephrectomy and identified four risk categories. We aimed to externally validate Martini’s nomogram on a large, national, multi-institutional data set including open, laparoscopic, and robot-assisted partial nephrectomy. Methods: Data of 2584 patients treated with partial nephrectomy for renal masses at 26 urological Italian centers (RECORD2 project) were collected. Renal function was assessed at baseline, on third postoperative day, and then at 6, 12, 24, and 48 months postoperatively. Multivariable models accounting for variables included in the Martini’s nomog…
Transperitoneal vs retroperitoneal minimally invasive partial nephrectomy: comparison of perioperative outcomes and functional follow-up in a large multi-institutional cohort (The RECORD 2 Project).
Abstract Background Aim of this study was to evaluate and compare perioperative outcomes of transperitoneal (TP) and retroperitoneal (TR) approaches in a multi-institutional cohort of minimally invasive partial nephrectomy (MI-PN). Material and methods All consecutive patients undergone MI-PN for clinical T1 renal tumors at 26 Italian centers (RECORd2 project) between 01/2013 and 12/2016 were evaluated, collecting the pre-, intra-, and postoperative data. The patients were then stratified according to the surgical approach, TP or RP. A 1:1 propensity score (PS) matching was performed to obtain homogeneous cohorts, considering the age, gender, baseline eGFR, surgical indication, clinical dia…
Oral chemotherapy in hormone-refractory prostate carcinoma patients unwilling to be admitted to hospital.
<i>Objectives:</i> To investigate the safety and efficacy in terms of PSA response of a low-dose oral combination of estramustine phosphate (EMP) and etoposide (VP16) in hormone- refractory prostate cancer (HRPC) patients. Well-tolerated outpatient chemotherapy regimens for patients unfit and/or unwilling to be admitted to hospital are needed. <i>Methods:</i> Fifty-six HRPC patients with metastatic disease (median age 75 years) were randomized between arm A (daily oral EMP 10 mg/kg, in 3 doses) and arm B (28-day cycle with low-dose EMP 3 mg/kg once daily plus VP16 25 mg/m<sup>2</sup> once daily on days 1 through 14). Baseline characteristics between the t…
A 1-year maintenance after early adjuvant intravesical chemotherapy has a limited efficacy in preventing recurrence of intermediate risk non-muscle-invasive bladder cancer
Study Type – Therapy (RCT) Level of Evidence 1b OBJECTIVE To evaluate the efficacy of 1-year maintenance after a 6-week cycle of early intravesical chemotherapy, as the role of maintenance in intravesical chemotherapy is debated. PATIENTS AND METHODS Between May 2002 and August 2003, 577 patients with non-muscle-invasive bladder cancer (NMI-BC) underwent transurethral resection (TUR) and early intravesical chemotherapy (epirubicin, 80 mg/50 mL). They were randomized between a 6-week induction cycle and the induction cycle plus maintenance with 10 monthly instillations. In all, 95 patients with T1G3, Tis or single and primary Ta–T1 G1–G2 tumours were excluded; 482 patients at intermediate ri…
Predicting positive surgical margins in partial nephrectomy: A prospective multicentre observational study (the RECORd 2 project)
PURPOSE: to evaluate clinical predictors of positive surgical margins (PSMs) in a large multicenter prospective observational study and to develop a clinic nomogram to predict the likelihood of PSMs after partial nephrectomy (PN). MATERIALS AND METHODS: We prospectively evaluated 4308 patients who had surgical treatment for renal tumors between January 2013 and December 2016 at 26 urological Italian Centers (RECORd 2 project). Two multivariable logistic models were evaluated to predict the likelihood of PSMs. Center caseload was dichotomized using a visual assessment adjusted for several predictors of PSMs. A nomogram predicting PSMs was developed. RESULTS: Overall, 2076 patients treated wi…
Out-patient low-dose oral chemotherapy in hormone refractory prostate carcinoma (HRPC) patients unfit for hospital admittance.
Objectives: Well tolerated out-patient regimens for HRPC chemotherapy in elderly patients with geographical difficulties and/or unwilling hospital admission are needed. The aim of the present study was to investigate the safety and efficacy of a low-dose oral combination of estramustine phosphate (EMP) and etoposide (VP16). Patients: Fifty-six HRPC patients, median age 75 years, were randomized between daily EMP (10mg/kg) – arm A, and low-dose EMP (3mg/kg) plus VP16 (25mg/mq) 2 weeks monthly – arm B. Randomization ratio was 2:3. Median PSA was 41.1 ng/ml. Baseline characteristics between the 2 groups were similar. LHRH therapy was maintained. Antiandrogen was stopped one month before entry.…
A randomized phase II study of estramustine phosphate versus estramustine phosphate plus etoposide in hormone refractory prostate cancer (HRPC)
20632 Background: Docetaxel-based regimens represent the treatment of choice of HRPC. However, in some patients toxicity may be a concern and the quality of life may be compromised. The aim of this phase II randomized study is to investigate the efficacy and safety of low-dose chemotherapy regimen adopting a combination of EMP and VP16 in patients affected by HRPC. Methods: 54 HRPC patients were randomized between: arm A, daily oral standard dose EMP (10mg/kg) and arm B, low-dose EMP (3mg/kg) plus VP16 (25mg/mq) for 2 weeks followed by 2-weeks’rest. Systemic toxicity and hematologic exams were monitored every 2 weeks. Performance status, pain and analgesic use were evaluated according to WH…