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Introduction and Objectives. The reported rate of seminal vesicles invasion in RP series varies between 6-26%. Invasion of seminal vesicles by adenocarcinoma of the prostate is considered an adverse prognostic factor and consequently patients are at high risk of cancer recurrence after radical prostatectomy. The reported biochemical recurrence free rates at 5 years after RP are between 5-60% (median 30%). The aim of this paper is to assess the role of postoperative radiation in patients with seminal vesicle (SV) invasion after radical prostatectomy (RP). Materials and Methods. From a database of 500 consecutive patients who underwent RP at the University of Florida, sixty two (12%) were diagnosed with seminal vesicle invasion. All patients underwent adjuvant radiation (RT). Median age was 65 (range 48-77), median pre RP PSA was 15 ng/ml (range 4.3-91). Median pre RT PSA was 0.2 ng/ml (range 0.1 - 19 ng/ml). The PSA cut off value signifying serological failure after RP was ≥ 0.4 ng/ml. Median follow up was 56 months (range 12-104). Results. Thirty three patients (53%) relapsed serologically. Median time to PSA failure was 34 months (range 1-75). One patient (1.6%) died of metastatic prostate cancer. Pre RT PSA was the most significant prognostic factor with respect to serological failure (p=0.003). Perineural invasion (PNI) was also found as statistically significant prognostic factor (p=0.05). Pre operative PSA, pathological Gleason score, extra capsular cancer extension in addition to SV invasion (eCe) and positive surgical margins were not found to be significant prognostic factors with respect to PSA failure. Conclusions. When analyzed in the light of other reports in the literature, the present study suggests that adjuvant radiation given in pT3c patients that have undetectable PSA after RP, the PSA recurrence rate at 5 years is lower than that of patients treated with RP alone. [ABSTRACT FROM AUTHOR]

Background: Erdafitinib, a fibroblast growth factor receptor (FGFR) inhibitor is a standard post chemotherapy advanced treatment line for metastatic urothelial carcinoma harboring FGFR2/3 genomic alterations. It was approved based on a phase 2 clinical trial, revealing a 40% response rate, and 13.8 months overall survival. These FGFR genomic alterations are uncommon. Thus, real-world data on erdafitinb use is scant. We herein describe erdafitinib treatment outcome in a real world patient cohort., Methods: We retrospectively reviewed the data of patients treated with erdafitinib from 9 Israeli medical centers., Results: Twenty-five patients with metastatic urothelial carcinoma (median age 73, 64% male, 80% with visceral metastases) were treated with erdafitinib between January 2020 to October 2022. A clinical benefit (complete response 12%, partial response 32%, stable disease 12%) was seen in 56%. Median progression-free survival was 2.7 months, and median overall survival 6.73 months. Treatment related toxicity ≥ grade 3 occurred in 52%, and 32% discontinued therapy due to adverse events., Conclusions: Erdafitinib therapy is associated with a clinical benefit in the real world setting, and associated with similar toxicity as reported in prospective clinical trials., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Rouvinov, Levanon, Peer, Sarfaty, Sarid, Neiman, Grikshtas, Rosenbaum, Kushnir, Talmor, Friger, Zarbiv, Gez, Dresler, Shalata, Meirovitz, Shrem, Yakobson, Mermershtain and Keizman.)

Background: Bicalutamide monotherapy (BMT) is an option for androgen deprivation therapy (ADT) in patients with low- and intermediate-risk prostate cancer (LIR-PC). Painful gynecomastia (PG) is a common side effect of BMT. Few therapeutic options are available for preventing BMT-induced PG., Objectives: To assess the efficacy and side effects of single fraction (SF) prophylactic breast irradiation (PBI) to prevent painful gynecomastia (PG) in patients LIR-PC treated with BMT., Methods: We reviewed the results of bilateral PBI in a prospective cohort of LIR-PC patients who received 150 mg bicalutamide daily as a first-line treatment for at least 12 months. A single fraction of 8 Gy was administered to both breasts by a stationary field of 10 × 10 cm, using 10-15 MeV electron beam. PBI was commenced on the same day as BMT, but prior to the first dose of bicalutamide. A radiotherapy treatment plan was designed to cover breast tissue by the 90% isodose line. Subsequent monthly physical examinations were scheduled for all patients during the first year of BMT to evaluate any PG symptoms., Results: Seventy-six patients received BMT and PBI, 80% (61/76) showed no signs of PG; 20% (15/76) experienced mild gynecomastia. The main adverse effect of PBI was grade 1 radiation dermatitis., Conclusions: PBI using a SF of 8 Gy is an effective, safe, and low-cost strategy for the prevention of BMT-induced PG in LIR-PC patients.

Introduction: For the last two years, the medical world has been focused on the COVID-19 pandemic. Most health organizations throughout the world agree that this pandemic will disappear or become less virulent in the coming years, like most viral infectious diseases. While the focus of the medical authorities in Israel changed in the last two years, cancer diseases remained the leading cause of death in Israel. Nevertheless, the percentage of cancer survivors is rising slowly in the Western world, as well as in Israel. Some of these wonderful achievements are related to new technologies in cancer diagnosis and treatment, together with completely new treatment strategies based on innovative medications that entered the treatment of oncology in the last decade. In this edition of "Harefuah", dedicated to oncology, we will present some examples of the new paradigms in the treatment of cancer diseases, described in research articles, case reports and reviews.

Background: Limited data about biomarkers are available to predict the outcomes of targeted therapy in metastatic renal cell carcinoma (mRCC). Circulating cell-free DNA (CFD) is elevated in various cancers., Patients and Methods: We performed a prospective study of patients with mRCC who received targeted therapy in the Soroka Medical Center between 2013 and 2015. CFD levels were measured using a simple fluorometric assay. Blood samples for CFD were collected before treatment and at weeks 1, 4, 12, 18, and 24 of treatment. The normal cut-off level of CFD was defined as 800 ng/ml. The association of CFD with objective response, progression-free survival (PFS), and overall survival was tested, with adjustment for known confounding risk factors., Results: A total of 23 patients were included; 18 were treated with first-line therapy and 5 with second- and third-line therapies. Patients with normal pretreatment CFD level had a better PFS versus patients with increased levels (p = 0.023). In multivariate analysis, factors associated with PFS were pretreatment CFD levels (p = 0.020) and Heng risk (p = 0.006)., Conclusions: Elevated pretreatment CFD levels measured using a simple fluorometric assay may be associated with a worse PFS in patients with mRCC. A larger prospective study is warranted in order to validate our observation., (© 2017 S. Karger GmbH, Freiburg.)

Background: Although studies in several cancer types suggest that metformin has antitumor activity, its effect on the outcome of targeted therapies in metastatic renal cell carcinoma (mRCC) is poorly defined. We aimed to analyze the effect of metformin use on the outcome of sunitinib treatment in diabetic patients with mRCC., Patients and Methods: We performed a retrospective study of diabetic patients with mRCC, who were treated with sunitinib in 8 centers across 2 countries. Patients were divided into metformin users and nonusers. The effect of metformin use on response rate, progression-free survival (PFS), and overall survival (OS), was tested. Furthermore, univariate and multivariate analyses of the association between clinicopathologic factors and metformin use, and outcome were performed using the entire patient cohort., Results: Between 2004 and 2014, 108 diabetic patients with mRCC were treated with sunitinib. There were 52 metformin users (group 1) and 56 nonusers (group 2). The groups were balanced regarding clinicopathologic factors. Clinical benefit (partial response + stable disease) in group 1 versus 2 was 96% versus 84% (P = .054). Median PFS was 15 versus 11.5 months (P = .1). Median OS was 32 versus 21 months (P = .001). In multivariate analyses of the entire patient cohort (n = 108), factors associated with PFS were active smoking and pretreatment neutrophil to lymphocyte ratio > 3. Factors associated with OS were metformin use (hazard ratio, 0.21; P < .0001), Heng risk, active smoking, liver metastases, and pretreatment neutrophil to lymphocyte ratio > 3., Conclusion: Metformin might improve the OS of diabetic patients with mRCC who are treated with sunitinib., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Sunitinib is a standard treatment for metastatic clear cell renal cell carcinoma (mccRCC). Data on its activity in the rare variant of metastatic chromophobe renal cell carcinoma (mchRCC), are limited. We aimed to analyze the activity of sunitinib in a relatively large and homogenous international cohort of mchRCC patients in terms of outcome and comparison with mccRCC., Methods: Records from mchRCC patients treated with first-line sunitinib in 10 centers across 4 countries were retrospectively reviewed. Univariate and multivariate analyses of association between clinicopathologic factors and outcome were performed. Subsequently, mchRCC patients were individually matched to mccRCC patients. We compared the clinical benefit rate, progression-free survival (PFS), and overall survival (OS) between the groups., Results: Between 2004 and 2014, 36 patients (median age, 64 years; 47% male) with mchRCC were treated with first-line sunitinib. Seventy-eight percent achieved a clinical benefit (partial response + stable disease). Median PFS and OS were 10 and 26 months, respectively. Factors associated with PFS were the Heng risk (hazard ratio [HR], 3.3; p = .03) and pretreatment neutrophil-to-lymphocyte ratio (NLR) >3 (HR, 0.63; p = .02). Factors associated with OS were the Heng risk (HR, 4.1; p = .04), liver metastases (HR, 3.8; p = .03), and pretreatment NLR <3 (HR, 0.55; p = .03). Treatment outcome was not significantly different between mchRCC patients and individually matched mccRCC patients. In mccRCC patients (p value versus mchRCC), 72% achieved a clinical benefit (p = .4) and median PFS and OS were 9 (p = .6) and 25 (p = .7) months, respectively., Conclusion: In metastatic chromophobe renal cell carcinoma, sunitinib therapy may be associated with similar outcome and toxicities as in metastatic clear cell renal cell carcinoma. The Heng risk and pretreatment NLR may be associated with PFS and OS., Implications for Practice: Data on the activity of sunitinib in metastatic chromophobe renal cell carcinoma (mchRCC) are limited. This study analyzed the activity of sunitinib in a cohort of mchRCC patients. Of 36 patients with mchRCC who were treated with first-line sunitinib, 78% achieved a clinical benefit. Median PFS and OS were 10 and 26 months, respectively. Treatment outcome was not significantly different between mchRCC patients and individually matched metastatic clear cell RCC patients., Competing Interests: of potential conflicts of interest may be found at the end of this article., (©AlphaMed Press.)

Objective: The aim was to investigate the value of postoperative brachytherapy for patients with Stage IB, Grade 2 endometrial carcinoma., Patients and Methods: Forty-six patients with Stage IB, Grade 2 endometrial carcinoma, were treated with simple hysterectomy and bilateral oophorectomy in our institution. The mean age was 63 (range, 42-81). Surgical staging, defined as peritoneal washing and pelvic lymph node sampling was performed in 73% of patients. Twenty-two patients (47%) received a postoperative intravaginal brachytherapy (IVRT), and 24 patients (53%) were followed-up without additional treatment., Results: The median follow-up was 60 months. The 5-year overall survival for irradiated and nonirradiated patients, was 83.5 and 94.7%, respectively. Four patients (8.7%) developed relapse, two in the group of postoperative IVRT and 2 in the follow-up only group. Multivariate analysis demonstrated a borderline association (P = 0.06) between lower uterine segment involvement and poor pelvic-vaginal control. The presence of GOG #99 high-risk features did not affect the pelvic control rate., Conclusion: According to our experience and previously published data, most patients with FIGO Stage IB, Grade 2 endometrial carcinoma may be cured with surgery alone.

Purpose: Studies suggested the existence of a 'trial effect', in which for a given treatment, participation in a clinical trial is associated with a better outcome. Sunitinib is a standard treatment for metastatic renal cell carcinoma (mRCC). We aimed to study the effect of clinical trial participation on the outcome of mRCC patients treated with sunitinib, which at present, is poorly defined., Materials and Methods: The records of mRCC patients treated with sunitinib between 2004-2013 in 7 centers across 2 countries were reviewed. We compared the response rate (RR), progression free survival (PFS), and overall survival (OS), between clinical trial participants (n=49) and a matched cohort of non-participants (n=49) who received standard therapy. Each clinical trial participant was individually matched with a non-participant by clinicopathologic factors. PFS and OS were determined by Cox regression., Results: The groups were matched by age (median 64), gender (male 67%), Heng risk (favorable 25%, intermediate 59%, poor 16%), prior nephrectomy (92%), RCC histology (clear cell 86%), pre-treatment NLR (>3 in 55%, n=27), sunitinib induced hypertension (45%), and sunitinib dose reduction/treatment interruption (41%). In clinical trial participants versus non-participants, RR was partial response/stable disease 80% (n=39) versus 74% (n=36), and progressive disease 20% (n=10) versus 26% (n=13) (p=0.63, OR 1.2). The median PFS was 10 versus 11 months (HR=0.96, p=0.84), and the median OS 23 versus 24 months (HR=0.97, p=0.89)., Conclusions: In mRCC patients treated with sunitinib, the outcome of clinical trial participants was similar to that of non-participants who received standard therapy.

Background: The VEGFR/PDGFR inhibitor sunitinib was approved in Israel in 2008 for the treatment of metastatic renal cell carcinoma (mRCC), based on an international trial. However, the efficacy of sunitinib treatment in Israeli mRCC patients has not been previously reported., Objectives: To report the outcome and associated factors of sunitinib treatment in a large cohort of Israeli mRCC patients., Methods: We conducted a retrospective study of an unselected cohort of mRCC patients who were treated with sunitinib during the period 2006-2013 in six Israeli hospitals. Univariate and multivariate analyses were performed to determine the association between treatment outcome and clinicopathologic factors., Results: We identified 145 patients; the median age was 65 years, 63% were male, 80% had a nephrectomy, and 28% had prior systemic treatment. Seventy-nine percent (n = 115) had clinical benefit (complete response 5%, n = 7; partial response 33%, n = 48; stable disease 41%, n = 60); 21% (n = 30) were refractory to treatment. Median progression-free survival (PFS) was 12 months and median overall survival 21 months. Factors associated with clinical benefit were sunitinib-induced hypertension: [odds ratio (OR) 3.6, P = 0.042] and sunitinib dose reduction or treatment interruption (OR 2.4, P = 0.049). Factors associated with PFS were female gender [hazard ratio (HR) 2, P = 0.0041, pre-sunitinib treatment neutrophil-to-lymphocyte ratio < or = 3 (HR 2.19, P = 0.002), and active smoking (HR 0.19, P < 0.0001). Factors associated with overall survival were active smoking (HR 0.25, P < 0.0001) and sunitinib-induced hypertension (HR 0.48, P = 0.005). To minimize toxicity, the dose was reduced or the treatment interrupted in 39% (n = 57)., Conclusions: The efficacy of sunitinib treatment for mRCC among Israeli patients is similar to that in international data.