Extended Safety and Tolerability of Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer and Adverse Event Time Course in ARAMIS.

Background: Patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) are usually asymptomatic and seek treatments that improve survival but have a low risk of adverse events. Darolutamide, a structurally distinct androgen receptor inhibitor (ARi), significantly reduced the risk of metastasis and death versus placebo in ARAMIS. We assessed the extended safety and tolerability of darolutamide and the time-course profile of treatment-emergent adverse events (TEAEs) related to ARis and androgen-suppressive treatment.

Real-world Treatment Sequencing in Patients with Metastatic Castration-resistant Prostate Cancer: Results from the Prospective, International, Observational Prostate Cancer Registry.

Background: Prostate cancer has a multifaceted treatment pattern. Evidence is lacking for optimal treatment sequences for metastatic castration-resistant prostate cancer (mCRPC).

Objective: To increase the understanding of real-world treatment pathways and outcomes in patients with mCRPC.

Underrepresentation of vulnerable older patients with cancer in phase II and III oncology registration trials: A case-control study.

Objectives: We aimed to determine the proportion of "fit" versus "vulnerable" older patients with cancer included in phase II and III oncology registration trials, as compared to the proportions in a real life oncology setting.

Methods: Trial and patient characteristics of older (≥70years) patients treated at the OECI-designated clinical cancer centre in Kortrijk and included in a phase II or III oncology registration trial were collected retrospectively. These patients were matched individually with randomly-selected patients from the general oncology setting, based on gender, age, tumour type, tumour stage, and treatment intent.

Subjective, but not objective, cognitive complaints impact long-term quality of life in cancer patients.

Objectives: Cognitive complaints, of objective or subjective nature, may negatively impact cancer patients' quality of life (QoL). Further, the early detection of cognitive alterations may lead to an improved QoL. However, the content of such screening is yet unclear.

The use of uHear™ to screen for hearing loss in older patients with cancer as part of a comprehensive geriatric assessment.

Objective: We previously validated uHear™ to screen for hearing loss in older patients with cancer without a known hearing loss, as part of a comprehensive geriatric assessment (CGA). In view of low specificity, we tested a new modified uHear™ scoring system as described by Handzel.

Methods: Patients, aged ≥70 years, were evaluated by uHear™ and conventional audiometry, which is considered the gold standard, as part of a CGA.

Long-Term Antitumor Activity and Safety of Enzalutamide Monotherapy in Hormone Naïve Prostate Cancer: 3-Year Open Label Followup Results.

Purpose: A phase 2 study of enzalutamide monotherapy in patients with hormone naïve prostate cancer demonstrated high prostate specific antigen response rates at 25 weeks, 1 year and 2 years with minimal effects on total body bone mineral density and favorable safety. In this followup analysis we evaluated enzalutamide antitumor activity and safety at 3 years.

Materials And Methods: In a single arm analysis 67 patients with hormone naïve prostate cancer and noncastrate testosterone (230 ng/dl or greater) received enzalutamide 160 mg per day orally until disease progression or unacceptable toxicity.

Antitumour Activity and Safety of Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer Previously Treated with Abiraterone Acetate Plus Prednisone for ≥24 weeks in Europe.

Background: Enzalutamide and abiraterone acetate plus prednisone, which target the androgen receptor axis, have expanded the treatment of advanced prostate cancer. Retrospective analyses suggest some cross-resistance between these two drugs when used sequentially, but robust, prospective studies have not yet been reported.

Objective: To fulfil a regulatory postregistration commitment by evaluating the efficacy and safety of enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed following abiraterone acetate plus prednisone treatment.

The distress thermometer predicts subjective, but not objective, cognitive complaints six months after treatment initiation in cancer patients.

Objectives: Research has indicated that cancer-related cognitive impairments (CRCI) may be influenced by psychosocial factors such as distress, worry and fatigue. Therefore, we aimed to validate the distress thermometer (DT) as a screening tool to detect CRCI six months post-treatment-initiation in a group of general cancer patients.

Methods: Patients (≥18 years, n = 125) with a histologically confirmed diagnosis of a solid cancer or hematological malignancy, scheduled for a curative treatment, were evaluated at baseline (T0) and six months post-treatment-initiation (T1) for CRCI by a neuropsychological assessment, including patient-reported outcome measures (PROMs).

Which Factors Predict Overall Survival in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Abiraterone Acetate Post-Docetaxel?

Background: Abiraterone acetate (AA) increases overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel. However, survival time varies substantially between individuals. Our goal was to identify prognostic factors that better estimate OS.

Predictors of baseline cancer-related cognitive impairment in cancer patients scheduled for a curative treatment.

Introduction: Recent research in the field of cancer-related cognitive impairments (CRCI) has shown CRCI presentation prior to treatment initiation. Some have attributed these problems to worry and fatigue, whereas others have suggested an influence of age, IQ, and other psychosocial and medical factors.

Methods: Patients (≥18 years) with a histologically confirmed diagnosis of a solid cancer or hematological malignancy, scheduled for a curative treatment, were evaluated with a baseline neuropsychological assessment including Patient-Reported Outcome Measures (PROMs).

Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic Castration-Resistant Prostate Cancer.

Purpose: Tasquinimod, a novel oral therapy targeting the tumor microenvironment, significantly improved progression-free survival (PFS) in a randomized, placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer (mCRPC). This phase III study was conducted to confirm the phase II results and to detect an overall survival (OS) benefit.

Patients And Methods: Men with chemotherapy-naïve mCRPC and evidence of bone metastases were assigned (2:1) to receive tasquinimod once per day or placebo until progression or toxicity.

Abiraterone acetate post-docetaxel for metastatic castration-resistant prostate cancer in the Belgian compassionate use program.

Background: Abiraterone acetate (AA) is licensed for treating metastatic castration-resistant prostate cancer (mCRPC). Real-world data on oncological outcome after AA are scarce. The current study assesses efficacy and safety of AA in mCRPC patients previously treated with docetaxel who started treatment during the Belgian compassionate use program (January 2011-July 2012).

Long-term Efficacy and Safety of Enzalutamide Monotherapy in Hormone-naïve Prostate Cancer: 1- and 2-Year Open-label Follow-up Results.

Background: Enzalutamide is an androgen receptor inhibitor with a demonstrated overall survival benefit in metastatic castration-resistant prostate cancer. A phase 2 study of enzalutamide monotherapy in patients with hormone-naïve prostate cancer (HNPC) showed a high response rate for the prespecified primary endpoint (ie, prostate-specific antigen [PSA] response at week 25), regardless of metastases at baseline, and favorable tolerability.

Objective: To determine the long-term efficacy and safety of enzalutamide monotherapy at 1 and 2 yr.

Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study.

Background: The androgen receptor inhibitor enzalutamide is approved for the treatment of metastatic castration-resistant prostate cancer that has progressed on docetaxel. Our aim was to assess the activity and safety of enzalutamide monotherapy in men with hormone-naive prostate cancer.

Methods: This trial is an ongoing open-label, single-arm, phase 2 study, done across 12 European sites.

Validation of the Freund Clock Drawing Test as a screening tool to detect cognitive dysfunction in elderly cancer patients undergoing comprehensive geriatric assessment.

Objective: We aimed to validate the Freund Clock Drawing Test (CDT), with its predefined cutoff score of ≤4, as a screening tool to detect elderly cancer patients in need of a more in-depth cognitive evaluation within a comprehensive geriatric assessment (CGA).

Methods: Patients aged 70 years or older with a histologically confirmed diagnosis of cancer were evaluated with a full CGA, including CDT and Folstein Mini Mental State Examination (MMSE) as gold standard. Validation of the Freund CDT was defined in terms of diagnostic accuracy of the test through receiver operating characteristics (ROC)-analysis.

FDG-PET/CT for the preoperative lymph node staging of invasive bladder cancer.

Background: Locoregional lymph node metastasis is an important prognostic factor in patients with bladder cancer. Multimodal treatment, depending on preoperative stage, may improve survival. The standard imaging modalities for staging (computed tomography [CT] or magnetic resonance imaging [MRI]) have an accuracy range of 70-90% for lymph node staging.

Recurrent flank pain caused by eosinophilic ureteritis mimicking urinary stone disease: a case report.

Flank pain is caused by a variety of pathologies of which urinary stone disease is the most frequent. Eosinophilic ureteritis is a rare stenosing condition of the ureter. Eosinophilic ureteritis can cause flank pain and/or unilateral hydronephrosis.

Cystectomy and orthotopic ileal neobladder construction. Evaluation of continence and complications in a regional hospital.

Introduction: This study evaluates the outcome of orthotopic neobladder construction in a regional hospital setting.

Material And Methods: Orthotopic ileal neobladders were constructed in 51 patients between 1990 and 2001. All complications were reported systematically and continence was evaluated in a standardized manner.

Neoadjuvant hormonal therapy before radical prostatectomy decreases the number of positive surgical margins in stage T2 prostate cancer: interim results of a prospective randomized trial. The Belgian Uro-Oncological Study Group.

Purpose: We investigated the effect of neoadjuvant treatment before radical prostatectomy for clinically localized prostate cancer.

Materials And Methods: A total of 130 patients with stages T2b and T3 prostate cancer was randomized in a multicenter study: 62 underwent immediate radical prostatectomy and 65 received 560 mg. estramustine phosphate daily for 6 weeks preoperatively.

[Hormone therapy before radical prostatectomy. Effects on surgical method and resection margins. Belgian Uro-Oncological Study Group (B.U.O.S.)].

127 patients with a clinical stage T2b and T3 prostate cancer were randomized in order to undergo either a radical prostatectomy alone or a radical prostatectomy after hormonal treatment (560 mg of estramustine phosphate daily for 6 weeks) in a prospective multi-center study. The clinical or radiological evaluation of an eventual downstaging being extremely difficult, the authors compared in the 2 groups the influence on the surgical act and the number of positive surgical margins at pathological examination of the resected specimen. There was no significant difference between the 2 groups concerning the surgery (duration of the procedure, blood transfusion, degree of difficulty).

[Composition of urinary calculi defined with precision by infrared spectrophotometry].

In order to reduce the relapse of the disease lithiasis, it is very important to have a very good idea about the growth process of the urinary stone. The greatest concern is the recuperation and the profound analysis of the nucleus and the peripheral layers. The preceding morphological study of the stone fragments in combination with the infrared spectrometry is the only manner to know all about the urinary calculus.

Implantation of the urethral stent for treatment of complex urethral strictures. Evaluation of the functional and radiological results.

We describe the results after implantation of a urethral stent in 6 patients with recurrent urethral strictures. Four patients had strictures located in close vicinity to the external sphincter. In 3 of these 4 patients open urethroplasty procedures had failed.

Balloon dilation of the prostate. Critical evaluation.

We describe the results of prostatic balloon dilation in 7 patients with a follow-up of 9 months. Symptom scores dramatically fell in 5 patients (success rate 71%), which is confirmed by a significant improvement in peak flow in 4 of them. Two patients failed to improve and needed a subsequent intervention which revealed a stage A2 prostatic carcinoma in one.

Balloon dilatation of the external urethral sphincter: a case study.

A new and simple endoscopic treatment procedure of external urethral sphincters is described. The external urethral sphincter was dilated with a balloon catheter 25mm in diameter in a multiple sclerosis patient; the sphincter spasticity made intermittent catheterization impossible. Post dilatation, the resistance to catheterization completely disappeared and the urethral pressure profile showed a dramatic fall in sphincteric pressure.

Embryonal adenoma of the kidney.

We report on a 24-year-old woman with a clinically and histologically benign mixed epithelial-mesenchymal tumor of the kidney. Since the epithelial component was by far the most predominant, we found the term 'embryonal adenoma' suitable. To our knowledge this is the first case reported in the literature.