Cochlear Implantation: Concept, Results Outcomes and Quality of Life. / Cochlea-Implantation: Konzept, Therapieergebnisse und Lebensqualität.

Cochlear implant today are an essential method of auditory rehabilitation in patients with severe to profound hearing loss. Due to the rapid development of implant technology the results have been markedly improved. Today about 80 % of patients can use the telephone and children achieve near to normal hearing and speech development. In consequence, more patients are candidates for a cochlear implant today including those with high frequency deafness and single sided deafness. However, today only 60,000 out of 1 Million CI-candidates in Germany have been implanted so far. In future multi modal universal auditory implants will provide combined electric-mechanical stimulation to make best use of the residual auditory hearing and the electrical stimulation of the auditory nerve. They allow a continuous adaptation of the stimulation strategy onto the given functional status of haircells and auditory nerve fibers especially in cases of progressive hearing loss. Brain computer interfaces will allow the automated fitting and adaptation to the acoustic scene by optimizing the signal processing for best possible auditory performance. Binaural hearing systems will improve directional hearing and speech perception in noise. Advanced implants are composed of individualized electrodes by additive manufacturing which can be inserted atraumaticly by a computer and robot assisted surgery. After insertion they automatically adept to the anatomy of the individual cochlear. These advanced implants are composed with additional integrated biological components for the preservation of residual hearing and regeneration of neural elements to improve the electrode nerve interface. This will allow to increase the number of electrical contacts as a major step towards the bionic ear. This will allow overcoming the principal limits of today's cochlear implant technology. Advanced care models will allow an easy way for the patient towards hearing preservation cochlear implantation under local anesthesia using minimal invasive high precision cochlear implant surgery. These implant systems will become a personal communicator with improved connectivity. Remote care and self-fitting will empower the patient to optimize his own hearing.

Towards single-trial classification of invasively recorded auditory evoked potentials in cochlear implant users.

Objective.One promising approach towards further improving cochlear implants (CI) is to use brain signals controlling the device in order to close the auditory loop. Initial electroencephalography (EEG) studies have already shown promising results. However, they are based on noninvasive measurements, whereas implanted electrodes are expected to be more convenient in terms of everyday-life usability. If additional measurement electrodes were implanted during CI surgery, then invasive recordings should be possible. Furthermore, implantation will provide better signal quality, higher robustness to artefacts, and thus enhanced classification accuracy.Approach.In an initial project, three additional epidural electrodes were temporarily implanted during the surgical procedure. After surgery, different auditory evoked potentials (AEPs) were recorded both invasively (epidural) and using surface electrodes, with invasively recorded signals demonstrated as being markedly superior. In this present analysis, cortical evoked response audiometry (CERA) signals recorded in seven patients were used for single-trial classification of sounds with different intensities. For classification purposes, we used shrinkage-regularized linear discriminant analysis (sLDA). Clinical speech perception scores were also investigated.Main results.Analysis of CERA data from different subjects showed single-trial classification accuracies of up to 99.2% for perceived vs. non-perceived sounds. Accuracies of up to 89.1% were achieved in classification of sounds perceived at different intensities. Highest classification accuracies were achieved by means of epidural recordings. Required loudness differences seemed to correspond to speech perception in noise.Significance.The proposed epidural recording approach showed good classification accuracy into sound perceived and not perceived when the best-performing electrodes were selected. Classifying different levels of sound stimulation accurately proved more challenging. At present, the methods explored in this study would not be sufficiently reliable to allow automated closed-loop control of CI parameters. However, our findings are an important initial contribution towards improving applicability of closed auditory loops and for next-generation automatic fitting approaches.

The Association of Clinical Characteristics and Tumour Markers With Image-Defined Risk Factors in the Management of Neuroblastoma in South Africa.

AIMS: Image-defined risk factors (IDRFs) in neuroblastoma predict surgical complications and management outcomes. As there is a lack of data regarding the association of IDRFs with clinical and pathological factors, this study evaluated the prognostic value of IDRFs to predict neuroblastoma survival outcomes. MATERIALS AND METHODS: This was a retrospective study including 345 patients and reviewed diagnostic imaging for 20 IDRFs, pleural effusions and ascites. The IDRFs were grouped into five 'primary IDRFs' cohorts with vascular encasement, involvement of multiple body compartments, organ infiltration, airway obstruction and intraspinal extension. The association between clinical, histopathological and biological characteristics of neuroblastoma and management was evaluated. RESULTS: More patients without IDRFs had operations compared with patients with IDRFs, with a trend towards significance (64.4% versus 35.6%, P = 0.082). Patients with multiple compartment tumour involvement (P = 0.003) and organ infiltration (P < 0.001) had a higher risk of surgical complications. The 5-year overall survival of the group with more than one IDRF was 0.0% and those with pleural effusions or ascites 6.7%, associated with the worst outcome (P = 0.005). The total number of IDRFs was not predictive of the metastatic remission rate (P = 0.585) or overall survival (P = 0.142), with no conclusive association found between IDRF groups and clinical or biological markers. CONCLUSIONS: Patients with more than one IDRF had the shortest survival time, whereas those with pleural effusions and ascites at diagnosis had a poor outcome. Standardised reporting of IDRFs is crucial for predicting prognosis.

Postoperative change in Gleason score of prostate cancer in fusion targeted biopsy: a matched pair analysis.

OBJECTIVE: To evaluate if MRI/ultrasound fusion based targeted biopsy (FBx) leads to a reduced rate of change in Gleason score (GS) compared to prostatectomy specimen. METHODS: The histopathological findings of the biopsy of the prostate and the radical prostatectomy (RP) specimen of 210 patients who were referred to our hospital between 2012 and 2017 were compared retrospectively in this study. One hundred and five patients who underwent FBx combined with ultrasound-guided 12-core biopsy of the prostate (SBx) were matched with 105 patients who underwent SBx only. This study evaluated the rate of up- or downgrading in the RP specimen in both groups and compared the results via matched pair analysis. RESULTS: Concordance in Gleason grade group (GGG) was found in 52/105 patients (49.5%) in SBx and in 49/105 patients (46.7%) with FBx (p = 0.679). The rate of downgrading was statistically significant (p = 0.014) and was higher in the FBx group (14/105 patients, 13.3%) than in the SBx group (4/105 patients, 3.8%). A higher rate of upgrading was seen in SBx (49/105 patients; 46.7%) compared to FBx (42/105 patients; 40%), with no statistical significance (p = 0.331). The change in GGG from biopsy to final pathology in patients with GGG 1 and 2 at biopsy level was not statistically significant (p = 0.168). CONCLUSION: FBx does not decrease the rate of upgrading between biopsy and final pathology in RP specimens. Our results indicate that FBx tends to overestimate the final GGG compared to SBx.

Efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (B-NHL): results of the randomized, open-label, non-inferiority AVOID neutropenia study.

BACKGROUND: Lipegfilgrastim has been shown to be non-inferior to pegfilgrastim for reduction of the duration of severe neutropenia (DSN) in breast cancer patients. This open-label, non-inferiority study assessed the efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (NHL) at high risk for chemotherapy-induced neutropenia. PATIENT AND METHODS: One hundred and one patients (median age, 75 years) were randomized to lipegfilgrastim or pegfilgrastim (6 mg/cycle) during six cycles of R-CHOP21. RESULTS: Lipegfilgrastim was non-inferior to pegfilgrastim for the primary efficacy endpoint, reduction of DSN in cycle 1. In the per-protocol population, mean (standard deviation) DSN was 0.8 (0.92) and 0.9 (1.11) days in the two groups, respectively; the adjusted mean difference between groups was - 0.3 days (95% confidence interval, - 0.70 to 0.19). Non-inferiority was also demonstrated in the intent-to-treat population. The incidence of severe neutropenia in cycle 1 was 51% (21/41) in the lipegfilgrastim group and 52% (23/44) in the pegfilgrastim group. Very severe neutropenia (ANC < 0.1 × 109/L) in cycle 1 was reported by 5 (12%) patients in the lipegfilgrastim group and 8 (18%) patients in the pegfilgrastim group. However, over all cycles, febrile neutropenia (strict definition) was reported by only 1 (2%) patient in each treatment group (during cycle 1 in the lipegfilgrastim group and cycle 6 in the pegfilgrastim group). The mean time to absolute neutrophil count recovery (defined as ≥ 2.0 × 109/L) was 8.3 and 9.4 days in the two groups, respectively. Serious adverse events occurred in 46% of patients in each group; none were considered treatment-related. Eight patients died during the study (2 in the lipegfilgrastim group, 5 in the pegfilgrastim group, and 1 who died before starting study treatment). No deaths occurred during the treatment period, and all were considered to be related to the underlying disease. CONCLUSIONS: This study shows lipegfilgrastim to be non-inferior to pegfilgrastim for the reduction of DSN in elderly patients with aggressive B cell NHL receiving myelosuppressive chemotherapy, with a comparable safety profile. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT02044276; EudraCT number 2013-001284-23.

[Practical skills training : How suitable is Peyton's four-step approach for residents in urology?] / Vermittlung praktischer Fertigkeiten : Wie geeignet ist Peytons Vier-Schritte-Ansatz für urologische WeiterbildungsassistentInnen?

INTRODUCTION: The aim of residency is to acquire medical skills and abilities. One didactic model is "Peyton's four-step approach". The aim of the present study was to develop and evaluate a modified Peytonian approach for group interactions. The aim was to develop a course for the acquisition of practical skills and training assistants in suture techniques for urology. METHODS: A prospective study was conducted with a total of 38 participants and 6 tutors. In a modified four-step Peytonian approach, various suturing and knotting techniques were taught in a structured manner. Tutors evaluated the procedural activity using observation sheets. In addition, the learning method was evaluated by the participants and the tutors at the end of the course. In order to check the long-term learning success, a renewed survey of the participants was conducted after 6 months. RESULTS: 80% of the participants rated the modified teaching method as useful and 83% of the tutors rated the procedural implementation as good. Fluid movement sequences were difficult independent of the technique taught. After 6 months, the participants significantly improved their procedural skills in all techniques that were taught. CONCLUSION: This paper defines a four-step Peyton-based approach to teaching practical skills such as suturing and knotting used in urological training. The modified teaching method improved practical skills used in urology. This method should be considered in continuing education to promote self-confidence and increase the competence in surgical skills.

Correction to: The natural course of pT2 prostate cancer with positive surgical margin: predicting biochemical recurrence.

In multivariate analysis, GS of the regular prostatectomy specimen was the only statistically significant parameter for pT2R1 prostate cancer.

Prospective evaluation of 4-D contrast-enhanced-ultrasound (CEUS) imaging in bladder tumors.

PURPOSE: The evaluation of the potential clinical benefit of four-dimensional ultrasound (4D-US) in the assessment of bladder cancer (BC). MATERIAL AND METHODS: 20 patients with indication for cystoscopy for suspicion of bladder cancer were prospectively included in this study. All patients underwent two-dimensional ultrasound (2D-US), contrast enhanced ultrasound (CEUS) and real-time four-dimensional ultrasound (4D-US). All acquisitions were compared to each other in regard to image quality. This assessment was done using a 6 point scale (1 = best). All patients underwent subsequently cystoscopy with resection of the tumor (TURB), due a histopathological analysis was possible. RESULTS: All examinations were performed successfully and no patient had to be excluded from the study. Patients acceptance of 4D-US was consistently good. No adverse events occurred. Image quality of real time 4D-US (score: 1.27±0.46) was significantly superior (p < 0.001) to both, conventional 2D-US (score: 2.33±0.62) and also to 2D-CEUS (score: 2.00±0.53). In terms of tumor detection no superiority was evident for 4D-US compared to 2D-US or in utilization of CEUS (sensitivity = 0.89; specificity = 1.00; positive predictive value = 1.00; negative predictive value = 0.50; AUC = 0.944; (95% CI: 07.43-0.998)). CONCLUSION: The assessment of bladder cancer using real time 4D-US is feasible and improves the image quality and therefore also the precise anatomical consistency of intravesical tumor masses.

Detection of Gleason 6 prostate cancer in patients with clinically significant prostate cancer on multiparametric magnetic resonance imaging.

INTRODUCTION: Multiparametric-Magnetic Resonance Imaging (mpMRI)-Ultrasound fusion guided biopsy (Fbx) has emerged as the new standard of risk stratification for prostate cancer (PCa) with superior detection rates of clinically significant PCa than randomized biopsy. In the present study, we evaluated patients with suspicion of clinically significant PCa on mpMRI, but histopathologically proven Gleason 6 PCa in Fbx. MATERIAL AND METHODS: Between 2015 and 2019, 849 patients underwent Fbx and concurrent systematic 12-core biopsy at our department. 234 patients were diagnosed with Gleason 6 PCa in either mpMRI-targeted and/or concurrent systematic biopsy. Patients were analyzed regarding PSA, mpMRI findings according to PI-RADS classification, histopathological results of Fbx and systematic 12-core biopsy. 99/234 patients were also analyzed in regards of histopathology of the whole-mount specimen of subsequent radical prostatectomy (RP). RESULTS: In 131/234 patients (56%), Gleason 6 PCa was detected in the mpMRI target. In 103/234 patients (44%), Gleason 6 PCa was detected in the concurrent systematic 12-core biopsy with negative mpMRI-targeted biopsy. Men with evidence of Gleason 6 in the mpMRI target had significantly higher amounts of overall positive biopsies (median 4 vs. 2, p < 0.001) and higher maximum tumor infiltration per biopsy core (30% vs. 20%, p < 0.001) compared to men with negative mpMRI-targeted biopsy. Detection of Gleason 6 in mpMRI Target lesions correlated significantly with the PI-RADS score (p < 0.001). Patients with positive mpMRI-target had significantly higher tumor infiltration in whole-mount specimen after prostatectomy (20% vs. 15%, p = 0.0026) compared to men without detection of Gleason 6 in mpMRI-targeted biopsy but in additional systematic biopsy. CONCLUSION: Detection of Gleason 6 PCa in mpMRI-targeted biopsy indicates higher tumor burden compared to detection of Gleason 6 PCa in concurrent systematic biopsy and negative mpMRI-targeted biopsy.

Epidural recordings in cochlear implant users.

OBJECTIVE: In the long term it is desirable for CI users to control their device via brain signals. A possible strategy is the use of auditory evoked potentials (AEPs). Several studies have shown the suitability of auditory paradigms for such an approach. However, these investigations are based on non-invasive recordings. When thinking about everyday life applications, it would be more convenient to use implanted electrodes for signal acquisition. Ideally, the electrodes would be directly integrated into the CI. Further it is to be expected that invasively recorded signals have higher signal quality and are less affected by artifacts. APPROACH: In this project we investigated the feasibility of implanting epidural electrodes temporarily during CI surgery and the possibility to record AEPs in the course of several days after implantation. Intraoperatively, auditory brainstem responses were recorded, whereas various kinds of AEPs were recorded postoperatively. After a few days the epidural electrodes were removed. MAIN RESULTS: Data sets of ten subjects were obtained. Invasively recorded potentials were compared subjectively and objectively to clinical standard recordings using surface electrodes. Especially the cortical evoked response audiometry depicted clearer N1 waves for the epidural electrodes which were also visible at lower stimulation intensities compared to scalp electrodes. Furthermore the signal was less disturbed by artifacts. The objective quality measure (based on data sets of six patients) showed a significant better signal quality for the epidural compared to the scalp recordings. SIGNIFICANCE: Altogether the approach revealed to be feasible and well tolerated by the patients. The epidural recordings showed a clearly better signal quality than the scalp recordings with AEPs being clearer recognizable. The results of the present study suggest that including epidural recording electrodes in future CI systems will improve the everyday life applicability of auditory closed loop systems for CI subjects.

MRI-TRUS fusion biopsy of the prostate: Quality of image fusion in a clinical setting.

INTRODUCTION: Prostate cancer (PCa) is one of the most common malignancies in men. The diagnostic standard to confirm prostate cancer is the transrectal ultrasound-guided biopsy. However, this procedure is associated with the underdetection of clinically significant prostate cancer and therefore needs to be improved. In the last years MRI fusion based targeted biopsy gained importance as consequence. In this study, we evaluated the quality of MRI ultrasound image fusion and evaluated factors influencing the image fusion quality. This was done by comparing fusion quality with the histopathological findings in the defined MRI target on the one hand and the PIRADS score on the other hand. MATERIALS AND METHODS: Single arm study including patients with elevated prostate specific antigen (PSA) and a multiparametric MRI showing a suspicious lesion underwent a MRI fusion targeted biopsy at our institution. MRI fusion targeted biopsy and an additional 12-core transrectal ultrasound (TRUS) guided biopsy was performed using the Philips Percunav device (Philips Medical Systems, Bothell, WA). The fusion accuracy was rated by two experienced clinicians (1 radiologist, 18 years of experience, 1 urologist, 5 years of experience) using a five-point rank scale (1 = best) and comparing the result with the histological findings in the target and the PIRADS score. RESULTS: The detection rate of clinically significant cancer (Gleason 7a or greater) by MRI-ultrasound fusion targeted biopsy was 58.6% (17/29) compared to 50% (19/38) in the standard transrectal ultrasound-guided approach. PCa was found in 36.4% (4/11 patients) of patients with a PIRADS 3 lesion, in 57.7% (15/26 patients) of patients with a PIRADS 4 lesion. In 76.9% (10/13 patients) of patients with a PIRADS 5 lesion PCa was diagnosed. No statistical significance was found comparing the quality of registration either with the PIRADS (p = 0.7873) nor with the Gleason score (p = 0.4376). The study is limited by the small number of patients. CONCLUSIONS: MRI fusion based targeted biopsy improves the identification of clinical significant cancer. The Gleason score of detected PCa is not influenced by the quality of fusion.

Risks and benefits of pelvic lymphadenectomy in octogenarians undergoing radical cystectomy due to urothelial carcinoma of the bladder.

OBJECTIVES: According to current guidelines, radical cystectomy (RC) should be combined with an extended pelvic lymphadenectomy (PLND) as therapeutic and staging instrument. Objective of this study was to analyze the influence of PLND on survival rates and complication rates in a selected group of elderly patients with a minimum age of 80 years. MATERIALS AND METHODS: In this single-center retrospective analysis, we evaluated 102 patients who underwent RC due to UCB from 2004 to 2015 at our institution. In 74 patients (73%), RC was combined with PLND; in 28 cases (27%), RC was performed without PLND. Impact of PLND on cancer specific survival (CSS), overall survival (OS) and progression-free survival (PFS) was analyzed using log-rank test and COX regression model. RESULTS: In univariate analysis of the data, we were not able to show a significant impact of PLND on CSS (p = 0.606), OS (p = 0.979) or PFS (p = 0.883). Also in multivariate analysis of the data, we were not able to identify PLND as an independent prognostic parameter on survival rates of patients undergoing RC, neither for CSS (p = 0.912) nor OS (p = 0.618) or PFS (p = 0.900). CONCLUSIONS: Our small and single-center study was not able to demonstrate a significant independent influence of PLND on CSS, OS and PFS in octogenarians undergoing RC due to UCB. There is no doubt that RC should usually be combined with PLND, but the results of this small data set with a selected patient cohort indicate that RC without PLND might be an option in selected cases of elderly patients.

[Technical advancements in cochlear implants : State of the art]. / Technische Entwicklungen bei Cochleaimplantaten : Stand der Technik.

Twenty years ago, cochlear implants (CI) were indicated only in cases of profound hearing loss or complete deafness. While from today's perspective the technology was clumsy and provided patients with only limited speech comprehension in quiet scenarios, successive advances in CI technology and the consequent substantial hearing improvements over time have since then resulted in continuous relaxation of indication criteria toward residual hearing. While achievements in implant and processor electronics have been one key factor for the ever-improving hearing performance, development of electro-acoustic CI systems-together with atraumatic implantation concepts-has led to enormous improvements in patients with low-frequency residual hearing. Manufactures have designed special processors with integrated hearing aid components for this patient group, which are capable of conveying acoustic and electric stimulation. A further milestone in improvement of hearing in challenging listening environments was the adoption of signal enhancement algorithms and assistive listening devices from the hearing aid industry. This article gives an overview of the current state of the art in the abovementioned areas of CI technology.

Perioperative and oncologic outcomes of robot-assisted vs. open radical cystectomy in bladder cancer patients: A comparison of two high-volume referral centers.

OBJECTIVES: To examine perioperative and oncologic outcomes of open (ORC) and robot-assisted radical cystectomy (RARC) in bladder cancer (BCa) patients. METHODS AND MATERIALS: 368 consecutive patients with cT1-4 M0 BCa treated at two high-volume European centers between 2004 and 2013 were evaluated. Data on complications, operative time, blood loss, postoperative transfusion, reoperation, length of stay (LOS), positive margins, recurrence, cancer-specific mortality (CSM), and overall survival were evaluated. Uni- and multivariable regression analyses tested the impact of the surgical approach on perioperative and oncologic outcomes. RESULTS: Overall, 230 (62.5%) and 138 (37.5%) patients were treated with ORC and RARC. In multivariable analyses RARC patients had higher odds of prolonged operative time and low-grade complications (all P ≤ 0.001). Patients treated with ORC had higher odds of blood loss >500 ml and prolonged LOS (all P ≤ 0.03). No differences were observed in high-grade complications and positive margins (all P ≥ 0.06). No differences were observed in 5-year recurrence-free and CSM-free survival rates between patients treated with ORC vs. RARC (57.1 vs. 54.2% and 61.9 vs. 73.5%; all P ≥ 0.3). This was confirmed in multivariable analyses, where the surgical approach was not associated with the risk of recurrence and CSM (all P ≥ 0.1). CONCLUSIONS: Although ORC might be associated with a shorter operative time, RARC led to lower blood loss and shorter LOS. No differences exist in high-grade complications and positive margins. RARC and ORC provide similar oncologic control.

Shear-wave elastography of the testis in the healthy man - determination of standard values.

PURPOSE: Real-time shear-wave elastography (SWE) is a newly developed technique for the sonographic quantification of tissue elasticity, which already is used in the assessment of breast and thyroid lesions. Due to limited overlying tissue, the testes are ideally suited for assessment using shear wave elastography. To our knowledge, no published data exist on real-time SWE of the testes. MATERIALS AND METHODS: Sixty six male volunteers (mean age 51.86±18.82, range 20-86) with no known testicular pathology underwent normal B-mode sonography and multi-frame shear-wave elastography of both testes using the Aixplorer ® ultrasound system (SuperSonic Imagine, Aix en Provence, France). Three measurements were performed for each testis; one in the upper pole, in the middle portion and in the lower pole respectively. The results were statistically evaluated using multivariate analysis. RESULTS: Mean shear-wave velocity values were similar in the inferior and superior part of the testicle (1.15 m/s) and were significantly lower in the centre (0.90 m/s). These values were age-independent. Testicular stiffness was significantly lower in the upper pole than in the rest of the testis with increasing volume (p = 0.007). CONCLUSION: Real-time shear-wave elastography proved to be feasible in the assessment of testicular stiffness. It is important to consider the measurement region as standard values differ between the centre and the testicular periphery. Further studies with more subjects may be required to define the normal range of values for each age group. Useful clinical applications could include the diagnostic work-up of patients with scrotal masses or male infertility.

Impact of preoperative hemoglobin and CRP levels on cancer-specific survival in patients undergoing radical cystectomy for transitional cell carcinoma of the bladder: results of a single-center study.

PURPOSE: Different blood parameters have shown to be associated with patient's oncological outcome. There is only limited knowledge about the prognostic relevance of routine blood parameters in patients undergoing radical cystectomy for transitional cell carcinoma (TCC). Therefore, we retrospectively analyzed the influence of preoperative C-reactive protein (CRP) and hemoglobin (Hb) levels on overall survival (OS) and cancer-specific survival (CSS). MATERIALS AND METHODS: Preoperative CRP and Hb levels were available in 664 patients who underwent RC due to TCC from 2004 to 2013 at our institution. More men than women (77 vs. 23 %) underwent surgery with a median age of 70 years (35-97). Median follow-up time was 24 months (max. 108). Outcome was analyzed using Kaplan-Meier method, log-rank test, and Cox regression models. RESULTS: Median CRP level was 0.5 mg/dl (0.1-28.3), and median Hb level was 13.4 g/dl (6.7-17.9). Patients with CRP value above the median died significantly earlier due to their disease than those with CRP below the median (median CSS 19 vs. 70 months; p < 0.001). Patients with preoperative Hb level below the median had significantly worse outcome than those with Hb level above the median (median CSS 25 vs. 78 months; p < 0.001). In multivariate analysis, CRP and Hb levels were independent prognostic parameters regarding CSS/OS (CRP p = 0.016/p = 0.004; Hb p = 0.006/p = 0.004, respectively). CONCLUSIONS: In our single-center study, preoperative CRP and Hb levels were found to be independent prognostic factors, indicating impaired outcome in patients undergoing RC for TCC. These findings could be used for individual risk stratification and optimization of therapeutic strategies.

Incidence of bone pain in patients with breast cancer treated with lipegfilgrastim or pegfilgrastim: an integrated analysis from phase II and III studies.

PURPOSE: Lipegfilgrastim is a once-per-cycle, fixed-dose, glycoPEGylated recombinant granulocyte colony-stimulating factor (G-CSF) recently approved in Europe to reduce the duration of chemotherapy-induced neutropenia and incidence of febrile neutropenia in patients with cancer receiving chemotherapy. Bone pain-related (BPR) adverse events are commonly associated with G-CSF therapy. This post hoc analysis examined BPR treatment-emergent adverse events (TEAEs) in two comparative studies of lipegfilgrastim or pegfilgrastim in patients receiving chemotherapy. METHODS: A post hoc analysis was conducted using integrated data from two double-blind randomized studies in patients with breast cancer receiving docetaxel and doxorubicin and treated prophylactically with subcutaneous lipegfilgrastim 6 mg or pegfilgrastim 6 mg once per cycle. BPR TEAEs were defined as arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, noncardiac chest pain, and pain in extremity. Relationship of BPR TEAEs to study treatment or chemotherapy was also reported by the investigators. RESULTS: The analysis included 306 patients (lipegfilgrastim: n = 151; pegfilgrastim: n = 155). The proportion of patients experiencing BPR TEAEs was similar with lipegfilgrastim and pegfilgrastim (25.2 vs 21.9%, respectively), as was the proportion of patients experiencing BPR treatment-emergent adverse drug reactions (TEADRs) (18.5 vs 16.8%, respectively). No BPR TEADRs were serious, and none led to discontinuation. CONCLUSIONS: Nonsevere BPR TEAEs and TEADRs were observed in patients with breast cancer receiving chemotherapy and G-CSF; rates of BPR events were similar between lipegfilgrastim and pegfilgrastim. The similar BPR safety profile of lipegfilgrastim and pegfilgrastim provides support for use in patients with breast cancer receiving chemotherapy.

Tumours of the Chest in Children: A Review

Tumours of the chest in children constitute an array of pathology and clinical symptomatology. These tumours can be benign or malignant; cystic or solid; primary or as a result of secondary metastases. Collectively; tumours of the chest in children are very rare; the exact incidence of which is largely unknown globally. Non neoplastic lesions of the lung including bronchogenic cysts; sequestrations; congenital pulmonary airway malformations as well as infective and inflammatory disorders are 60 times more common than neoplastic causes.1 A tumour of the chest is considerably difficult to diagnose since patients can be asymptomatic for many years before symptoms evolve. Even more so; the symptoms are non-specific and can suggest more common and less sinister pathology. Clinically patients present with a variety of symptoms that depend largely on the location of the tumour.Airway tumours can be symptomatic or can present with chronic cough; wheeze; haemoptysis; atelectasis or persistent pneumonia. Secondary malignant parenchymal tumours are likely to be symptomatic from the primary lesion. Anterior mediastinal tumours can cause compression of the large airways or superior vena caval structures.It stands to reason that the physician needs to have a very high index of suspicion when dealing with these non-specific signs and symptoms. This article provides an approach to tumours of chest and reviews the common aetiology in the different compartments of the chest. The article will focus on common tumours of the airway; lung parenchyma; mediastinum; cardiac and chest wall pathology

The natural course of pT2 prostate cancer with positive surgical margin: predicting biochemical recurrence.

PURPOSE: To predict biochemical recurrence respecting the natural course of pT2 prostate cancer with positive surgical margin (R1) and no adjuvant/neoadjuvant therapy. METHODS: A multicenter data analysis of 956 patients with pT2R1N0/Nx tumors was performed. Patients underwent radical prostatectomy between 1994 and 2009. No patients received neoadjuvant or adjuvant therapy. All prostate specimens were re-evaluated according to a well-defined protocol. The association of pathological and clinical features, in regard to BCR, was calculated using various statistical tests. RESULTS: With a mean follow-up of 48 months, BCR was found in 25.4 %. In univariate analysis, multiple parameters such as tumor volume, PSA, Gleason at positive margin were significantly associated with BCR. However, in multivariate analysis, Gleason score (GS) of the prostatectomy specimen was the only significant parameter for BCR. Median time to recurrence for GS ≤ 6 was not reached; 5-year BCR-free survival was 82 %; and they were 127 months and 72 % for GS 3+4, 56 months and 54 % for GS 4 + 3, and 27 months and 32 % for GS 8-10. The retrospective approach is a limitation of our study. CONCLUSIONS: Our study provides data on the BCR in pT2R1-PCa without adjuvant/neoadjuvant therapy and thus a rationale for an individual's risk stratification. The data support patients and physicians in estimating the individual risk and timing of BCR and thus serve to personalize the management in pT2R1-PCa.