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Background The ABCSG-28 trial compared primary surgery followed by systemic therapy versus primary systemic therapy without surgery in patients with de novo stage IV BC. The present report describes QoL results of this trial. Methods Ninety patients with primary operable MBC were randomised to surgery of the primary tumor followed by systemic therapy or to primary systemic therapy without surgery. QoL analyses covering the results at baseline, 6,12,18 and 24 months follow up of 79 (88%) patients, was assessed with the EORTC QLQ-C30 and QLQ-BR23 questionnaires. Results There were no statistically significant differences in any of the scales of the QLQ-C30 and QLQ-BR23 questionnaires between the two groups over the time. Baseline global health status and physical functioning were predictors for OS (patients with a higher score lived longer ( p =0.0250, p =0.0225; p =0.0355, p =0.0355)). Global health status, social functioning scale, breast symptoms and future perspective were predictors for longer TTPd ( p =0.0244; p =0.0140, p =0.020; p =0.0438, p =0.0123). Patients in both arms reported significant improvement on the emotional functioning scale. Cognitive functioning decreased over time in both groups. Younger women had clinically relevant better physical and sexual functioning scores ( p =0.039 and 0.024). Conclusion Primary surgery does not improve nor alter QoL of patients with de novo stage IV BC. Global health status and physical functioning were predictors for OS and could be use as additional marker for prediction of OS and TTTd in patients with de novo stage IV BC. Trial registration The trial is registered on clinicaltrial.gov ( NCT01015625 , date of registration:18/11/2009).

BackgroundTriple negative breast cancer (TNBC) harbors a heterogeneous group of carcinomas with poor prognosis and high genetic variability. As a potential aim for targeted therapy, genetic mutations leading to an activation of the phosphoinositide 3-kinase pathway in a catalytic subunit (PIK3CA) in breast cancer have been analyzed currently. Little is known about the clinical impact and prognostic or predictive value of this marker in TNBC subtypes.MethodsSamples from 119 TNBC cases were submitted to immunohistochemical PIK3CA protein expression analysis and scored semi-quantitatively as negative, weak (1 +), or strongly expressed (2 +). Expression scores were correlated to patient’s characteristics, imaging features, and TNBC subtypes. TNBC subtypes were categorized into four subtypes: basal like, mesenchymal like, luminal androgen receptor (LAR), and immunomodulatory.ResultsWe did not observe differences in clinical aspects and imaging features between TNBC with and without PIK3CA expression. PIK3CA expression was in general higher in the LAR subtype. The disease-free survival and overall survival were significantly better in TNBC with PIK3CA protein expression, independent of TNBC subtypes.ConclusionDespite conflicting results in the literature, our study clearly shows a better outcome of PIK3CA-expressing TNBC, independent of TNBC subtypes. PIK3CA expression in TNBC is not associated with specific clinical or diagnostic features. Further molecular studies and meta-analysis are warranted to clarify the prognostic and predictive role of PIK3CA protein expression.

BackgroundTriple-negative breast cancer (TNBC) includes mostly aggressive types of breast cancer with poor prognosis. Due to its growth pattern, misinterpretation in clinical imaging is more frequent than in non-TNBC. As the group of TNBC contains heterogeneous types of tumors, marker expression-based subtypes have recently been established. We analyzed clinical features and false-negative imaging findings that could potentially lead to diagnostic delay within the subtypes.MethodsAn exploratory analysis compared the imaging features across the a priori defined subtypes and related these findings to molecular subtype, disease stage, potential diagnostic delay, and patient outcome.ResultsTNBC cases were categorized into basal-like (BL; 38.6%), mesenchymal-like (ML; 19.9%), luminal androgen receptor (LAR; 28.3%), and immunomodulatory (IM; 13.3%) subtype. In almost every third patient, malignant classification was missed in at least one imaging method. Misclassification in mammogram was more frequent in ML, while benign ultrasound features were reported more often in the BL subtype. Diagnostic delay due to misclassification in imaging led to tumor growth and/or upgrading of the tumor stage in 8.9% of BL tumors, which had the lowest overall survivals. Despite misclassification rate was higher in the ML subtype it showed better outcomes. Misdiagnosis of axillary lymph node metastasis was higher in LAR; however, this subtype showed a higher percentage of affected axillary lymph nodes.ConclusionTNBC subtypes have different clinical features, benign appearances, and diagnostic delay, which can lead to tumor stage upgrade. Future clinical studies on TNBC outcomes might consider the confounder of clinical delay in the subtypes.

Introduction and hypothesis Several mesh repair systems for pelvic organ prolapse (POP) were introduced into clinical practice with limited data on safety, complications or success rates, and impact on sexual function. The Austrian Urogynecology Working Group initiated a registry to assess the use of transvaginal mesh devices for POP repair. We looked at perioperative data, as well as outcomes at 3 and 12 months. Methods Between 2006 and 2010 a total of 20 gynecology departments in Austria participated in the Transvaginal Mesh Registry. Case report forms were completed to gather data on operations, the postoperative course, and results at 3 and 12 months. Results A total of 726 transvaginal procedures with 10 different transvaginal kits were registered. Intra- and perioperative complications were reported in 6.8 %. The most common complication was increased intraoperative bleeding (2.2 %). Bladder and bowel perforation occurred in 6 (0.8 %) and 2 (0.3 %) cases. Mesh exposure was seen in 11 % at 3 and in 12 % at 12 months. 24 (10 %) previously asymptomatic patients developed bowel symptoms by 1 year. De novo bladder symptoms were reported in 39 (10 %) at 3 and in 26 (11 %) at 12 months. Dyspareunia was reported by 7 % and 10 % of 265 and 181 sexually active patients at 3 and 12 months postoperatively respectively. Conclusions The 6.8 % rate of intra- and perioperative complications is in line with previous reports. Visceral injury was rare. The 12 % rate of mesh exposure is consistent with previous series.

Fortschritte der chirurgischen und systemischen Therapien des Ovarialkarzinoms haben die Überlebenszeiten von Patientinnen verlängert und den Fokus auf deren Lebensqualität (LQ) erhöht. Die Berücksichtigung von Patient Reported Outcomes (PROs) als primäre oder sekundäre Endpunkte in klinischen Ovarialkarzinomstudien ist in den letzten Jahren deutlich angestiegen. Für die Messung von PROs stehen standardisierte Instrumente zur Verfügung, die speziell für Patientinnen mit Ovarialkarzinom entwickelt wurden. PRO-Instrumente sind mittels internetbasierter Erfassungsmethoden als ePROs verfügbar und weniger zeit- und kostenintensiv. Klinische Studienergebnisse mit PRO-Endpunkten haben in der Behandlung des Ovarialkarzinoms zur Veränderung des international anerkannten Therapiestandards geführt. Auf Grundlage der Daten wurden Carboplatin plus Paclitaxel weltweit als neuer Standard der Primärtherapie des fortgeschrittenen Ovarialkarzinoms festgelegt. Eine weitere Individualisierung der Therapie unter Berücksichtigung der LQ von Patientinnen konnte in der späten Rezidivsituation des Ovarialkarzinoms ermöglicht werden. Neben klinischen Studien finden PROs zunehmend auch in der klinischen Routine Eingang. Die Mehrheit onkologischer Patienten befürwortet die routinemäßige Erfassung der LQ. PRO-Daten geben wichtige Information über die subjektive Auswirkung der Erkrankung und der Therapie auf die LQ der Patientinnen, können für gemeinsame Therapieentscheidungen herangezogen werden und Behandlungsoptionen an die Bedürfnisse der Patientinnen anpassen.

Background We conducted a prospective randomized controlled noninferiority trial to compare objective and subjective outcomes of retropubic tension-free vaginal tape (TVT) with those of transobturator tape (TVT-O) as primary treatment for stress urinary incontinence (SUI) in women. Study design The study was conducted at 25 gynecology units in Austria and Germany; regional and academic hospitals participated. A total of 569 patients were randomly assigned to undergo TVT or TVT-O. Results A total of 480 patients (85 %) were examined at 3 months. A negative cough stress test with stable cystometry to 300 ml was seen in 87 % of patients after TVT and in 84 % after TVT-O; 64 % and 59 % of patients, respectively, reported no pad use, and 88 % of patients in both groups considered themselves much or very much better on the Patient Global Impression of Improvement (PGI-I) scale. Quality of life (QoL) as assessed with the SF-12 Health Survey, Kings’ Health Questionnaire, (KHQ), and EuroQol-5D (EQ-5D) was significantly improved in both arms, with no differences between arms. There were no significant differences in postoperative pain or complications. Conclusions Results of this trial demonstrate noninferiority between TVT and TVT-O with regard to postoperative continence and QoL and suggest little difference in perioperative problems (ClinicalTrials.gov NCT 00441454).

A Schuchardt incision is frequently performed to facilitate access to the parametrium during radical vaginal hysterectomy for cervical cancer. We report an adenocarcinoma recurrence in a Schuchardt incision 12 months after radical vaginal hysterectomy for FIGO stage IB1 cervical cancer. Histology of the primary tumor had shown a well-differentiated adenocarcinoma and poorly differentiated squamous cell carcinoma of the cervix 2.6 cm in maximum diameter. After further surgical therapy and adjuvant radiotherapy, the patient died of disease 51 months after the initial operation. Cervical cancers can implant and recur in perineal incisions. Thus, it appears prudent to avoid such incisions or, if they are made, to irrigate them copiously before closing them.

Die spontane Uterusruptur bei Primipara bei nicht voroperiertem Uterus ist ein sehr seltenes, akut lebensbedrohliches Ereignis. Bei klinisch stummem Verlauf ist sie schwer zu diagnostizieren, muss aber bei Auftreten klinischer Symptome und präpartal vorliegenden Risikofaktoren in Betracht gezogen werdenEine 24-jährige, in der Frühschwangerschaft mehrfach körperlich misshandelte Erstgebärende mit Gestationsdiabetes und Polyhydramnion wurde in der 40+1. SSW zur Geburtseinleitung aufgenommen. Wegen Beckenendlage wurde zweimal eine äußere Wendung in Schädellage durchgeführt. Nach Erhalt von Prostaglandin und Oxytocin erfolgte die Entbindung per sectionem wegen Geburtsstillstandes im Beckeneingang. Intraoperativ imponierte eine gedeckte Uterusruptur im unteren Uterinsegment. Nach Erweiterung der Ruptur nach lateral wurde ein gesunder Knabe entwickelt. Die chirurgische Sanierung der Uterusruptur sowie der postoperative Verlauf verliefen komplikationslos.Spontane Uterusrupturen ereignen sich vorwiegend bei Multiparae. Dennoch können sie, wenn auch äußerst selten, bei Primipara mit nicht voroperiertem und anatomisch normal strukturiertem Uterus in Erscheinung treten; z. B. als Folge uteriner Hyperstimulation, äußerer Traumata oder – möglicherweise – nach äußerer Wendung. Ein kontinuierliches Monitoring zur Evaluierung der Uteruskontraktionen bei kontinuierlicher Oxytocingabe ist daher sowohl aus fetalen als auch maternalen Gründen unerlässlich, um auch klinisch inapparente Verläufe erfassen zu können.

Table of contents A1 68Ga-PSMA PET/CT in staging and restaging of Prostate Cancer Patients: comparative study with 18F-Choline PET/CT W Langsteger, A Rezaee, W Loidl, HS Geinitz, F Fitz, M Steinmair, G Broinger, L Pallwien-Prettner, M Beheshti A2 F18 Choline PET – CT: an accurate diagnostic tool for the detection of parathyroid adenoma? L Imamovic, M Beheshti, G Rendl, D Hackl, O Tsybrovsky, M Steinmair, K Emmanuel, F Moinfar, C Pirich, W Langsteger A3 [18F]Fluoro-DOPA-PET/CT in the primary diagnosis of medullary thyroid carcinoma A Bytyqi, G Karanikas, M Mayerhöfer, O Koperek, B Niederle, M Hartenbach A4 Variations of clinical PET/MR operations: An international survey on the clinical utilization of PET/MRI T Beyer, K Herrmann, J Czernin A5 Standard Dixon-based attenuation correction in combined PET/MRI: Reproducibility and the possibility of Lean body mass estimation I Rausch, P Rust, MD DiFranco, M Lassen, A Stadlbauer, ME Mayerhöfer, M Hartenbach, M Hacker, T Beyer A6 High resolution digital FDG PET/MRI imaging for assessment of ACL graft viability K Binzel, R Magnussen, W Wei, MU Knopp, DC Flanigan, C Kaeding, MV Knopp A7 Using pre-existing hematotoxicity as predictor for severe side effects and number of treatment cycles of Xofigo therapy A Leisser, M Nejabat, M Hartenbach, G Kramer, M Krainer, M Hacker, A Haug A8 QDOSE – comprehensive software solution for internal dose assessment Wencke Lehnert, Karl Schmidt, Sharok Kimiaei, Marcus Bronzel, Andreas Kluge A9 Clinical impact of Time-of-Flight on next-generation digital PET imaging of Yttrium-90 radioactivity following liver radioembolization CL Wright, K Binzel, J Zhang, Evan Wuthrick, Piotr Maniawski, MV Knopp A10 Snakes in patients! Lessons learned from programming active contours for automated organ segmentation M Blaickner, E Rados, A Huber, M Dulovits, H Kulkarni, S Wiessalla, C Schuchardt, RP Baum, B Knäusl, D Georg A11 Influence of a genetic polymorphism on brain uptake of the dual ABCB1/ABCG2 substrate [11C]tariquidar M Bauer, B Wulkersdorfer, W Wadsak, C Philippe, H Haslacher, M Zeitlinger, O Langer A12 Outcome prediction of temporal lobe epilepsy surgery from P-glycoprotein activity. Pooled analysis of (R)-[11C]-verapamil PET data from two European centres M Bauer, M Feldmann, R Karch, W Wadsak, M Zeitlinger, MJ Koepp, M-C Asselin, E Pataraia, O Langer A13 In-vitro and in-vivo characterization of [18F]FE@SNAP and derivatives for the visualization of the melanin concentrating hormone receptor 1 M Zeilinger, C Philippe, M Dumanic, F Pichler, J Pilz, M Hacker, W Wadsak, M Mitterhauser A14 Reducing time in quality control leads to higher specific radioactivity of short-lived radiotracers L Nics, B Steiner, M Hacker, M Mitterhauser, W Wadsak A15 In vitro 11C-erlotinib binding experiments in cancer cell lines with epidermal growth factor receptor mutations A Traxl, Thomas Wanek, Kushtrim Kryeziu, Severin Mairinger, Johann Stanek, Walter Berger, Claudia Kuntner, Oliver Langer A16 7-[11C]methyl-6-bromopurine, a PET tracer to measure brain Mrp1 function: radiosynthesis and first PET evaluation in mice S Mairinger, T Wanek, A Traxl, M Krohn, J Stanek, T Filip, M Sauberer, C Kuntner, J Pahnke, O Langer A17 18F labeled azidoglucose derivatives as “click” agents for pretargeted PET imaging D Svatunek, C Denk, M Wilkovitsch, T Wanek, T Filip, C Kuntner-Hannes, J Fröhlich, H Mikula A18 Bioorthogonal tools for PET imaging: development of radiolabeled 1,2,4,5-Tetrazines C Denk, D Svatunek, T Wanek, S Mairinger, J Stanek, T Filip, J Fröhlich, H Mikula, C Kuntner-Hannes A19 Preclinical evaluation of [18F]FE@SUPPY- a new PET-tracer for oncology T Balber, J Singer, J Fazekas, C Rami-Mark, N Berroterán-Infante, E Jensen-Jarolim, W Wadsak, M Hacker, H Viernstein, M Mitterhauser A20 Investigation of Small [18F]-Fluoroalkylazides for Rapid Radiolabeling and In Vivo Click Chemistry C Denk, D Svatunek, B Sohr, H Mikula, J Fröhlich, T Wanek, C Kuntner-Hannes, T Filip A21 Microfluidic 68Ga-radiolabeling of PSMA-HBED-CC using a flow-through reactor S Pfaff, C Philippe, M Mitterhauser, M Hartenbach, M Hacker, W Wadsak A22 Influence of 24-nor-ursodeoxycholic acid on hepatic disposition of [18F]ciprofloxacin measured with positron emission tomography T Wanek, E Halilbasic, M Visentin, S Mairinger, B Stieger, C Kuntner, M Trauner, O Langer A23 Automated 18F-flumazenil production using chemically resistant disposable cassettes P Lam, M Aistleitner, R Eichinger, C Artner A24 Similarities and differences in the synthesis and quality control of 177Lu-DOTA-TATE, 177Lu -HA-DOTA-TATE and 177Lu-DOTA-PSMA (PSMA-617) H Eidherr, C Vraka, A Haug, M Mitterhauser, L Nics, M Hartenbach, M Hacker, W Wadsak A25 68Ga- and 177Lu-labelling of PSMA-617 H Kvaternik, R Müller, D Hausberger, C Zink, RM Aigner A26 Radiolabelling of liposomes with 67Ga and biodistribution studies after administration by an aerosol inhalation system U Cossío, M Asensio, A Montes, S Akhtar, Y te Welscher, R van Nostrum, V Gómez-Vallejo, J Llop A27 Fully automated quantification of DaTscan SPECT: Integration of age and gender differences F VandeVyver, T Barclay, N Lippens, M Troch A28 Lesion-to-background ratio in co-registered 18F-FET PET/MR imaging – is it a valuable tool to differentiate between low grade and high grade brain tumor? L Hehenwarter, B Egger, J Holzmannhofer, M Rodrigues-Radischat, C Pirich A29 [11C]-methionine PET in gliomas - a retrospective data analysis of 166 patients N Pötsch, I Rausch, D Wilhelm, M Weber, J Furtner, G Karanikas, A Wöhrer, M Mitterhauser, M Hacker, T Traub-Weidinger A30 18F-Fluorocholine versus 18F-Fluorodeoxyglucose for PET/CT imaging in patients with relapsed or progressive multiple myeloma: a pilot study T Cassou-Mounat, S Balogova, V Nataf, M Calzada, V Huchet, K Kerrou, J-Y Devaux, M Mohty, L Garderet, J-N Talbot A31 Prognostic benefit of additional SPECT/CT in sentinel lymph node mapping of breast cancer patients S Stanzel, G Pregartner, T Schwarz, V Bjelic-Radisic, B Liegl-Atzwanger, R Aigner A32 Evaluation of diagnostic value of TOF-18F-FDG PET/CT in patients with suspected pancreatic cancer S Stanzel, F Quehenberger, RM Aigner A33 New quantification method for diagnosis of primary hyperpatahyroidism lesions and differential diagnosis vs thyropid nodular disease in dynamic scintigraphy A Koljević Marković, Milica Janković, V Miler Jerković, M Paskaš, G Pupić, R Džodić, D Popović A34 A rare case of diffuse pancreatic involvement in patient with merkel cell carcinoma detected by 18F-FDG MC Fornito, D Familiari A35 TSH-stimulated 18F-FDG PET/CT in the diagnosis of recurrent/metastatic radioiodine-negative differentiated thyroid carcinomas in patients with various thyroglobuline levels P Koranda, H Polzerová, I Metelková, L Henzlová, R Formánek, E Buriánková, M Kamínek A36 Breast Dose from lactation following I131 treatment WH Thomson, C Lewis A37 A new concept for performing SeHCAT studies with the gamma camera WH Thomson, J O’Brien, G James, A Notghi A38 Whole body F-18-FDG-PET and tuberculosis: sensitivity compared to x-ray-CT H Huber, I Stelzmüller, R Wunn, M Mandl, F Fellner, B Lamprecht, M Gabriel A39 Emerging role 18F-FDG PET-CT in the diagnosis and follow-up of the infection in heartware ventricular assist system (HVAD) MC Fornito, G Leonardi A40 Validation of Poisson resampling software WH Thomson, J O’Brien, G James A41 Protection of PET nuclear medicine personnel: problems in satisfying dose limit requirements J Hudzietzová, J Sabol, M Fülöp

Adjuvant endocrine therapy compromises bone health in patients with breast cancer, causing osteopenia, osteoporosis, and fractures. Antiresorptive treatments such as bisphosphonates prevent and counteract these side-effects. In this trial, we aimed to investigate the effects of the anti-RANK ligand antibody denosumab in postmenopausal, aromatase inhibitor-treated patients with early-stage hormone receptor-positive breast cancer. In this prospective, double-blind, placebo-controlled, phase 3 trial, postmenopausal patients with early hormone receptor-positive breast cancer receiving treatment with aromatase inhibitors were randomly assigned in a 1:1 ratio to receive either denosumab 60 mg or placebo administered subcutaneously every 6 months in 58 trial centres in Austria and Sweden. Patients were assigned by an interactive voice response system. The randomisation schedule used a randomly permuted block design with block sizes 2 and 4, stratified by type of hospital regarding Hologic device for DXA scans, previous aromatase inhibitor use, and baseline bone mineral density. Patients, treating physicians, investigators, data managers, and all study personnel were masked to treatment allocation. The primary endpoint was time from randomisation to first clinical fracture, analysed by intention to treat. As an additional sensitivity analysis, we also analysed the primary endpoint on the per-protocol population. Patients were treated until the prespecified number of 247 first clinical fractures was reached. This trial is ongoing (patients are in follow-up) and is registered with the European Clinical Trials Database, number 2005-005275-15, and with ClinicalTrials.gov, number NCT00556374. Between Dec 18, 2006, and July 22, 2013, 3425 eligible patients were enrolled into the trial, of whom 3420 were randomly assigned to receive denosumab 60 mg (n=1711) or placebo (n=1709) subcutaneously every 6 months. Compared with the placebo group, patients in the denosumab group had a significantly delayed time to first clinical fracture (hazard ratio [HR] 0·50 [95% CI 0·39–0·65], p<0·0001). The overall lower number of fractures in the denosumab group (92) than in the placebo group (176) was similar in all patient subgroups, including in patients with a bone mineral density T-score of −1 or higher at baseline (n=1872, HR 0·44 [95% CI 0·31–0·64], p<0·0001) and in those with a bone mineral density T-score of less than −1 already at baseline (n=1548, HR 0·57 [95% CI 0·40–0·82], p=0·002). The patient incidence of adverse events in the safety analysis set (all patients who received at least one dose of study drug) did not differ between the denosumab group (1366 events, 80%) and the placebo group (1334 events, 79%), nor did the numbers of serious adverse events (521 vs 511 [30% in each group]). The main adverse events were arthralgia and other aromatase-inhibitor related symptoms; no additional toxicity from the study drug was reported. Despite proactive adjudication of every potential osteonecrosis of the jaw by an international expert panel, no cases of osteonecrosis of the jaw were reported. 93 patients (3% of the full analysis set) died during the study, of which one death (in the denosumab group) was thought to be related to the study drug. Adjuvant denosumab 60 mg twice per year reduces the risk of clinical fractures in postmenopausal women with breast cancer receiving aromatase inhibitors, and can be administered without added toxicity. Since a main side-effect of adjuvant breast cancer treatment can be substantially reduced by the addition of denosumab, this treatment should be considered for clinical practice. Amgen.