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Introduction: Prognosis of patients diagnosed with HER2+ early breast cancer (eBC) has substantially improved, but distant recurrences impacting quality of life and survival still occur. One treatment option for extended adjuvant treatment of patients with HER2+/HR+ eBC is neratinib, available in Europe for patients who completed adjuvant trastuzumab-based therapy within 1 year. The ELEANOR study is investigating the real-world use of neratinib in Germany, Austria, and Switzerland. Results from an interim analysis of the first 200 patients observed for ≥3 months are reported. Methods: The primary objective of this prospective, multicenter, observational study is to assess patient adherence to neratinib (defined as the percentage of patients taking neratinib on ≥75% prescribed days). Secondary objectives are patient characteristics and treatment outcomes. Results: At cut-off (May 2, 2022), a total of 202 patients had been observed for ≥3 months, with neratinib treatment documented for 187 patients (median age: 53.0 years; 67.9% at increased risk of disease recurrence). In total, 151 (80.7%) patients had received prior neoadjuvant treatment; of these, 82 (54.3%) patients achieved a pathologically complete response. Neratinib was initiated at a median 3.6 months after trastuzumab-based treatment, with 36.4% starting at a dose <240 mg/day. Treatment is ongoing for 46.0% of patients, with median treatment duration of 11.2 (interquartile range 0.9–12.0) months. Diarrhea was the most common adverse event (78.6% any grade, 20.3% grade ≥3); pharmacologic prophylaxis was used in 85.6% of patients. Conclusions: The pattern of anti-HER2 pretreatment observed reflected the current treatment for HER2+/HR+ eBC in Germany, Austria, and Switzerland. These interim results suggest that neratinib as an extended adjuvant is a feasible option after various anti-HER2 pretreatments and that its tolerability can be managed and improved with proactive diarrhea management. [ABSTRACT FROM AUTHOR]

Purpose: Recurrent anterior shoulder instability caused by critical bone loss of the glenoid is a challenging condition for shoulder surgeons. The purpose of this prospective multicenter trial was to compare the arthroscopic transfer of the coracoid process (Latarjet procedure) with the arthroscopic reconstruction of the glenoid using iliac crest autografts. Methods: A prospective multi-center trial was performed in nine orthopaedic centres in Austria, Germany and Switzerland between July 2015 and August 2021. Patients were prospectively enrolled and received either an arthroscopic Latarjet procedure or an arthroscopic iliac crest graft transfer. Standardized follow-up after 6 months and mimimum 24 months included range of motion, Western Ontario stability index (WOSI), Rowe score and subjective shoulder value (SSV). All complications were recorded. Results: 177 patients (group Latarjet procedure: n = 110, group iliac crest graft: n = 67) were included in the study. WOSI (n.s.), SSV (n.s.) and Rowe score (n.s.) showed no difference at final follow-up. 10 complications were seen in group Latarjet procedure and 5 in group iliac crest graft; the frequency of complications did not differ between the two groups (n.s.). Conclusion: The arthrosopic Latarjet procedure and arthroscopic iliac crest graft transfer lead to comparable results regarding clinical scores, frequency of recurrent dislocations and complication rates. Level of evidence: Level II. [ABSTRACT FROM AUTHOR]

Patients with low socioeconomic status (SES) are among the most underserved groups of people regarding cancer care. Analyzing the impact of the coronavirus‐induced disease 2019 (COVID‐19) pandemic on health care disparities and calling attention to inequalities in cancer care is crucial to justify and initiate adequate countermeasures. We aimed to determine whether the COVID‐19 pandemic aggravated health care disparities of cancer outpatients related to their SES and analyzed patient data of the largest university center providing services for patients with hematologic and oncologic disorders in Austria from 2018 to 2021. SES was assessed using three indicators: monthly net household income, level of education and occupational prestige. In total, 1217 cancer outpatients (51.1% female) with a mean age of 59.4 years (SD = 14.2) participated. In the first year of the pandemic, the relative proportion of individuals with low income, low education level and low occupational prestige seeking cancer care at our outpatient center decreased significantly (P ≤.015). The strongest indicator was income, with a consistent effect throughout the first pandemic year. Countermeasures and specific interventions to support cancer patients with low SES in their access to health care should be initiated and prioritized. [ABSTRACT FROM AUTHOR]

Background: In August 2018, neratinib – an oral, irreversible pan-HER-tyrosine-kinase inhibitor – was approved by the European Commission for the extended adjuvant treatment of adult patients with early-stage, hormone receptor-positive (HR+), HER2 overexpressed/amplified (HER2+) breast cancer who completed trastuzumab-based adjuvant therapy within the last year. Despite recent improvements in long-term outcome, there is still an unmet need to further reduce the risk of recurrence, especially in patients with poor response to neoadjuvant treatment. Summary: National and international guidelines included recommendations for using neratinib. Based on the health technology assessment for neratinib, the Federal Joint Committee (G-BA) in Germany has granted an added benefit for neratinib compared with the standard "watch and wait" strategies. Inclusion in the Reimbursement Code, however, was rejected by the Austrian social insurance companies in July 2020, and neratinib is now in the "No Box" for individual head physician reimbursement. Key Messages: We analysed the value of extended adjuvant therapy with neratinib in early HER2+/HR+ breast cancer based on current data and made recommendations for the evidence-based and economical use of neratinib in Austria. In particular, prognostic factors associated with an increased risk of recurrence following standard therapy are considered. Extended adjuvant therapy should be offered primarily to nodal-positive patients at surgery. For nodal-negative patients, neratinib therapy may be considered in case of large and/or inflammatory primary tumours (T3–4) without pathological complete response after neoadjuvant therapy. For all other patients, neratinib may be considered depending on additional risk factors on an individual basis that should be evaluated by interdisciplinary tumour conferences. [ABSTRACT FROM AUTHOR]

The aim of this study was to investigate the safety and performance of Princess VOLUME Lidocaine in nasolabial fold correction. In this prospective, open label, multicenter, postmarket study subjects received injections of Princess VOLUME Lidocaine into both NLF at Baseline (Day 0) and if considered necessary by the investigator, at Week 2 (touch‐up treatment). This study was conducted in Austria at the Department of Dermatology and Venereology, Medical University of Graz, at the medical aesthetic center MÄZ WIEN, and at the medical aesthetic center Ordination Dr. Bartsch, Vienna. The 62 mainly female (95.2%) subjects had a median age of 52 years with two fully visible, approximately symmetrical NLFs, each scoring grade 2 or 3 on the nasolabial fold severity rating scale (NLF‐SRS) developed by Croma‐Pharma. The nasolabial fold severity was assessed by NLF‐SRS and Global Aesthetic Improvement Scale (GAIS) 4, 24, and 36 weeks later. Adverse events (AEs) were recorded throughout the investigation. With 95.1% of subjects showing an improvement of at least 1 grade of the NLF‐SRS at 24 weeks after the treatment, the primary endpoint was achieved, and clinical performance was demonstrated. Princess VOLUME Lidocaine was well tolerated, with only mild AEs, mainly injection site reactions, reported. Subject satisfaction (≥93.5%) and GAIS scores (≥93.5% improvement) were high. Princess VOLUME Lidocaine was effective in reducing NLFs as shown by an improvement in the severity of NLFs by at least one grade in 95.1% of subjects at Weeks 4 and 24. [ABSTRACT FROM AUTHOR]

STEPAUT, an Austrian non-interventional study, evaluated the safety and efficacy of everolimus plus exemestane in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (ABC) recurring/progressing on/after nonsteroidal aromatase inhibitors (NSAIs) in routine clinical practice. Postmenopausal women with HR+, HER2− ABC progressing on/after NSAIs receiving everolimus plus exemestane in accordance with routine practice and the current version of Summary of Product Characteristics were eligible. Planned individual observation period corresponded to the duration of treatment until formal study end. Overall, 236 patients (median age: 65 years) were enrolled at 17 sites across Austria. The median progression-free survival (mPFS) in the overall population was 9.5 months (95% confidence interval [CI]: 8.6–10.7 months). The mPFS (95% CI) in patients who received everolimus 10 and 5 mg was 9.9 months (7.3–11.5 months) and 8 months (4.7–10.7 months), respectively. The median time to progression was numerically longer in patients who had a therapy break (11.9 months, 95% CI: 10.0–14.6 months) versus those who did not have any therapy break (10.7 months, 95% CI: 8.9–12.6 months). Patients experienced grade 1 (53.7%), grade 2 (35.9%), grade 3 (9.9%), grade 4 (0.2%) adverse events (AEs). The most common AEs of any grade were stomatitis, mucositis (53.8%), rash, exanthema (29.7%), loss of appetite, nausea (28.4%). Real-world safety and efficacy data from STEPAUT were consistent with results from BOLERO-2, supporting everolimus plus exemestane as a suitable treatment option for HR+, HER2− ABC recurring/progressing on/after NSAIs. • STEPAUT, an Austrian non-interventional study, evaluated everolimus plus exemestane. • The median progression-free survival in the overall population was 9.5 months. • Majority of the patients had grade 1 (53.7%) to grade 2 (35.9%) adverse events. • Real-world data from STEPAUT were consistent with results from the BOLERO-2. Trial registration: BASG, AGES, NIS002843 [ABSTRACT FROM AUTHOR]

Body mass index ( BMI) is a prognostic factor in several cancer types. We investigated the prognostic role of BMI in a large patient cohort with newly diagnosed lung cancer brain metastases ( BM) between 1990 and 2013. BMI at diagnosis of BM and graded prognostic assessment ( GPA) were calculated. Definitions were underweight ( BMI <18.50), weight within normal range ( BMI 18.50-24.99) and overweight ( BMI ≥ 25.00). A total of 624 patients (men 401/624 [64.3%]; women 223/624 [35.7%]; median age of 61 [range 33-88]) were analysed. Histology was non-small cell lung cancer in 417/622 (66.8%), small cell lung cancer ( SCLC) in 205/624 (32.9%) and not otherwise specified in 2/624 (0.3%) patients. About 313/624 (50.2%) had normal BMI, 272/624 (43.5%) were overweight and 39/624 (6.3%) were underweight. Underweight patients had shorter median overall survival (3 months) compared to patients with normal BMI (7 months) and overweight (8 months; p < .001; log rank test). At multivariate analysis, higher GPA class ( HR 1.430; 95% cumulative incidence, CI 1.279-1.598; p < .001; Cox regression model), SCLC histology ( HR 1.310; 95% CI 1.101-1.558) and presence of underweight ( HR 1.845; 95% CI 1.317-2.585; p = .014; Cox regression model) were independent prognostic factors. Underweight at diagnosis of BM in lung cancer is associated with an unfavourable prognosis. [ABSTRACT FROM AUTHOR]

A new approach for the construction of highresolution gridded fields of reference evapotranspiration for the Austrian domain on a daily time step is presented. Gridded data of minimum and maximum temperatures are used to estimate reference evapotranspiration based on the formulation of Hargreaves. The calibration constant in the Hargreaves equation is recalibrated to the Penman Monteith equation in a monthly and station-wise assessment. This ensures, on one hand, eliminated biases of the Hargreaves approach compared to the formulation of Penman Monteith and, on the other hand, also reduced root mean square errors and relative errors on a daily timescale. The resulting new calibration parameters are interpolated over time to a daily temporal resolution for a standard year of 365 days. The overall novelty of the approach is the use of surface elevation as the only predictor to estimate the recalibrated Hargreaves parameter in space. A third-order polynomial is fitted to the recalibrated parameters against elevation at every station which yields a statistical model for assessing these new parameters in space by using the underlying digital elevation model of the temperature fields. With these newly calibrated parameters for every day of year and every grid point, the Hargreaves method is applied to the temperature fields, yielding reference evapotranspiration for the entire grid and time period from 1961-2013. This approach is opening opportunities to create high-resolution reference evapotranspiration fields based only temperature observations, but being as close as possible to the estimates of the Penman-Monteith approach. [ABSTRACT FROM AUTHOR]

Upon disease progression on trastuzumab-based therapy, patients with HER-2 positive metastatic breast cancer ( MBC) may switch to lapatinib or continue on trastuzumab. We aimed to assess the impact of both strategies on overall survival ( OS) in all patients treated for HER-2 positive MBC at the Medical University Vienna from 1999 until 2009. A total of 201 patients were identified from a breast cancer data base. Of these 115 (57.2%) received multiple lines of trastuzumab-based therapy, whereas 58 (28.9%) were treated with a single line. A control group of 28 patients (13.9%) had never received trastuzumab as they were treated before 1999, when trastuzumab was registered. OS from diagnosis of metastatic disease was defined as primary study endpoint. Trastuzumab significantly prolonged OS in HER-2 positive MBC (41 versus 13 months; p < 0.001). Administration of multiple lines further improved OS; this, however, did not reach statistical significance (47 versus 28 months; p = 0.069). Positive estrogen receptor ( ER) status ( HR 1.6; 95% CI 1.13-2.27) was associated with better outcome compared to negative estrogen receptor status (p = 0.02). Addition of lapatinib did not improve OS significantly in patients with prior trastuzumab-based therapy (62 versus 47 months; p = n.s.). Patients receiving lapatinib after diagnosis of BM, however, experienced an improvement of OS (22 versus 5 months; p = 0.022). Trastuzumab improves OS in patients with HER-2 positive MBC with further nonsignificant improvement when administered in multiple lines. Lapatinib did not further improve OS in the entire population; however, lapatinib might improve OS in patients with BM. [ABSTRACT FROM AUTHOR]

Background. Results of trial E2100 led to the accelerated approval of bevacizumab as first-line therapy for patients with metastatic breast cancer (MBC) in the U.S. in February 2008. Based on results from subsequent trials, the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC) issued a statement proposing to withdraw the license for bevacizumab in July 2010, whereas bevacizumab approval for MBC was not withdrawn in Europe. In this nationwide survey, we investigated the influence of the discrepancy between the ODAC and European Medicines Agency (EMA) positions on the prescription practice of bevacizumab for MBC in Austria during the period January 2006 to June 2011. Methods. The absolute number of bevacizumab administrations for MBC patients per month in all Austrian hospitals within the mentioned time frame was retrieved from a comprehensive national database. Bevacizumab prescription numbers for other malignancies were retrieved in order to rule out that a change in bevacizumab prescribing practice might reflect general changes in Austrian health care policy. Results. A steady increase in bevacizumab use was seen from January 2006 to June 2010 (42 versus 1,357 administrations per month) for MBC. Thereafter, a significant decline in bevacizumab prescriptions for MBC became evident, with numbers dropping to 842 in March 2011 and 662 in June 2011. Bevacizumab prescriptions showed only minor variations in control cohorts. Conclusions. The Austrian bevacizumab prescribing practice in MBC patients was significantly influenced by the ODAC statement issued in July 2010, whereas the EMA position was accepted to a lesser degree. [ABSTRACT FROM AUTHOR]

Abstract: A new halacarid species, Halacarellus fontinalis n. sp., from a spring in the Gesäuse National Park, Austria is described. The species is characterized by three pairs of large, equal-sized acetabula and slender claws and is expected to have evolved in the Tertiary from a Tethyan-Paratethyan Halacarellus species. Caspihalacarus, with a single species, C. hyrcanus, has large and external acetabula similar to those in H. fontinalis. Caspihalacarus is synonymized with Halacarellus. [Copyright &y& Elsevier]

There are two papers in this section this month. The first, by authors from Austria, concerns growth curves of the fetal prostate, correlating gestational age and maternal testosterone using three-dimensional reconstructions. The second, from the UK, investigated testicular microlithiasis, and found no convincing evidence that alone it is a premalignant condition. OBJECTIVE To create a nomogram of the fetal growth of the human prostate corresponding to gestational age, and to investigate the relationship between the expansive growth of the fetal prostate and the maternal testosterone surge during pregnancy. MATERIALS AND METHODS In all, 27 fetal prostates at 11–40 weeks of gestation, and seven neonatal specimens at 1–20 weeks after birth, were analysed. Serial sections of prostates were immunostained and examined using light microscopy. After modular image acquisition the volumes were calculated using three-dimensional reconstruction. The prostate volumes were correlated with gestational age, and related to reference testosterone levels during pregnancy. RESULTS There was exponential growth of the fetal prostate with gestational age. The increasing volume of the prostate during the fetal period corresponded with maternal testosterone levels. In the second trimester there was a significant increase in prostate volume in relation to the bladder. In infants, macroscopically there was an inverse proportion between bladder size and prostate volume. CONCLUSIONS Starting from the second trimester there is distinct growth of the fetal prostate, obviously triggered by the maternal testosterone surge. In neonates there is an inversion of the dimensions between bladder and prostate. These results indicating exponential growth of the fetal prostate provide evidence of a gender-related transient infravesical obstruction in human fetuses. [ABSTRACT FROM AUTHOR]

Two of the papers in this section refer to surgical technique in cancer operations. In the first, authors from Innsbruck examine their rates of urinary extravasation after removing the catheter 10 days after radical retropubic prostatectomy; the rate was very low, the continence rates were excellent, and the rate of anastomic stricture was low. This is a large and well-studied group of patients.In the second of these papers, authors from Paris describe a technique of radical cystectomy where there is sparing of the prostate capsule and of the seminal vesicles, to preserve potency and improve continence. They found very little positive support in their results in favour of this technique, and felt it should have only a limited role.A study from Sacramento assesses a modified yeast assay as an aid to detect p53 gene mutations in localized prostate cancer. They found it to be superior to other methods, and felt that p53 mutations carried important prognostic implications.To evaluate the feasibility of urinary catheter removal 10 days after a radical retropubic prostatectomy (RRP) by assessing the incidence of urinary extravasation and its effect on postoperative stricture and continence rates.During a 4.5-year period, 619 patients undergoing RRP were evaluated. If no extravasation was detected on gravity cystography, the urinary catheter was removed 10 days after RRP. In patients with significant extravasation the catheter was left in place for 3 weeks. Overall stricture and continence rates were recorded in patients at 3, 6 and 12 months after surgery.There was extravasation during cystography in 29 patients (4.6%). At 3, 6 and 12 months, continence rates after catheter removal at 10 days were 74.9%, 87.9%, and 93.6%, respectively, while in the late-removal group they were 72.4%, 84.6% and 90.9%, respectively, with no significant difference between the groups. At 3 months the overall continence rate was 74.8% and at 12 months up to 93.5%. There was no difference in stricture rates between the groups, with an overall stricture rate of 0.7%.Catheter removal 10 days after RRP is feasible, giving excellent early and late continence rates, with low anastomotic stricture rates obtained using good surgical technique. Extravasation at 10 days was rare and with proper management did not influence the final results. [ABSTRACT FROM AUTHOR]

Several preclinical and epidemiologic studies have indicated tumour-promoting effects of thyroid hormones (THs). However, very limited knowledge exists on the prognostic impact of thyroid function in metastatic cancer. We compiled a discovery cohort of 1692 patients with newly diagnosed brain metastases (BMs) of solid cancers treated at the Medical University of Vienna and an independent validation cohort of 191 patients with newly diagnosed BMs treated at the University Hospital Zurich. Hypothyroidism before diagnosis of cancer was evident in 133 of 1692 (7.9%) patients of the discovery, and in 18 of 191 (9.4%) patients of the validation cohort. In the discovery cohort, hypothyroidism was statistically significantly associated with favourable survival prognosis from diagnosis of cancer (31 vs. 21 months; p = 0.0026) and with survival prognosis from diagnosis of BMs (12 vs. 7 months; p = 0.0079). In multivariate analysis including the diagnosis-specific graded prognostic assessment score, primary tumour type and sex, hypothyroidism was an independent factor associated with survival after diagnosis of BMs (hazard ratio: 0.76; 95% confidence interval [CI]: (0.63; 0.91; p = 0.0034). In the validation cohort, the association of hypothyroidism and favourable survival prognosis from diagnosis of cancer (55 vs. 11 months; p = 0.00058), as well as from diagnosis of BMs (40 vs. 10 months; p = 0.0036) was confirmed. Pre-existing hypothyroidism was strongly and independently associated with prognosis in patients with newly diagnosed BMs, supporting the evidence from preclinical data that THs may indeed have a tumour-promoting effect. Further investigation of the underlying pathobiological mechanism and potential therapeutic implications are required. • Association of thyroid function and prognosis was analysed in a discovery cohort patients with newly diagnosed brain metastases (BMs) and an independent validation cohort. • Hypothyroidism was associated with increased survival from primary tumour, as well as from BMs diagnosis. • Hyperthyroidism was less frequently observed and not observed with clinical characteristics. [ABSTRACT FROM AUTHOR]

Background: Totally implanted access ports (PACs) are valuable tools for the treatment of patients with cancer because they ease the administration of chemotherapy, stem cells, and supportive care by reducing the rate of peripheral vein punctures. Objectives: The purpose of this study was to evaluate the satisfaction and impairments of activities of daily living of ambulatory patients with PAC systems receiving chemotherapy. Methods: This cross-sectional, questionnaire-based study evaluated 202 patients with PAC systems in a comprehensive cancer center and cancer rehabilitation center. From November 2012 to August 2013, patients were invited to answer a questionnaire concerning quality of life and satisfaction with their PAC devices. Data regarding PAC-related complications were collected retrospectively by searching patients' medical history. Findings: A total of 202 patients with 230 PAC devices were included. Median time from PAC implantation to inclusion in the study was nine months. Surgical complications occurred in some cases, with bleeding and hematoma being the most frequently observed events. Late complications consisted of infections, drug extravasation, PAC malposition, PAC malfunction, and thrombosis. A third of the patients reported that their PAC interfered with activities of daily living. However, most agreed that PAC systems alleviated the burden of chemotherapy administration, and the vast majority said they would choose the implantation of a PAC system for chemotherapy administration again. [ABSTRACT FROM AUTHOR]

Objective: To describe two predictive models that predict for prostate cancer on biopsy derived from a large screening population. There are no published predictive models that predict prostate cancer in a screened population. Methods: The patients from the Tyrol screening study of known age, total prostate-specific antigen (PSA) level, digital rectal examination (DRE) findings, prostate volume, and percentage of free PSA, and who underwent an initial prostate biopsy from January 1992 to June 2004 were included (n = 2271). Multivariate logistic regression models were used to develop the biopsy positivity predictive models: nomogram 1, age, DRE, and total PSA; and nomogram 2, age, DRE, total PSA, and percentage of free PSA. The predictive accuracy of the models was assessed in terms of discrimination and calibration. External validation of the nomograms was performed using a urologically referred population of patients who underwent prostate biopsy (n = 599). Results: Both nomograms were well-calibrated internally and externally and discriminated well between patients with positive and negative biopsy findings for both the European and U.S. cohorts (model 2 better than model 1). Conclusion: Our nomogram with age, total PSA, and DRE had good predictive ability to differentiate between screened patients with cancer on the initial prostate biopsy and those without. Adding the percentage of free PSA improves this predictive power further. These models might aid in clinical decision making regarding the need for biopsy in both European and U.S. populations. [ABSTRACT FROM AUTHOR]

The article presents a study on the comparison of mountain bikers and on-road cyclists on prevalence of scrotal abnormalities. The study was conducted in the Medical University in Innsbruck, Austria. The subject of the study includes only those mountain bikers and on-road cyclists who have engaged extensively on the sports. They were exposed to ultrasonographic examination of the scrotum. The ultrasound applies the linear array transducer with a frequency of 8.0 MHz. Scrotal disorders such as scrotoliths, spermatoceles and epididymal calcifications were manifested by most of the respondents. Morevover, mountain bikers have a higher risks compared to on-road cyclists for disorders concerning the scrotum.