Alternating gemcitabine plus nab-paclitaxel and gemcitabine alone versus continuous gemcitabine plus nab-paclitaxel after induction treatment of metastatic pancreatic cancer (ALPACA): a multicentre, randomised, open-label, phase 2 trial.

Background: A standardised dose-reduction strategy has not been established for the widely used gemcitabine plus nab-paclitaxel regimen in patients with metastatic pancreatic ductal adenocarcinoma. We aimed to investigate the efficacy and tolerability of alternating treatment cycles of nab-paclitaxel-gemcitabine combination therapy and gemcitabine alone versus continuous treatment with the nab-paclitaxel-gemcitabine combination.

Methods: ALPACA was a randomised, open-label, phase 2 trial conducted at 29 study centres across Germany.

Ramucirumab, Avelumab, and Paclitaxel as Second-Line Treatment in Esophagogastric Adenocarcinoma: The Phase 2 RAP (AIO-STO-0218) Nonrandomized Controlled Trial.

Importance: Adding immune checkpoint inhibitors to chemotherapy has been associated with improved outcomes in metastatic esophagogastric adenocarcinoma, but treatment combinations and optimal patient selection need to be established.

Objective: To investigate the efficacy and tolerability of the programmed cell death ligand 1 (PDL-1) inhibitor avelumab with paclitaxel plus ramucirumab.

Design, Setting, And Participants: This multicenter, single-group, phase 2 nonrandomized controlled trial was conducted among patients with second-line metastatic esophagogastric adenocarcinoma.

Children diagnosed with presymptomatic type 1 diabetes through public health screening have milder diabetes at clinical manifestation.

Aims/hypothesis: We aimed to determine whether disease severity was reduced at onset of clinical (stage 3) type 1 diabetes in children previously diagnosed with presymptomatic type 1 diabetes in a population-based screening programme for islet autoantibodies.

Methods: Clinical data obtained at diagnosis of stage 3 type 1 diabetes were evaluated in 128 children previously diagnosed with presymptomatic early-stage type 1 diabetes between 2015 and 2022 in the Fr1da study and compared with data from 736 children diagnosed with incident type 1 diabetes between 2009 and 2018 at a similar age in the DiMelli study without prior screening.

Results: At the diagnosis of stage 3 type 1 diabetes, children with a prior early-stage diagnosis had lower median HbA (51 mmol/mol vs 91 mmol/mol [6.

Standard diametric versus volumetric early tumor shrinkage as a predictor of survival in metastatic colorectal cancer: subgroup findings of the randomized, open-label phase III trial FIRE-3 / AIO KRK-0306.

Objectives: Early tumor shrinkage (ETS) quantifies the objective response at the first assessment during systemic treatment. In metastatic colorectal cancer (mCRC), ETS gains relevance as an early available surrogate for patient survival. The aim of this study was to increase the predictive accuracy of ETS by using semi-automated volumetry instead of standard diametric measurements.

The clinical impact of multiplex PCR panel diagnostics in paediatric meningitis/ encephalitis: a bicenter cohort study.

Purpose: In infections of the Central Nervous System (iCNS), rapid identification of causing pathogens is crucial for survival and to avoid long-term sequelae. Targeted therapy may reduce side effects and development of antibiotic resistance. New molecular-based syndromic tests such as the "meningitis/encephalitis panel" (MEP) allow accelerated pathogen identification from cerebrospinal fluid.

Telemedical cardiac risk assessment by implantable cardiac monitors in patients after myocardial infarction with autonomic dysfunction (SMART-MI-DZHK9): a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial.

Background: Cardiac autonomic dysfunction after myocardial infarction identifies patients at high risk despite only moderately reduced left ventricular ejection fraction. We aimed to show that telemedical monitoring with implantable cardiac monitors in these patients can improve early detection of subclinical but prognostically relevant arrhythmic events.

Methods: We did a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial at 33 centres in Germany and Austria.

COVID-19 in 28-Week Triplets Caused by Intrauterine Transmission of SARS-CoV-2-Case Report.

Since the beginning of the COVID-19 pandemic, in-utero transmission of SARS-CoV-2 remains a rarity and only very few cases have been proven across the world. Here we depict the clinical, laboratory and radiologic findings of preterm triplets born at 28 6/7 weeks to a mother who contracted COVID-19 just 1 week before delivery. The triplets showed SARS-CoV-2 positivity right after birth, developed significant leukopenia and early-onset pulmonary interstitial emphysema.

Rare Tumors in Children and Adolescents - the STEP Working Group's Evolution to a Prospective Registry.

Background Very rare tumors (VRT) in children and adolescents have such a low incidence that until recently, they have not been integrated into the clinical and scientific network of pediatric oncology. Data is very limited and consistent treatment strategies are missing. Thus, VRTs are classic orphan diseases.

Discontinuation versus continuation of renin-angiotensin-system inhibitors in COVID-19 (ACEI-COVID): a prospective, parallel group, randomised, controlled, open-label trial.

Background: SARS-CoV-2 entry in human cells depends on angiotensin-converting enzyme 2, which can be upregulated by inhibitors of the renin-angiotensin system (RAS). We aimed to test our hypothesis that discontinuation of chronic treatment with ACE-inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) mitigates the course o\f recent-onset COVID-19.

Methods: ACEI-COVID was a parallel group, randomised, controlled, open-label trial done at 35 centres in Austria and Germany.

Risk to Radiology Staff for Occupational COVID-19 Infection in a High-Risk and a Low-Risk Region in Germany: Lessons from the "First Wave".

Purpose: The recent COVID-19 pandemic has resulted in an increasing overload of the medical system. Healthcare workers (HCW) in radiology departments are exposed to a high infection risk similar to HCWs in the ICU or dedicated COVID wards. The goal of our paper is to evaluate the prevalence of IgG antibody against SARS-CoV-2 among radiology HCWs in two different hospitals and regions in Germany with a low and high COVID-19 prevalence and to compare it to the prevalence in other clinical personnel.

Epidemiology, Clinical Features, and Use of Early Supportive Measures in PHACE Syndrome: A European Multinational Observational Study.

Background: PHACE syndrome is a rare inborn condition characterized by large facial hemangiomas and variable malformations of the arterial system, heart, central nervous system, and eyes. According to Orphanet estimates, the prevalence is <1.0 per million.

Clavicle Elevation or Shoulder Girdle Depression in Acromioclavicular Joint Dislocation: A Radiological Investigation.

Background: The side-comparative coracoclavicular (CC) distance is used to describe the vertical instability component of acute acromioclavicular (AC) joint dislocations. Elevation of the clavicle or a depression of the shoulder girdle can lead to an increased CC distance. The dislocation direction has not yet been investigated and is not included in common classification systems.

MAGE-A expression in oral and laryngeal leukoplakia predicts malignant transformation.

Leukoplakia is a potential precursor of oral as well as laryngeal squamous cell carcinoma. Risk assessment of malignant transformation based on the grade of dysplasia of leukoplakia often does not lead to reliable results. However, oral squamous cell carcinoma, laryngeal squamous cell carcinoma, and leukoplakia express single or multiple members of the melanoma-associated antigens A (MAGE-A) family, while MAGE-A are absent in healthy mucosal tissue.

Randomised phase II trial to investigate catumaxomab (anti-EpCAM × anti-CD3) for treatment of peritoneal carcinomatosis in patients with gastric cancer.

Background: Peritoneal carcinomatosis (PC) represents an unfavourable prognostic factor for patients with gastric cancer (GC). Intraperitoneal treatment with the bispecific and trifunctional antibody catumaxomab (EpCAM, CD3), in addition to systemic chemotherapy, could improve elimination of PC.

Methods: This prospective, randomised, phase II study investigated the efficacy of catumaxomab followed by chemotherapy (arm A, 5-fluorouracil, leucovorin, oxaliplatin, docetaxel, FLOT) or FLOT alone (arm B) in patients with GC and PC.

CabaGast: multicentre, Phase II study with cabazitaxel in previously treated patients with advanced or metastatic adenocarcinoma of the esophagogastric junction and stomach.

Introduction: This is a single-arm study (NCT01956149) to determine the prolonged (≥ 4 months) disease control rate with cabazitaxel administered in second-(or later) setting for patients with advanced or metastatic adenocarcinoma of the esophagogastric junction (EGJ) and stomach.

Methods: 65 patients with advanced EGJ and stomach cancer were treated with 20 mg/m cabazitaxel every 3 weeks for a maximum of six cycles. The main objective of the study is a prolonged disease control rate (pDCR: CR, PR or SD lasting at least 4 months).

Interdisciplinary consensus statement on indication and application of a hydrogel spacer for prostate radiotherapy based on experience in more than 250 patients.

Background: The aim of the study was to reach a consensus on indication and application of a hydrogel spacer based on multicentre experience and give new users important information to shorten the learning curve for this innovative technique.

Methods: The interdisciplinary meeting was attended by radiation oncologists and urologists, each with experience of 23 - 138 hydrogel injections (SpaceOAR®) in prostate cancer patients before dose-escalated radiotherapy. User experience was discussed and questions were defined to comprise practical information relevant for successful hydrogel injection and treatment.

HAROW: the first comprehensive prospective observational study comparing treatment options in localized prostate cancer.

Purpose: To collect data on primary treatment decision and follow-up in patients with diagnosed, histologically confirmed localized (T1a-T2c/N0/M0) prostate cancer (PCa) for up to 5 years in a prospective observational non-interventional study.

Methods: Patients were non-randomly allocated to one of the five treatment strategies: hormone therapy, active surveillance, radiation, operation, or watchful waiting.

Results: A total of 3169 patients were included by 259 participating sites; 2957 patients had at least one follow-up visit.

DEGRO practical guidelines for radiotherapy of non-malignant disorders: Part I: physical principles, radiobiological mechanisms, and radiogenic risk.

Purpose: Synopsis of the introductory paragraph of the DEGRO consensus S2e-guideline recommendations for the radiotherapy of benign disorders, including physical principles, radiobiological mechanisms, and radiogenic risk.

Materials And Methods: This work is based on the S2e-guideline recommendations published November 14, 2013. The basic principles of radiation physics and treatment delivery, evaluation of putative underlying radiobiological mechanisms, and the assessment of genetic and cancer risk following low-dose irradiation will be presented.

Gender differences in outcomes of a multimodal pain management program.

Although gender differences in pain and analgesia are well known, it still remains unclear whether men and women vary in response to multimodal pain treatment. This study was conducted to investigate whether men and women exhibited different outcomes after an intensive multimodal pain treatment program. The daily outpatient program consisted of individual treatment as well as group therapy, with a total amount of therapy of 117.