Effect of Neoadjuvant Chemotherapy Followed by Surgical Resection on Survival in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Cancer: The AIO-FLOT3 Trial

IMPORTANCE: Surgical resection has a potential benefit for patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction. OBJECTIVE: To evaluate outcome in patients with limited metastatic disease who receive chemotherapy first and proceed to surgical resection. DESIGN, SETTING, AND PARTICIPANTS: The AIO-FLOT3 (Arbeitsgemeinschaft Internistische Onkologie-fluorouracil, leucovorin, oxaliplatin, and docetaxel) trial is a prospective, phase 2 trial of 252 patients with resectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Patients were enrolled from 52 cancer care centers in Germany between February 1, 2009, and January 31, 2010, and stratified to 1 of 3 groups: resectable (arm A), limited metastatic (arm B), or extensive metastatic (arm C). Data cutoff was January 2012, and the analysis was performed in March 2013. INTERVENTIONS: Patients in arm A received 4 preoperative cycles of fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) followed by surgery and 4 postoperative cycles. Patients in arm B received at least 4 cycles of neoadjuvant FLOT and proceeded to surgical resection if restaging (using computed tomography and magnetic resonance imaging) showed a chance of margin-free (R0) resection of the primary tumor and at least a macroscopic complete resection of the metastatic lesions. Patients in arm C were offered FLOT chemotherapy and surgery only if required for palliation. Patients received a median (range) of 8 (1-15) cycles of FLOT. MAIN OUTCOMES AND MEASURES: The primary end point was overall survival. RESULTS: In total, 238 of 252 patients (94.4%) were eligible to participate. The median (range) age of participants was 66 (36-79) years in arm A (n = 51), 63 (28-79) years in arm B (n = 60), and 65 (23-83) years in arm C (n = 127). Patients in arm B (n = 60) had only retroperitoneal lymph node involvement (27 patients [45%]), liver involvement (11 [18.3%]), lung involvement (10 [16.7%]), localized peritoneal involvement (4 [6.7%]), or other (8 [13.3%]) incurable sites. Median overall survival was 22.9 months (95% CI, 16.5 to upper level not achieved) for arm B, compared with 10.7 months (95% CI, 9.1-12.8) for arm C (hazard ratio, 0.37; 95% CI, 0.25-0.55) (P < .001). The response rate for arm B was 60% (complete, 10%; partial, 50%), which is higher than the 43.3% for arm C. In arm B, 36 of 60 patients (60%) proceeded to surgery. The median overall survival was 31.3 months (95% CI, 18.9-upper level not achieved) for patients who proceeded to surgery and 15.9 months (95% CI, 7.1-22.9) for the other patients. CONCLUSIONS AND RELEVANCE: Patients with limited metastatic disease who received neoadjuvant chemotherapy and proceeded to surgery showed a favorable survival. The AIO-FLOT3 trial provides a rationale for further randomized clinical trials. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT00849615.info:eu-repo/semantics/publishedVersio

Certification of breast centres in Germany: proof of concept for a prototypical example of quality assurance in multidisciplinary cancer care

<p>Abstract</p> <p>Background</p> <p>The main study objectives were: to develop a set of requirements of comprehensive breast centres; to establish a nationwide voluntary certification programme for breast centres based on such requirements, a certified quality management system (QMS), and scheduled independent, external audits and periodic recertification; and to demonstrate the general acceptance of such a certification programme with a view to introducing similar certification programmes for other major cancers.</p> <p>Methods</p> <p>Breast centres introduced a QMS and voluntarily participated in an external certification procedure based on guideline-derived Requirements of Breast Centres specifically developed for the application procedure, all subsequent audits and recertification. All data (numbers of pending and successful applications, sites/centre, etc.) were collected by a newly founded, independent organisation for certification of cancer services delivery. Data analysis was descriptive.</p> <p>Results</p> <p>Requirements of Breast Centres were developed by the German Cancer Society (DKG), the German Society of Senology (DGS) and other relevant specialist medical societies in the form of a questionnaire comprising 185 essential items based on evidence-based guidelines and the European Society of Breast Cancer Specialists' (EUSOMA) requirements of specialist breast units. From late 2002 to mid 2008, the number of participating breast centres rose from 1 to 175. As of mid 2008, 77% of an estimated 50,000 new breast cancers in Germany were diagnosed and treated at certified breast centres, 78% of which were single-site centres.</p> <p>Conclusion</p> <p>Nationwide voluntary certification of breast centres is feasible and well accepted in Germany. Dual certification of breast centres that involves certification of breast services to guideline-derived requirements in conjunction with independent certification of a mandatory QMS can serve as a model for other multidisciplinary site-specific cancer centres.</p

Monitoring the newly qualified nurses in Sweden: the Longitudinal Analysis of Nursing Education (LANE) study

BACKGROUND: The Longitudinal Analysis of Nursing Education (LANE) study was initiated in 2002, with the aim of longitudinally examining a wide variety of individual and work-related variables related to psychological and physical health, as well as rates of employee and occupational turnover, and professional development among nursing students in the process of becoming registered nurses and entering working life. The aim of this paper is to present the LANE study, to estimate representativeness and analyse response rates over time, and also to describe common career pathways and life transitions during the first years of working life. METHODS: Three Swedish national cohorts of nursing students on university degree programmes were recruited to constitute the cohorts. Of 6138 students who were eligible for participation, a total of 4316 consented to participate and responded at baseline (response rate 70%). The cohorts will be followed prospectively for at least three years of their working life. RESULTS: Sociodemographic data in the cohorts were found to be close to population data, as point estimates only differed by 0-3% from population values. Response rates were found to decline somewhat across time, and this decrease was present in all analysed subgroups. During the first year after graduation, nearly all participants had qualified as nurses and had later also held nursing positions. The most common reason for not working was due to maternity leave. About 10% of the cohorts who graduated in 2002 and 2004 intended to leave the profession one year after graduating, and among those who graduated in 2006 the figure was almost twice as high. Intention to leave the profession was more common among young nurses. In the cohort who graduated in 2002, nearly every fifth registered nurse continued to further higher educational training within the health professions. Moreover, in this cohort, about 2% of the participants had left the nursing profession five years after graduating. CONCLUSION: Both high response rates and professional retention imply a potential for a thorough analysis of professional practice and occupational health

Recommendations on basic requirements for intensive care units: structural and organizational aspects

OBJECTIVE: To provide guidance and recommendations for the planning or renovation of intensive care units (ICUs) with respect to the specific characteristics relevant to organizational and structural aspects of intensive care medicine. METHODOLOGY: The Working Group on Quality Improvement (WGQI) of the European Society of Intensive Care Medicine (ESICM) identified the basic requirements for ICUs by a comprehensive literature search and an iterative process with several rounds of consensus finding with the participation of 47 intensive care physicians from 23 countries. The starting point of this process was an ESICM recommendation published in 1997 with the need for an updated version. RESULTS: The document consists of operational guidelines and design recommendations for ICUs. In the first part it covers the definition and objectives of an ICU, functional criteria, activity criteria, and the management of equipment. The second part deals with recommendations with respect to the planning process, floorplan and connections, accommodation, fire safety, central services, and the necessary communication systems. CONCLUSION: This document provides a detailed framework for the planning or renovation of ICUs based on a multinational consensus within the ESIC

Trends in der Epidemiologie, Therapie und den Behandlungsergebnissen von Kopf-Hals-Tumoren: Eine populationsbezogene Langzeitanalyse der Thüringer Krebsregister von 1996 bis 2011

Nature regulates complex structures in space and time via feedback loops, kinetically controlled transformations, and under energy dissipation to allow non-equilibrium processes. Although man-made static self-assemblies realize excellent control over hierarchical structures via molecular programming, managing their temporal destiny by self-regulation is a largely unsolved challenge. Herein, we introduce a generic concept to control the time domain by programming the lifetimes of switchable self-assemblies in closed systems. We conceive dormant deactivators that, in combination with fast promoters, enable a unique kinetic balance to establish an autonomously self-regulating, transient pH-state, whose duration can be programmed over orders of magnitudefrom minutes to days. Coupling this non-equilibrium state to pH-switchable self-assemblies allows predicting their assembly/disassembly fate in time, similar to a precise self-destruction mechanism. We demonstrate a platform approach by programming self-assembly lifetimes of block copolymers, nanoparticles, and peptides, enabling dynamic materials with a self-regulation functionality

A two-arm multicenter phase II trial of one cycle chemoselection split-dose docetaxel, cisplatin and 5-fluorouracil (TPF) induction chemotherapy before two cycles of split TPF followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1)

Inhestern J, Schmalenberg H, Dietz A, et al. A two-arm multicenter phase II trial of one cycle chemoselection split-dose docetaxel, cisplatin and 5-fluorouracil (TPF) induction chemotherapy before two cycles of split TPF followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1). Annals of Oncology. 2017;28(8):1917-1922