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Objective: "History, Theory, Ethics of Medicine" (German: "Geschichte, Theorie, Ethik der Medizin", abbreviation: GTE) forms part of the obligatory curriculum for medical students in Germany since the winter semester 2003/2004. This paper presents the results of a national survey on the contents, methods and framework of GTE teaching.Methods: Semi-structured questionnaire dispatched in July 2014 to 38 institutions responsible for GTE teaching. Descriptive analysis of quantitative data and content analysis of free-text answers. Results: It was possible to collect data from 29 institutes responsible for GTE teaching (response: 76%). There is at least one professorial chair for GTE in 19 faculties; two professorial chairs or professorships remained vacant at the time of the survey. The number of students taught per academic year ranges from <100 to >350. Teaching in GTE comprises an average of 2.18 hours per week per semester (min: 1, max: 6). Teaching in GTE is proportionally distributed according to an arithmetic average as follows: history: 35.4%, theory 14.7% and ethics 49.9%. Written learning objectives were formulated for GTE in 24 faculties. The preferred themes of teaching in history, theory or ethics which according to respondents should be taught comprise a broad spectrum and vary. Teaching in ethics (79 from a max. of 81 possible points) is, when compared to history (61/81) and theory (53/81), attributed the most significance for the training of medical doctors. Conclusion: 10 years after the introduction of GTE the number of students and the personnel resources available at the institutions vary considerably. In light of the differences regarding the content elicited in this study the pros and cons of heterogeneity in GTE should be discussed., Zielsetzung: Der Querschnittsbereich "Geschichte, Theorie, Ethik der Medizin (GTE)" gehört seit dem Wintersemester 2003/2004 zum Pflichtcurriculum für Medizinstudierende. In dieser Arbeit werden die Ergebnisse einer nationalen Umfrage zu Inhalten, Methoden und Rahmenbedingungen der GTE-Lehre vorgestellt.Methodik: Semistrukturierter Fragebogen, der im Juli 2014 an 38 für die Lehre in GTE verantwortliche Institutionen versandt wurde. Deskriptive Analyse quantitativer Daten und Inhaltsanalyse der Freitextantworten. Ergebnisse: Es konnten Daten von 29 für die GTE-Lehre verantwortlichen Institutionen erhoben werden (Rücklauf: 76%). An 19 Fakultäten ist mindestens eine Professorenstelle für ein Arbeitsgebiet des Querschnittsbereichs besetzt; zwei Lehrstühle bzw. Professuren sind zum Zeitpunkt der Befragung unbesetzt. Die Anzahl der unterrichteten Studierenden pro Studienjahr reicht von < 100 bis > 350. Die Lehre in GTE umfasst durchschnittlich 2,18 SWS (Min: 1, Max: 6). Die SWS verteilen sich anteilig im arithmetischen Mittel wie folgt: Geschichte: 35,4%, Theorie 14,7% und Ethik 49,9%. An 24 Fakultäten wurden schriftlich Lernziele für GTE formuliert. Die von den Befragten befürworteten Themen, die in den Arbeitsgebieten Geschichte, Theorie beziehungsweise Ethik gelehrt werden sollen, umfassen ein breites Spektrum und variieren. Der Lehre in Ethik (79 von max. zu vergebenden 81 Punkten) wird im Vergleich zur Geschichte (61/81) und der Theorie (53/81) die größte Bedeutung für die Ausbildung zum Arzt zugeordnet. Schlussfolgerungen: Zehn Jahre nach Einführung von GTE in das Medizinstudium variieren die Anzahl der in der Pflichtlehre zu unterrichtenden Studierenden sowie die personelle Ausstattung der Institute erheblich. Die ermittelten Unterschiede bei den Lehrinhalten sollten mit Blick auf Vor- und Nachteile der Heterogenität im Querschnittsbereich diskutiert werden.

In this trial, stopping bevacizumab after completion of induction chemotherapy was associated with a shorter time to progression, but no statistically significant difference in overall survival compared with the bevacizumab continuation strategy. Non-inferiority could not be demonstrated. Treatment costs are substantially higher for continuous bevacizumab treatment

Background: Gemcitabine remains the mainstay of palliative treatment of advanced pancreatic carcinoma (APC). Adding capecitabine or a platinum derivative each significantly prolonged survival in recent meta-analyses. The purpose of this study was to determine dose, safety and preliminary efficacy of a first-line regimen combining all three classes of active cytotoxic drugs in APC. Patients and methods: Chemotherapy-naive patients with locally advanced or metastatic, histologically proven adenocarcinoma of the pancreas were treated with a 21-day regimen of gemcitabine [1000 mg/m2 day (d) 1, d8], escalating doses of oxaliplatin (80-130 mg/m2 d1) and capecitabine (650-800 mg/m2 b.i.d. d1-d14). The recommended dose (RD), determined in the phase I part of the study by interpatient dose escalation in cohorts of three to six patients, was further studied in a two-stage phase II part with the primary end point of response rate by RECIST criteria. Results: Forty-five patients were treated with a total of 203 treatment cycles. Thrombocytopenia and diarrhea were the toxic effects limiting the dose to an RD of gemcitabine 1000 mg/m2 d1, d8; oxaliplatin 130 mg/m2 d1 and capecitabine 650 mg/m2 b.i.d. d1-14. Central independent radiological review showed partial remissions in 41% [95% confidence interval (CI) 26% to 56%] of patients and disease stabilization in 37% (95% CI 22% to 52%) of patients. Conclusion: This triple combination is feasible and, by far, met the predefined efficacy criteria warranting further investigations

Background: To determine the activity and tolerability of adding cetuximab to the oxaliplatin and capecitabine (XELOX) combination in first-line treatment of metastatic colorectal cancer (MCC). Patients and methods: In a multicenter two-arm phase II trial, patients were randomized to receive oxaliplatin 130 mg/m2 on day 1 and capecitabine 1000 mg/m2 twice daily on days 1-14 every 3 weeks alone or in combination with standard dose cetuximab. Treatment was limited to a maximum of six cycles. Results: Seventy-four patients with good performance status entered the trial. Objective partial response rates after external review and radiological confirmation were 14% and 41% in the XELOX and in the XELOX + Cetuximab arm, respectively. Stable disease has been observed in 62% and 35% of the patients, with 76% disease control in both arms. Cetuximab led to skin rash in 65% of the patients. The median overall survival was 16.5 months for arm A and 20.5 months for arm B. The median time to progression was 5.8 months for arm A and 7.2 months for arm B. Conclusion: Differences in response rates between the treatment arms indicate that cetuximab may improve outcome with XELOX. The correct place of the cetuximab, oxaliplatin and fluoropyrimidine combinations in first-line treatment of MCC has to be assessed in phase III trials

BACKGROUND: Chemotherapy plus bevacizumab is a standard option for first-line treatment in metastatic colorectal cancer (mCRC) patients. We assessed whether no continuation is non-inferior to continuation of bevacizumab after completing first-line chemotherapy. PATIENTS AND METHODS: In an open-label, phase III multicentre trial, patients with mCRC without disease progression after 4-6 months of standard first-line chemotherapy plus bevacizumab were randomly assigned to continuing bevacizumab at a standard dose or no treatment. CT scans were done every 6 weeks until disease progression. The primary end point was time to progression (TTP). A non-inferiority limit for hazard ratio (HR) of 0.727 was chosen to detect a difference in TTP of 6 weeks or less, with a one-sided significance level of 10% and a statistical power of 85%. RESULTS: The intention-to-treat population comprised 262 patients: median follow-up was 36.7 months. The median TTP was 4.1 [95% confidence interval (CI) 3.1-5.4] months for bevacizumab continuation versus 2.9 (95% CI 2.8-3.8) months for no continuation; HR 0.74 (95% CI 0.58-0.96). Non-inferiority could not be demonstrated. The median overall survival was 25.4 months for bevacizumab continuation versus 23.8 months (HR 0.83; 95% CI 0.63-1.1; P = 0.2) for no continuation. Severe adverse events were uncommon in the bevacizumab continuation arm. Costs for bevacizumab continuation were estimated to be ∼30,000 USD per patient. CONCLUSIONS: Non-inferiority could not be demonstrated for treatment holidays versus continuing bevacizumab monotheray, after 4-6 months of standard first-line chemotherapy plus bevacizumab. Based on no impact on overall survival and increased treatment costs, bevacizumab as a single agent is of no meaningful therapeutic value. More efficient treatment approaches are needed to maintain control of stabilized disease following induction therapy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT00544700.