Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Background: The phase III CLinical Evaluation Of Pertuzumab And TRAstuzumab (CLEOPATRA) trial established the combination of pertuzumab, trastuzumab and docetaxel as standard first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive locally recurrent/metastatic breast cancer (LR/mBC). The multicentre single-arm PERtUzumab global SafEty (PERUSE) study assessed the safety and efficacy of pertuzumab and trastuzumab combined with investigator-selected taxane in this setting. Patients and methods: Eligible patients with inoperable HER2-positive LR/mBC and no prior systemic therapy for LR/mBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab and pertuzumab until disease progression or unacceptable toxicity. The primary endpoint was safety. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Prespecified subgroup analyses included subgroups according to taxane, hormone receptor (HR) status and prior trastuzumab. Exploratory univariable analyses identified potential prognostic factors; those that remained significant in multivariable analysis were used to analyse PFS and OS in subgroups with all, some or none of these factors. Results: Of 1436 treated patients, 588 (41%) initially received paclitaxel and 918 (64%) had HR-positive disease. The most common grade 653 adverse events were neutropenia (10%, mainly with docetaxel) and diarrhoea (8%). At the final analysis (median follow-up: 5.7 years), median PFS was 20.7 [95% confidence interval (CI) 18.9-23.1] months overall and was similar irrespective of HR status or taxane. Median OS was 65.3 (95% CI 60.9-70.9) months overall. OS was similar regardless of taxane backbone but was more favourable in patients with HR-positive than HR-negative LR/mBC. In exploratory analyses, trastuzumab-pretreated patients with visceral disease had the shortest median PFS (13.1 months) and OS (46.3 months). Conclusions: Mature results from PERUSE show a safety and efficacy profile consistent with results from CLEOPATRA and median OS exceeding 5 years. Results suggest that paclitaxel is a valid alternative to docetaxel as backbone chemotherapy. Exploratory analyses suggest risk factors that could guide future trial design

Perceptions of entrepreneurship in translation training

This article examines the perceptions that students and teachers of translation, as well as professional translators, have of entrepreneurship education at Universitat Aut\uf2noma de Barcelona (UAB). Based on a case-study design, the study aims to describe the views of a group of students and a group of trainers on the Translation and Interpreting degree course at UAB, as well as those of a group of professional translators, on entrepreneurship and on the need to introduce entrepreneurship education into the degree course. Focus groups were used to collect the data. Our findings show that entrepreneurship education should be embedded in the curriculum of the Degree in Translation and Interpreting, although such content should not focus solely on translation and interpreting as professional tasks, but should also address the whole range of career opportunities that this degree offers. Nevertheless, all the groups agree that this should not lead to a decrease in the number of hours of translation and interpreting practice

Translation competence acquisition. Design and results of the PACTE group\u2019s experimental research

This issue provides a study on translation competence acquisition (TCA). The study consisted of an TCA experiment involving 129 first to fourth year trainee translators and recent graduates. The experiment was conducted in November 2011, when the first-year subjects had just begun their degree course; the graduates had completed their studies in June 2011. Firstly, the conceptual and methodological framework of the research is described. Then the study's measurements and results beginning with translation acceptability (a cross-cutting indicator whose results are brought together with those of most of the other indicators) are presented, and followed by the different study variables: knowledge of translation; translation project; identification and solution of translation problems; decision-making; efficacy of the translation process; and use of instrumental resources. Finally, the study's conclusions, defining features of TCA, are presented. The publication also includes six online appendices containing the hypotheses, the main instruments used, the statistical test results and a glossary of key terms from the research

Competence levels in translation: working towards a European framework

This paper presents the research project the PACTE group is carrying out on \u2018Establishing Competence Levels in the Acquisition of Translation Competence in Written Translation\u2019. A continuation of PACTE\u2019s previous experimental research on translation competence and its acquisition, the project aims to propose level descriptors as a first step towards developing a common European framework of reference for translation\u2019s academic and professional arenas, both of which are represented among its participants. The project is organized into three stages, the first of which involved the production of a first level descriptor proposal, including a three-level scale with sub-levels and five descriptive categories (language competence; cultural, world knowledge and thematic competence; instrumental competence; translation service provision competence; and translation problem solving competence). In the second stage, the proposal produced is to be evaluated by experts from the academic and professional arenas. In the third stage, the data obtained through the expert judgement process will be analysed and the proposal revised. This paper sets out the project\u2019s objectives, our grounds for undertaking it, its conceptual framework and its methodology, as well as the results obtained in the first stage and the future direction of the research

Establishing levels of competence in translation: First results of the nact project

This paper presents the research project the PACTE group is carrying out on "Establishing Competence Levels in the Acquisition of Translation Competence in Written Translation". The project aims to propose level descriptors as a first step towards developing a common European framework of reference for translation's academic and professional arenas. The project is a continuation of PACTE's previous experimental research on translation competence and its acquisition. Representatives of both academic and professional arenas participate in the project. It is organized into three stages, the first of which involved the production of a first level descriptor proposal, including a three-level scale with sub-levels and five descriptive categories (language competence; cultural, world knowledge, and thematic competence; instrumental competence; translation service provision competence; and translation problem solving competence). This proposal produced is to be evaluated by experts from the academic and professional arenas. This paper sets out the project, as well as the first level descriptor proposal

Evolution of the efficacy of the translation process in translation competence acquisition

The aim of this paper is to present PACTE's measurement of and results for the variable "efficacy of the Translation Process" in its experiment on Translation Competence Acquisition (TCA). This is one of the variables that provide information about the acquisition of the strategic sub-competence. We define this variable as the relationship between the time taken to complete a translation task, its distribution in stages, and solution acceptability. We consider translation process efficacy to be based on an optimal relationship between solution acceptability and time, i.e. achieving maximum acceptability in minimum time. In that respect, our initial premise was that finding acceptable solutions should take less time as the TCA process advances. Our aim as regards this variable was to investigate whether, as Translation Competence is acquired, differences occur in terms of: (1) the time taken to carry out a translation task; (2) the distribution of the time spent on a translation task between stages; (3) the relationship between the time spent on a translation task and solution acceptability

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)