The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) in daily practice: A real-life feasibility analysis at the Medical University Vienna.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18151-e18151
Author(s):  
Barbara Kiesewetter ◽  
Markus Raderer ◽  
Guenther G. Steger ◽  
Rupert Bartsch ◽  
Robert Pirker ◽  
...  

e18151 Background: The ESMO-MCBS constitutes a new tool to quantify the clinical benefit that may be anticipated from a novel anticancer treatment based on original data from randomized or controlled trials. In contrast to comparable concepts, this score appears somehow unique as it concentrates on the clinical benefit for the individual patient irrespective of socioeconomic factors. Being introduced 2015; the MCBS has excited great public interest in Europe in the last year. We present here the first feasibility analysis of the MCBS under real-life conditions at the Medical University Vienna (MUV), one of Europe’s largest centers. Methods: This study evaluated systematically the practicability of the MCBS for advanced/metastatic malignant diseases treated at the MUV ( > 15 tumor entities). A 3-step approach including data analysis of regimens in regular use, assessment of scores (1 = not recommended to 5 = highly recommended) and evaluation of results with a focus on clinical feasibility was applied. Results: In the majority of tumor entities and clinical settings the assessed MCBS scores were consistent with our daily practice and particularly with our 1st line standards for common tumors like metastatic breast-, colorectal- or lung cancer. However, there were certain limitations including orphan diseases with a lack of randomized data (e.g. rare sarcoma subtypes) or tumor entities with cascade like treatment settings (e.g. colorectal cancer). Interestingly, new immunomodulatory approaches and checkpoint inhibitors in particular, scored strikingly high in comparison to conventional chemo due to a favorable toxicity profile, positive influence on quality of life and strong efficacy data in many cases. A broad selection of data will be presented at the meeting. Conclusions: Our analysis encompasses a wide range of tumor entities and clinical settings and reflects the daily experience of a university clinic. Mostly, the MCBS scores supported treatment decisions based on the clinical benefit to be expected from a novel therapy and might also support socioeconomic questions exemplified by high scoring of immunomodulatory approaches.

2016 ◽  
Vol 27 ◽  
pp. vi585
Author(s):  
B. Kiesewetter ◽  
M. Raderer ◽  
C. Marosi ◽  
T. Brodowicz ◽  
G. Prager ◽  
...  

ESMO Open ◽  
2016 ◽  
Vol 1 (4) ◽  
pp. e000066 ◽  
Author(s):  
Barbara Kiesewetter ◽  
Markus Raderer ◽  
Günther G Steger ◽  
Rupert Bartsch ◽  
Robert Pirker ◽  
...  

2021 ◽  
Vol 25 (3-4) ◽  
pp. 24-27
Author(s):  
Yu.V. Lysanets ◽  
O.M. Bieliaieva ◽  
I.V. Znamenska ◽  
H.Yu. Morokhovets ◽  
I.V. Rozhenko

The present paper explores the methods for effective mastering the past tense relying on an activity-based approach following the Common European Framework of Reference for Languages. The aim of the research is to facilitate the teaching and revising the grammar material on the past simple (indefinite) tense, the past continuous (progressive) tense, and the past perfect tense in the process of training undergraduates, Ph.D. students, academic and clinical teachers at a medical university. The results of the research have been integrated into the 1st edition of “Medical English for Academic Purposes” (2018) and “Medical English for Public Health Purposes” (2021). The authors developed the methodological mechanisms to support courses in professional English at higher medical educational institutions through an activity-based approach, which ensures the effective acquisition of a foreign language, promotes the formation of a linguistic personality capable not only of communicating in all areas, but also of successful integration into the international community. The paper provides a wide range of scaffolding activities and methods: using visuals (graphic organizers, charts, etc.), selecting historically meaningful texts, peer-to-peer talk, strategic pairings, “real-life tasks” and modelling situations, the “fishbowl” model and others. The suggested methodological algorithm is feasible for both oral and written communication, reading and listening comprehension activities, group work, individual and self-directed work in class, as well as for in-class or self-paced learning, depending on the features of the curriculum and students’ English proficiency. The receptive aspect of teaching is represented by read-and-translate exercises, targeted texts describing significant events in the history of medicine, as well as true-false exercises to check students’ comprehension. Meanwhile, the reproductive aspect of teaching covers exercises involving opening the brackets, filling the blanks, as well as creating negative and interrogative forms of verbs. Eventually, the productive aspect of teaching is ensured by a wide range of creative speaking and writing activities and “real-life tasks”, aimed at developing students’ communicative competence in English for Professional Purposes (in-class speaking activities (peer-to-peer talk, class discussion). In addition, collecting family history is yet another pragmatically feasible task to revise and study past tenses. The application of an activity-based approach to teaching the past tenses at a medical university is highly effective to foster essential job-related skills, experience and professional readiness. The authors believe that this, in turn, will promote academic mobility and scientific cooperation, thus contributing to the development of higher medical education in Ukraine, which renders the research relevant.


2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 274-274
Author(s):  
Jaekyung Cheon ◽  
Choong-kun Lee ◽  
Yunbeom Sang ◽  
Chan Kim ◽  
Beodeul Kang ◽  
...  

274 Background: A recent phase II trial (NCT02392637) demonstrated prolonged survival by treatment with GemCis/nab-P in patients (pts) with aBTC. Further evaluation in real-world setting is necessary to measure the clinical outcomes of GemCis/nab-P in daily practice in Asian pts. Methods: This is a multicenter retrospective analysis of data from 3 institutes in Korea. Between September 2019 and August 2020, a total of 104 pts who received GemCis/nab-P for the management of aBTC were included in this analysis. Results: Median age was 64 years (range, 34-84), and 60 pts (57.7%) were male. GemCis/nab-P was used as the starting regimen in 60 pts (57.7%), 16 pts (15.4%) received GemCis/nab-P after failure of GemCis ± investigational drug (mainly immune checkpoint inhibitors), and 28 pts (26.9%) added nab-P to initial Gem/Cis without progressive disease. Baseline characteristics were as follows: Intrahepatic cholangiocarcinoma (CCC)/extrahepatic CCC/gallbladder cancer in 42 (40.4%)/33 (31.7%)/29 (27.9%); metastatic or recurred/locally advanced in 82 (78.8%)/22 (21.2%) pts. According to RECIST v 1.1, objective response rates (ORR) and disease control rate (DCR) were 30.8% and 81.8% of all pts, 33.4% and 88.4% in initial GemCis/nab-P, 28.6% and 73.8% in intrahepatic CCC, 36.3% and 96.9% in extrahepatic CCC, and 27.6% and 75.9% in gallbladder cancer groups, respectively. In nab-P addition group, while the ORR and DCR of pts without GemCis failure were 39.3% and 85.7%, those with GemCis failure were 6.3%, 50.0%, respectively. Median overall survival and progression-free survival were not reached, with a median follow-up duration of 3.3 months (95% confidence interval [CI], 2.9-6.7). The most common grade 3-4 toxicities were neutropenia (n=36, 34.6%), anemia (n=17, 16.4%), thrombocytopenia (n=10, 9.6%), and febrile neutropenia (n=9, 8.1%). In patients with locally advanced BTC (n=22), 5 patients (22.7%) were converted to resectable disease and underwent surgery. Conclusions: GemCis/nab-P showed consistent real-life efficacy and safety outcomes for Korean aBTC pts compared with those from the phase 2 trial. [Table: see text]


2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e12027-e12027
Author(s):  
Ornella Garrone ◽  
Massimo Di Maio ◽  
Anna Maria Vandone ◽  
Rodolfo Brizio ◽  
Paola Vanella ◽  
...  

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 490-490
Author(s):  
Jaekyung Cheon ◽  
Changhoon Yoo ◽  
Yeonghak Bang ◽  
Hong Jae Chon ◽  
Baek-Yeol Ryoo

490 Background: LEN has demonstrated the efficacy and safety in pts with aHCC as first-line treatment in the pivotal REFLECT trial. Further evaluation in real-world setting is necessary to measure the clinical outcomes of LEN in daily practice. Methods: This is a multicenter retrospective analysis from 3 Korean referral cancer institutions. Between September 2018 and August 2019, a total of 74 pts received LEN for the management of BCLC B or C aHCC, and 66 pts who had at least one follow-up visit after the start of LEN were included in this analysis. Results: Median age was 58 years (range, 19-81), and 46 pts (69.7%) were male. Baseline characteristics were as follows; Child-Pugh class A/B/C in 46 (69.7%)/14 (21.2%)/6 (9.1%), BCLC B/C/D in 1 (1.5%)/63 (95.5%)/2 (3.0%), prior systemic therapy in 25 (37.9%) including 14 (21.2%) with prior immune checkpoint inhibitors (ICIs). LEN was used as first/second/third to fourth lines of therapy in 41 (62.1%)/13 (19.7%)/12 (18.2%) pts, and 27 (40.9%) had extensive disease extent excluded in the REFLECT trial. With a median follow-up duration of 4.8 months (95% CI, 3.4–6.1), the median PFS and OS were 4.6 (95% CI, 3.2-6.0) and 7.5 months (mo) (95% CI, 3.7–11.2), respectively, in overall pts: first-line setting, 4.2 (95% CI, 3.2-5.2) and 6.5 mo (95% CI, 5.0-8.1), respectively; ≥ second-line setting, 6.1 mo (95% CI, 3.6–8.5) and not reached, respectively. In pts with prior ICIs, median PFS was 6.1 mo (95% CI, 1.8-8.4) and median OS was not reached. According to the RECIST v 1.1, response rates and disease control rate were 12.1% and 71.2%, respectively, in overall pts. The most common grade 3-4 toxicities were hyperbilirubinemia (n=9, 13.6%), AST elevation (n=5, 7.6%), diarrhea (n=4, 6.1%) and fatigue (n=4, 6.1%). Conclusions: LEN was effective and well tolerated in pts with aHCC in Korean real-life setting.


2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Cristina Valero ◽  
Mark Lee ◽  
Douglas Hoen ◽  
Kate Weiss ◽  
Daniel W. Kelly ◽  
...  

AbstractTreatment with immune checkpoint inhibitors (ICI) has demonstrated clinical benefit for a wide range of cancer types. Because only a subset of patients experience clinical benefit, there is a strong need for biomarkers that are easily accessible across diverse practice settings. Here, in a retrospective cohort study of 1714 patients with 16 different cancer types treated with ICI, we show that higher neutrophil-to-lymphocyte ratio (NLR) is significantly associated with poorer overall and progression-free survival, and lower rates of response and clinical benefit, after ICI therapy across multiple cancer types. Combining NLR with tumor mutational burden (TMB), the probability of benefit from ICI is significantly higher (OR = 3.22; 95% CI, 2.26-4.58; P < 0.001) in the NLR low/TMB high group compared to the NLR high/TMB low group. NLR is a suitable candidate for a cost-effective and widely accessible biomarker, and can be combined with TMB for additional predictive capacity.


2020 ◽  
Vol 7 (1) ◽  
pp. 9 ◽  
Author(s):  
Shelina Bhamani ◽  
Areeba Zainab Makhdoom ◽  
Vardah Bharuchi ◽  
Nasreen Ali ◽  
Sidra Kaleem ◽  
...  

<p align="center"><em>The widespread prevalence of COVID-19 pandemic has affected academia and parents alike. Due to the sudden closure of schools, students are missing social interaction which is vital for better learning and grooming while most schools have started online classes. This has become a tough routine for the parents working online at home since they have to ensure their children’s education. The study presented was designed to explore the experiences of home learning in times of COVID-19. A descriptive qualitative study was planned to explore the experiences of parents about home learning and management during COVID-19 to get an insight into real-life experiences.  Purposive sampling technique was used for data collection.  Data were collected from 19 parents falling in the inclusion criteria. Considering the lockdown problem, the data were collected via Google docs form with open-ended questions related to COVID-19 and home learning. Three major themes emerged after the data analysis: impact of COVID on children learning; support given by schools; and strategies used by caregivers at home to support learning. It was analyzed that the entire nation and academicians around the world have come forward to support learning at home offering a wide range of free online avenues to support parents to facilitate home-learning. Furthermore, parents too have adapted quickly to address the learning gap that have emerged in their children’s learning in these challenging times. Measures should be adopted to provide essential learning skills to children at home. Centralized data dashboards and educational technology may be used to keep the students, parents and schools updated.</em></p>


2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Spyridoula Vazou ◽  
Collin A. Webster ◽  
Gregory Stewart ◽  
Priscila Candal ◽  
Cate A. Egan ◽  
...  

Abstract Background/Objective Movement integration (MI) involves infusing physical activity into normal classroom time. A wide range of MI interventions have succeeded in increasing children’s participation in physical activity. However, no previous research has attempted to unpack the various MI intervention approaches. Therefore, this study aimed to systematically review, qualitatively analyze, and develop a typology of MI interventions conducted in primary/elementary school settings. Subjects/Methods Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed to identify published MI interventions. Irrelevant records were removed first by title, then by abstract, and finally by full texts of articles, resulting in 72 studies being retained for qualitative analysis. A deductive approach, using previous MI research as an a priori analytic framework, alongside inductive techniques were used to analyze the data. Results Four types of MI interventions were identified and labeled based on their design: student-driven, teacher-driven, researcher-teacher collaboration, and researcher-driven. Each type was further refined based on the MI strategies (movement breaks, active lessons, other: opening activity, transitions, reward, awareness), the level of intrapersonal and institutional support (training, resources), and the delivery (dose, intensity, type, fidelity). Nearly half of the interventions were researcher-driven, which may undermine the sustainability of MI as a routine practice by teachers in schools. An imbalance is evident on the MI strategies, with transitions, opening and awareness activities, and rewards being limitedly studied. Delivery should be further examined with a strong focus on reporting fidelity. Conclusions There are distinct approaches that are most often employed to promote the use of MI and these approaches may often lack a minimum standard for reporting MI intervention details. This typology may be useful to effectively translate the evidence into practice in real-life settings to better understand and study MI interventions.


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