Literature DB >> 34007260

Challenges and Opportunities for Real-World Evidence in Metastatic Luminal Breast Cancer.

Diana Lüftner1, Andreas D Hartkopf2, Michael P Lux3,4, Friedrich Overkamp5, Hans Tesch6, Adriana Titzmann7, Patrik Pöschke7, Markus Wallwiener8, Volkmar Müller9, Matthias W Beckmann7, Erik Belleville10, Wolfgang Janni11, Tanja N Fehm12, Hans-Christian Kolberg13, Johannes Ettl14, Diethelm Wallwiener2, Andreas Schneeweiss15, Sara Y Brucker2, Peter A Fasching7.   

Abstract

BACKGROUND: The therapeutic armamentarium for patients with metastatic breast cancer is becoming more and more specific. Recommendations from clinical trials are not available for all treatment situations and patient subgroups, and it is therefore important to collect real-world data.
SUMMARY: To develop recommendations for up-to-date treatments and participation in clinical trials for patients with metastatic breast cancer, the Prospective Academic Translational Research PRAEGNANT Network was established to optimize the quality of oncological care in the advanced therapeutic setting. The main aim of PRAEGNANT is to systematically record medical care for patients with metastatic breast cancer in the real-life setting, including the outcome and side effects of different treatment strategies, to monitor quality-of-life changes during therapy, to identify patients eligible for participation in clinical studies, and to allow targeted therapies based on the molecular structures of breast carcinomas. KEY MESSAGES: This article describes the PRAEGNANT network and sheds light on the question of whether the various end points from clinical trials can be transferred to the real-world treatment situation.
Copyright © 2021 by S. Karger GmbH, Freiburg.

Entities:  

Keywords:  Breast cancer; Luminal; Metastasis; PRAEGNANT; Real-world evidence

Year:  2021        PMID: 34007260      PMCID: PMC8114055          DOI: 10.1159/000515701

Source DB:  PubMed          Journal:  Breast Care (Basel)        ISSN: 1661-3791            Impact factor:   2.860


  17 in total

1.  Eliminating bias in randomized controlled trials: importance of allocation concealment and masking.

Authors:  Anthony J Viera; Shrikant I Bangdiwala
Journal:  Fam Med       Date:  2007-02       Impact factor: 1.756

2.  Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation.

Authors:  Jennifer K Litton; Hope S Rugo; Johannes Ettl; Sara A Hurvitz; Anthony Gonçalves; Kyung-Hun Lee; Louis Fehrenbacher; Rinat Yerushalmi; Lida A Mina; Miguel Martin; Henri Roché; Young-Hyuck Im; Ruben G W Quek; Denka Markova; Iulia C Tudor; Alison L Hannah; Wolfgang Eiermann; Joanne L Blum
Journal:  N Engl J Med       Date:  2018-08-15       Impact factor: 91.245

3.  Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry.

Authors:  Markus Wallwiener; Felix Heindl; Sara Y Brucker; Florin-Andrei Taran; Andreas Hartkopf; Friedrich Overkamp; Hans-Christian Kolberg; Peyman Hadji; Hans Tesch; Johannes Ettl; Michael P Lux; Claudia Rauh; Simon Blum; Naiba Nabieva; Tobias F Brodkorb; Cornelia Faschingbauer; Hanna Langemann; Carla Schulmeyer; Bernhard Volz; Matthias Rübner; Diana Lüftner; Volkmar Müller; Erik Belleville; Wolfgang Janni; Tanja N Fehm; Diethelm Wallwiener; Thomas Ganslandt; Matthias W Beckmann; Andreas Schneeweiss; Peter A Fasching; Paul Gass
Journal:  Geburtshilfe Frauenheilkd       Date:  2017-08-24       Impact factor: 2.915

Review 4.  Oral stomatitis and mTOR inhibitors: A review of current evidence in 20,915 patients.

Authors:  L Lo Muzio; C Arena; G Troiano; A Villa
Journal:  Oral Dis       Date:  2018-03       Impact factor: 3.511

5.  Clinical Outcomes, Treatment Patterns, and Health Resource Utilization Among Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutation: A Real-World Retrospective Study.

Authors:  Ruben G W Quek; Jack Mardekian
Journal:  Adv Ther       Date:  2019-01-17       Impact factor: 3.845

6.  Real-world physician and patient behaviour across countries: Disease-Specific Programmes - a means to understand.

Authors:  P Anderson; M Benford; N Harris; M Karavali; J Piercy
Journal:  Curr Med Res Opin       Date:  2008-10-02       Impact factor: 2.580

7.  Computerized patient identification for the EMBRACA clinical trial using real-time data from the PRAEGNANT network for metastatic breast cancer patients.

Authors:  Alexander Hein; Paul Gass; Christina Barbara Walter; Florin-Andrei Taran; Andreas Hartkopf; Friedrich Overkamp; Hans-Christian Kolberg; Peyman Hadji; Hans Tesch; Johannes Ettl; Rachel Wuerstlein; Debra Lounsbury; Michael P Lux; Diana Lüftner; Markus Wallwiener; Volkmar Müller; Erik Belleville; Wolfgang Janni; Tanja N Fehm; Diethelm Wallwiener; Thomas Ganslandt; Matthias Ruebner; Matthias W Beckmann; Andreas Schneeweiss; Peter A Fasching; Sara Y Brucker
Journal:  Breast Cancer Res Treat       Date:  2016-06-09       Impact factor: 4.872

8.  Treatment landscape of advanced breast cancer patients with hormone receptor positive HER2 negative tumors - Data from the German PRAEGNANT breast cancer registry.

Authors:  Andreas D Hartkopf; Jens Huober; Bernhard Volz; Naiba Nabieva; Florin-Andrei Taran; Judith Schwitulla; Friedrich Overkamp; Hans-Christian Kolberg; Peyman Hadji; Hans Tesch; Lothar Häberle; Johannes Ettl; Michael P Lux; Diana Lüftner; Markus Wallwiener; Volkmar Müller; Matthias W Beckmann; Erik Belleville; Pauline Wimberger; Carsten Hielscher; Matthias Geberth; Nikos Fersis; Wolfgang Abenhardt; Christian Kurbacher; Rachel Wuerstlein; Christoph Thomssen; Michael Untch; Peter A Fasching; Wolfgang Janni; Tanja N Fehm; Diethelm Wallwiener; Sara Y Brucker; Andreas Schneeweiss
Journal:  Breast       Date:  2017-10-26       Impact factor: 4.380

Review 9.  The randomized clinical trial: bias in analysis.

Authors:  G S May; D L DeMets; L M Friedman; C Furberg; E Passamani
Journal:  Circulation       Date:  1981-10       Impact factor: 29.690

10.  The ongoing French metastatic breast cancer (MBC) cohort: the example-based methodology of the Epidemiological Strategy and Medical Economics (ESME).

Authors:  David Pérol; Mathieu Robain; Patrick Arveux; Simone Mathoulin-Pélissier; Emmanuel Chamorey; Bernard Asselain; Delphine Berchery; Sophie Gourgou; Mathias Breton; Stéphanie Delaine-Clisant; Muriel Mons; Véronique Diéras; Matthieu Carton; Anne-Valérie Guizard; Lilian Laborde; Carine Laurent; Agnès Loeb; Marie-Ange Mouret-Reynier; Damien Parent; Geneviève Perrocheau; Loïc Campion; Michel Velten; Christian Cailliot; Monia Ezzalfani; Gaëtane Simon
Journal:  BMJ Open       Date:  2019-02-21       Impact factor: 2.692

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  1 in total

1.  BTG2 as a tumor target for the treatment of luminal A breast cancer.

Authors:  Runzhi Wang; Ronghua Wang; Jinjun Tian; Jian Wang; Huaxiao Tang; Tao Wu; Hui Wang
Journal:  Exp Ther Med       Date:  2022-03-21       Impact factor: 2.447

  1 in total

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