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Review
. 2021 Apr;16(2):108-114.
doi: 10.1159/000515701. Epub 2021 Mar 16.

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

Diana Lüftner  1 , Andreas D Hartkopf  2 , Michael P Lux  3   4 , Friedrich Overkamp  5 , Hans Tesch  6 , Adriana Titzmann  7 , Patrik Pöschke  7 , Markus Wallwiener  8 , Volkmar Müller  9 , Matthias W Beckmann  7 , Erik Belleville  10 , Wolfgang Janni  11 , Tanja N Fehm  12 , Hans-Christian Kolberg  13 , Johannes Ettl  14 , Diethelm Wallwiener  2 , Andreas Schneeweiss  15 , Sara Y Brucker  2 , Peter A Fasching  7
Affiliations
Review

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

Diana Lüftner et al. Breast Care (Basel). 2021 Apr.

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.

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

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Conflict of interest statement

E.B. has received honoraria from Novartis, Celgene, Riemser, Pfizer, Hexal, Amgen, and onkowissen.de for consulting, clinical research management, and medical education activities. M.W.B.'s institution has received research funding from Novartis and BioNTech. J.E. has received honoraria from AstraZeneca, Daiichi Sankyo, Eisai, Lilly, Novartis, Pierre Fabre, and Pfizer. T.N.F. has received honoraria from AstraZeneca, Celgene, Eisai, Pfizer, and Roche. P.A.F. reports grants from Novartis, Cepheid, and BioNTech, personal fees from Novartis, Roche, Pfizer, Celgene, Daiichi Sankyo, TEVA, AstraZeneca, Merck Sharp & Dohme, Myelo Therapeutics, Macrogenics, Eisai, and Puma. A.D.H. has received honoraria from Teva, Genomic Health, Celgene, AstraZeneca, Novartis, Pfizer, Lilly, MSD, Eisai, and Roche. W.J. has received honoraria and research grants from Novartis. H.-C.K. has received honoraria from Carl Zeiss Meditec, TEVA, Theraclion, Novartis, Amgen, AstraZeneca, Pfizer, Janssen-Cilag, GSK, LIV Pharma, MSD, Onkowissen, SurgVision, Roche, and Genomic Health. D.L. has received honoraria from Amgen, AstraZeneca, Celgene, Lilly, Loreal, MSD, Novartis, Pfizer, Tesaro, Teva. M.P.L. has received honoraria from Pfizer, Lilly, Roche, MSD, Hexal, Novartis, AstraZeneca, Eisai, Medac, and Exact Sciences for consultancy services, lectures, and travel support. V.M. has received speaker honoraria from Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, Pfizer, Pierre Fabre, Novartis, Roche, Teva, and Janssen-Cilag, and consultancy honoraria from Genomic Health, Roche, Pierre Fabre, Amgen, Daiichi Sankyo, and Eisai. F.O. has received speaker and consultancy honoraria from Amgen, AstraZeneca, Bayer, Beiersdorf, BMS, Boehringer, Celgene, Cellex, Chugai, Eisai, Gilead, Hexal, Ipsen, Janssen, Merck, MSD, Novartis, Novonordisc, Riemser, Roche, Servier, Shire, Tesaro, and Teva. A.S. has received honoraria from Roche, Celgene, AstraZeneca, Novartis, Pfizer, Zuckschwerdt Verlag GmbH, Georg Thieme Verlag, Aurikamed GmbH, MCI Deutschland GmbH, bsh medical communications GmbH, and proMedicis GmbH. H.T. has received honoraria from Novartis, Roche, Celgene, TEVA, and Pfizer, and travel support from Roche, Celgene, and Pfizer. M.W. has received speaker honoraria from AstraZeneca, Celgene, and Novartis. S.Y.B. has received honoraria from Roche, Novartis, Pfizer, MSD, Teva, and Astra Zeneca. All of the remaining authors (D.W., A.T., and P.P.) have declared that they have no conflicts of interest.

Figures

Fig. 1
Fig. 1
Course of the PRAEGNANT registry in relation to the initial assessment of disease progression, study entry, blood samples, tumor evaluation, and identification of progressive disease [3].
Fig. 2
Fig. 2
Analyses in the PRAEGNANT registry [3].
See this image and copyright information in PMC

References

    1. Gliklich RE, Leavy MB, Dreyer NA, editors. 4th ed. Rockville (MD): Agency for Healthcare Research and Quality; 2020. Registries for evaluating patient outcomes: a user's guide. Available from https://www.ncbi.nlm.nih.gov/books/n/cerregistries4ed/pdf/ - PubMed
    1. LaBresh KA, Gliklich R, Liljestrand J, Peto R, Ellrodt AG. Using “get with the guidelines” to improve cardiovascular secondary prevention. Jt Comm J Qual Saf. 2003 Oct;29((10)):539–50. - PubMed
    1. Fasching PA, Brucker SY, Fehm TN, Overkamp F, Janni W, Wallwiener M, et al. Biomarkers in patients with metastatic breast cancer and the PRAEGNANT study network. Geburtshilfe Frauenheilkd. 2015 Jan;75((1)):41–50. - PMC - PubMed
    1. Lo Muzio L, Arena C, Troiano G, Villa A. Oral stomatitis and mTOR inhibitors: A review of current evidence in 20,915 patients. Oral Dis. 2018 Mar;24((1-2)):144–71. - PubMed
    1. Decker T, Steering Board OPAL Die klinische Tumorregisterplattform OPAL stellt sich vor: Umfassende Daten zu Behandlung und Outcome von Patienten mit fortgeschrittenem Mammakarzinom aus der Routinebehandlung. Forum. 2019 Feb;34((1)):74–6.

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