Skip to main content
SpringerLink
Log in

Klinische Endpunkte in Real-World-Register-Studien

PRAEGNANT-Netzwerk für Patientinnen mit fortgeschrittenem Mammakarzinom

Clinical endpoints in real-world registry studies

PRAEGNANT network for women with advanced breast cancer

  • Leitthema
  • Published:
Der Onkologe Aims and scope

Zusammenfassung

Hintergrund

Die individuellen Therapiemöglichkeiten der Patientin mit einem metastasierten Brustkrebs werden immer spezifischer. Für Therapieentscheidungen in der metastasierten Situation liegt keine ausreichende Evidenz aus klinischen Studien für alle Behandlungssituationen und Subgruppen vor. Dieses macht die Erhebung und systematische Auswertung von Real-World-Daten zur Erstellung von Real-World-Evidenz sinnvoll.

Methoden und Ziele

Um bei der Behandlung von Patientinnen mit einem metastasierten Mammakarzinom eine stadien- und tumorspezifische Therapie identifizieren zu können, wurde das PRAEGNANT-Netzwerk (Prospective Academic Translational Research Network zur Optimierung der onkologischen Versorgungsqualität im fortgeschrittenen therapeutischen Umfeld) etabliert. Ziel ist es, die medizinische Versorgung von Patientinnen mit metastasiertem Mammakarzinom in der realen Welt zu beleuchten, Wirkungen und Nebenwirkungen der Therapiekonzepte zu erfassen, die Veränderung der Lebensqualität unter der Therapie mit zu verfolgen, Patientinnen zu identifizieren, die an einer klinischen Arzneimittelstudie teilnehmen können, und durch Untersuchung der molekularen Tumoreigenschaften des Mammakarzinoms Patientinnen eine zielgerichtete Therapie in klinischen Studien zu ermöglichen.

Schlussfolgerung

Dieser Artikel fasst die bereits erhobenen Daten aus dem PRAEGNANT-Netzwerk zusammen und beleuchtet die Frage der Übertragbarkeit der verschiedenen Endpunkte aus klinischen Studien in die reale Behandlungssituation.

Abstract

Background

The therapeutic options for the individual patient with metastatic breast cancer are becoming more and more specific. Evidence for therapeutic recommendations from clinical trials is not available for all treatment situations and patient subgroups. This makes the collection and evaluation of real-world data meaningful.

Methods and aims

To provide recommendations for up-to-date treatments and participation in clinical trials for patients with metastatic breast cancer, the Prospective Academic Translational Research Network (PREAGNANT) has been established to optimize the oncological quality of care in the advanced therapeutic setting. The main aim is to systematically record medical care of patients with metastatic breast cancer in real life including the therapeutic effects and side effects of the different treatment strategies, to monitor the quality of life changes during therapy, to identify patients who could participate in a clinical drug study and to enable a targeted therapy based on molecular structures of breast cancer patients.

Conclusion

This article presents a summary of the PRAEGNANT network and sheds light on the question of the portability of the various endpoints from clinical trials into the real world treatment situation.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Abb. 1
Abb. 2
Abb. 3
Abb. 4

Literatur

  1. Anderson P, Benford M, Harris N et al (2008) Real-world physician and patient behaviour across countries: disease-specific programmes—a means to understand. Curr Med Res Opin 24:3063–3072

    CAS  PubMed  Google Scholar 

  2. Andre F, Ciruelos E, Rubovszky G et al (2019) Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med 380:1929–1940

    CAS  PubMed  Google Scholar 

  3. Bayraktar S, Gutierrez-Barrera AM, Liu D et al (2011) Outcome of triple-negative breast cancer in patients with or without deleterious BRCA mutations. Breast Cancer Res Treat 130:145–153

    CAS  PubMed  PubMed Central  Google Scholar 

  4. Conte B, Fabi A, Poggio F et al (2019) T‑DM1 efficacy in patients with HER2-positive metastatic breast cancer progressing after a Taxane plus pertuzumab and trastuzumab: an Italian multicenter observational study. Clin Breast Cancer. https://doi.org/10.1016/j.clbc.2019.09.001

    Article  PubMed  Google Scholar 

  5. Cortes J, O’shaughnessy J, Loesch D et al (2011) Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet 377:914–923

    CAS  PubMed  Google Scholar 

  6. Custodio-Santos T, Videira M, Brito MA (2017) Brain metastasization of breast cancer. Biochim Biophys Acta 1868:132–147

    CAS  Google Scholar 

  7. Dawood S, Ueno NT, Valero V et al (2011) Differences in survival among women with stage III inflammatory and noninflammatory locally advanced breast cancer appear early: a large population-based study. Cancer 117:1819–1826

    PubMed  Google Scholar 

  8. Decker T (2018) Die klinische Tumorregisterplattform OPAL stellt sich vor. Forum 34:74–76

    Google Scholar 

  9. Dieras V, Miles D, Verma S et al (2017) Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol 18:732–742

    CAS  PubMed  PubMed Central  Google Scholar 

  10. Fasching P, Hu C, Hart S et al (2018) Abstract PD1-02: cancer predisposition genes in metastatic breast cancer—association with metastatic pattern, prognosis, patient and tumor characteristics. Cancer Res 78:PD1-02–PD01-02

    Google Scholar 

  11. Fasching PA, Brucker SY, Fehm TN et al (2015) Biomarkers in patients with metastatic breast cancer and the PRAEGNANT study network. Geburtshilfe Frauenheilkd 75:41–50

    CAS  PubMed  PubMed Central  Google Scholar 

  12. Fasching PA, Hartkopf AD, Gass P et al (2019) Efficacy of neoadjuvant pertuzumab in addition to chemotherapy and trastuzumab in routine clinical treatment of patients with primary breast cancer: a multicentric analysis. Breast Cancer Res Treat 173:319–328

    CAS  PubMed  Google Scholar 

  13. Finn RS, Crown JP, Lang I et al (2015) The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol 16:25–35

    CAS  PubMed  Google Scholar 

  14. Finn RS, Martin M, Rugo HS et al (2016) Palbociclib and Letrozole in advanced breast cancer. N Engl J Med 375:1925–1936

    CAS  PubMed  Google Scholar 

  15. Fremd C, Hack CC, Schneeweiss A et al (2017) Use of complementary and integrative medicine among German breast cancer patients: predictors and implications for patient care within the PRAEGNANT study network. Arch Gynecol Obstet 295:1239–1245

    PubMed  Google Scholar 

  16. Gianni L, Pienkowski T, Im YH et al (2012) Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol 13:25–32

    Article  CAS  PubMed  Google Scholar 

  17. Gliklich RE (2014) AHRQ methods for effective health care. In: Gliklich RE, Dreyer NA, Leavy MB (Hrsg) Registries for evaluating patient outcomes: a user’s guide. Agency for Healthcare Research and Quality (US), Rockville

    Google Scholar 

  18. Hartkopf AD, Huober J, Volz B et al (2018) Treatment landscape of advanced breast cancer patients with hormone receptor positive HER2 negative tumors—data from the German PRAEGNANT breast cancer registry. Breast 37:42–51

    PubMed  Google Scholar 

  19. Hein A, Gass P, Walter CB et al (2016) Computerized patient identification for the EMBRACA clinical trial using real-time data from the PRAEGNANT network for metastatic breast cancer patients. Breast Cancer Res Treat 158:59–65

    PubMed  Google Scholar 

  20. Im SA, Lu YS, Bardia A et al (2019) Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med 381:307–316

    CAS  PubMed  Google Scholar 

  21. Johnston S, Martin M, Di Leo A et al (2019) MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. Breast Cancer 5:5

    PubMed  PubMed Central  Google Scholar 

  22. Labresh KA, Gliklich R, Liljestrand J et al (2003) Using “get with the guidelines” to improve cardiovascular secondary prevention. Jt Comm J Qual Saf 29:539–550

    PubMed  Google Scholar 

  23. Lakdawalla DN, Shafrin J, Hou N et al (2017) Predicting real-world effectiveness of cancer therapies using overall survival and progression-free survival from clinical trials: empirical evidence for the ASCO value framework. Value Health 20:866–875

    PubMed  Google Scholar 

  24. Leitlinienprogramm Onkologie DK, Deutsche Krebshilfe, Awmf (2019) S3-Leitlinie Früherkennung, Diagnose, Therapie und Nachsorge des Mammakarzinoms, Version 4.2, AWMF Registernummer: 032-045OL. https://www.leitlinienprogramm-onkologie.de/fileadmin/user_upload/Downloads/Leitlinien/Mammakarzinom_4_0/Version_4.3/LL_Mammakarzinom_Kurzversion_4.2.pdf. Zugegriffen: 01.03.2020

  25. Litton JK, Rugo HS, Ettl J et al (2018) Talazoparib in patients with advanced breast cancer and a Germline BRCA mutation. N Engl J Med 379:753–763

    CAS  PubMed  Google Scholar 

  26. Lo Muzio L, Arena C, Troiano G et al (2018) Oral stomatitis and mTOR inhibitors: a review of current evidence in 20,915 patients. Oral Dis 24:144–171

    CAS  PubMed  Google Scholar 

  27. Lux MP, Nabieva N, Hartkopf AD et al (2018) Therapy landscape in patients with metastatic HER2-positive breast cancer: data from the PRAEGNANT real-world breast cancer registry. Cancers (Basel). https://doi.org/10.3390/cancers11010010

    Article  Google Scholar 

  28. Macpherson I, Kilburn L, Kernaghan S et al (2019) Results from plasmaMATCH trial treatment cohort a: a phase II trial of extended-dose fulvestrant in patients with an ESR1 mutation identified via ctDNA screening (CRUK/15/010). San Antonio Breast Cancer Symposium, S P1-19-04

  29. May GS, Demets DL, Friedman LM et al (1981) The randomized clinical trial: bias in analysis. Circulation 64:669–673

    CAS  PubMed  Google Scholar 

  30. Modi S, Saura C, Yamashita T et al (2019) Trastuzumab deruxtecan in previously treated HER2-positive breast cancer. N Engl J Med 382:610–621. https://doi.org/10.1056/NEJMoa1914510

    Article  PubMed  PubMed Central  Google Scholar 

  31. Muller V, Nabieva N, Haberle L et al (2018) Impact of disease progression on health-related quality of life in patients with metastatic breast cancer in the PRAEGNANT breast cancer registry. Breast 37:154–160

    PubMed  Google Scholar 

  32. Murthy R, Borges VF, Conlin A et al (2018) Tucatinib with capecitabine and trastuzumab in advanced HER2-positive metastatic breast cancer with and without brain metastases: a non-randomised, open-label, phase 1b study. Lancet Oncol 19:880–888

    CAS  PubMed  Google Scholar 

  33. Murthy RK, Loi S, Okines A et al (2019) Tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer. N Engl J Med. https://doi.org/10.1056/nejmx190039

    Article  PubMed  Google Scholar 

  34. Nallamothu BK, Hayward RA, Bates ER (2008) Beyond the randomized clinical trial: the role of effectiveness studies in evaluating cardiovascular therapies. Circulation 118:1294–1303

    PubMed  Google Scholar 

  35. Perez EA, Barrios C, Eiermann W et al (2019) Trastuzumab emtansine with or without pertuzumab versus trastuzumab with taxane for human epidermal growth factor receptor 2‑positive advanced breast cancer: Final results from MARIANNE. Cancer 125:3974–3984

    CAS  PubMed  Google Scholar 

  36. Perol D, Robain M, Arveux P et al (2019) The ongoing French metastatic breast cancer (MBC) cohort: the example-based methodology of the epidemiological strategy and medical economics (ESME). BMJ Open 9:e23568

    PubMed  PubMed Central  Google Scholar 

  37. Quek RGW, Mardekian J (2019) Clinical outcomes, treatment patterns, and health resource utilization among metastatic breast cancer patients with Germline BRCA1/2 mutation: a real-world retrospective study. Adv Ther 36:708–720

    CAS  PubMed  Google Scholar 

  38. Rennert G, Bisland-Naggan S, Barnett-Griness O et al (2007) Clinical outcomes of breast cancer in carriers of BRCA1 and BRCA2 mutations. N Engl J Med 357:115–123

    CAS  PubMed  Google Scholar 

  39. Robson M, Im SA, Senkus E et al (2017) Olaparib for metastatic breast cancer in patients with a Germline BRCA mutation. N Engl J Med 377:523–533

    CAS  PubMed  Google Scholar 

  40. Robson ME, Tung N, Conte P et al (2019) OlympiAD final overall survival and tolerability results: olaparib versus chemotherapy treatment of physician’s choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Ann Oncol 30:558–566

    CAS  PubMed  PubMed Central  Google Scholar 

  41. Schmid P, Adams S, Rugo HS et al (2018) Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer. N Engl J Med 379:2108–2121

    CAS  PubMed  Google Scholar 

  42. Slamon DJ, Neven P, Chia S et al (2018) Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2‑negative advanced breast cancer: MONALEESA‑3. J Clin Oncol 36:2465–2472

    CAS  PubMed  Google Scholar 

  43. Sledge GW Jr., Toi M, Neven P et al (2019) The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy-MONARCH 2: a randomized clinical trial. JAMA Oncol 6(1):116–124. https://doi.org/10.1001/jamaoncol.2019.4782

    Article  PubMed Central  Google Scholar 

  44. Suvarna VR (2018) Real world evidence (RWE)—are we (RWE) ready? Perspect Clin Res 9:61–63

    PubMed  PubMed Central  Google Scholar 

  45. Swain SM, Baselga J, Kim SB et al (2015) Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med 372:724–734

    CAS  PubMed  PubMed Central  Google Scholar 

  46. Tabouret E, Chinot O, Metellus P et al (2012) Recent trends in epidemiology of brain metastases: an overview. Anticancer Res 32:4655–4662

    PubMed  Google Scholar 

  47. Tamura K, Tsurutani J, Takahashi S et al (2019) Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol 20:816–826

    CAS  PubMed  Google Scholar 

  48. Taran F‑A, Fasching P, Volz B et al (2018) Abstract P5-21-09: overall survival of metastatic breast cancer patients—data from the PRAEGNANT breast cancer registry. Cancer Res 78:P5-21-09–P25-21-09

    Google Scholar 

  49. Tripathy D, Im SA, Colleoni M et al (2018) Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol 19:904–915

    CAS  PubMed  Google Scholar 

  50. Viera AJ, Bangdiwala SI (2007) Eliminating bias in randomized controlled trials: importance of allocation concealment and masking. Fam Med 39:132–137

    PubMed  Google Scholar 

  51. Wallwiener M, Heindl F, Brucker SY et al (2017) Implementation and feasibility of electronic patient-reported outcome (ePRO) data entry in the PRAEGNANT real-time advanced and metastatic breast cancer registry. Geburtshilfe Frauenheilkd 77:870–878

    PubMed  PubMed Central  Google Scholar 

  52. Wilk N, Wierzbicka N, Skrzekowska-Baran I et al (2017) Study types and reliability of Real World Evidence compared with experimental evidence used in Polish reimbursement decision-making processes. Public Health 145:51–58

    CAS  PubMed  Google Scholar 

  53. Witzel I, Oliveira-Ferrer L, Pantel K et al (2016) Breast cancer brain metastases: biology and new clinical perspectives. Breast Cancer Res 18:8

    PubMed  PubMed Central  Google Scholar 

  54. Yang Y, Fasching PA, Tresp V Modeling clinical decisions with multinomial hierarchical classification. Proceedings of the 34th International Conference on Machine Learning, Sydney, Australia, PMLR 70, 2017. Copyright 2017 by the author(s)

  55. Yang Y, Fasching PA, Tresp V (2017) Predictive modeling of therapy decisions in metastatic breast cancer with recurrent neural network encoder and multinomial hierarchical regression decoder. In: 2017 IEEE International Conference on Healthcare Informatics (ICHI) 2017 IEEE International Conference on Healthcare Informatics (ICHI). IEEE, S 46–55

  56. Yang Y, Fasching PA, Wallwiener M et al (2016) Predictive clinical decision support system with RNN encoding and tensor decoding. Paper presented at the 30th Conference on Neural Information Processing Systems (NIPS 2016), Barcelona, Spain. (arXiv preprint arXiv:1612.00611)

Download references

Danksagung

Diese Studie wird gefördert von Forschungsgrants der Firmen Novartis, Celgene und Roche. Des Weiteren wird sie gefördert von TRR (Translational Research Ressources) der Frauenklinik des Universitätsklinikums Erlangen.

Author information

Authors and Affiliations

  1. Department of Obstetrics and Gynecology, University of Tuebingen, Tübingen, Deutschland

    Andreas D. Hartkopf, Diethelm Wallwiener & Sara Y. Brucker

  2. Erlangen University Hospital, Department of Gynecology and Obstetrics; Comprehensive Cancer Center Erlangen EMN, Friedrich Alexander University of Erlangen–Nuremberg, Universitätsstraße 21–23, 91054, Erlangen, Deutschland

    Julius Emons, Adriana Titzmann, Patrik Pöschke, Matthias W. Beckmann & Peter A. Fasching MD

  3. Klinik für Gynäkologie und Geburtshilfe, Frauenklinik St. Louise, Paderborn, Deutschland

    Michael P. Lux

  4. OncoConsult Overkamp GmbH, Berlin, Deutschland

    Friedrich Overkamp

  5. Oncology Practice, Bethanien Hospital Frankfurt, Frankfurt am Main, Deutschland

    Hans Tesch

  6. Department of Hematology, Oncology and Tumour Immunology, Charité University Hospital, Campus Benjamin Franklin, Berlin, Deutschland

    Diana Lüftner

  7. Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Deutschland

    Markus Wallwiener

  8. Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Deutschland

    Volkmar Müller

  9. ClinSol GmbH & Co KG, Würzburg, Deutschland

    Erik Belleville

  10. Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Deutschland

    Wolfgang Janni

  11. Department of Gynecology and Obstetrics, University Hospital Düsseldorf, Düsseldorf, Deutschland

    Tanja N. Fehm

  12. Department of Gynecology and Obstetrics, Marienhospital Bottrop, Bottrop, Deutschland

    Hans-Christian Kolberg

  13. Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technical University of Munich, München, Deutschland

    Johannes Ettl

  14. National Center for Tumor Diseases and Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Deutschland

    Andreas Schneeweiss

  15. Klinik für Gynäkologie, Universitätsspital Zürich, Zürich, Schweiz

    Florin-Andrei Taran

  16. St. Josefs-Krankenhaus, Salzkotten, Deutschland

    Michael P. Lux

  17. Kooperatives Brustzentrum Paderborn, Paderborn, Deutschland

    Michael P. Lux

Authors
  1. Andreas D. Hartkopf
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Julius Emons
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Michael P. Lux
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Florin-Andrei Taran
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Friedrich Overkamp
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Hans Tesch
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Adriana Titzmann
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Patrik Pöschke
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Diana Lüftner
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Markus Wallwiener
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Volkmar Müller
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Matthias W. Beckmann
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Erik Belleville
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Wolfgang Janni
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Tanja N. Fehm
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. Hans-Christian Kolberg
    View author publications

    You can also search for this author in PubMed Google Scholar

  17. Johannes Ettl
    View author publications

    You can also search for this author in PubMed Google Scholar

  18. Diethelm Wallwiener
    View author publications

    You can also search for this author in PubMed Google Scholar

  19. Andreas Schneeweiss
    View author publications

    You can also search for this author in PubMed Google Scholar

  20. Sara Y. Brucker
    View author publications

    You can also search for this author in PubMed Google Scholar

  21. Peter A. Fasching MD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Peter A. Fasching MD.

Ethics declarations

Interessenkonflikt

E. Belleville erhielt Honorare von Novartis, Celgene, Riemser, Pfizer, Hexal, Amgen, onkowissen.de für Beratung, Leitung klinischer Forschung oder medizinische Fortbildungsaktivitäten. F.-A. Taran erhielt Honorare von AstraZeneca, Genomic Health, Novartis, Roche, Tesaro und Teva sowie Reisekostenunterstützung von Novartis und Tesaro. Die Institution von M. Beckmann erhielt Forschungsförderung von Novartis and Biontech. J. Emons erhielt Honorare von Eisai, Pfizer und Novartis. T.N. Fehm erhielt Honorare von AstraZeneca, Celgene, Eisai, Pfizer und Roche. P.A. Fasching gibt Zuschüsse von Novartis, Cepheid und Biontech an, persönliche Honorare von Novartis, Roche, Pfizer, Celgene, Daiichi-Sankyo, TEVA, AstraZeneca, Merck Sharp & Dohme, Myelo Therapeutics, Macrogenics, Eisai und Puma. A.D. Hartkopf erhielt Honorare von Teva, Genomic Health, Celgene, AstraZeneca, Novartis, Pfizer, Lilly, MSD, Eisai und Roche. W. Janni erhielt Honorare und Forschungsbeihilfen von Novartis. H.‑C. Kolberg erhielt Honorare von Carl Zeiss Meditec, TEVA, Theraclion, Novartis, Amgen, AstraZeneca, Pfizer, Janssen-Cilag, GSK, LIV Pharma, MSD, Onkowissen, SurgVision, Roche und Genomic Health. D. Lüftner erhielt Honorare von Amgen, AstraZeneca, Celgene, Lilly, L’Oréal, MSD, Novartis, Pfizer, Tesaro, Teva. M.P. Lux erhielt Honorare von Pfizer, Lilly, Roche, MSD, Hexal, Novartis, AstraZeneca, Eisai, medac und Genomic Health für Teilnahme an Beratungsausschüssen, Vortragstätigkeiten und Reisekostenunterstützung. V. Müller erhielt Rednerhonorare von Amgen, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, Pfizer, Pierre-Fabre, Novartis, Roche, Teva, Janssen-Cilag und Honorare für Beratungstätigkeiten von Genomic Health, Roche, Pierre Fabre, Amgen, Daiichi-Sankyo und Eisai. F. Overkamp erhielt Rednerhonorare und Honorare für Beratungstätigkeiten von Amgen, AstraZeneca, Bayer, BMS, Boehringer, Celgene, Chugai, Eisai, Gilead, Hexal, Ipsen, Janssen, Merck, MSD, AstraZeneca, Novartis, Novonordisc, Riemser, Roche, Servier, Shire, Tesaro, Teva und MSD. A. Schneeweiss erhielt Honorare von Roche, Celgene, AstraZeneca, Novartis, Pfizer, Zuckschwerdt Verlag GmbH, Georg Thieme Verlag, Aurikamed GmbH, MCI Deutschland GmbH, bsh medical communications GmbH und promedicis GmbH. H. Tesch erhielt Honorare von Novartis, Roche, Celgene, TEVA, Pfizer sowie Reisekostenunterstützung von Roche, Celgene und Pfizer. M. Wallwiener erhielt Rednerhonorare von AstraZeneca, Celgene und Novartis. A. Titzmann, P. Pöschke, J. Ettl, D. Wallwiener und S. Y. Brucker geben an, dass kein Interessenkonflikt besteht.

Alle beschriebenen Untersuchungen am Menschen oder an menschlichem Gewebe wurden mit Zustimmung der zuständigen Ethikkommission, im Einklang mit nationalem Recht sowie gemäß der Deklaration von Helsinki von 1975 (in der aktuellen, überarbeiteten Fassung) durchgeführt. Von allen beteiligten Patienten liegt eine Einverständniserklärung vor.

Additional information

Die Autoren A.D. Hartkopf, J. Emons, S.Y. Brucker und P.A. Fasching haben zu gleichen Teilen zum Manuskript beigetragen.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Hartkopf, A.D., Emons, J., Lux, M.P. et al. Klinische Endpunkte in Real-World-Register-Studien. Onkologe 26, 530–541 (2020). https://doi.org/10.1007/s00761-020-00766-x

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00761-020-00766-x

Schlüsselwörter

Keywords

Search

Navigation