Gunther Hartmann

About Gunther Hartmann:

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LHA ID: 84WJX7CFX4-2

Location: Germany

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Other Projects: POLAR - Polypharmacy, Drug Interactions, Risks (Universitätsklinikum Bonn, AöR)

The aim of the project is to use methods and processes of the Medical Informatics Initiative (MII) to contribute to the detection of health risks in patients with polypharmacy. Polypharmacy occurs especially in elderly patients with multimorbidity. Polypharmacy associated with an increased risk for medication errors and drug-drug or drug-disease interactions, which either reduce or intensify the desired effect of individual active substances or lead to undesired adverse drug effects (ADE). In the ...

Programme: MII - Medical Informatics Initiative

Public web page: https://www.medizininformatik-initiative.de/en/POLAR

Organisms: Homo sapiens

Universitätsklinikum Bonn, AöR

Country: Germany

City: Bonn

Web page: https://www.ukbonn.de

Four versus six cycles of CHOP chemotherapy in combination with six applications of rituximab in patients with aggressive B-cell lymphoma with favourable prognosis (FLYER): a randomised, phase 3, non-inferiority trial.

GLA - German Lymphoma Alliance

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Abstract (Expand)

BACKGROUND: Six cycles of R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) are the standard treatment for aggressive B-cell non-Hodgkin lymphoma. In the FLYER trial, … we assessed whether four cycles of CHOP plus six applications of rituximab are non-inferior to six cycles of R-CHOP in a population of patients with B-cell non-Hodgkin lymphoma with favourable prognosis. METHODS: This two-arm, open-label, international, multicentre, prospective, randomised phase 3 non-inferiority trial was done at 138 clinical sites in Denmark, Israel, Italy, Norway, and Germany. We enrolled patients aged 18-60 years, with stage I-II disease, normal serum lactate dehydrogenase concentration, ECOG performance status 0-1, and without bulky disease (maximal tumour diameter <7.5 cm). Randomisation was computer-based and done centrally in a 1:1 ratio using the Pocock minimisation algorithm after stratification for centres, stage (I vs II), and extralymphatic sites (no vs yes). Patients were assigned to receive either six cycles of R-CHOP or four cycles of R-CHOP plus two doses of rituximab. CHOP comprised cyclophosphamide (750 mg/m(2)), doxorubicin (50 mg/m(2)), and vincristine (1.4 mg/m(2), with a maximum total dose of 2 mg), all administered intravenously on day 1, plus oral prednisone or prednisolone at the discretion of the investigator (100 mg) administered on days 1-5. Rituximab was given at a dose of 375 mg/m(2) of body surface area. Cycles were repeated every 21 days. No radiotherapy was planned except for testicular lymphoma treatment. The primary endpoint was progression-free survival after 3 years. The primary analysis was done in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of assigned treatment. A non-inferiority margin of -5.5% was chosen. The trial, which is completed, was prospectively registered at ClinicalTrials.gov, NCT00278421. FINDINGS: Between Dec 2, 2005, and Oct 7, 2016, 592 patients were enrolled, of whom 295 patients were randomly assigned to receive six cycles of R-CHOP and 297 were assigned to receive four cycles of R-CHOP plus two doses of rituximab. Four patients in the four-cycles group withdrew informed consent before the start of treatment, so 588 patients were included in the intention-to-treat analysis. After a median follow-up of 66 months (IQR 42-100), 3-year progression-free survival of patients who had four cycles of R-CHOP plus two doses of rituximab was 96% (95% CI 94-99), which was 3% better (lower limit of the one-sided 95% CI for the difference was 0%) than six cycles of R-CHOP, demonstrating the non-inferiority of the four-cycles regimen. 294 haematological and 1036 non-haematological adverse events were documented in the four-cycles group compared with 426 haematological and 1280 non-haematological adverse events in the six-cycles group. Two patients, both in the six-cycles group, died during study therapy. INTERPRETATION: In young patients with aggressive B-cell non-Hodgkin lymphoma and favourable prognosis, four cycles of R-CHOP is non-inferior to six cycles of R-CHOP, with relevant reduction of toxic effects. Thus, chemotherapy can be reduced without compromising outcomes in this population. FUNDING: Deutsche Krebshilfe.

Authors: V. Poeschel, G. Held, M. Ziepert, M. Witzens-Harig, H. Holte, L. Thurner, P. Borchmann, A. Viardot, M. Soekler, U. Keller, C. Schmidt, L. Truemper, R. Mahlberg, R. Marks, H. G. Hoeffkes, B. Metzner, J. Dierlamm, N. Frickhofen, M. Haenel, A. Neubauer, M. Kneba, F. Merli, A. Tucci, P. de Nully Brown, M. Federico, E. Lengfelder, A. di Rocco, R. Trappe, A. Rosenwald, C. Berdel, M. Maisenhoelder, O. Shpilberg, J. Amam, K. Christofyllakis, F. Hartmann, N. Murawski, S. Stilgenbauer, M. Nickelsen, G. Wulf, B. Glass, N. Schmitz, B. Altmann, M. Loeffler, M. Pfreundschuh

Date Published: 21st Dec 2019

Publication Type: Journal article

Human Diseases: lymphoma, diffuse large B-cell lymphoma

PubMed ID: 31868632

Citation: Lancet. 2019 Dec 21;394(10216):2271-2281. doi: 10.1016/S0140-6736(19)33008-9.

Created: 4th May 2021 at 15:08, Last updated: 7th Dec 2021 at 17:58

Original Polar Test Data

POLAR - Polypharmacy, Drug Interactions, Risks

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Dies sind die originalen Polar-Testdaten. Die Patienten sind aus echten Fällen abgeleitet. 61 Patienten (Patient)

mit jeweils 1 Einrichtungskontakt (Encounter) und jeweils 1 - 3 Abteilungskontakten (Encounter)
mit Diagnosen (Condition)
mit Laborwerten (Observation)
mit Vitalwerten (Observation)
mit Prozeduren (Procedure)
mit Medikation (Medication, Medication Administration, Medication Statement)

Condition : 270 Encounter : 129 Medication : 242 MedicationAdministration : 165 ...

Creators: Alexander Strübing, Jan Erik Gewehr, Friederike Salman, Yvonne Lemke, Norman Freier, Steffen Härterich, Thomas Maulhardt, Martin Böker, Ingolf Cascorbi, Ruwen Böhm, Felix Rottmann, Claudia Bulin, Anna Böhmer, Ulrich Jaehde, Katharina Karsten Dafonte, Martin Coenen, Gunther Hartmann, Martin Fromm, Renke Maas, Pauline Dürr, Melanie Then, Wahram Andrikyan

Submitter: Alexander Strübing

Data file type: Not specified

Investigations: Test Data

Studies: FHIR Test Data

Resources: General FHIR Test Data

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Created: 24th Jan 2023 at 09:13, Last updated: 25th Jan 2023 at 09:44

MII - Medical Informatics Initiative

The medical informatics initiative was created to close the gap between research and healthcare. All of Germany’s university hospitals have joined forces with research institutions, businesses, health insurers, and patient advocacy groups to create a framework that harnesses research findings to the direct benefit of patients. The German Federal Ministry of Education and Research (BMBF) is investing around 160 million euros in the programme through 2021. The digitisation of medicine is creating ...

Projects: Methodical Use Case PheP, SMITH - Smart Medical Information Technology for Healthcare, POLAR - Polypharmacy, Drug Interactions, Risks

Web page: https://www.medizininformatik-initiative.de/en

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Health Atlas - Local Data Hub/Leipzig

The Health Atlas - Local Data Hub/Leipzig is an alliance of medical ontologists, medical systems biologists and clinical trials groups to design and implement a multi-functional and quality-assured atlas. It provides models, data and metadata on specific use cases from medical research fields.

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Gunther Hartmann

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