Influence of Biopsy Technique on Molecular Genetic Tumor Characterization in Non-Small Cell Lung Cancer—The Prospective, Randomized, Single-Blinded, Multicenter PROFILER Study Protocol

Maik Haentschel*, Michael Boeckeler, Irina Bonzheim, Florian Schimmele, Werner Spengler, Franz Stanzel, Christoph Petermann, Kaid Darwiche , Lars Hagmeyer, Reinhard Buettner, Markus Tiemann, Hans-Ulrich Schildhaus, Rainer Muche, Hans Boesmueller, Felix Everinghoff, Robert Mueller, Bijoy Atique, Richard A. Lewis, Lars Zender, Falko Fend and Juergen Hetzel

The detection of molecular alterations is crucial for the individualized treatment of advanced non-small cell lung cancer (NSCLC). Missing targetable alterations may have a major impact on patient’s progression free and overall survival. Although laboratory testing for molecular alterations has continued to improve; little is known about how biopsy technique affects the detection rate of different mutations. In the retrospective study detection rate of epidermal growth factor (EGFR) mutations in tissue extracted by bronchoscopic cryobiopsy (CB was significantly higher compared to other standard biopsy techniques. This prospective, randomized, multicenter, single blinded study evaluates the accuracy of molecular genetic characterization of NSCLC for different cell sampling techniques. Key inclusion criteria are suspected lung cancer or the suspected relapse of known NSCLC that is bronchoscopically visible. Patients will be randomized, either to have a CB or a bronchoscopic forceps biopsy (FB). If indicated, a transbronchial needle aspiration (TBNA) of suspect lymph nodes will be performed. Blood liquid biopsy will be taken before tissue biopsy. The primary endpoint is the detection rate of molecular genetic alterations in NSCLC, using CB and FB. Secondary endpoints are differences in the combined detection of molecular genetic alterations between FB and CB, TBNA and liquid biopsy. This trial plans to recruit 540 patients, with 178 evaluable patients per study cohort. A histopathological and molecular genetic evaluation will be performed by the affiliated pathology departments of the national network for genomic medicine in lung cancer (nNGM), Germany. We will compare the diagnostic value of solid tumor tissue, lymph node cells and liquid biopsy for the molecular genetic characterization of NSCLC. This reflects a real world clinical setting, with potential direct impact on both treatment and survival.

Integration of Tumor Mutation Burden and PD-L1 Testing in Routine Laboratory Diagnostics in Non-Small Cell Lung Cancer

Stefanie Schatz*, Markus Falk*, Balázs Jóri*, Hayat O Ramdani, Stefanie Schmidt, Eva-Maria Willing, Roopika Menon, Harry J M Groen, Linda Diehl, Matthias Kröger, Claas Wesseler, Frank Griesinger, Petra Hoffknecht, Markus Tiemann, Lukas C Heukamp
Cancers (Basel). 2020 Jun 24;12(6):E1685. doi: 10.3390/cancers12061685
PMID: 32599951

Mast cells and collagen fibrillogenesis

Atiakshin D, Buchwalow I, Tiemann M.
Histochem Cell Biol. 2020 Mar 28. doi: 10.1007/s00418-020-01875-9.
PMID: 32222902

The small molecule Bcl-2/Mcl-1 inhibitor TW-37 shows single-agent cytotoxicity in neuroblastoma cell lines

Klenke S, Akdeli N, Stelmach P, Heukamp L, Schulte JH, Bachmann HS.
BMC Cancer. 2019 Mar 18;19(1):243. doi: 10.1186/s12885-019-5439-1.
PMID: 30885150

Initial Characterization of Transgenic Mice Overexpressing Human Histamine H2 Receptors

Gergs U, Bernhardt G, Buchwalow IB, Edler H, Fröba J, Keller M, Kirchhefer U, Köhler F, Mißlinger N, Wache H, Neumann J.
J Pharmacol Exp Ther. 2019 Apr;369(1):129-141. doi: 10.1124/jpet.118.255711. Epub 2019 Feb 6.
PMID: 30728249

Spatial analysis of p63, K5 and K7 defines two groups of progenitor cells that differentially contribute to the maintenance of normal sebaceous glands, extraocular sebaceous carcinoma and benign sebaceous tumors

Boecker W, Reusch M, Mielke V, Reusch U, Loening T, Tiemann M, Buchwalow I.
J Dermatol. 2019 Jan 21. doi: 10.1111/1346-8138.14765. [Epub ahead of print]
PMID: 30663115

Histochimija: Metoditscheskoje Possobije

Buchwalow I, Atjakshin D, Pawlowa T, Tiemann M
„Histochemistry: Textbook“ Woronesch: Isdatelstvo-Poligrafitscheski Zenter „Nautschnaja Kniga“, 2018. — 226 с. ISBN 978-5-4446-1036-7

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