Universität zu Köln

Griesinger, Frank, Eberhardt, Wilfried, Nusch, Arnd, Reiser, Marcel, Zahn, Mark-Oliver, Maintz, Christoph, Bernhardt, Christiane, Losem, Christoph, Stenzinger, Albrecht, Heukamp, Lukas C., Buettner, Reinhard, Marschner, Norbert, Jaenicke, Martina, Fleitz, Annette, Spring, Lisa, Sahlmann, Joerg, Karatas, Aysun, Hipper, Annette, Weichert, Wilko, Heilmann, Monika, Sadjadian, Parvis, Gleiber, Wolfgang, Grah, Christian, Waller, Cornelius F., Reck, Martin, Rittmeyer, Achim ORCID: 0000-0002-5280-6052, Christopoulos, Petros ORCID: 0000-0002-7966-8980, Sebastian, Martin and Thomas, Michael (2021). Biomarker testing in non-small cell lung cancer in routine care: Analysis of the first 3,717 patients in the German prospective, observational, nation-wide CRISP Registry (AIO-TRK-0315). Lung Cancer, 152. S. 174 - 185. CLARE: ELSEVIER IRELAND LTD. ISSN 1872-8332

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Abstract

Objectives: An increasing number of treatment-determining biomarkers has been identified in non-small cell lung cancer (NSCLC) and molecular testing is recommended to enable optimal individualized treatment. However, data on implementation of these recommendations in the real-world setting are scarce. This study presents comprehensive details on the frequency, methodology and results of biomarker testing of advanced NSCLC in Germany. Patients and methods: This analysis included 3,717 patients with advanced NSCLC (2,921 non-squamous; 796 squamous), recruited into the CRISP registry at start of systemic therapy by 150 German sites between December 2015 and June 2019. Evaluated were the molecular biomarkers EGFR, ALK, ROS1, BRAF, KRAS, MET, TP53, RET, HER2, as well as expression of PD-L1. Results: In total, 90.5 % of the patients were tested for biomarkers. Testing rates were 92.2 % (non-squamous), 70.7 % (squamous) and increased from 83.2 % in 2015/16 to 94.2% in 2019. Overall testing rates for EGFR, ALK, ROS1, and BRAF were 72.5 %, 74.5 %, 66.1 %, and 53.0 %, respectively (non-squamous). Testing rates for PD-L1 expression were 64.5 % (non-squamous), and 58.5 % (squamous). The most common testing methods were immunohistochemistry (68.5 % non-squamous, 58.3 % squamous), and next-generation sequencing (38.7 % nonsquamous, 14.4 % squamous). Reasons for not testing were insufficient tumor material or lack of guideline recommendations (squamous). No alteration was found in 37.8 % (non-squamous), and 57.9 % (squamous), respectively. Most common alterations in non-squamous tumors (all patients/all patients tested for the respective biomarker): KRAS (17.3 %/39.2 %), TP53 (14.1 %/51.4 %), and EGFR (11.0 %/15.1 %); in squamous tumors: TP53 (7.0 %/69.1 %), MET (1.5 %/11.1 %), and EGFR (1.1 %/4.4 %). Median PFS (non-squamous) was 8.7 months (95 % CI 7.4-10.4) with druggable EGFR mutation, and 8.0 months (95 % CI 3.9-9.2) with druggable ALK alterations. Conclusion: Testing rates in Germany are high nationwide and acceptable in international comparison, but still leave out a significant portion of patients, who could potentially benefit. Thus, specific measures are needed to increase implementation.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Griesinger, Frank UNSPECIFIED UNSPECIFIED UNSPECIFIED Eberhardt, Wilfried UNSPECIFIED UNSPECIFIED UNSPECIFIED Nusch, Arnd UNSPECIFIED UNSPECIFIED UNSPECIFIED Reiser, Marcel UNSPECIFIED UNSPECIFIED UNSPECIFIED Zahn, Mark-Oliver UNSPECIFIED UNSPECIFIED UNSPECIFIED Maintz, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Bernhardt, Christiane UNSPECIFIED UNSPECIFIED UNSPECIFIED Losem, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Stenzinger, Albrecht UNSPECIFIED UNSPECIFIED UNSPECIFIED Heukamp, Lukas C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Buettner, Reinhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Marschner, Norbert UNSPECIFIED UNSPECIFIED UNSPECIFIED Jaenicke, Martina UNSPECIFIED UNSPECIFIED UNSPECIFIED Fleitz, Annette UNSPECIFIED UNSPECIFIED UNSPECIFIED Spring, Lisa UNSPECIFIED UNSPECIFIED UNSPECIFIED Sahlmann, Joerg UNSPECIFIED UNSPECIFIED UNSPECIFIED Karatas, Aysun UNSPECIFIED UNSPECIFIED UNSPECIFIED Hipper, Annette UNSPECIFIED UNSPECIFIED UNSPECIFIED Weichert, Wilko UNSPECIFIED UNSPECIFIED UNSPECIFIED Heilmann, Monika UNSPECIFIED UNSPECIFIED UNSPECIFIED Sadjadian, Parvis UNSPECIFIED UNSPECIFIED UNSPECIFIED Gleiber, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Grah, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Waller, Cornelius F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Reck, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Rittmeyer, Achim UNSPECIFIED orcid.org/0000-0002-5280-6052 UNSPECIFIED Christopoulos, Petros UNSPECIFIED orcid.org/0000-0002-7966-8980 UNSPECIFIED Sebastian, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Thomas, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-604980
DOI:	10.1016/j.lungcan.2020.10.012
Journal or Publication Title:	Lung Cancer
Volume:	152
Page Range:	S. 174 - 185
Date:	2021
Publisher:	ELSEVIER IRELAND LTD
Place of Publication:	CLARE
ISSN:	1872-8332
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Oncology; Respiratory System Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/60498