TY  - JOUR
A1  - Griesinger, Frank
A1  - Eberhardt, Wilfried E. E.
A1  - Nusch, Arnd
A1  - Reiser, Marcel
A1  - Zahn, Mark-Oliver
A1  - Maintz, Christoph
A1  - Bernhardt, Christiane
A1  - Losem, Christoph
A1  - Stenzinger, Albrecht
A1  - Heukamp, Lukas
A1  - Büttner, Reinhard
A1  - Marschner, Sebastian
A1  - Jänicke, Martina
A1  - Fleitz, Annette
A1  - Spring, Lisa
A1  - Sahlmann, Jörg
A1  - Karatas, Aysun
A1  - Hipper, Annette
A1  - Weichert, Wilko
A1  - Heilmann, Monika
A1  - Sadjadian, Parvis
A1  - Gleiber, Wolfgang
A1  - Grah, Christian
A1  - Waller, Cornelius
A1  - Reck, Martin
A1  - Rittmeyer, Achim
A1  - Christopoulos, Petros
A1  - Sebastian, Martin
A1  - Thomas, Michael
T1  - 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)
T2  - Lung cancer
N2  - 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 % non-squamous, 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.
KW  - Non-small cell lung cancer
KW  - Cohort studies
KW  - Registries
KW  - Biomarkers
KW  - Molecular diagnostic testing
Y1  - 2020
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/63105
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-631050
SN  - 1872-8332
N1  - The CRISP project is supported by grants from AstraZeneca GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol-Myers Squibb GmbH & Co. KGaA, Celgene GmbH, MSD Sharp & Dohme GmbH, Lilly Deutschland GmbH, Novartis Pharma GmbH, Pfizer Pharma GmbH, Roche Pharma AG, and Takeda Pharma Vertriebs GmbH & Co. KG.
VL  - 152
SP  - 174
EP  - 184
PB  - Elsevier
CY  - Amsterdam [u.a.]
ER  -