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)

被引：62

作者：

Griesinger, Frank ^{[1
]}

Eberhardt, Wilfried ^{[2
]}

Nusch, Arnd ^{[3
]}

Reiser, Marcel ^{[4
]}

Zahn, Mark-Oliver ^{[5
]}

Maintz, Christoph ^{[6
]}

Bernhardt, Christiane ^{[7
]}

Losem, Christoph ^{[8
]}

Stenzinger, Albrecht ^{[9
]}

Heukamp, Lukas C. ^{[10
,11
]}

Buettner, Reinhard ^{[12
]}

Marschner, Norbert ^{[13
]}

Jaenicke, Martina ^{[14
]}

Fleitz, Annette ^{[14
]}

Spring, Lisa ^{[14
]}

Sahlmann, Joerg ^{[15
]}

Karatas, Aysun ^{[16
]}

Hipper, Annette ^{[16
]}

Weichert, Wilko ^{[17
,18
]}

Heilmann, Monika ^{[19
]}

Sadjadian, Parvis ^{[20
]}

Gleiber, Wolfgang ^{[21
]}

Grah, Christian ^{[22
]}

Waller, Cornelius F. ^{[23
]}

Reck, Martin ^{[24
]}

Rittmeyer, Achim ^{[25
]}

Christopoulos, Petros ^{[26
]}

Sebastian, Martin ^{[27
]}

Thomas, Michael ^{[26
]}

机构：

[1] Univ Klin Innere Med, Pius Hosp Oldenburg, Oldenburg, Germany

[2] Westdeutsch Lungenzentrum Univ Zentrum, Ruhrlandklin, Essen, Germany

[3] Praxis Hamatol & Internist Onkol, Ratingen, Germany

[4] PIOH Praxis Internist Onkol & Hamatol, Cologne, Germany

[5] MVZ Onkol Kooperat Harz, Goslar, Germany

[6] MVZ West GmbH Wurselen, Hamatol Onkol, Wurselen, Germany

[7] Gemeinschaftspraxis Hamatol & Onkol, Dortmund, Germany

[8] MVZ Onkol & Hamatol Rhein Kreis, Neuss, Germany

[9] Univ Hosp Heidelberg, Inst Pathol, Heidelberg, Germany

[10] Hamatopathol Hamburg, Hamburg, Germany

[11] Lungen Netzwerk NOWEL Org, Oldenburg, Germany

[12] Univ Klin Koln, Inst Pathol, Cologne, Germany

[13] Praxis Interdisziplinare Onkol & Hamatol, Freiburg, Germany

[14] iOMEDICO, Clin Epidemiol & Hlth Econ, Freiburg, Germany

[15] iOMEDICO, Biostat, Freiburg, Germany

[16] AIO Studien gGmbH, Berlin, Germany

[17] Tech Univ Munich, Inst Pathol, Partner Site Munich, Munich, Germany

[18] German Canc Consortium DKTK, Partner Site Munich, Munich, Germany

[19] KRH Klinikum Siloah, Lungenkrebszentrum, Hannover, Germany

[20] Univ Klinikum Ruhr Univ Bochum, Univ Klin Hamatol Onkol Hamostaseol & Palliat Med, Johannes Wesling Klinikum, Minden, Germany

[21] Univ Klinikum Frankfurt, Med Klin 1, Schwerpunkt Pneumol Allergol, Frankfurt, Germany

[22] MVZ Havelhohe Gemeinschaftskrankenhaus Havelhohe, Berlin, Germany

[23] Univ Klinikum Freiburg, Med Klin 1, Hamatol Onkol & Stammzelltransplantat, Fak Med, Freiburg, Germany

[24] German Ctr Lung Res, Airway Res Ctr North, LungenClin, Grosshansdorf, Germany

[25] Lungenfachklin Immenhausen, Immenhausen, Germany

[26] German Ctr Lung Res DZL, Onkol Thoraxtumore Thoraxklin Heidelberg gGmbH, Giessen, Germany

[27] Univ Klinikum Frankfurt, Med Klin 2, Hamatol Onkol, Frankfurt, Germany

来源：

LUNG CANCER | 2021年 / 152卷

关键词：

Non-small cell lung cancer; Cohort studies; Registries; Biomarkers; Molecular diagnostic testing;

D O I：

10.1016/j.lungcan.2020.10.012

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：174 / 184

页数：11

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