期刊
LUNG CANCER
卷 152, 期 -, 页码 174-184出版社
ELSEVIER IRELAND LTD
DOI: 10.1016/j.lungcan.2020.10.012
关键词
Non-small cell lung cancer; Cohort studies; Registries; Biomarkers; Molecular diagnostic testing
资金
- German Working Group of Medical Oncologists (AIO) [AIO-TRK-0315]
- AstraZeneca GmbH
- Boehringer Ingelheim Pharma GmbH Co. KG
- BristolMyers Squibb GmbH Co. KGaA
- Celgene GmbH
- MSD Sharp Dohme GmbH
- Lilly Deutschland GmbH
- Novartis Pharma GmbH
- Pfizer Pharma GmbH
- Roche Pharma AG
- Takeda Pharma Vertriebs GmbH Co. KG
The testing rates for biomarkers in advanced NSCLC patients in Germany are high but still leave out a significant portion of patients who could potentially benefit, highlighting the need for specific measures to increase implementation.
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.
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