PMID- 37330972
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230826
IS  - 2366-1089 (Electronic)
IS  - 2366-1070 (Print)
IS  - 2366-1089 (Linking)
VI  - 11
IP  - 3
DP  - 2023 Sep
TI  - Real-World Biomarker Test Utilization and Subsequent Treatment in Patients with 
      Early-Stage Non-small Cell Lung Cancer in the United States, 2011-2021.
PG  - 343-360
LID - 10.1007/s40487-023-00234-7 [doi]
AB  - INTRODUCTION: Biomarker testing is increasingly crucial for patients with 
      early-stage non-small cell lung cancer (eNSCLC). We explored biomarker test 
      utilization and subsequent treatment in eNSCLC patients in the real-world 
      setting. METHODS: Using COTA's oncology database, this retrospective 
      observational study included adult patients >/= 18 years old diagnosed with eNSCLC 
      (disease stage 0-IIIA) between January 1, 2011 and December 31, 2021. Date of 
      first eNSCLC diagnosis was the study index date. We reported testing rates by 
      index year for patients who received any biomarker test within 6 months of eNSCLC 
      diagnosis and by each molecular marker. We also evaluated treatments received 
      among patients receiving the five most common biomarker tests. RESULTS: Among the 
      1031 eNSCLC patients included in the analysis, 764 (74.1%) received >/= 1 biomarker 
      test within 6 months of eNSCLC diagnosis. Overall, epidermal growth factor 
      receptor (EGFR; 64%), anaplastic lymphoma kinase (ALK; 60%), programmed death 
      receptor ligand 1 (PD-L1; 48%), ROS proto-oncogene 1 (ROS1; 46%), B-Raf 
      proto-oncogene (40%), mesenchymal epithelial transition factor receptor (35%), 
      Kirsten rat sarcoma viral oncogene (29%), RET proto-oncogene (22%), human 
      epidermal growth factor receptor 2 (21%), and 
      phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (20%) were 
      the 10 most frequently tested biomarkers. The proportion of patients undergoing 
      biomarker testing rose from 55.3% in 2011 to 88.1% in 2021. The most common 
      testing methods were Sanger sequencing for EGFR (244, 37%), FISH (fluorescence in 
      situ hybridization) for ALK (464, 75%) and ROS1 (357, 76%), immunohistochemical 
      assay for PD-L1 (450, 90%), and next-generation sequencing testing for other 
      biomarkers. Almost all the 763 patients who received the five most common 
      biomarker tests had a test before the initiation of a systemic treatment. 
      CONCLUSION: This study suggests a high biomarker testing rate among patients with 
      eNSCLC in the US, with testing rates for various biomarkers increasing over the 
      past decade, indicating a continuous trend towards the personalization of 
      treatment decisions.
CI  - (c) 2023. The Author(s).
FAU - Yan, Jessie T
AU  - Yan JT
AD  - Roche Information Solutions, Roche Diagnostics, Santa Clara, CA, USA. 
      jessie.yan@roche.com.
FAU - Jin, Yue
AU  - Jin Y
AD  - Roche Information Solutions, Roche Diagnostics, Santa Clara, CA, USA.
FAU - Lo, Ernest
AU  - Lo E
AD  - Roche Information Solutions, Roche Diagnostics, Santa Clara, CA, USA.
FAU - Chen, Yilin
AU  - Chen Y
AUID- ORCID: 0000-0003-0040-3881
AD  - The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, School 
      of Pharmacy, University of Washington, Seattle, WA, USA.
FAU - Hanlon Newell, Amy E
AU  - Hanlon Newell AE
AD  - Clinical Development/Medical Affairs, Global, Roche Diagnostics Solutions, 
      Tucson, AZ, USA.
FAU - Kong, Ying
AU  - Kong Y
AD  - Clinical Development/Medical Affairs, Global, Roche Diagnostics Solutions, 
      Tucson, AZ, USA.
FAU - Inge, Landon J
AU  - Inge LJ
AUID- ORCID: 0000-0003-0082-3464
AD  - Clinical Development/Medical Affairs, Global, Roche Diagnostics Solutions, 
      Tucson, AZ, USA.
LA  - eng
PT  - Journal Article
DEP - 20230618
PL  - New Zealand
TA  - Oncol Ther
JT  - Oncology and therapy
JID - 101677510
PMC - PMC10447355
OTO - NOTNLM
OT  - Biomarkers
OT  - Diagnostic testing
OT  - Early-stage
OT  - Non-small cell lung cancer
OT  - Real-world testing
COIS- Jessie T. Yan, Yue Jin, and Ernest Lo are employees of Roche Diagnostics, Santa 
      Clara, and hold Roche stocks; Ying Kong and Landon J. Inge are employees of Roche 
      Diagnostics Solutions, Tucson, and hold Roche stocks; Yilin Chen was a summer 
      intern at Roche Diagnostics during the conduct of the study; Amy E. Hanlon Newell 
      was an employee of Roche Diagnostics Solutions, Tucson, at the time of analysis 
      and holds Roche stock.
EDAT- 2023/06/18 19:17
MHDA- 2023/06/18 19:18
PMCR- 2023/06/18
CRDT- 2023/06/18 14:48
PHST- 2023/03/13 00:00 [received]
PHST- 2023/05/11 00:00 [accepted]
PHST- 2023/06/18 19:18 [medline]
PHST- 2023/06/18 19:17 [pubmed]
PHST- 2023/06/18 14:48 [entrez]
PHST- 2023/06/18 00:00 [pmc-release]
AID - 10.1007/s40487-023-00234-7 [pii]
AID - 234 [pii]
AID - 10.1007/s40487-023-00234-7 [doi]
PST - ppublish
SO  - Oncol Ther. 2023 Sep;11(3):343-360. doi: 10.1007/s40487-023-00234-7. Epub 2023 
      Jun 18.