檢測指引

NCCN Guidelines® 建議非鱗狀細胞癌的病人進行ALK及其他已知驅動變異的基因檢測1

Clinical Presentation
Metastatic Disease
 
  • Establish histologic subtype with adequate tissue for molecular testing (consider rebiopsy if appropriate)
  • Smoking cessation counseling
  • Integrate palliative care (see NCCN Guidelines for Palliative Care)
 
HISTOLOGIC SUBTYPE
 
  • Adenocarcinoma
  • Large cell
  • NSCLC not otherwise specified (NOS)
  • Squamous cell carcinoma
   
TESTING TESTING
  • Molecular testing
    • EGFR mutation testing (category 1)
    • ALK testing (category 1)
    • ROS1 testing
    • BRAF testing
    • Testing should be conducted as part of broad molecular profiling
  • PD-L1 testing
  • Molecular testing
    • Consider EGFR mutation and ALK testing in never smokers or small biopsy specimens, or mixed histology
    • Consider ROS1 testing
    • Consider BRAF testing
    • Testing should be conducted as part of broad molecular profiling
  • PD-L1 testing
   
TESTING RESULTSa TESTING RESULTSa
  • Sensitizing EGFR mutation positive
  • ALK positive
  • ROS1 positive
  • BRAF V600E positive
  • PD-L1 positiveb and EGFR, ALK, ROS1, BRAF negative or unknown
  • EGFR, ALK, ROS1, BRAF negative or unknown, PD-L1 <50% or unknown
  • Sensitizing EGFR mutation positive
  • ALK positive
  • ROS1 positive
  • BRAF V600E positive
  • PD-L1 positiveb and EGFR, ALK, ROS1, BRAF negative orunknown
  • EGFR, ALK, ROS1, BRAF, negative or unknown, PD-L1 <50% or unknown

CAP/IASLC/AMP指引

各種指引(College of American Pathologists, CAP/ International Association for the Study of Lung Cancer, IASLC/ Association for Molecular Pathology, AMP) 都同意NCCN的建議,應該要對病患進行包含ALK在內的各項基因檢測2,甚至認為檢測結果應該在取樣後10天內提出報告。

AMP=Association for Molecular Pathology; CAP=College of American Pathologists; IASLC=International Association for the Study of Lung Cancer; TNM=tumor node metastasis.

Molecular Testing Guidelines for the selection of NSCLC patients
for ALK tyrosine kinase inhibitors
Who should be tested?2,3
  • Adenocarcinomas
  • Mixed lung cancers with an adenocarcinoma component, regardless of histologic grade
When should patients be tested?1,2
  • At time of diagnosis for patients presenting with advanced-stage disease who are suitable for therapy (reflex testing is appropriate if agreed on by the lung cancer care team)
  • At time of recurrence/progression in patients not previously tested
What tests should be the priority?2,3
  • Tissue should be prioritized for ALK testing
  • Critical to retain sufficient material for molecular analysis
How long should the testing process take?2
  • ALK results should be available within 2 weeks (10 working days) of receiving the specimen in the testing laboratory