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
Advanced or metastatic disease
 
  • Establish histologic subtype with adequate tissue for molecular testing (consider rebiopsy or plasma testing if appropriate)
  • Smoking cessation counseling
  • Integrate palliative care (NCCN Guidelines for Palliative Care)
 
HISTOLOGIC SUBTYPE
 
  • Adenocarcinoma
  • Large cell
  • NSCLC not otherwise specified (NOS)
  • Squamous cell carcinoma
   
BIOMARKER TESTING BIOMARKER TESTING
  • Molecular testing, including:
    • EGFR mutation (category 1), ALK (category 1), KRAS, ROS1, BRAF, NTRK1/2/3, METex14 skipping, RET
    • Testing should be conducted as part of broad molecular profiling
  • PD-L1 testing (category 1)
  • Consider molecular testing, including:
    • EGFR mutation, ALK, KRAS, ROS1, BRAF, NTRK1/2/3, METex14 skipping, RET
    • Testing should be conducted as part of broad molecular profiling
  • PD-L1 testing (category 1)
   
TESTING RESULTS TESTING RESULTS
  • Sensitizing EGFR mutation positive
  • ALK positive
  • ROS1 positive
  • BRAF V600E positive
  • PD-L1 ≥1% and EGFR, ALK, ROS1, BRAF negative
  • EGFR, ALK, ROS1, BRAF negative PD-L1 <1%
  • Sensitizing EGFR mutation positive
  • ALK positive
  • ROS1 positive
  • BRAF V600E positive
  • PD-L1 ≥1% and EGFR, ALK, ROS1, BRAF negative
  • EGFR, ALK, ROS1, BRAF negative PD-L1 <1%

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。

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

AMP= association for molecular pathology; CAP= college of american pathologists; IASLC= international association for the study of lung cancer; NCCN= national comprehensive cancer network; NSCLC= non–small-cell lung cancer; NOS= not otherwise specified; PD-L1= programmed death ligand-1; EGFR= epidermal growth factor receptor; KRAS= KRAS proto-oncogene, GTPase; ROS= ROS proto-oncogene, receptor tyrosine kinase; BRAF= B-Raf proto-oncogene, serine/threonine kinase; NTRK= neurotrophic tyrosine receptor kinase; MET= MET proto-oncogene, receptor tyrosine kinase; RET= ret proto-oncogene

References:

  1. NCCN Clinical Practice Guidelines in Oncology, Non-Small Cell Lung Cancer, V.3.2022.
  2. Lindeman NI, et al. Thorac Oncol. 2013;8(7):823-59.
  3. Lindeman NI, et al. J Thorac Oncol. 2018;13(3):323-358.