One-step nucleic acid amplification for detecting lymph node metastasis of head and neck squamous cell carcinoma

Oral Oncol. 2020 Mar:102:104553. doi: 10.1016/j.oraloncology.2019.104553. Epub 2020 Jan 28.

Abstract

Background: In head and neck squamous cell carcinoma (HNSCC) 30% of cN0 patients have occult metastasis. LN invasion is a major prognostic factor. Sentinel lymph node (SLN) is an option for cN0 neck management. One-step nucleic acid amplification (OSNA) used to analyze SLN in breast cancer is also a candidate to get more reliable intraoperative HNSCC lymph node (LN) staging.

Objective: To compare OSNA analysis to pathological analysis in cN0 HNSCC.

Materials and methods: 157 LN from 26 cN0 HNSCC patients were prospectively analyzed (6.3LN/patient). Exclusion criteria were previous surgery or radiotherapy. Each node was cut into 4 equal pieces alternatively sent to pathological analysis and OSNA technique. IHC CK19 was performed on the primary tumor biopsy and RT-qPCR of CK19, PVA and EPCAM on the LN lysate of discordant cases.

Results: OSNA was able to provide intraoperative result in all patients. OSNA detected 21 metastases. There were 139 concordant LN (88.5%). There were 18 initial discordant LN (11.5%), 13 (8.3%) were OSNA positive/pathological analysis negative, 5 (3.2%) were OSNA negative/pathological analysis positive. After elimination of allocation bias, false negative rate was 1.3%, sensitivity and specificity were 90% and 95.6%, PPV and NPV were 75% and 98.5%.

Conclusion: Our results suggest that OSNA should be considered to improve SNB analysis both for increasing micro metastasis diagnosis and offer extemporaneous results. Study registered under clinicaltrials.gov database number NCT02852343.

Keywords: CK19; Head and neck squamous cell carcinoma; Lymph node; Micro metastasis; OSNA; Pathological analysis; Sentinel lymph node biopsy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Epithelial Cell Adhesion Molecule / analysis
  • Epithelial Cell Adhesion Molecule / genetics
  • Feasibility Studies
  • Female
  • Head and Neck Neoplasms / genetics*
  • Head and Neck Neoplasms / pathology
  • Humans
  • Keratin-19 / analysis
  • Keratin-19 / genetics
  • Lymph Node Excision / methods
  • Lymphatic Metastasis / genetics*
  • Male
  • Middle Aged
  • Nucleic Acid Amplification Techniques / methods*
  • Oligopeptides / analysis
  • Oligopeptides / genetics
  • Prospective Studies
  • RNA, Messenger / analysis
  • Sensitivity and Specificity
  • Sentinel Lymph Node
  • Squamous Cell Carcinoma of Head and Neck / genetics*
  • Squamous Cell Carcinoma of Head and Neck / secondary

Substances

  • Epithelial Cell Adhesion Molecule
  • KRT19 protein, human
  • Keratin-19
  • Oligopeptides
  • RNA, Messenger
  • peptide PVA

Associated data

  • ClinicalTrials.gov/NCT02852343