Molecular Lymph Node Staging with One-Step Nucleic Acid Amplification and its Prognostic Value for Patients with...

Area of Science:

• Oncology
• Molecular Diagnostics

Background:

• One-step nucleic acid amplification (OSNA) is a validated diagnostic tool for breast cancer staging.
• Its application for colon cancer (CC) staging is appealing but not yet fully evaluated.
• This study investigates the prognostic value of OSNA in CC staging for the first time.

Purpose of the Study:

• To evaluate the prognostic value of OSNA in stage I-III colon cancer (CC).
• To compare the diagnostic accuracy of OSNA with conventional H&E staining for CC staging.

Main Methods:

• Retrospective study of 87 patients with stage I-III CC from three centers.
• Lymph nodes analyzed using both H&E staining and OSNA with a CK19 mRNA threshold of 250 copies/μL.
• Survival analysis, sensitivity, specificity, and time-dependent ROC curves were used to assess diagnostic value.

Main Results:

• A mean follow-up of 53.4 months revealed disease recurrence in 16.1% of patients.
• H&E staging independently predicted worse cancer-specific survival (HR=10.77, p=0.019), but OSNA did not (HR=3.08, p=0.197).
• H&E sensitivity was 46.7% and specificity 84.7%; OSNA sensitivity was 60.0% and specificity 75.0%.

Conclusions:

• OSNA does not provide additional prognostic value to conventional H&E staining in colon cancer patients.
• Further studies are recommended to investigate lower OSNA thresholds (below 250 copies/μL).