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Evaluation of the one-step nucleic acid amplification method for rapid detection of lymph node metastases in endometrial cancer: prospective, multicenter, comparative study
  1. Eleonora La Fera1,
  2. Nicolò Bizzarri1,
  3. Alessandro Petrecca2,
  4. Giorgia Monterossi1,
  5. Giorgia Dinoi1,
  6. Gian Franco Zannoni3,
  7. Stefano Restaino4,
  8. Emilia Palmieri2,
  9. Laura Mariuzzi5,
  10. Inge Peters1,
  11. Giovanni Scambia1,6 and
  12. Francesco Fanfani1,6
  1. 1UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
  2. 2Università Cattolica del Sacro Cuore Scuole di Specializzazione, Roma, Italy
  3. 3Unità di Ginecopatologia e Patologia Mammaria, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
  4. 4Department of Medicinal Area (DAME) Clinic of Obstetrics and Gynecology, Santa Maria della Misericordia University Hospital, Udine, Italy
  5. 5Institute of Pathologic Anatomy, DAME, Santa Maria della Misericordia University Hospital, Udine, Italy
  6. 6Università Cattolica del Sacro Cuore, Roma, Italy
  1. Correspondence to Dr Francesco Fanfani, UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Lazio, Italy; francesco.fanfani74{at}gmail.com

Abstract

Objective To evaluate the diagnostic performance of the one-step nucleic acid amplification (OSNA) method for the detection of sentinel lymph node (SLN) metastases in women with apparent early-stage endometrial cancer compared with standard ultrastaging.

Methods Prospective, multicentric, interventional study. Patients with apparent early-stage endometrial cancer who underwent primary surgical staging with SLN mapping were included. SLNs were serially sectioned with 2 mm slices perpendicular to the longest axis of the node: the odd slices were submitted to ultrastaging, whereas the even slices were submitted to the OSNA analysis. Diagnostic performance was calculated taking ultrastaging as referral standard.

Results Three-hundred and sixteen patients with 668 SLNs were included. OSNA assay detected 22 (3.3%) positive SLNs, of which 17 (2.5%) were micrometastases and 5 (0.7%) macrometastases, whereas ultrastaging detected 24 (3.6%) positive SLNs, of which 15 (2.2%) were micrometastases and 9 (1.3%) macrometastases (p=0.48). Regarding negative SLNs, OSNA detected 646 (96.7%) negative nodes, including 8 (1.2%) isolated tumor cells, while ultrastaging detected 644 (96.4%) negative nodes with 26 (3.9%) isolated tumor cells. Specificity of OSNA was 98.4% (95% CI 97.5 to 99.4), accuracy was 96.7% (95% CI 95.4 to 98.1), sensitivity was 50% (95% CI 30.0 to 70.0), while negative predictive value was 98.1% (95% CI 97.1 to 99.2). Discordant results were found in 22 SLNs (3.3%) corresponding to 20 patients (6.3%). These were 10 (1.5%) false-positive SLNs (all micrometastases): one (0.1%) of these was a benign epithelial inclusion at ultrastaging. There were 12 (1.8%) false-negative SLNs of OSNA, of which 9 (1.3%) were micrometastases and 3 (0.5%) macrometastases. Overall, 17/668 (2.5%) benign epithelial inclusions were detected at ultrastaging.

Conclusion The OSNA method had high specificity and high accuracy in detecting SLN metastasis in apparent early-stage endometrial cancer. The advantage of the OSNA method could be represented as the possibility to analyze the entire lymph node thus eliminating sampling bias.

  • Endometrial Neoplasms
  • Sentinel Lymph Node
  • Laparoscopes

Data availability statement

Data are available upon reasonable request.

http://dx.doi.org/10.1136/ijgc-2023-004346

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Twitter @frafanfani

    • Contributors Conception of study: FF and GS. Guarantor: FF. Design and development: ELF, AP, and FF. Data collection: AP, ELF, GD, EP, IP, SR, NB, LM, GM, GFZ. Data analysis: ELF, NB, GD. Preparation of tables: ELF and NB. Initial draft of manuscript: ELF, GD, NB. Guarantor: FF, GS. Manuscript writing, review, and approval: all authors.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.