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Multicenter Validation Study of the Sentinel Lymph Node Concept in Cervical Cancer: AGO Study Group

Christopher Altgassen, Hermann Hertel, Antje Brandstädt, Christhardt Köhler, Matthias Dürst, Achim Schneider

From the Department of Obstetrics and Gynecology, University of Schleswig-Holstein, Luebeck; Department of Obstetrics and Gynecology, Medical School Hannover, Hannover; Information Sciences and Documentation, Institute of Medical Statistics, and Department of Obstetrics and Gynecology, Friedrich-Schiller-University, Jena; and Department of Gynecology and Gynecologic Oncology, Universitätsmedizin Berlin, Charité, Berlin, Germany

Corresponding author: Achim Schneider, MD, MPH, Universitätsmedizin Berlin, Charité, Department of Gynecology and Gynecologic Oncology, Hindenburgdamm 30, D-12203 Berlin, Germany; e-mail: achim.schneider{at}charite.de

Purpose: Single-institution case series have demonstrated the feasibility of the sentinel concept in cervical cancer. However, the diagnostic accuracy remains to be validated. We evaluated detection rate and diagnostic accuracy to predict the histopathologic pelvic nodal status in patients with cervical cancer of all stages.

Patients and Methods: In a hypothesis-based, prospective, multicenter cohort study, patients underwent lymph node detection after labeling with technetium, patent blue, or both. After systematic pelvic and, if indicated, para-aortic node dissection, all lymph nodes were histopathologically examined. Detection rate, sensitivity, and negative predictive value (NPV) were calculated.

Results: According to the protocol, 590 patients were eligible. Detection rate of pelvic sentinel nodes was 88.6% (95% CI, 85.8% to 91.1%) and was significantly higher for the combination of technetium and patent blue (93.5%; 95% CI, 90.3% to 96.0%). Of 106 patients with pelvic lymph node metastases, 82 had pelvic sentinel node metastases. The overall sensitivity was 77.4% (95% CI, 68.2% to 85.0%), which was lower than 90%, the predefined noninferiority margin (P < .001). Sensitivity in women with tumors 20 mm (90.9%), with bilateral detection (87.2%), or with both substances applied (80.3%) was higher compared with the total population. The overall NPV was 94.3% (95% CI, 91.6% to 96.4%) and was higher in patients with tumors 20 mm (99.1%; 95% CI, 96.6% to 100%) compared with patients with tumors more than 20 mm (88.5%; 95% CI, 82.9% to 92.8%; P < .001).

Conclusion: In our cohort (all stages), sensitivity of the sentinel concept was low. However, patients with tumor diameter 20 mm may profit from this concept.

Supported in part by the Deutsche Krebshilfe (German Cancer Aid), Bonn, Germany.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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• Quality Control in Sentinel Lymph Node Biopsy in Cervical Cancer
  Lilian T. Gien and Allan Covens
  JCO 2008 26: 2930-2931 [Full Text]

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