Multicenter validation study of the sentinel lymph node concept in cervical cancer: AGO Study Group.
OBJECTIVE
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.


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 <or= 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 <or= 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).


CONCLUSIONS
In our cohort (all stages), sensitivity of the sentinel concept was low. However, patients with tumor diameter <or= 20 mm may profit from this concept.
Department of Gynecology and Gynecologic Oncology, Universitätsmedizin Berlin, Charité, Hindenburgdamm 30, D-12203 Berlin, Germany. achim.schneider@charite.de
Christopher
C
Altgassen
Hermann
H
Hertel
Antje
A
Brandstädt
Christhardt
C
Köhler
Matthias
M
Dürst
Achim
A
Schneider
D000293:Adolescent; D000328:Adult; D000368:Aged; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000000981:diagnostic imaging / Q000473:pathology*; D008207:Lymphatic Metastasis; D008875:Middle Aged; D011446:Prospective Studies; D011877:Radionuclide Imaging; D019275:Radiopharmaceuticals; D012680:Sensitivity and Specificity; D021701:Sentinel Lymph Node Biopsy / Q000379:methods / Q000592:standards*; D013668:Technetium Tc 99m Aggregated Albumin; D002583:Uterine Cervical Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology*
D019275:Radiopharmaceuticals; D013668:Technetium Tc 99m Aggregated Albumin; C083602:technetium Tc 99m nanocolloid