A multi-center retrospective study comparing one-step nucleic amplification and conventional ultrastaging for sentinel lymph node assessment in early-stage endometrial cancer.
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Vallés Elvira, Bebia Vicente, García-Pineda Virginia, Gracia Myriam, Hardisson David, Díaz-Feijoo Berta, Carreras Núria, Fernández-González Sergi, Padilla-Iserte Pablo, Carballas Elvira, López de la Manzanara Carlos, Oliver-Pérez Reyes, Sanchis Josep, Pantoja Manuel, Mancebo Gemma, Agababyan Cristina, Escayola Cecilia, Torrent Anna, Gómez Del Valle Margarita, Fidalgo Soledad, Gómez Tomás, Roldán Fernando, Alonso Paula, Quesada Alfonso, Chacón Enrique, Muruzabal Juan Carlos, García-Cano Daniel González, Calvo Ana, Gil-Moreno Antonio, Cabrera Silvia, Spain-GOG and the MULTISENT Study Group
Аннотация
METHODS: We conducted a multi-center retrospective study including patients with pre-operatively uterine-confined endometrial cancer who underwent sentinel lymph node biopsy. Two independent cohorts were analyzed: one in which conventional ultrastaging (serial hematoxylin and eosin staining and immunohistochemistry) was performed, and another assessed using one-step nucleic acid amplification. Only patients with a minimum follow-up of 2 years were included in the analysis.
RESULTS: A total of 945 patients were included (immunohistochemistry = 653; one-step nucleic acid amplification = 292). Overall, 11.6% (n = 109) of cases were positive, predominantly with low-volume disease-isolated tumor cells 3.0% (n = 28), micrometastases 4.0% (n = 38), macrometastases 4.6% (n = 43). Both methods demonstrated high diagnostic accuracy with low false-negative rates (overall 1.9%; immunohistochemistry = 1.6%, one-step nucleic acid amplification = 2.8%). Median follow-up was 3.6 years. Three-year overall survival was 92.2% (95% confidence interval 90.0% to 93.9%), with comparable survival rates between immunohistochemistry (92.8%, 95% confidence interval 90.2% to 94.7%) and one-step nucleic acid amplification (90.9%, 95% confidence interval 86.2% to 94.0%, p =.929). The ultrastaging method was not associated with overall survival in the Cox multi-variate analysis.
CONCLUSIONS: Sentinel lymph node assessment using one-step nucleic acid amplification and conventional immunohistochemistry ultrastaging did not show significant differences in accuracy for detecting nodal metastases and yielded comparable oncological outcomes, both in overall and disease -free survival. These findings reflect real-world clinical practice, supporting the reliability of both techniques for endometrial cancer staging and suggesting that the choice of sentinel lymph node evaluation method does not affect long-term patient outcomes.