1. Sentinel-node biopsy in apparent early stage ovarian cancer: final results of a prospective multicentre study (SELLY)
- Author
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Nero, Camilla, Bizzarri, Nicolo', Di Berardino, Stefano, Sillano, F., Vizzielli, Giuseppe, Cosentino, F., Vargiu, V., De Iaco, P., Perrone, A. M., Vizza, E., Chiofalo, B., Uccella, S., Ghezzi, F., Turco, L. C., Corrado, Giacomo, Giannarelli, Diana, Pasciuto, Tina, Zannoni, Gian Franco, Fagotti, Anna, Scambia, Giovanni, Nero C., Bizzarri N., Di Berardino S., Vizzielli G., Corrado G., Giannarelli D., Pasciuto T. (ORCID:0000-0003-2959-8571), Zannoni G. F. (ORCID:0000-0003-1809-129X), Fagotti A. (ORCID:0000-0001-5579-335X), Scambia G. (ORCID:0000-0003-2758-1063), Nero, Camilla, Bizzarri, Nicolo', Di Berardino, Stefano, Sillano, F., Vizzielli, Giuseppe, Cosentino, F., Vargiu, V., De Iaco, P., Perrone, A. M., Vizza, E., Chiofalo, B., Uccella, S., Ghezzi, F., Turco, L. C., Corrado, Giacomo, Giannarelli, Diana, Pasciuto, Tina, Zannoni, Gian Franco, Fagotti, Anna, Scambia, Giovanni, Nero C., Bizzarri N., Di Berardino S., Vizzielli G., Corrado G., Giannarelli D., Pasciuto T. (ORCID:0000-0003-2959-8571), Zannoni G. F. (ORCID:0000-0003-1809-129X), Fagotti A. (ORCID:0000-0001-5579-335X), and Scambia G. (ORCID:0000-0003-2758-1063)
- Abstract
Aim: To evaluate the sensitivity and specificity of sentinel-lymph-node mapping compared with the gold standard of systematic lymphadenectomy in detecting lymph node metastasis in apparent early stage ovarian cancer. Methods: Multicenter, prospective, phase II trial, conducted in seven centers from March 2018 to July 2022. Patients with presumed stage I-II epithelial ovarian cancer planned for surgical staging were eligible. Patients received injection of indocyanine green in the infundibulo-pelvic and, when feasible, utero-ovarian ligaments and sentinel lymph node biopsy followed by pelvic and para-aortic lymphadenectomy was performed. Histopathological examination of all nodes was performed including ultra-staging protocol for the sentinel lymph node. Results: 174 patients were enrolled and 169 (97.1 %) received study interventions. 99 (58.6 %) patients had successful mapping of at least one sentinel lymph node and 15 (15.1 %) of them had positive nodes. Of these, 11 of 15 (73.3 %) had a correct identification of the disease in the sentinel lymph node; 7 of 11 (63.6 %) required ultra-staging protocol to detect nodal metastasis. Four (26.7 %) patients with node-positive disease had a negative sentinel-lymph-node (sensitivity 73.3 % and specificity 100.0 %). Conclusions: In a multicenter setting, identifying sentinel-lymph nodes in apparent early stage epithelial ovarian cancer did not reach the expected sensitivity: 1 of 4 patients might have metastatic lymphatic disease unrecognized by sentinel-lymph-node biopsy. Nevertheless, 35.0 % of node positive patients was identified only thanks to ultra-staging protocol on sentinel-lymph-nodes.
- Published
- 2024