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1080 Update of the GroSNaPET study: on the way to overcome sentinel node limits in vulvar cancer
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  1. SM Fragomeni1,
  2. A Collarino2,
  3. V Rufini2,3,
  4. A Federico1,
  5. F Inzani4,
  6. G Corrado1,
  7. S Gentileschi5,6,
  8. L Tagliaferri7,
  9. D Verri8,
  10. A Zampolini Faustini9,
  11. A Florit2,
  12. A Fagotti1,9,
  13. G Scambia1,9 and
  14. G Garganese8,9
  1. 1Fondazione Policlinico Universitario A. Gemelli IRCCS, Unità di Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Rome, Italy
  2. 2Fondazione Policlinico Universitario A. Gemelli IRCCS, Unità di Medicina Nucleare, Dipartimento di diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Rome, Italy
  3. 3Università Cattolica del Sacro Cuore, Unità di Medicina Nucleare, Dipartimento di diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Rome, Italy
  4. 4Fondazione Policlinico universitario Agostino Gemelli IRCCS, Unità di Gineco-Patologia e Patologia Mammaria, Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Rome, Italy
  5. 5Università Cattolica del Sacro Cuore, Istituto di Clinica Chirurgica, Rome, Italy
  6. 6Fondazione Policlinico Universitario A. Gemelli IRCCS, Unità di Chirurgia Plastica, Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Rome, Italy
  7. 7Fondazione Policlinico Universitario A. Gemelli, IRCCS, Unità Operativa Complessa di Radioterapia, Dipartimento di Scienze Radiologiche, Radioterapiche ed Ematologiche, Rome, Italy
  8. 8Mater Olbia Hospital, Gynecology and Breast Care Center, Olbia, Italy
  9. 9Università Cattolica del Sacro Cuore, Istituto di Clinica Ostetrica e Ginecologica, Rome, Italy

Abstract

Introduction/Background*Sentinel node biopsy (SNB) is the standard of care for vulvar cancer patients clinically N0 (cN0) at preoperative assessment, with unifocal primary tumor, < 4 cm, not previously excised nor subjected to neoadjuvant treatment. The cN0 patients unsuitable for these strict criteria currently undergo to radical lymphadenectomy, resulting unnecessary in the 70% of cases, due to a negative final histology. In our previous prospective trial (GroSNaPET study) we performed in this subgroup of patients the SNB followed by standard lymphadenectomy, demonstrating safety and accuracy of SLN (73 groins enrolled). In this report on the extended series including a total of 111 groins, we update the follow up data.

Methodology According to the Grosnapet study design, lymph node status was assessed by pre-operative PET/CT scan and cN0 patients were enrolled on the base of the following criteria: a) Tumor > 4 cm, b) Multifocal tumors, c) previous complete excision; d) contralateral nodal involvement, e) previous RTCT treatment or f) vulvar recurrence. Vulvar surgery was performed according to current recommendations, as appropriate. Sentinel lymph node was detected by radiotracer and blue dye to reach the maximum detection rate. Radical lymphadenectomy was always provided after SNB, according to the standard of care. Both PET/CT scan and SNB were compared to final pathology report. Patients were followed up quarterly, undergoing clinical visit, groin ultrasound and PET/CT scan.

Result(s)*During the study period, 72 patients were considered eligible for a total of 111 groins included. Median patient’s age was 73yrs. Histopathology revealed 16 (14.4%) groins with metastatic sentinel nodes (SLNs). Only one case had further involved non SLNs. Overall, 18/274 (6.5%) SLN excised were positive at histology. Median metastasis diameter was 4.8 (1.5-12). One false negative SN was identified (NPV 99%). PET/CT showed an NPV of 92%. After a median follow-up of 38 months (range 1-97 months), 19 recurrences and 6 deaths were registered. The 3-year disease-free survival (DFS) was 72.6%.

Conclusion*This is the largest series that strongly support the use of SNB in cN0 patients currently excluded. A careful preoperative study could safely select eligible patients. Further validation is advisable.

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