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86 Quality assurance for surgery and pathology for patients randomized before 2022 in SENTICOL III (international validation study of sentinel node biopsy in early cervical cancer)
  1. Fabrice Lecuru1,
  2. Gwenael Ferron2,
  3. Glauco Baiocchi3,
  4. Julie Henriques4,
  5. Tao Zhu5,
  6. Giampaolo Di Martino6,
  7. Akira Yabuno7,
  8. Ane Gerda Zahl Eriksson8,
  9. Milan Krkoska9,
  10. Francois Golfier10,
  11. Gustavo Guitmann11,
  12. Virginie Fourchotte12,
  13. Jeremie Belghiti13,
  14. Amelie Charnevriat14,
  15. Fabrice Narducci15,
  16. Martin Koskas16,
  17. Estelle Wafo17,
  18. Anca Birsan18,
  19. Eric Lambaudie19 and
  20. Marie Plante20
  1. 1Gineco Group – Institut Curie – Université Paris Cité, Paris, France
  2. 2IUCT Oncopole – Institut Claudius Régaud, Toulouse, France
  3. 3AC Camargo Center, Sao Paulo, Brazil
  4. 4CHU Besancon and GINECO Group, Besancon, France
  5. 5Zhejiang Cancer Hospital, China, China
  6. 6MANGO Group, Milano, Italy
  7. 7GOTIC Group, Saitama, Japan
  8. 8NSGO Group – Radium Hospital, Oslo, Norway
  9. 9CEECOG Group, Bratislava, Czech Republic
  10. 10Hospices Civils de Lyon, Lyon, France
  11. 11Brazilian National Cancer Institute, Rio De Janeiro, Brazil
  12. 12Insitut Curie, Paris, France
  13. 13APHP Hopital Pitie Salpetriere, Paris, France
  14. 14CHU Poitiers, Hopital de la Milétrie, Poitiers, France
  15. 15Centre Oscar Lambret, Lille, France
  16. 16APHP Hopital Bichat Claude Bernard, Paris, France
  17. 17Centre Hospitalier de Marne la Vallée, Meaux, France
  18. 18CHU Nord Réunion, St Denis, France
  19. 19Institut Paoli Calmette, Marseille, France
  20. 20CCTG Group – CHU Québec, Québec, Canada


Introduction/Background Quality assurance in surgical trials is a key point for interpretation and applicability of results. We wanted to assess this point after one third of inclusions.

Methodology We included patients randomized between 07/06/2018 and 01/01/2022 in SENTICOL III (Arm A: SLN only; Arm B: SLN + PLND). We extracted data concerning inclusion/exclusion criteria, surgical and pathological features and completion of quality-of-life questionnaires.

Results 447 patients were included and 362 were randomized (bilateral SLN detection and negative frozen section; 181 patients in each arm). Almost all patients fulfilled the inclusion criteria in terms of histopathological factors: 52.2% had stage Ib1 and 28.4% stage Ib2 (FIGO 2018); 55.7% were squamous and 35.6% were adenocarcinomas. Diagnosis was based on conization in 53.7%. ICG was the most commonly used tracer (76.4%). SLN detection rate was 94.4%. One SLN (median) was removed from each pelvic sidewall [3 (1–11)]. Three patients had at least one SLN harvested in the paraaortic area. 161/165 patients had a completion lymphadenectomy in Arm B. Minimally invasive surgery was used in 43.7% of patients, robotic in 26.9% and laparotomy in 29.4%. False negative rate was 4% in arm B patients. The median number of pathological levels for SLN evaluation was 4 (0–12). Final pathological analysis showed isolated tumor cells in 6 patients (1.9%), micrometastasis in 8 (2.6%) and macrometastasis in 3 (1%). False negative rate of frozen section was 5.5%. Quality of life questionnaires were available at baseline in 93.6% and 86.5% at 36 months.

Conclusion This analysis showed that quality assurance was respected in this trial. The rate of minimally invasive surgery was higher than expected. The next time points are the interim analysis (after 45 DFS events), end of inclusions in Q2 2024 and final results in 2029.

Disclosures No disclosure.

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