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966 SENTIX – accuracy of preoperative local staging in the sentix trial (CEEGOG-CX01; ENGOT-CX2; NCT02494063)
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  1. J Klat1,
  2. R Kocian2,
  3. C Kohler3,
  4. J Jarkovsky4,
  5. I Zapardiel5,
  6. A Buda6,
  7. L Van Lonkhuijzen7,
  8. B Sehnal8,
  9. O Arencibia Sanchez9,
  10. A Torne10,
  11. F Raspagliesi11,
  12. J Presl12,
  13. M Felsinger13,
  14. R Pilka14,
  15. M Ostojich15,
  16. A Petiz16,
  17. S Smrkolj17,
  18. F Kridelka18,
  19. P Dundr19 and
  20. D Cibula2
  1. 1University Hospital Ostrava, CEEGOG*, Department of Obstetrics and Gynecology, Ostrava, Czech Republic
  2. 2First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, , CEEGOG*, Gynecologic Oncology Center, Department of Obstetrics and Gynecolog , Prague, Czech Republic
  3. 3Asklepios-Clinic Hamburg, Department of Special Operative and Oncologic Gynaecology, Hamburg, Germany
  4. 4Faculty of Medicine, Masaryk University, Institute of Biostatistics and Analyses, Brno, Czech Republic
  5. 5La Paz University Hospital, Department of Obstetrics and Gynecology, , Madrid, Spain
  6. 6San Gerardo Hospital, Department of Obstetrics and Gynecology, Unit of Gynecologic Oncology Surgery, Monza, Italy
  7. 7Academic Medical Centre, Center for Gynecologic Oncology, , Amsterdam, Netherlands
  8. 8University Hospital Bulovka, First Faculty of Medicine, Charles University , CEEGOG*, Department of Obstetrics and Gynecology, Prague, Czech Republic
  9. 9University Hospital of the Canary Islands, Department of Gynecologic Oncology, Las Palmas de Gran Canaria, Spain
  10. 10Institute Clinic of Gynecology, Obstetrics and Neonatology (ICGON), Hospital Clinic of Barcelona, Unit of Gynecological Oncology, Barcelona, Spain
  11. 11IRCCS Foundation National Cancer Institute in Milan, Milano, Italy
  12. 12University Hospital Pilsen, Charles University, CEEGOG*, Department of Obstetrics and Gynecology, Pilsen, Czech Republic
  13. 13Faculty of Medicine, Masaryk University, CEEGOG*, Department of Obstetrics and Gynecology, Brno, Czech Republic
  14. 14Faculty of Medicine and Dentistry, Palacky University, University Hospital Olomouc, CEEGOG*, Department of Obstetrics and Gynecology, Olomouc, Czech Republic
  15. 15Institute of Oncology Angel H. Roffo, University of Buenos Aires, Department of Gynaecology and Obstetrics, , Buenos Aires, Argentina
  16. 16Francisco Gentil Portuguese Oncology Institute, Department of Gynecology, , Porto, Portugal
  17. 17University Medical Centre Ljubljana, CEEGOG*, Ljubljana, Slovenia
  18. 18CHU Liege, Department of Obstetrics and Gynecology, Liege, Belgium
  19. 19First Faculty of Medicine, Charles University and General University Hospital, Institute of Pathology, , Prague, Czech Republic

Abstract

Introduction/Background*The SENTIX is a prospective cohort international study on sentinel lymph node (SLN) biopsy without pelvic lymph node dissection (PLND) in patients with early-stage cervical cancer. The primary end point is a recurrence rate at 24 months´ follow-up after the surgery. Either magnetic resonance imaging (MRI) or expert ultrasound (EUS) was mandatory as a preoperative staging method. The aim of this study is to report the accuracy of preoperative local staging.

Methodology Forty-seven sites from 18 countries participated in the study. Patients with stages T1a1/LVSI+ – T1b1 (FIGO 2009), common histological types and no suspicious lymph nodes on imaging were eligible. Patients were excluded from further study if SLN were not detected on both sides and if SLN was positive on frozen section histological evaluation. Compared were results from preoperative imaging with final pathology reports.

Result(s)*From May 2016 to October 2020, 733 registered patients underwent surgery, 132 were excluded intraoperatively, data from 708 were analysed in this study. Patients’ characteristics are in table 1. Out of 90 patients clinically staged as 1A tumours, 42 (46.7%) were upstaged to IB1 (86% ≤ 2 cm, 14% 2-4cm, 0% > 4cm); 76.3% had conisation as diagnostic procedure. Fourteen out of 547 preoperatively IB1 tumours (2.6%) were upstaged to IB2 > 4cm. Analogously 33 patients (6%) with IB tumours were downstaged to IA. Preoperatively unrecognized parametrial involvement was found by pathology only in 22 out of 637 patients (3.5%). EUS and MRI were used equally in the study (53.5% vs 56.1%), both were comparable in the accuracy of tumour size measurement (2 cm size categories shift in stage IB) (p=1.000) and in the failure to detect parametrial involvement (2.9% vs 4.0%) (p=0.535). Chart 1.

Abstract 966 Figure 1

Chart 1 the accuracy of local staging

Abstract 966 Table 1

Patient’s characteristics

Conclusion*Clinical staging with EUS and MRI failed to detect positive parametria only in 3.5% of patients in the Sentix trial. Upstaging from IA tumours was frequent, mostly after previous conization. Only 2.6% of patients were upstaged to IB2 tumours >4 cm (IB3 FIGO 2018). Both EUS and MRI were equally reliable in tumour size and parametrial involvement assessment.

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