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648 Tumour size assessment in patients with early-stage cervical cancer and its impact on a tailored management: final results of a prospective, international multicenter study SENTIX (CEEGOG CX-01; ENGOT-CX2)
  1. Roman Kocián1,
  2. Christhardt Köhler2,3,
  3. Ignacio Zapardiel4,
  4. Kristýna Nemejcová5,
  5. Jaroslav Klát6,
  6. Vladimír Kalist7,
  7. Wiktor Szatkowski8,
  8. Dariusz Wydra9,
  9. Karl Tamussino10,
  10. Róbert Tóth11,
  11. Marcin Misiek12,
  12. Mikuláš Redecha13,
  13. Isabel Martin14,
  14. Frédéric Kridelka15,
  15. Jirí Jarkovský16,
  16. Alla Vinnytska17,
  17. Francisco Javier De Santiago García18,
  18. Martina Borcinová1,
  19. Grzegorz Szewczyk19,20 and
  20. David Cibula1
  1. 1Gynecologic Oncology Centre, Department of Gynecology, Obstetrics and Neonatology, First Faculty of Medicine, Charles University and General University Hospital, (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Prague, Czech Republic
  2. 2Department of Gynecology, Asklepios Klinik Hamburg Altona, Hamburg, Germany
  3. 3Department of Gynecology DRK Klinik Berlin Westend, Berlin, Germany
  4. 4Gynecologic Oncology Unit. La Paz University Hospital, Madrid, Spain
  5. 5Department of Pathology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic
  6. 6Department of Obstetrics and Gynecology, University Hospital Ostrava and Medical Faculty University of Ostrava, (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Ostrava, Czech Republic
  7. 7Krajská nemocnice T. Bati, a.s., (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Zlín, Czech Republic
  8. 8M. Sklodowska-Curie Memorial Institute, Krakow, Poland
  9. 9Department of Gynecology and Obstetrics, Medical University of Gdansk, Gdansk, Poland
  10. 10Medical University Graz, Graz, Austria
  11. 11Oncology institute of East Slovakia, (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Košice, Slovakia
  12. 12Holy Cross Cancer Center, Kielce, Poland
  13. 13Gynekologicko-pôrodnícke oddelenie, Nemocnica BORY, (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Bratislava, Slovakia
  14. 14Fundación Instituto Valenciano de Oncología, Valencia, Spain
  15. 15Service de Gynécologie-Obstétrique, Uliège, Site du CHU, Avenue de l’Hopital 1, (Belgium and Luxembourg Gynaecological Oncology Group, BGOG), Liège, Belgium
  16. 16Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic
  17. 17LISOD – Israeli Oncological Hospital, (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Plyuty, Ukraine
  18. 18MD Anderson Cancer Center, Madrid, Spain
  19. 19Department of Biophysics, Physiology and Pathophysiology, Medical University of Warsaw, Warsaw, Poland
  20. 20Department of Obstetrics and Gynecology, Mazovian Voivodship Hospital, Siedlce, Poland

Abstract

Introduction/Background Tumour size is one of the key prognostic markers currently used to tailor the type and radicality of surgical treatment. Presented study aimed to evaluate the accuracy of preoperative tumour size assessment by imaging using data from SENTIX: a prospective, single-arm, international multicenter study of sentinel lymph node biopsy without pelvic lymph node dissection in patients with early-stage cervical cancer.

Methodology Between 05/2016–09/2020, forty-seven sites across 18 countries enrolled cervical cancer patients with stages 1A1/LVSI-positive to 1B1 (FIGO 2009). Preoperative pelvic staging included biopsy or conization as a diagnostic procedure and pelvic MRI or ultrasound as a mandatory imaging test.

Results Of the 680 patients meeting inclusion criteria, T stage was postoperatively upgraded in 187 (27.5%) patients, and it was downgraded in 74 (10.9%). Discrepancy in tumour size between imaging and pathology ≥10mm was observed among 155 (22.8%) patients, out of which the size was underestimated and overestimated in 105 and 50, respectively. There was a trend towards bigger size discrepancy in larger tumours (P<0.001). Diagnostic biopsy was associated with bigger size discrepancy (P=0.026), while preoperative stage <IB1 was a protective factor (P=0.043). Based on the current threshold for radical hysterectomy*, underestimation led to an inadequate surgery in 9.0% of patients, while overestimation resulted in 5.1% receiving too radical procedures. If the SHAPE** trial criteria were imposed, the proportion of inadequately scheduled procedures would be even higher (figure 1).

Conclusion The study highlights, that even with the use of modern imaging in preoperative staging, inaccuracy in tumour measurement is a frequent reason for incorrect stage assessment, and consequently for scheduling of inadequate surgery. International guidelines should specify acceptable deviations in tumour size assessment and the threshold for adjuvant treatment for patients who received insufficient radicality of surgery.

Disclosures The authors declare no conflict of interest. Trial registration: ClinicalTrials.gov: NCT02494063. Funding: This work was supported by Charles University in Prague (UNCE 204065 and PROGRES Q28/LF1) and by a grant from the Czech Health Research Council (NV19–03-00023).

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