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P36 SENTIX – a prospective cohort international study on sentinel lymph node biopsy without pelvic lymph node dissection in cervical cancer patients: central quality control of SLN pathological assessment (CEEGOG-CX01; ENGOT-CX2; NCT02494063)
  1. K Němejcová1,
  2. R Kocian2,
  3. C Köhler3,
  4. J Klat4,
  5. P Dundr1,
  6. A Germanova5,
  7. A Plaikner3,
  8. S Bajsova4,
  9. P Mallmann3,
  10. M Ostojich6,
  11. A Berjón7,
  12. A Torne8,
  13. F Raspagliesi9,
  14. M Pakiz10,
  15. P Kascak11,
  16. M Redecha12,
  17. L Snyman13,
  18. M Misiek14,
  19. C Zorrero15,
  20. S Tingulstad16,
  21. A Vinnytska17,
  22. I Vergote18,
  23. M Michal19,
  24. J Jarkovsky20 and
  25. D Cibula5
  1. 1Institute of Pathology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague
  2. 2Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital in Prague, CEEGOG*, Pragu, Czech Republic
  3. 3Department of Special Operative and Oncologic Gynaecology, Asklepios-Clinic Hamburg, Hamburg, Germany
  4. 4Department of Obstetrics and Gynecology, University Hospital Ostrava, CEEGOG*, Ostrava
  5. 5Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital in Prague, CEEGOG*, Prague, Czech Republic
  6. 6Department of Gynecology,Institute of Oncology Angel H Roffo University of Buenos Aires, Buenos Aires, Argentina
  7. 7Department of Pathology, Hospital Universitario La Paz, Madrid
  8. 8Unit of Gynecological Oncology, Institute Clinic of Gynecology, Obstetrics and Neonatology (ICGON), Hospital Clinic of Barcelona, Barcelona, Spain
  9. 9Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milano, Italy
  10. 10University Clinic for Gynaecology and Perinatology, University Medical Centre Maribor, CEEGOG*, Maribor, Slovenia
  11. 11Department of Obstetrics and Gynecology, Faculty Hospital Trencin, CEEGOG*, Trencin
  12. 12Department of Gynaecology and Obstetrics, University Hospital, Comenius University, CEEGOG*, Bratislava, Slovakia
  13. 13Gynaecologic Oncology Unit, Department of Obstetrics and Gynaecology, University of Pretoria, Pretoria, South Africa
  14. 14Department of Gynecologic Oncology, Holycross Cancer Center, CEEGOG*, Kielce, Poland
  15. 15Gynecology Department, Instituto Valenciano de Oncología (IVO), Valencia, Spain
  16. 16Department of Gynaecology, St Olav’s Hospital, Trondheim, Norway
  17. 17LISOD – Israeli Oncological Hospital, CEEGOG*, Plyuty, Ukraine
  18. 18Department of Gynecology and Obstetrics, University Hospital Leuven, BGOG#, Leuven, Belgium
  19. 19Department of Obstetrics and Gynaecology, Hospital České Budějovice, JSC., CEEGOG*, České Budějovice
  20. 20Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic


Introduction/Background The quality of pathological assessment is of pivotal importance in the management of cervical cancer patients if pelvic lymph node dissection (PLND) is to be replaced by sentinel lymph node (SLN) biopsy only.

Methodology The aim was to report the results of the quality control of pathological SLN assessment in the group of 300 patients treated per protocol. All specimens and full pathology reports from at least two patients per site were reviewed centrally in Prague. SLN ultrastaging protocol included a complete processing of all SLN tissue in slices of 2 mm thickness, 2 sections in 150 µm from each block until no tissue left, one stained with H&E and second examined immunohistochemically. The findings were classified as: Minor (minor protocol deviations), Major (additional sections completed at central pathology), or Critical (deviations could not have been fixed at central pathology). In the case of Major or Critical findings, sites were requested to submit all samples from all additional patients for the second-round assessment.

Results Samples from 77 cases from 36 sites with at least 1 patient treated per protocol were submitted for the central reading. Minor findings were identified in 27% of cases, Major in 30%, and Critical in 4%. Samples from 18 patients were submitted for the second control round; 9 were without deviations 7 had Minor, 2 Major, and 1 Critical findings. One site was prematurely closed due to repeated Critical findings. The most frequent deviations included incompletely processed SLN (36/95) and a lower number of immunohistochemical staining (31/95).

Conclusion Major deviations from the SLN protocol were identified in 33% of sites and 31% of samples. These deviations can impact detection of small metastases and, consequently, the safety of the SLN concept. Central pathology reading allowed for substantial improvement of SLN pathological assessment during the trial.

Disclosure Acknowledgements: This work was supported by a grant from the Czech Research Council (No 16-31643A). None of the authors declare a conflict of interest.

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